Malaria Rapid Diagnostic Test Performance

Results of WHO product testing of malaria RDTs: Round 1 (2008)

3

Malaria Rapid Diagnostic Test Performance

Results of WHO product testing of malaria RDTs: Round 1 (2008)

Conte

nts

WHO Library Cataloguing-in-Publication Data :

Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 1 (2008).

1.Malaria - diagnosis. 2.Antimalarials - therapeutic use. 3.Malaria - drug therapy. 4.Diagnostic tests, Routine. 5.Reagent kits, Diagnostic - utilization.. 6.Sensitivity and specificity. I.UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases. II.Centers for Disease Control (U.S.). III.Foundation for Innovative New Diagnostics.

ISBN 978 92 4 159807 1 (NLM classification: WC 750)

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Conte

ntsAcknowledgements d VAbbreviations d VI

1. EXECUTIVE SUMMARY d 11.1. Introduction d 11.2. The WHO Product Testing Programme d 11.3. Results of the evaluation d 11.4. Summary of outcomes d 31.5. Use of these results d 3

2. BACKGROUND d 3

3. OBJECTIVES d 5

4. DATA MANAGEMENT d 64.1. Test selection d 64.2. Outline of the Product Testing Protocol d 74.3. Evaluation panels d 74.4. RDT registration d 94.5. Specimen panel registration d 94.6. Test phases d 94.7. Performing rapid tests d 104.8. Interpretation of results d 10

5. MATERIALS AND METHODS d 11

6. QUALITY ASSURANCE d 11

7. ETHICAL CONSIDERATIONS d 12

8. DATA ANALYSIS d 128.1. Defining sensitivit y and specificit y/

detection and false positive rates d 128.2. False-positives d 128.2.1. Incorrect species identification d 128.2.2. False-positives from Plasmodium-

negative samples d 138.3. Band intensit y d 138.4. Lot agreement d 138.5. Reader variabilit y d 138.6. Invalid tests d 138.7. Heat (thermal) stabilit y d 13

9. LABORATORY VERSUS FIELD-BASED MALARIA RDT EVALUATIONS d 13

10. RESULTS d 1410.1. Summary d 1410.2. Phase 1 - P. falciparum culture panel d 20

10.3. Phase 2 - Wild t ype P. falciparum and P. vivax and Plasmodium spp. negative samples d 21

10.3.1. P. falciparum detection rate d 2110.3.2. P. vivax detection rate d 2210.3.3. Combined Detection of

P. falciparum and P. vivax d 2210.3.4. P. falciparum and P. vivax positivit y rate d 2310.3.5. Band intensit y d 2510.3.6. False positive rates d 2510.3.7. Inter-reader variabilit y d 29

11. HEAT STABILITY d 3211.1. P. falciparum test lines d 3211.2. Pan test lines d 34

12. EASE OF USE DESCRIPTION d 35

13. DISCUSSION OF KEY FINDINGS d 3813.1. Parasite detection and its relationship

to sensitivit y d 3813.2. False-positive rate and specificit y d 3913.3. Heat (thermal) stabilit y d 3913.4. Ease of use description d 4013.5. Inter-lot variabilit y d 4013.6. Inter-reader variabilit y d 4013.7. Target antigens and species d 41

14. ADDITIONAL MEASURES TO ENSURE QUALITY AND UTILITY OF RDT TESTING d 41

14.1. Beyond procurement d 4114.2. Lot testing d 42

15. CONCLUSIONS d 42

16. REFERENCES d 43

ANNEXES d 45Annex 1: Characteristics of rapid malaria

malaria tests in the evaluation d 46Annex 2: Malaria RDT guide to results

interpretation d 53Annex 3: Phase 1 results d 58Annex 4: Phase 2 results d 63Annex 5: Example algorithm for selecting

a malaria RDT d 90Annex 6: Introducing RDT-based malaria

diagnosis into national programmes d 92

FIGURES

Figure E1: Summary performance of malaria RDTs against blood samples containing wild type P. falciparum at low (200) and high (2000 or 5000) parasite densities (parasites/μl) and malaria-negative samples.

Figure 1: Mode of action of antigen-detecting malaria RDTs

Figure 2: Network of specimen collection, characterization and testing sites

Figure 3: Malaria RDT Product Testing Overview

Figure 4a: Origin of P. falciparum wild type samples

Figure 4b: Origin of P. vivax wild type samples

Figure 5: Testing procedure for Product A against a sample density of 2000 or 5000 parasites/μl

Figure 6: Testing procedure for Product A against a sample density of 200 parasites/μl

Figure 7: Phase 1 P. falciparum detection rate of malaria RDTs at low (200) and high (2000 or 5000) parasite densities (parasites/μl) according to target antigen type (HRP2 or pLDH)

Figure 8: Phase 2 P. falciparum detection rate of malaria RDTs at low (200) and high (2000 or 5000) parasite density (parasites/μl) according to target antigen type (HRP2 or pLDH)

Figure 9: Phase 2 P. vivax detection rate of malaria RDTs at low (200) and high (2000 or 5000) parasite densities (parasites/μl) according to target antigen type (aldolase, pLDH, aldolase + pLDH)

Figure 10: Phase 2 wild type P. falciparum detection rate and positivity rate at 200 parasites/μl

Figure 11: Phase 2 wild type P. vivax detection rate and positivity rate at 200 parasites/μl

Figure 12: P. falciparum (P. falciparum test line) false positive rate against clean negative samples

Figure 13: P. falciparum (P. falciparum test line) false positive rate against Plasmodium spp. negative samples containing potentially cross-reacting blood immunological abnormalities or infectious pathogens

Figure 14: Plasmodium spp. (pan or P. vivax test line) false positive rate against clean negatives

Figure 15: Plasmodium spp. (pan or P. vivax test line) false positive rate against Plasmodium spp. negative samples containing potentially cross-reacting blood immunological abnormalities or infectious pathogens

Figure 16: P. falciparum false positive rate versus P. falciparum detection rate at low (200) parasite density (parasites/μl)

Figure 17: P. vivax false positive rate versus P. vivax detection rate at low (200) parasite density (parasites/μl)

Figure 18: Wild type P. falciparum detection rate according to first and second readings at 200 parasites/μl

Figure 19: Wild type P. vivax detection rate according to first and second readings at 200 parasites/μl

Figure 20: Heat stability of P. falciparum specific (HRP2) test line of P. falciparum only tests against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.

Figure 21: Heat stability of P. falciparum specific (HRP2) test line of P. falciparum tests against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation.

Figure 22: Heat stability of P. falciparum specific (HRP2) test line in combination tests against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.

Figure 23: Heat stability of P. falciparum specific (HRP2) test line in combination tests against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)I

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)I I

Figure 24: Heat stability of pan-line of pan-specific tests against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.

Figure 25: Heat stability of pan-line of pan-specific tests against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation.

Figure 26: Heat stability of pan-line of combination tests against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.

Figure 27: Heat stability of pan-line of combination tests against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation.

Figure 28: Heat stability of pan-line of pan-specific tests only against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.

Figure 29: Heat stability of pan-line of pan-specific tests only against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation.

Figure A6.1: Example malaria RDT implementation budget

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)I I I

TABLES

Table 1: Manufacturers and products accepted into Round 1 of WHO-FIND Malaria RDT Evaluation Programme

Table 2: Characteristics of Plasmodium spp. negative specimens

Table 3: Summary performance of malaria RDTs against 20 cultured P. falciparum lines at low (200) and high (2000 or 5000) parasite densities (parasites/μl)

Table 3a: Summary performance of malaria RDTs against 20 cultured P. falciparum lines at low (200) and high (2000 or 5000) parasite densities (parasites/μl) based on a delayed reading when specified by the manufacturer

Table 4: Summary performance of malaria RDTs against wild type P. falciparum and P. vivax samples at low (200) and high (2000 or 5000) parasite densities (parasites/μl) and Plasmodium spp. negative samples

Table 4a: Summary performance of malaria RDTs against wild type P. falciparum at low (200) and high (2000 or 5000) parasite densities (parasites/μl) based on a delayed reading when specified by the manufacturer

Table 5: Heat stability testing results for 41 malaria RDTs on a cultured P. falciparum sample at low (200) and high (2000 or 5000) parasite densities (parasites/μl) . Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C

Table 6: Ease of use description of 41 malaria RDTs

Table A3.1: Lot variability in positive results against P. falciparum culture samples at low (200) and high (2000 or 5000) parasite densities (parasites/μl)

Table A3.1a: Lot variability in positive results against P. falciparum culture samples at low (200) and high (2000 or 5000) parasite densities (parasites/μl) based on a delayed reading when specified by the manufacturer

Table A3.2: Detection rate of 20 P. falciparum culture lines at low and high parasite densities based on initial reading according to manufacturers instructions and a delayed second reading performed within 1 hour.

Table A3.3: Distribution of test band intensity scores (0-4) against 20 P. falciparum cultured parasites at low (200) and high (2000 or 5000) parasite densities (parasites/μl)

Table A3.3a: Distribution of test band intensity scores (0-4) against 20 P. falciparum cultured parasites at low (200) and high (2000 or 5000) parasite densities (parasites/μl) based on a delayed reading when specified by the manufacturer.

Table A4.1: Lot variability in positive results against P. falciparum and P. vivax samples at low (200) and high (2000 or 5000) parasite densities (parasites/μl)

Table A4.1a: Lot variability in positive results against P. falciparum and P. vivax samples at low (200) and high (2000 or 5000) parasite densities (parasites/μl) based on delayed readings when specified by the manufacturer

Table A4.2: Reader variability in detection rate of P. falciparum samples (n=79) based on an initial reading according to manufacturers instructions and a second reading within 1 hour

Table A4.3: Reader variability in detection rate for P. vivax samples (n=20) based on an initial reading according to manufacturers instructions and a second reading within 1 hour

Table A4.4: Distribution of test band intensity (0-4) scores against wild type P. falciparum samples (n=79) at low (200) and high (2000 or 5000) parasite densities (parasites/μl)

Table A4.4a: Distribution of test band intensity (0-4) scores against wild type P. falciparum samples (n=79) at low (200) and high (2000 or 5000) parasite densities (parasites/μl) based on delayed readings when specified by the manufacturer

Table A4.5: Distribution of Pan/Pv test band intensity (0-4) scores for P. vivax (n=20) samples at low and high parasite densities (parasites/μl) samples

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)I V

Table A4.5a: Distribution of Pan/Pv test band intensity (0-4) scores for P. vivax (n=20) samples at low and high parasite densities (parasites/μl) samples based on a delayed reading according to manufacturers recommendation

Table A4.6: Detection rate of P. falciparum in low (200) and high (2000 or 5000) parasite densities (parasites/μl) by continent

Table A4.6a: Detection rate of P. falciparum in low (200) and high (2000 or 5000) parasite densities (parasites/μl) by continent based on a delayed reading when specified by the manufacturer

Table A4.7: P. falciparum test line false positive results for P. vivax samples (n=20) at low (200) and high (2000 or 5000) parasite densities (parasites/μl)

Table A4.7a: P. falciparum test line false positive results for P. vivax samples (n=20) at low (200) and high (2000 or 5000) parasite densities (parasites/μl) based on a delayed reading when specified by the manufacturer

Table A4.8: Combination test pan line false positive non Pf infection on P. falciparum samples (n=79) at low (200) and high (2000 or 5000) parasite densities (parasites/μl)

Table A4.8a: Combination test pan line false positive non Pf infection on Pf samples (n=79) at low (200) and high (2000 or 5000) parasite densities (parasites/μl) based on a delayed reading when specified by the manufacturer

Table A4.9: False positive rate of P. falciparum (or pan) test line results on all malaria-negative samples

Table A4.9a: False positive rate of P. falciparum (or pan) test line results on all malaria-negative samples based on a delayed reading when specified by the manufacturer

Table A4.10: False positive rate of P. falciparum (or pan) test line results for samples containing specific non-malarial infectious pathogens

Table A4.10a: False positive rate of P. falciparum (or pan) test line results for samples containing specific non-malarial infectious pathogens based on a delayed second reading when specified by the manufacturer

Table A4.11: False positive rate of P. falciparum (or pan) test line results for samples containing potentially cross-reacting blood immunological factors

Table A4.11a: False positive rate of P. falciparum (or pan) test line results for samples containing potentially cross-reacting blood immunological factors based on a delayed reading when specified by the manufacturer

Table A4.12: False positive rate of pan/Pv test line results on all malaria-negative samples

Table A4.12a: False positive rate of pan test line results on all malaria-negative samples based on a delayed second reading when specified by the manufacturer

Table A4.13: Heat stability testing results for P. falciparum test line on P. falciparum samples at low parasite density (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C

Table A4.13a: Heat stability testing results for pan test line of combination RDTs on P. falciparum samples at low parasite density (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C

Table A4.14: Heat stability testing results for P. falciparum test line on P. falciparum samples at high parasite density (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C

Table A4.14a: Heat stability testing results for pan test line of combination RDTs on P. falciparum samples at high parasite density (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C

Table A4.15: Heat stability testing results for P. falciparum (or pan) test line on parasite negative samples. Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C

Table A4.15a: Heat stability testing results for pan test line of combination RDTs on negative samples. Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C

Table A6.1: Example malaria RDT implementation budget

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)V

ACKNOWLEDGEMENTS

The evaluation described in this report was a joint project of the WHO Regional Office for the Western Pacific (WPRO), the Foundation for Innovative New Diagnostics (FIND), TDR, Special Programme for Research and Training in Tropical Diseases sponsored by UNICEF, UNDP, World Bank and WHO and the US Centers for Disease Control and Prevention (CDC), under the WHO-FIND Malaria RDT Evaluation Programme. The project was financed by FIND, the Australian Agency for International Development (AusAID), the United States Agency for International Development (USAID) and TDR. The project would not have been possible without the cooperation and support of the specimen collection sites, and the specimen characterization laboratories mentioned herein. The project acknowledges the technical advice from many malaria diagnostic manufacturers and developers in the development of the programme. The WHO-FIND Malaria RDT Evaluation Programme is grateful to all those who contributed to the conduct of the evaluation and preparation of this report.

Salim Abdullah Ifakara Health Research and Development Centre, Tanzania

Audrey Albertini FIND, Switzerland

Frederic Ariey Institut Pasteur, Cambodia

John Barnwell US Centers for Disease Control and Prevention / National Center for Infectious Diseases, USA

David Bell WHO – Regional Office for the Western Pacific, Philippines

Qin Cheng Army Malaria Institute, Australia

Peter Chiodini Hospital for Tropical Diseases, United Kingdom

Jane Cunningham TDR, Special Programme for Research and Training in Tropical Diseases, Switzerland

Linda Dantes WHO – Regional Office for the Western Pacific, Philippines

Djibrine Djalle Institut Pasteur Bangui, Central African Republic

Dionicia Gamboa Universidad Peruana Cayetano Heredia Instituto de Medicina Tropical, Peru

Michelle Gatton Queensland Institute of Medical Research, Australia

Iveth Gonzalez FIND, Switzerland

Beatrice Gordis FIND, Switzerland

Sandra Incardona Consultant, FIND, Switzerland

Jean Joly TDR, Special Programme for Research and Training in Tropical Diseases, Switzerland

Sophie Jones US Centers for Disease Control and Prevention / National Center for Infectious Diseases, USA

Derryck Klarkowski Médecins Sans Frontières, Netherlands

Myat Phone Kyaw Department of Medical Research, Myanamar

Jennifer Luchavez Research Institute of Tropical Medicine, Philippines

Lucian Marts US Centers for Disease Control and Prevention / National Center for Infectious Diseases, USA

James McCarthy Queensland Institute of Medical Research, University of Queensland, Australia

Didier Menard Institut Pasteur de Madagascar, Madagascar

Claribel Murillo Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Colombia

Bernhards Ogutu Kenya Medical Research Institute (KEMRI), Kenya

Wellington Oyibo University of Lagos, Nigeria

Rosanna Peeling TDR, Special Programme for Research and Training in Tropical Diseases, Switzerland

Anita Pelecanos Queensland Institute of Medical Research, Australia

Mark Perkins FIND, Switzerland

Charuni Senanayake WHO – Regional Office for the Western Pacific, Philippines

Michael Valentine US Centers for Disease Control and Prevention / National Center for Infectious Diseases , USA

Melissa Vega TDR, Special Programme for Research and Training in Tropical Diseases, Switzerland

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)V I

ABBREVIATIONS

ACT Artemisinin-based combination therapy

AMI Army Malaria Institute

AusAID Australian Agency for International Development

CDC US Centers for Disease Control and Prevention

CLIA Clinical Laboratory Improvement Amendments

FIND Foundation for Innovative New Diagnostics

HRP2 Histidine-rich protein 2

HTD Hospital for Tropical Diseases

pLDH Plasmodium lactate dehydrogenase

p/μL Parasites per microlitre

QA Quality Assurance

QC Quality Control

QMS Quality Management Systems

RDT Rapid Diagnostic Test (for the purposes of this report, this refers to immunochromatographic lateral flow devices for the detection of malaria parasite antigens)

SOP Standard Operating Procedure

TDR Special Programme for Research and Training in Tropical Diseases sponsored by UNICEF, UNDP, World Bank and WHO

USAID United States Agency for International Development

WPRO Western Pacific Regional Office

WHO World Health Organization

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)1

1. EXECUTIVE SUMMARY

1.1. INTRODUCTIONThe World Health Organization estimates that 3.3 billion persons were at risk of acquiring malaria in 2006, with 247 million of these developing clinical malaria (86% in Africa), and nearly 1 million (mostly African children) dying from the disease. Malaria remains endemic in 109 countries, and while parasite-based diagnosis is increasing, most suspected cases of malaria are still not properly identified, with accurate diagnosis and disease monitoring consequently remaining elusive (1).

WHO recommends that malaria case management be based on parasite-based diagnosis in all cases, with the exception of young children in areas of high transmission and where lack of resources or need for urgent response temporarily limits its application. The use of antigen-detecting rapid diagnostic tests (RDTs) forms a vital part of this strategy, providing the possibility of parasite-based diagnosis in areas where good quality microscopy can not be maintained. The number of RDTs available, and the scale of their use, has rapidly increased over the past few years. However, limitations of comparative field trials and the heterogeneous nature of malaria transmission has limited the availability of good quality performance data that national malaria programmes require to make informed decisions on procurement and implementation. To this end in 2006, WHO and FIND (Foundation for Innovative New Diagnostics) launched an evaluation program to assess the performance of commercially available malaria RDTs and allow direct product comparisons that would assist WHO, other UN agencies and national governments in making procurement decisions and would ultimately encourage improvement in the quality of manufacturing.

1.2. THE WHO PRODUCT TESTING PROGRAMME

This report, which presents the results of the first round of WHO product testing of malaria antigen-detecting RDTs, was completed in November 2008 in collaboration with FIND, the US Centers for Disease Control and Prevention (CDC) and other partners (Fig.2). All companies manufacturing under ISO-13485 Quality System Standard were invited to submit up to 3 tests for evaluation under the programme. In this first round of testing, 41 products from 21 manufacturers were evaluated against prepared blood panels of cultured Plasmodium falciparum parasites and patient-derived P. falciparum and P. vivax parasites, and a parasite-negative panel. Thermal stability was assessed after 2 months of storage at elevated temperature and humidity, and a descriptive ease of use assessment was recorded. Of the 41 products, 16 detect P. falciparum alone, 22 detect and

1 One is P. vivax specific

differentiate P. falciparum from non-P. falciparum malaria1, and 3 detect P. falciparum and non-P. falciparum malaria without distinguishing between them. Manufacturers submitted 2 lots of each product for evaluation.

The evaluation is designed to provide comparative data on the performance of the submitted production lots of each product. Such data will be used to guide procurement decisions of WHO and other UN agencies and national governments. Product testing is part of a continuing programme of work to improve the quality of RDTs that are used, and to support broad implementation of reliable malaria diagnosis in areas where malaria is prevalent. A second round of product testing began in April 2009. It is anticipated that a further round will be undertaken in 2010, with a call for expressions of interest later in 2009.

1.3. RESULTS OF THE EVALUATIONThe results (summarized in Tables 3, 3a, 4, 4a and Figure E1) provide comparative data on 2 lots of products against a panel of parasite samples diluted to a low parasite density (200 parasites/μL) and a higher parasite density (2000 or 5000 parasites/μL). The former is below the mean parasite density found in many populations with endemic malaria. For the purposes of this report, 'detection rate' of a product is the percentage of malaria samples in the panel giving a positive result by two RDTs per lot at the lower parasite density, and a single RDT per lot at the higher parasite density. Thus, it is not a measure of RDT clinical sensitivity, or positivity rate against the panel but rather a combined measure of positivity rate, along with inter-test and inter-lot consistency.

The clinical sensitivity of an RDT to detect malaria is highly dependent on the local conditions, including parasite density, in the target population, and so will vary highly between malaria-endemic populations. The results in this report show comparative performance between RDTs, and give an idea of which products are likely to provide higher sensitivity in the field, particularly in populations with low-density infections. As the detection rate at 2000 parasites/μL indicates, the sensitivity of many of these products will be similar in populations with higher parasite densities, although a subset of any population will include vulnerable individuals who may develop illness at low parasite densities (e.g. young children, pregnant women, those well protected by bed nets) and must always be taken into account when interpreting RDT results.

Heat stability (summarized in Table 5) is vital to maintaining sensitivity of the test in the field. As a result, for procurement, it is essential that careful consideration be given to stability results to ensure that products to be used in areas with high temperatures of transport and storage have demonstrated great stability in the product testing programme. Requirements will vary between countries: for example, if tests are to be deployed in areas where temperatures rarely rise above 30°C, less emphasis needs to be placed on stability at high temperatures.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)2

Figure E1: Summary performance of malaria RDTs against blood samples containing wild type P. falciparum at low (200) and high (2000 or 5000) parasite densities (parasites/μl) and malaria-negative samples.

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Pan

(Dev

ice)

Quick

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Mala

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st

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

200 parasites/µl (HRP2)

200 parasites/µl (non HRP2)

2000 or 5000 parasites/µl (HRP2)

2000 or 5000 parasites/µl (non HRP2)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Pf - Plasmodium falciparum Pv - Plasmodium vivaxpan - Plasmodium species ‡ - A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive. Phase

2 Evaluation Panel: 79 P. falciparum wild type samples; 20 P. vivax wild type samples and 90 Plasmodium spp. negative samples. Rapid diagnostic tests (RDTs) - 2 tests x 2 lots at 200 parasites/µl and 1 test x 2 lots at 2000 parasites/µl

* - The total number of times a positive result for malaria was generated when it should not have been (Pf+; Pf +/Pan or Pv -; Pf+/Pan or Pv+; Pf-/Pan or Pv+)

Fals

e po

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e Pl

asm

odiu

m s

pp. i

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tion

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* (%

) and

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)

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)3

Ease of use requirements will also vary, depending on the extent of training and the work environment of the end-users. Particularly in primary health care settings, the simpler the tests, the easier it will be to avoid errors in preparation and interpretation.

1.4. SUMMARY OF OUTCOMES There is now a mechanism in place that allows •laboratory-based evaluation of RDT performance in a standardized way to distinguish between well and poorly performing tests to inform procurement and prioritization for entry into WHO prequalification and procurement schemes.

Several RDTs are available that demonstrated consistent •detection of malaria at low parasite densities (200 parasites/μl), have low false positive rates, are stable at tropical temperatures, are relatively easy to use, and can detect P. falciparum, P. vivax infections, or both.

Performance between products varied widely at low •parasite density (200 parasites/μl); however, most products showed a high level of detection at 2000 or 5000 parasites/μl.

• P. falciparum tests targeting HRP2 antigen demonstrated the highest detection rates, but some tests targeting pLDH also exhibited high detection rates.

Test performance varied between lots, and widely •between similar products, confirming the advisability of lot-testing post purchase and prior to use in the field.

The results underscore the need for manufacturers •to have adequate reference materials for product development and lot-release. The WHO-FIND malaria RDT evaluation programme, in collaboration with the CDC, will soon offer quality standard panels to manufacturers to assist in this process.

1.5. USE OF THESE RESULTSUltimately, it is imperative that procurement decisions based on these results take into consideration local conditions of malaria transmission and illness where the tests will be used (e.g. Plasmodium species, target antigen variation, parasite densities, climate). Procurement of RDTs must not occur without programmatic and infrastructure preparation for proper use, including supply chain management, training on test usage and disposal, and training on patient management in response to results. This report provides an algorithm to assist in this decision-making process (Annex 5).

2. BACKGROUND

In 2006, WHO estimated that 3.3 billion persons were at risk of acquiring malaria. Of these, 247 million were infected (86% in Africa) and nearly 1 million (mostly African children) died of the infection. In 2008, malaria was still endemic in 109 countries worldwide, 45 of them in Africa. WHO estimates that approximately 1.1 million persons were still dying of malaria that year (1).

In the past decade, major new opportunities for the control of malaria have emerged, including implementation of long-lasting insecticidal nets, indoor residual spraying of insecticides and artemisinin-based combination therapy (ACT). These tools, in combination with increased coverage of malaria control programs, are likely to reduce the burden of malaria infection in countries where they are adequately implemented. In turn, the proportion of febrile episodes attributable to malaria is likely to decrease substantially.

Despite WHO recommendations for laboratory-confirmed diagnosis of malaria infections2, diagnosis is often made

2 With the exception of children under 5 years of age in areas of high transmission in whom treatment may be provided on the basis of a clinical diagnosis

on clinical grounds (2). However, in most endemic areas malaria makes up a minority of 'malaria-like' febrile illness. Microscopy has been the cornerstone of diagnosis and remains the recommended method of malaria diagnosis at a central level, but the need for trained personnel, adequate reagents and equipment limit its availability and accessibility. Rapid, accurate and accessible diagnostic tools are becoming increasingly important, as programmes expand parasite-based diagnosis and the prevalence of malaria decreases. In recent years, rapid diagnostic tests (RDTs), which detect Plasmodium-specific antigens (proteins) in whole blood of infected people, have emerged as an attractive alternative to microscopy. Currently available RDTs come in various formats (dipstick, cassette or card) and contain bound antibodies to specific antigens such as histidine-rich protein-2 (HRP2) (specific to P. falciparum), pan-specific or species-specific plasmodium lactate dehydrogenase (pLDH) or aldolase (specific to all the major Plasmodium species: P. falciparum, P. vivax, P. malariae, P. ovale (Figure 1).

To be widely useful, a RDT must have high sensitivity to ensure all clinically-significant malaria infections are detected; high specificity to enable monitoring of low malaria prevalence and appropriate management of non-malarial fever; and high stability to allow transport and storage in ambient conditions in malaria-endemic areas. Published field trials of RDTs show high variability in performance, likely due to inadequate quality of manufacture, incorrect storage and handling, poor preparation and interpretation,

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)4

a

b

c

Bound Ab

Free labelledAb

Captured Ag–labelledAb complex

Capturedlabelled Ab

Parasite Agcaptured bylabelled Ab

Labelled Ab–Agcomplex capturedby bound Ab oftest band

Lysing agentand labelled Ab

Test line(bound Ab)*

Parasitized blood

Buffer/flushing agent

Control line(bound Ab)*

Nitrocellulose strip

Blood and labelled Ab flushed along strip

*Not normally visible

Labelled Abcaptured by bound Ab ofcontrol band

Figure 1: Mode of action of antigen-detecting malaria RDTs

Mode of action of common malaria RDT format: (a) Dye-labeled antibody (Ab), specific for target antigen, is present on the lower end of the nitrocellulose strip or in a well provided with the strip. Antibody, also specific for the target antigen, is bound to the strip in a thin (test) line, and either antibody specific for the labeled antibody, or antigen, is bound at the control line. (b) Blood and buffer, which have been placed on the strip or in the well, are mixed with the labeled antibody and are drawn up the strip across the lines of bound antibody. (c) If antigen is present, some labeled antibody will be trapped on the test line. Other labeled antibody is trapped on the control line.

and sometimes poor study methods, analysis and reporting ( 3-11).

The number of RDTs available on the market has grown rapidly since their introduction in the late 1990s. It is estimated that there are 60 brands and over 200 tests commercially available today, with an estimated 50-70 million tests used in 20083. However, regulatory oversight of diagnostics is often weak, and procurement agencies have faced considerable problems in selecting appropriate RDTs and ensuring quality. In view of the inconsistency in field study results and the inherent difficulties in

3 WHO. Unpublished data

assessing large numbers of products in a standardized way through field trials, WHO and various partners embarked on a Malaria Rapid Diagnostic Test Product Evaluation Programme in 2002 to develop and employ standardized assessment of malaria RDT performance, and to guide procurement decisions and regulatory mechanisms. The Programme has been overseen by WPRO and TDR in partnership with FIND, and has been guided by a Steering Committee4 and several consultations from 2003 to 2008. A network of specimen collection sites was established to contribute specimens to a global bank at the US CDC and to facilitate local quality control activities (Figure 2).

4 WHO/FIND/CDC, Methods manual for product testing of malaria rapid diagnostic tests (version 1). 2008

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)5

3. OBJECTIVES

Evaluate malaria RDTs to produce performance data •that can guide procurement of RDTs for use in the field.

Areas where malaria transmission occurs

Areas with limited risk of malaria transmission

No malaria

This map is intended as a visual aid only and not as a definitive source of information about malaria endemicity. Source: © WHO, 2009. All rights reserved.

Collection and testing site

Specimen characterization

Global specimen bank

CDC

HTD

CIDEIM

IMT

UL IPB

IHRDC

IPM

RITMIPC

DMR

AMI

Figure 2: Network of specimen collection, characterization and testing sites

Abbreviations: AMI Army Malaria Institute (Queensland, Australia); CDC Centers for Disease Control and Prevention (Atlanta, United States of America); CIDEIM Centro Internacional de Entrenamiento y Investigaciones Médicas (Cali, Colombia); DMR Experimental Medicine Research Division (Department of Medical Research, Yangon, Myanmar); HTD Hospital for Tropical Diseases (London, United Kingdom of Great Britain and Ireland); IHRDC Ifakara Health Research and Development Center (Bagamoyo, The United Republic of Tanzania); IMT Instituto de Medicina Tropical (Universidad Peruana Cayetano Heredia, Lima, Peru); IPB Institut Pasteur de Bangui (Bangui, Central African Republic); IPC Institut Pasteur du Cambodge (Phnom Penh, Cambodia); IPM Institut Pasteur de Madagascar (Antananarivo, Madagascar); RITM Research Institute of Tropical Medicine (Manila, Philippines); UL University of Lagos (Lagos, Nigeria).

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)6

4. MATERIALS AND METHODS

4.1. TEST SELECTION In August 2007, the WHO-FIND Malaria RDT Evaluation Programme issued a call for expression of interest to manufacturers of malaria RDTs along with information regarding the requirements for submission of a product and the conditions for participation in the Evaluation Programme5. Requirements included: ISO 13485:2003

5 http://www.wpro.who.int/sites/rdt/who_rdt_evaluation/ (accessed 08 April 2009)

certification, supply of sufficient quantities of products (1100 tests from each of 2 lots), and compliance with in-house real time stability testing protocol6.

After an initial call for expressions of interest, 21 manufacturers submitted a total of 41 products to be included in Round 1 (including 2 co-listed (identical) products).

In summary, of the 41 products: 16 detect P. falciparum alone, 22 detect and differentiate P. falciparum from non-P. falciparum malaria7, and 3 detect P. falciparum and non-P. falciparum malaria without distinguishing between them. Annexes 1 and 2 provide a comprehensive overview of product characteristics.

6 Methods Manual for Product Testing of Malaria RDT Version One 2008. SOP 2.2d; available at www.wpro.who.int/sites/rdt/documents.htm (accessed 08 April 2009)

7 One is P. vivax specific

Table 1: Manufacturers and products accepted into Round 1 of WHO-FIND Malaria RDT Evaluation Programme

Manufacturer Product name Catalogue No.* Target Antigen

Access Bio, Inc.CareStart Malaria HRP2 (Pf)CareStart Malaria HRP2/pLDH (Pf/PAN) COMBOCareStart Malaria pLDH (PAN)

G0141G0131G0111

HRP2HRP2/pLDHpLDH

ACON Laboratories, Inc. Malaria Plasmodium falciparum Rapid test Device (Whole blood) IMA-402 HRP2Amgenix International, Inc. OnSight – ParaQuick (Pan, Pf) Test 536-25DB HRP2/pLDHAZOG, Inc. AZOG Malaria pf (HRP-II) /pv (pLDH) Antigen Detection Test Device MFV-124R HRP2/pLDH

BiosynexImmunoquick Malaria FalciparumImmunoquick Malaria +4

0502_K250506_K25

HRP2HRP2/pLDH

Diagnostics Automation/ Cortez Diagnostics, Inc.

Malaria P.F/Vivax 17211OP-25 HRP2/aldolase

DiaMed AG OptiMAL-IT 710024 pLDH/pLDH

Human GmbHHexagon MalariaHexagon Malaria Combi

5805158024

HRP2HRP2/aldolase

IND Diagnostic Inc. One Step Malaria Antigen Strip 820-1 pLDH

Innovatek Medical Inc.Quickstick Malaria Antigen Test (Co- listing with IND Diagnostics Inc. One Step Malaria Antigen Strip)**

-- pLDH

InTec Products, Inc.ADVANCED QUALITYTM One Step Malaria (p.f.) Test (whole blood)ADVANCED QUALITYTM MALARIA (p.f) POCT

ITP11002TC40ITP11002TC1

HRP2HRP2

Inverness Medical Innovations, Inc. Binax Now Malaria IN660050 HRP2/aldolase

J. Mitra & Co. Pvt. Ltd.Advantage Pan Malaria CardAdvantage P.f. Malaria Card Advantage Mal Card

IR013025IR016025IR221025

pLDHHRP2pLDH/pLDH

Orchid Biomedical SystemsParacheck Pf Rapid test for P. falciparum Malaria (Device) Paracheck Pf Rapid test for P. falciparum Malaria (Dipstick)

3030102530302025

HRP2HRP2

Premier Medical Corporation Ltd.First Response Malaria Ag HRP2First Response Malaria Ag Combo (pLDH/HRP2)

II3FRC30II6FRC30

HRP2pLDH/HRP2

ICT DiagnosticsICT Malaria Pf Cassette Test (ML01)ICT Malaria Combo Cassette Test (ML02)

ML01 ML02

HRP2HRP2/aldolase

Span Diagnostics Ltd.

Parahit-f DIPSTICK FOR FALCIPARUM MALARIAParahit-f TEST DEVICE FOR FALCIPARUM MALARIAParahit-Total Device Rapid test for P. falciparum and Pan malarial species

259772597525989

HRP2HRP2HRP2/pLDH/aldolase

Standard Diagnostics, Inc.SD BIOLINE Malaria AgSD BIOLINE Malaria Ag Pf SD BIOLINE Malaria Ag Pf/Pan

05FK40-02-5 05FK50-02-4 05FK60-02-3

pLDH/pLDHHRP2HRP2/pLDH

Unimed International, Inc.FirstSign – Malaria Pf Card TestFirstSign – ParaView-2 (Pv + Pf) Card Test

--2102CB-25

HRP2HRP2/pLDH

Vision Biotech (Pty) Ltd.Malaria Rapid PfMalaria Rapid ComboMalaria Rapid Dual

VB01VB011VB020

HRP2HRP2/aldolaseHRP2/pLDH

Guangzhou Wondfo Biotech Co., Ltd Wondfo One Step Malaria Pf/Pan Whole Blood Test W56-C (4.0 mm) HRP2/pLDH

Zephyr BiomedicalsParascreen Rapid Test for Malaria Pan/Pf (Device)Malascan Rapid Test for Malaria Pf/Pan (Device)Parabank Rapid Test for Malaria Pan (Device)

503100255040202550301025

HRP2/pLDHHRP2/aldolasepLDH

* Some products may include different catalogue numbers for different box sizes, contact manufacturers for details.** Co-listing: One product is submitted for assessment. Manufacturers confirm that second product is identical with different label.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)7

Participating manufacturers received results of test performance and reproducibility prior to publication.

4.2. OUTLINE OF THE PRODUCT TESTING PROTOCOL

The testing process is outlined in Figure 3 and in the Methods Manual for Product Testing of Malaria Rapid Diagnostic Tests - Version One8. In brief, RDTs from each of two lots of each product were evaluated against a panel of parasite-positive and parasite-negative cryo-preserved blood samples, and a panel of parasite-negative samples. Both lots were also tested for heat (thermal) stability, evaluated before and after 2 months’ storage at 4°C, 35°C and 45°C. Finally, an ease-of-use description was developed using a standard assessment format (Figure 3). The testing process and all results were overseen by the specimen bank steering committee, and manufacturers were given an opportunity to comment on individual product results prior to publication.

8 Available at www.wpro.who.int/sites/rdt/documents.htm

4.3. EVALUATION PANELSRDTs were evaluated against three panels, specifically: i) P. falciparum culture lines (includes a subset,

'manufacturer's panel') at low (200 parasites/μl) and high parasite densities (2000 or 5000 parasites/μl).

ii) Wild-type Plasmodium species (P. falciparum, P. vivax) from naturally infected humans and parasite-negative samples at low (200 parasites/μl) and high parasite densities (2000 or 5000 parasites/μl).

iii) Parasite-negative panel ('clean' samples and disease-specific or blood factor-specific samples).

An overview of the sample collection and characterization process can be found in the "Outline of Product Testing and Associated Protocols"9 and detailed methods manuals prepared for laboratory quality control10 and product testing of malaria RDTs9-15. Characterization results can be found at www.wpro.who.int/sites/rdt .

9 Initiative for Quality Assurance of Malaria Rapid Diagnostic Tests: Outline of product testing and associated protocols; available at www.wpro.who.int/sites/rdt/documents.htm (accessed 08 April 2009)

10 Methods Manual for Laboratory Quality Control Testing of Malaria Rapid Diagnostic Test Version 5a available at

www.wpro.who.int/sites/rdt/documents.htm (accessed 08 April 2009)

TEST RDTS AGAINST HIGH AND LOW DENSITY OF PHASE 1

PANEL

RECORD RESULTS RECORD RESULTS

DETECTION RATE AND FALSE POSITIVE RATE

EASE OF USE DESCRIPTION

RDT PRODUCT TESTING FLOW CHART

HEAT STABILITY

RECORD RESULTS

DENSITOMETER(INTERNAL USE ONLY)

PROCEED TO TEST RDTS AGAINST PHASE 2 PANEL, IF

PASS PHASE 1

IN EACH CASE, READ EACH RESULT WITH:

TECH 1 TECH 2

BLOOD SAFETY

NUMBER OF TIMED STEPS

TOTAL TIME TO OBTAIN RESULT

QUALITY OF THE INSTRUCTIONS

COMPLETED ASSESSMENT

FORMS

ADDITIONAL INFORMATION

• FORMAT• BLOOD TRANSFER METHOD• ITEMS INCLUDED IN PACKAGE• LANGUAGE

SELECT RDTS FROM 2 DIFFERENT LOTS

STORE FOR 2 MONTHS AT 75% HUMIDITY

REMOVE AND ALLOW RTDs TO REACH ROOM TEMPERATURE

PREPARE RDTS WITH A

200 p/µl SAMPLE

PREPARE RDTS WITH A

2000 p/µl SAMPLE

PLACE IN A 35°C

INCUBATOR

PLACE IN A 45°C

INCUBATOR

PLACE AT 4°C

INITIAL TEST VS. 200, 2000 p/µl

Figure 3: Malaria RDT Product Testing Overview

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)8

Figure 4a: Origin of P. falciparum wild type samplesNige

ria

Cent

ral Afri

can R

epub

licMad

agas

car

Philip

pines

Philip

pines

Cambo

dia

Cambo

dia Peru

Peru

0

5

10

15

20

0

2

4

6

8

10

Colom

bia

Colom

bia

Myanm

arCa

mbodia

United

Repu

blic o

f Tan

zania

Madag

asca

r

Figure 4b: Origin of P. vivax wild type samples

In summary, each panel specimen was characterized for: i) Geographical originii) Species by duplicate microscopy11 (two microscopists)

and confirmation by nested PCR of mono-species infection12

iii) HRP2 sequence by PCR amplification13

iv) Antigen concentration, determined by quantitative ELISA for HRP2, pLDH, aldolase14

v) PCR for malaria and confirmatory testing for other pathology in the case of parasite-negative samples

Panel composition

P. falciparum-cultured parasites panel

Twenty culture-adapted strains of P. falciparum of varied geographical origin were selected, including 13 strains with type B HRP2 sequence, 5 with Type A, and 3 with Type C HRP2 sequence. All specimens were derived from the culture bank of US CDC, and diluted in O+ US donor blood15.

Wild type parasite panel

The parasite-positive wild type panel consisted of samples from 79 cases of P. falciparum and 20 cases of P. vivax, derived from 9 collection sites in Asia, Africa and South America (Figs 2, 4a and 4b).

11 Methods Manual for Product Testing of Malaria RDTs Version One 2008. Chapter 4 SOP 4.5, 4.6

12 Methods Manual for Product Testing of Malaria RDTs Version One 2008 Chapter 5 SOP 5.7, 5.8

13 Methods Manual for Product Testing of Malaria RDTs Version One 2008 Chapter 5 SOP 5.9

14 Methods Manual for Product Testing of Malaria RDTs Version One 2008 Chapter 5 SOP 5.1-5.6

15 Methods Manual for Product Testing of Malaria RDTs Version One 2008. Chapter 3 SOP 3.9

Samples were collected from febrile patients and processed according to standardized methods designed to preserve target antigen concentration16. After dilutions and cryo-preservation, samples were transferred to the global bank at CDC for further characterization. The distribution of concentration of HRP2, aldolase and pLDH were determined on a larger sample, and a test panel developed that excluded samples with extremes of high or low antigen concentration.

Negative blood samples

The negative panel consisted of 'clean' parasite-negative samples from donor-derived blood banks in non-endemic areas of the Philippines, Madagascar, USA, and Nigeria, and parasite-negative samples from donors with diseases that may potentially be differential diagnoses of malaria, or with specific blood factors known to be common in the community or known to have the potential to cause false positive reactions on immunochromatographic tests (Table 2). Further details of the parasite-negative panel are found at http://www.wpro.who.int/sites/rdt.

16 Methods Manual for Laboratory Quality Control Testing of Malaria Rapid Diagnostic Tests Version 5a Chapter 3; available at www.wpro.who.int/sites/rdt/documents.htm

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)9

4.4. RDT REGISTRATIONThe receipt of each shipment of RDTs at the evaluation centre was recorded in a dedicated RDT register. Temperature monitoring devices were offered to manufacturers free of charge, to accompany RDTs shipments to CDC. All RDTs were stored at ≤ 25°C immediately and temperature monitors were labeled with receipt date and forwarded for downloading, when applicable.

4.5. SPECIMEN PANEL REGISTRATIONAll panel specimens were assigned unique identification numbers at the collection sites and stored in aliquots of 50μl at -70°C until the time of testing. All data pertaining to specimen ID, storage location and characteristics was stored in a dedicated database.

4.6. TEST PHASESThe evaluation was divided into two testing phases:

Phase 1 - A first screening step to allow the selection of RDTs meeting minimal quality requirements. Products from two lots were evaluated against a panel of 20 culture-derived P. falciparum samples at high (2000 or 5000 parasites/μl) and low (200 parasites/μl) parasite densities.

Phase 2 - Products from two lots were evaluated against a panel of blood samples containing wild type parasites and a parasite-negative panel, evaluated for heat (thermal) stability, and assessed for ease of use:

a. The parasite-positive and parasite-negative panel was comprised of 79 P. falciparum, 20 P. vivax at two parasite densities (200 parasites/μl and 2000 or 5000 parasites/μl), and 90 parasite-negative controls.

b. Heat stability evaluation: Baseline testing of 10 RDTs from each of two lots against a single culture-derived isolate (Nigeria XII strain, Pf HRP2 sequence type B with a typical antigen concentration) at 200 parasites/μl and 2000 parasites/μl and 4 RDTs from each lot against a negative sample. This procedure was repeated after RDTs were maintained for 60 days at 4°C, 35°C and 45°C at 75% humidity.

Figure 5: Testing procedure for Product A against a sample density of 2000 or 5000 parasites/μl

The first reading was at the minimum time specified by the manufacturer; the second reading was up to one hour later and contributed to the determination of the final result only if the manufacturer specified that reading should be repeated if the initial reading was negative for malaria.

Based on positive results of the first test reading in each lot, the mean band intensity score =a+b/2

Total number of tests =2

Total number of tests x readings =4

product a

a b

Reading 1 Reading 2

Lot 1

Test 1

Reading 3 Reading 4

Lot 2

Test 2

Table 2: Characteristics of Plasmodium spp. negative specimens

Nature of negative sample1 No

‘Clean’ negative2 42

Anti-nuclear antibody positive (sera) 13

Anti-mouse antibody positive (plasma) 1

Rheumatoid factor positive (whole blood and sera) 4

Rapid plasma reagin positive (sera) 9

Chagas’ disease antibody positive (plasma) 2

Dengue antibody positive (whole blood and sera) 4

Leishmaniasis antibody positive (sera) 5

Schistosomiasis antibody positive (whole blood and sera) 10

1 Whole blood unless indicated. Sera and plasma samples were reconstituted packed cells

2 Healthy volunteers with no known current illness or blood abnormality

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)10

c. Ease of use assessment: After becoming familiar with the test device, technicians jointly described the test for blood safety characteristics, quality of instructions, number of timed steps and total time to result, using a standard reference guide17.

d. A stability assessment was also required to be conducted by manufacturers at the manufacturing site. Manufac-turers were requested to assess real-time heat stability at three month intervals against high and low parasite densities supplied by WHO at the upper limit of their recommended storage temperature throughout shelf-life and at the end of shelf-life. Results are submitted to WHO at regular intervals, for internal use, only.

4.7. PERFORMING RAPID TESTSAll RDTs were brought to room temperature prior to first use. Desiccant was inspected for colour changes and products were discarded if present. RDTs were labeled with patient ID, dilution, and the date when test was performed. Performance of rapid tests was in accordance with manufacturer’s instructions, with the exception that blood transfer was carried out by micro-pipette from the sample tube. The result was recorded by a technician at the

17 Methods Manual for Product Testing of Malaria RDTs Version One 2008. Chapter 7, available at www.wpro.who.int/sites/rdt/documents.htm

minimum specified reading time and by a second technician within 1 hour. Technicians were rotated, and blinded to sample type and to each other's results during Phase II. Annexes 1 and 2 contain a descriptive and illustrated summary of the test characteristics, steps and guide to interpretation of results.

4.8. INTERPRETATION OF RESULTSResults of control and test lines were recorded as negative or positive by each technician. Each test was read against a standard colour chart and the band intensity graded as 0 (no band), 1, 2, 3 or 4. If the control line is recorded as absent by either technician, the test is recorded as invalid.

Figures 5 and 6 illustrate the testing sequence at low and high parasite densities.

Figure 6: Testing procedure for Product A against a sample density of 200 parasites/μl

The first reading was at the minimum time specified by the manufacturer; the second reading was up to one hour later and contributed to the determination of the final result only if the manufacturer specified that reading should be repeated if the initial reading was negative for malaria.

Based on the positive results of first test reading (2 tests per lot), the mean band intensity score =a+b+c+d/4 (excluding negative results).

product a

ba dcTest 1 Test 2

Lot 1

Reading 1 Reading 2

Test 3 Test 4

Lot 2

Reading 3 Reading 4

Total number of tests =4

Total number of tests x readings =8

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)11

5. DATA MANAGEMENT

The receipt of products was hand recorded in an RDT register at the CDC as per Standard Operating Procedures (SOPs). Data associated with specimen collection and characterization was recorded first on hard copy report forms as per the SOPs at the collection sites (Figure 2), HTD (ELISA reporting) and CDC (PCR) and then entered directly into formatted excel spreadsheets that were subsequently imported into a specially developed database.

The results of the product panel testing and heat stability testing conducted at the CDC were recorded on report forms by each technician individually, as per the SOP.

These results were transferred to a Master Results Sheet and subsequently registered in the database via one of two mechanisms: i) direct database entry or ii) into an excel spreadsheet formatted for subsequent importation into the database.

In order to control for data entry errors, all data discrepancies between Reader 1 and Reader 2 were resolved through inspection of the original hard copy report forms.

All source documents and electronic records of study data have been kept in secure areas until the conclusion of the evaluation, data analysis and report publication.

Individual product testing reports and accompanying raw data were assembled for manufacturers’ review 60 days prior to release of the published report.

6. QUALITY ASSURANCE

Product testing followed SOPs developed through prior testing experience and based on recommendations of expert consultations6,8. A pilot phase using a limited number of tests and an abbreviated panel was conducted to refine these procedures. The quality of critical steps was controlled, as follows:

Quality of the malaria RDTs and their use:•All RDTs were stored in a controlled environment at ≤ 25°C; the pouch was opened and desiccant checked immediately before use; manufacturer instructions were followed with the exception of use of the blood transfer device provided by the manufacturer (a micropipette was used to ensure correct blood volume).A temperature-monitoring device was offered to be included with the RDTs for shipment to the testing site.

Quality and objectivity of the RDT reading results:• Results were read in good lighting by trained technicians tested for visual acuity. Technicians were rotated. Readings of a second technician were reported for discrepant rates; it should be noted that these may have been affected by changes in presence or intensity of test lines with time. All wild parasite samples at low parasite density were first randomized with a similar number of negative control samples and re-labeled for blinded reading of the RDT results.

Quality of the specimen bank samples:• SOPs were established for the preparation of all specimen bank samples8. Culture lines of parasites and wild-type samples were selected taking into account previous evidence and data from specifically conducted studies. All diluted parasite samples were stored and transported at -70°C, and were used only once within 8 hours of thawing.

Quality of the product testing site: •The Malaria Epidemiology Branch of the Division of Parasitic Diseases at CDC is one of the major operating components of the Department of Health and Human Services (HHS) of the USA. The laboratory holds Clinical Laboratory Improvement Amendments (CLIA) accreditation and is monitored by internal Quality Management Systems (QMS) programmes.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)12

7. ETHICAL CONSIDERATIONS

Each specimen collection site obtained approval from a WHO Research Ethics Review Committee and local institutional review board for specimen collection, transport and archiving of blood samples for the purpose of product testing, lot testing and quality assurance procedures.

8. DATA ANALYSIS

8.1. DEFINING SENSITIVITY AND SPECIFICITY/DETECTION AND FALSE POSITIVE RATES

Malaria RDTs detect parasite-derived antigen. The relationship of the concentration of antigen available from the blood sample (after lysis of red cells and parasites) to the peripheral parasite density varies highly due to a series of host and parasite factors. The population frequency of specific factors that may result in false positive results may also vary. Therefore, field sensitivity and specificity of an RDT may change in different epidemiological situations. The evaluation reported here does not predict sensitivity or specificity in a given field situation. It reports comparative detection of target antigens and false positive rates of RDTs against a standardized panel, in a controlled, repeatable manner. As the panel is developed to be a close approximation of field samples, the comparative detection rates between products are expected to be reflected by similar comparative detection rates in the field. As the panel is designed to include a large number of samples close to the limits of detection of RDTs, the panel is likely to discriminate more clearly than a field trial. It follows that in some settings, such as where parasite density is very high, differences in detection rates between tests observed against the WHO evaluation panel may not be observed in patient populations. Furthermore, where parasite densities are very low, detection rates may be lower than those reported here.

Referring to Figure 6, to be classified as detecting a sample, a product must return 4 positive tests at the manufacturers’ recommended minimum reading time (2 from Lot 1, 2 from Lot 2 at initial reading time) when tested using a parasite density of 200 parasites/μl. When tested against 2000 or 5000 parasites/μl (Figure 5) the product must return 2 positive tests at the manufacturers’ recommended minimum reading time (1 from each lot). Thus, a “positive” result is a

measure of consistency of result, as well as ability to detect antigen.

The detection rate was defined as the percentage of P. falciparum wild type samples detected by the product. The non-P. falciparum detection rate is the percentage of Plasmodium positive/P. falciparum negative samples identified by the product.

8.2. FALSE POSITIVESFalse positive results are analysed and reported as two separate groups; those that had incorrect species identification, and those that returned a positive result for samples containing no Plasmodium spp. parasites. Specifically, the false positive rate is the percentage of all tests that returned a positive test when it shouldn't have, based on reader 1 results.

8.2.1. Incorrect species identificationA test is considered as returning an incorrect species result if a positive P. falciparum test line appears with a sample containing non-P. falciparum parasites. P. vivax samples resulting in a visible line on a P. falciparum-specific test line are also considered to be false positives.

8.2.2. False positives from Plasmodium-negative samples

Any test that produces a positive reading to samples with no Plasmodium parasites is considered a false-positive. In Phase 2, parasite-negative samples consist of clean negative samples and also samples containing other infectious agents (e.g. Dengue, Leishmania, Chagas) and immunological factors (rheumatoid factor, anti-nuclear antibodies, heterophile antibodies).

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)13

8.3. BAND INTENSITYAll positive tests results were recorded according to the band intensity against a standard reference chart, matched closely to line colour. Based on Reader 1 results, the distribution of band intensity results is presented as the mean band intensity of positive results. In addition, the intensity was expressed for each possible result (0, 1, 2, 3 or 4)18 as the percentage recorded at that level.

8.4. LOT AGREEMENT Disagreement between test lots is calculated from the number of samples that returned a positive result on both RDTs tested in that lot against parasite-positive samples at 200 parasites/μl, and on the single RDT from each lot tested against samples at 2000 or 5000 parasites/μl. Thus, high inter-lot agreement indicates consistency in detecting malaria parasites.

18 A standard intensity comparison chart is used, allowing matching to the closest of 4 common colour variants of labelled antibodies used on RDTs, each at 4 levels of intensity.

8.5. READER VARIABILITYTwo readings of each test are conducted, although only the first is certain to comply with the manufacturer’s guidelines for reading test results. A second reading is performed within one hour. Detection rates for both readers are calculated to assess how sensitive the results are to the time of reading.

8.6. INVALID TESTSThe total number of tests that were deemed invalid during testing of both lots, using samples at 200 parasites/μl and 2000 or 5000 parasites/μl.

8.7. HEAT (THERMAL) STABILITY The results of heat stability testing are reported as the number of positive tests (maximum 10) and mean band intensity (for positive tests only) per lot at baseline and after lots were stored at 4°C, 35°C and 45°C for 2 months against one P. falciparum parasite sample at 200 and 2000 parasites/μl.

9. LABORATORY VERSUS FIELD-BASED MALARIA RDT EVALUATIONS

Despite the strengths of the product testing programme, the evaluation is not completely analogous to field testing of malaria RDTs. In order to compose a panel that could be reproducibly used to evaluate RDTs, blood samples were diluted, frozen and stored below −70°C. Blood that has undergone a freeze thaw process may not have exactly the same characteristics as fresh blood, but as red cell lysis occurs as a first step on RDTs, the effect of this is limited. A further variation from field equivalence is the use of a micro-pipette to supply blood to the RDT device rather than the blood transfer device provided by the manufacturer. This was necessary because blood is collected from a cryo-tube rather than a finger-prick. This technique also ensured consistency of testing by reducing the likelihood of operator error.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)14

10. RESULTS

10.1. SUMMARY

In Round 1 of the WHO-FIND Malaria RDT Evaluation Programme, 41 products were evaluated against P. falciparum culture samples, blood samples collected from parasitaemic patients from three continents and a large panel of parasite negative samples. Heat stability was assessed at temperatures commonly encountered in malaria endemic countries. Twelve research institutes were engaged in either sample collection or sample characterization to establish the evaluation panels. Between May and November 2008, in total, over 41 000 tests were performed at the US Centers for Disease Control and Prevention.

The results of the evaluation reveal the following key outcomes:

1. Several RDTs are available that demonstrated consistent detection of malaria at low parasite densities (200 parasites/μl), have low false-positive rates, are stable at tropical temperatures, are relatively easy to use, and can detect P. falciparum, P. vivax infections, or both.

2. Performance between products varied widely at low parasite density (200 parasites/μl); however, most products showed a high level of detection at 2000 to 5000 parasites/μl.

3. P. falciparum tests targeting HRP2 antigen demonstrated the highest detection rates, but some tests targeting pLDH also exhibited high detection rates.

4. Test performance varied between lots, and widely between similar products.

Tables 3 and 4 summarize the performance of 41 malaria RDTs against P. falciparum cultured parasites (Table 3) and blood containing wild type P. falciparum and P. vivax parasites and Plasmodium spp. negative samples (Table 4). Tables 3a and 4a present summary results for 7 products based on a delayed reading when specified in the manufacturers' instructions. Detailed information pertaining to all product testing results is included in Annex 3 (Phase 1) and Annex 4 (Phase 2). A graphical representation of this data follows below.

In summary tables, data is colour coded according to arbitrary categories, to ease the interpretation of results, and these do not imply limits of acceptable or unacceptable performance.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)15

Tabl

e 3:

Sum

mar

y pe

rfor

man

ce o

f m

alar

ia R

DTs

agai

nst

20 c

ultu

red

P. f

alci

paru

m li

nes

at lo

w (

200)

and

hig

h (2

000

or 5

000)

par

asit

e de

nsit

ies

(par

asit

es/μ

l)

Prod

uct

Man

ufac

ture

r

Dete

ctio

n ra

te‡

(n=2

0)Fa

lse

posi

tive

non

-Pf

infe

ctio

n †

(%)

Inva

lid r

ate

(%)

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para

site

s/μl

2,00

0 or

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00

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vant

age

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aria

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a &

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Star

t Mal

aria

HRP

2 (P

f)Ac

cess

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aria

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ard

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med

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test

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cies

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ve in

dica

tes

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lse

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tive

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ampl

e is

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side

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dete

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all R

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h lo

ts re

ad b

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st te

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re p

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ve

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ctio

n ra

te (%

)≥9

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% o

f tes

ts

cond

ucte

d

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)16

Tabl

e 3a

: Sum

mar

y pe

rfor

man

ce o

f m

alar

ia R

DTs

agai

nst

20 c

ultu

red

P.fal

cipa

rum

line

s at

low

(20

0) a

nd h

igh

(200

0 or

500

0) p

aras

ite

dens

itie

s (p

aras

ites

/μl)

base

d on

a

dela

yed

read

ing

whe

n sp

ecifi

ed b

y th

e m

anuf

actu

rer

Prod

uct

Man

ufac

ture

r

Dete

ctio

n ra

te‡

(n=2

0)Fa

lse

posi

tive

non

-Pf

infe

ctio

n †

(%)

Inva

lid r

ate

(%)

200

para

site

s/μl

2,00

0 or

5,0

00

para

site

s/μl

200

para

site

s/μl

2,00

0 or

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00

para

site

s/μl

Pf &

Pan

/Pf

& P

vFi

rstS

ign

– Pa

raVi

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+ Pf

) Car

d Te

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nim

ed In

tern

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nal,

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mun

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ck M

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Auto

mat

ion/

Cort

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iagn

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s, In

c.0

(19)

0 (1

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96.1

534

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pid

Test

for M

alar

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f/Pa

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00

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med

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f/Pa

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od T

est

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0Pf

onl

yPa

raba

nk R

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t for

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aria

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(Dev

ice)

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yr B

iom

edic

als

095

N/A

N/A

0Pf

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lasm

odiu

m fa

lcip

arum

Pv

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lasm

odiu

m v

ivax

pan

- Pl

asm

odiu

m s

peci

es

† - P

an o

r Pv

line

only

pos

itive

indi

cate

s a

fals

e po

sitiv

e no

n P.

falc

ipar

um in

fect

ion

‡ - a

sam

ple

is c

onsi

dere

d de

tect

ed o

nly

if al

l RDT

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om b

oth

lots

read

by

the

first

tech

nici

an, a

t min

imum

spe

cifie

d re

adin

g tim

e, a

re p

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ve

Tabl

e 4:

Sum

mar

y pe

rfor

man

ce o

f m

alar

ia R

DTs

agai

nst

wild

typ

e P.

fal

cipa

rum

and

P. v

ivax

sam

ples

at

low

(20

0) a

nd h

igh

(200

0 or

500

0) p

aras

ite

dens

itie

s (p

aras

ites

/μl

) an

d Pl

asm

odiu

m s

pp. n

egat

ive

sam

ples

.

Prod

uct

Man

ufac

ture

r

Dete

ctio

n ra

te‡

(%)

Fals

e po

siti

ve r

ates

(%

) Fa

lse

posi

tive

rat

es (

%)

Tota

l fal

se

posi

tive

rat

es*

(%)

Inva

lid

rate

(%

)

200

para

site

s/μl

2000

or

5000

pa

rasi

tes/

μl20

0 pa

rasi

tes/

μl20

00 o

r 50

00 p

aras

ites

/μl

Clea

n N

egat

ive

sam

ples

Pf s

ampl

es

(n=7

9)Pv

sam

ples

(n

=20)

Pf

sam

ples

(n

=79)

Pv s

ampl

es

(n=2

0)

Pf s

ampl

es

Pv s

ampl

es

Pf s

ampl

es

Pv s

ampl

es

Fals

e po

siti

ve

non

Pf

infe

ctio

n† (n

=316

)

Fals

e po

siti

ve

Pf in

fect

ion◊

(n

=80)

Fal

se p

osit

ive

non

Pf

infe

ctio

n† (n

=158

)

Fals

e po

siti

ve

Pf in

fect

ion◊

(n

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Fals

e po

siti

ve

Plas

mod

ium

sp

p. in

fect

ion

(n=1

68)

Pf o

nly

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MAL

ARIA

(p.f)

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T In

Tec

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ucts

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N/A

100

N/A

N/A

12.5

N/A

17.5

16.0

70

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One

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p M

alar

ia (p

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est (

who

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ucts

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N/A

100

N/A

N/A

48.7

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27.9

80

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ntag

e P.

f. M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

97.4

7N

/A10

0N

/AN

/A1.

25N

/A2.

50

0Ca

reSt

art M

alar

ia H

RP2

(Pf)

Acce

ss B

io, I

nc.

98.7

3N

/A98

.73

N/A

N/A

5N

/A7.

52.

380

Firs

t Res

pons

e M

alar

ia A

g H

RP2

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.10

0N

/A10

0N

/AN

/A0

N/A

02.

980

Firs

tSig

n –

Mal

aria

Pf C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.31

.65

N/A

86.0

8N

/AN

/A12

.5N

/A15

2.41

(166

)0

Hex

agon

Mal

aria

Hum

an G

mbH

39.2

4N

/A94

.94

N/A

N/A

7.89

(76)

N/A

2.5

4.19

(167

)1.

18IC

T M

alar

ia P

f Cas

sett

e Te

st (M

L01)

ICT

Diag

nost

ics

82.2

8N

/A97

.47

N/A

N/A

1.27

N/A

2.5

0.6

0Im

mun

oqui

ck M

alar

ia F

alci

paru

mBi

osyn

ex91

.14

N/A

100

N/A

N/A

0N

/A0

0.6

0M

alar

ia P

lasm

odiu

m fa

lcip

arum

Rap

id te

st D

evic

e (W

hole

bl

ood)

ACON

Lab

orat

orie

s, In

c.92

.41

N/A

100

N/A

N/A

0N

/A0

00

Mal

aria

Rap

id P

fVi

sion

Bio

tech

(Pty

) Ltd

.68

.35

N/A

97.4

7N

/AN

/A0

N/A

00.

60

Para

chec

k Pf

Rap

id te

st fo

r P. f

alci

paru

m M

alar

ia (D

evic

e)

Orch

id B

iom

edic

al S

yste

ms

54.4

3N

/A97

.47

N/A

N/A

3.95

(76)

N/A

51.

25 (1

60)

2.69

Para

chec

k Pf

Rap

id te

st fo

r P. f

alci

paru

m M

alar

ia (D

ipst

ick)

Or

chid

Bio

med

ical

Sys

tem

s74

.68

N/A

100

N/A

N/A

16.4

6N

/A10

7.19

(167

)0.

51Pa

rahi

t-f D

IPST

ICK

FOR

FALC

IPAR

UM

MAL

ARIA

Span

Dia

gnos

tics

Ltd.

78.4

8N

/A10

0N

/AN

/A0

N/A

00.

60

Para

hit-

f TES

T DE

VICE

FOR

FAL

CIPA

RUM

MAL

ARIA

Span

Dia

gnos

tics

Ltd.

39.2

4N

/A97

.47

N/A

N/A

0N

/A0

00

SD B

IOLI

NE

Mal

aria

Ag

Pf

Stan

dard

Dia

gnos

tics,

Inc.

97.4

7N

/A98

.73

N/A

N/A

0N

/A0

2.38

0

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)17

Dete

ctio

n ra

te (%

)≥9

585

-94

50-8

4<

50

Fals

e po

sitiv

e ra

te (%

)<2

2-5

6-10

>10

Inva

lid ra

te (%

)<1

% o

f tes

ts

cond

ucte

d1-

2% o

f tes

ts

cond

ucte

d2-

5% o

f tes

ts

cond

ucte

d>5

% o

f tes

ts

cond

ucte

d

Prod

uct

Man

ufac

ture

r

Dete

ctio

n ra

te‡

(%)

Fals

e po

siti

ve r

ates

(%

) Fa

lse

posi

tive

rat

es (

%)

Tota

l fal

se

posi

tive

rat

es*

(%)

Inva

lid

rate

(%

)

200

para

site

s/μl

2000

or

5000

pa

rasi

tes/

μl20

0 pa

rasi

tes/

μl20

00 o

r 50

00 p

aras

ites

/μl

Clea

n N

egat

ive

sam

ples

Pf s

ampl

es

(n=7

9)Pv

sam

ples

(n

=20)

Pf

sam

ples

(n

=79)

Pv s

ampl

es

(n=2

0)

Pf s

ampl

es

Pv s

ampl

es

Pf s

ampl

es

Pv s

ampl

es

Fals

e po

siti

ve

non

Pf

infe

ctio

n† (n

=316

)

Fals

e po

siti

ve

Pf in

fect

ion◊

(n

=80)

Fal

se p

osit

ive

non

Pf

infe

ctio

n† (n

=158

)

Fals

e po

siti

ve

Pf in

fect

ion◊

(n

=40)

Fals

e po

siti

ve

Plas

mod

ium

sp

p. in

fect

ion

(n=1

68)

Pf &

Pan

/Pf

& P

vAd

vant

age

Mal

Car

dJ.

Mitr

a &

Co.

Pvt

. Ltd

.62

.03

100

100

100

2.53

00

04.

170

AZOG

Mal

aria

pf (

HRP

-II)

/pv

(pLD

H) A

ntig

en D

etec

tion

Test

De

vice

AZOG

, Inc

.77

.22

3010

095

1.9

00

2.5

9.52

0

Bina

x N

ow M

alar

ia

Inve

rnes

s M

edic

al In

nova

tions

, Inc

.91

.14

1010

085

0.32

3.8

0 (1

57)

50.

000.

34Ca

reSt

art M

alar

ia H

RP2/

pLDH

(Pf/

PAN

) COM

BOAc

cess

Bio

, Inc

.97

.47

9010

095

0.32

1.25

02.

52.

980

Firs

t Res

pons

e M

alar

ia A

g Co

mbo

(PLD

H/H

RP2)

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.10

075

100

650

3.75

020

3.57

0Fi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Car

d Te

stU

nim

ed In

tern

atio

nal,

Inc.

48.1

098

.73

850.

953.

750

50.

000

Hex

agon

Mal

aria

Com

biH

uman

Gm

bH46

.84

097

.47

500

00

(157

)2.

63 (3

8)2.

990.

67IC

T M

alar

ia C

ombo

Cas

sett

e Te

st (M

L02)

ICT

Diag

nost

ics

86.0

80

100

950.

323.

750

50.

60

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

93.6

730

98.7

310

00

(314

)0

0 (1

57)

00.

600

Mal

aria

P.F

/Viv

axDi

agno

stic

Aut

omat

ion

/ Cor

tez

Diag

nost

ics,

Inc.

73.5

8 (5

3)0

(15)

94.8

7 (3

9)30

.77

(13)

1.03

(97)

0 (3

0)2.

08 (4

8)0

(18)

1.56

67.5

1

Mal

aria

Rap

id C

ombo

Visi

on B

iote

ch (P

ty) L

td.

87.3

410

100

900.

327.

50

7.5

7.74

0M

alar

ia R

apid

Dua

l Vi

sion

Bio

tech

(Pty

) Ltd

.75

.95

598

.73

901.

270

00

10.1

20

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s63

.29

097

.47

750.

636.

250

17.5

5.36

0On

e St

ep M

alar

ia A

ntig

en S

trip

IND

Diag

nost

ic In

c.1.

270

67.0

960

2.22

3.75

1.9

01.

800

OnSi

ght –

Par

aQui

ck (P

an, P

f) Te

stAm

geni

x In

tern

atio

nal,

Inc.

59.4

950

100

100

01.

250

00.

000

OptiM

AL-I

TDi

aMed

AG

36.7

195

96.2

100

3.8

00.

630

0.00

0Pa

rahi

t-To

tal D

evic

e Ra

pid

test

for P

. fal

cipa

rum

and

Pan

m

alar

ial s

peci

es.

Span

Dia

gnos

tics

Ltd.

35.4

40

93.6

750

0 (3

15)

00

2.5

0.00

0.17

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf (

Devi

ce)

Zeph

yr B

iom

edic

als

50.6

325

100

950.

633.

80

01.

190.

17Qu

icks

tick

Mal

aria

Ant

igen

Tes

tIn

nova

tek

Med

ical

Inc.

1.27

067

.09

602.

223.

751.

91.

80SD

BIO

LIN

E M

alar

ia A

gSt

anda

rd D

iagn

ostic

s, In

c.29

.1150

96.2

100

01.

250

01.

790

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

an

Stan

dard

Dia

gnos

tics,

Inc.

96.2

3510

095

0 (3

10)

00

2.56

(39)

1.19

1.35

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

60.7

630

98.7

395

3.52

(312

)1.

3 (7

7)0

(155

)2.

56 (3

9)6.

591.

85Pa

n on

lyAd

vant

age

Pan

Mal

aria

Car

dJ.

Mitr

a &

Co.

Pvt

. Ltd

.72

.15

100

100

100

N/A

N/A

N/A

N/A

1.79

0Ca

reSt

art M

alar

ia p

LDH

(PAN

)Ac

cess

Bio

, Inc

.92

.41

100

100

100

N/A

N/A

N/A

N/A

6.55

0Pa

raba

nk R

apid

Tes

t for

Mal

aria

Pan

(Dev

ice)

Zeph

yr B

iom

edic

als

1.27

3087

.34

100

N/A

N/A

N/A

N/A

2.99

(167

)0

Pf -

Pla

smod

ium

falc

ipar

um

Pv -

Pla

smod

ium

viv

axpa

n - P

lasm

odiu

m sp

ecie

s † -

For

com

bina

tion

test

s, Pa

n or

Pv

line,

onl

y, po

sitiv

e in

dica

tes

a fa

lse

posi

tive

non

P. fa

lcip

arum

infe

ctio

n ‡ -

A s

ampl

e is

con

side

red

dete

cted

onl

y if

all R

DTs

from

bot

h lo

ts re

ad b

y th

e fir

st te

chni

cian

, at m

inim

um s

peci

fied

read

ing

time,

are

pos

itive

◊ - P

f lin

e po

sitiv

e in

dica

tes

a fa

lse

posi

tive

P. fa

lcip

arum

infe

ctio

n * -

The

tota

l num

ber o

f tim

es a

pos

itive

resu

lt fo

r mal

aria

was

gen

erat

ed w

hen

it sh

ould

not

hav

e be

en (P

f+; P

f +/P

an o

r Pv

-; P

f+/P

an o

r Pv+

; Pf-

/Pan

or P

v+)

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)18

Tabl

e 4a

: Sum

mar

y pe

rfor

man

ce o

f m

alar

ia R

DTs

agai

nst

P. f

alci

paru

m li

nes

at lo

w (

200)

and

hig

h (2

000

or 5

000)

par

asit

e de

nsit

ies

(par

asit

es/μ

l) ba

sed

on a

del

ayed

re

adin

g w

hen

spec

ified

by

the

man

ufac

ture

r

Prod

uct

Man

ufac

ture

r

Dete

ctio

n ra

te‡

(%)

Fals

e po

siti

ve r

ates

(%

) Fa

lse

posi

tive

rat

es (

%)

Tota

l fal

se

posi

tive

ra

tes*

(%

)

Inva

lid r

ate

(%)

200

para

site

s/μl

2000

or

5000

par

asit

es/μ

l20

0 pa

rasi

tes/

μl20

00 o

r 50

00 p

aras

ites

/μl

Pf s

ampl

es

(n=7

9)Pv

sam

ples

(n

=20)

Pf

sam

ples

(n

=79)

Pv s

ampl

es

(n=2

0)

Pf s

ampl

es

Pv s

ampl

es

Pf s

ampl

es

Pv s

ampl

es

Clea

n N

egat

ive

sam

ples

Fals

e po

siti

ve

non

Pf

infe

ctio

n† (n

=316

)

Fals

e po

siti

ve P

f in

fect

ion◊

(n

=80)

Fal

se

posi

tive

no

n Pf

in

fect

ion†

(n=1

58)

Fals

e po

siti

ve P

f in

fect

ion◊

(n

=40)

Fals

e po

siti

ve

Plas

mod

ium

sp

. Inf

ecti

on

(n=1

68)

Pf &

Pan

/Pf

& P

vFi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Car

d Te

stU

nim

ed In

tern

atio

nal,

Inc.

64,5

60

100

100

02.

5 (8

0)0

2,5

00

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

93,6

745

100

950

1.25

(80)

02,

57,

140,

17M

alar

ia P

.F/V

ivax

Diag

nost

ic A

utom

atio

n / C

orte

z Di

agno

stic

s, In

c.71

.43

(56)

0 (1

5)92

.5 (4

0)45

.45

(11)

00

(30)

4,17

0 (1

5)3,

2367

,17

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s68

,35

098

,73

851,

587.

5 (8

0)0

12,5

6,55

0Pa

rasc

reen

Rap

id T

est f

or M

alar

ia P

an/P

f (De

vice

)Ze

phyr

Bio

med

ical

s65

,82

5598

,73

100

0,63

00,

630

2,38

0,09

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

68,3

535

98,7

390

1,92

3.9

(77)

05.

13 (3

9)7,

381,

85Pa

n on

lyPa

raba

nk R

apid

Tes

t for

Mal

aria

Pan

(Dev

ice)

Zeph

yr B

iom

edic

als

13,9

275

97,4

710

0N

/AN

/AN

/AN

/AN

/A0

Pf -

Pla

smod

ium

falc

ipar

um

Pv -

Pla

smod

ium

viv

axpa

n -

Plas

mod

ium

spec

ies

† - F

or c

ombi

natio

n te

sts,

Pan

or P

v lin

e, o

nly,

posi

tive

indi

cate

s a

fals

e po

sitiv

e no

n P.

falc

ipar

um in

fect

ion

‡ - A

sam

ple

is c

onsi

dere

d de

tect

ed o

nly

if al

l RDT

s fr

om b

oth

lots

read

by

the

first

tech

nici

an, a

t min

imum

spe

cifie

d re

adin

g tim

e, a

re p

ositi

ve◊ -

Pf l

ine

posi

tive

indi

cate

s a

fals

e po

sitiv

e P.

falc

ipar

um in

fect

ion

Dete

ctio

n ra

te (%

)≥9

585

-94

50-8

4<

50

Fals

e po

sitiv

e ra

te (%

)<2

2-5

6-10

>10

Inva

lid ra

te (%

)<1

% o

f tes

ts

cond

ucte

d1-

2% o

f tes

ts

cond

ucte

d2-

5% o

f tes

ts

cond

ucte

d>5

% o

f tes

ts

cond

ucte

d

Tabl

e 5:

Hea

t st

abili

ty t

esti

ng r

esul

ts f

or m

alar

ia R

DTs

on a

cul

ture

d P.

fal

cipa

rum

sam

ple

at lo

w (2

00) a

nd h

igh

(200

0 or

500

0) p

aras

ite

dens

ity

(par

asit

es/μ

l). P

osit

ivit

y ra

te a

t ba

selin

e, a

nd a

fter

60

days

incu

bati

on a

t 35

°C a

nd 4

5°C

Prod

uct

Man

ufac

ture

r

Posi

tive

tes

ts r

esul

ts f

or P

. fa

lcip

arum

(Pf

line

)20

0 pa

rasi

tes/

μl

Posi

tive

tes

ts r

esul

ts f

or P

. fa

lcip

arum

(Pf

line

)20

00 p

aras

ites

/μl

Posi

tive

tes

ts r

esul

ts f

or P

. fa

lcip

arum

(Pa

n lin

e)20

0 pa

rasi

tes/

μl

Posi

tive

tes

ts r

esul

ts f

or P

. fa

lcip

arum

(Pa

n lin

e)20

00 p

aras

ites

/μl

Base

line

35°C

45°C

Base

line

35°C

45°C

Base

line

35°C

45°C

Base

line

35°C

45°C

Num

ber

of t

ests

pos

itiv

e (m

ax. 2

0)N

umbe

r of

tes

ts p

osit

ive

(max

. 20)

Num

ber

of t

ests

pos

itiv

e (m

ax. 2

0)N

umbe

r of

tes

ts p

osit

ive

(max

. 20)

Lots

1 a

nd 2

com

bine

dLo

ts 1

and

2 c

ombi

ned

Lots

1 a

nd 2

com

bine

dLo

ts 1

and

2 c

ombi

ned

Pf o

nly

ADVA

NCE

D QU

ALIT

Y TM

MAL

ARIA

(p.f)

POC

T In

Tec

Prod

ucts

, Inc

.16

1918

2020

20N

/AN

/AN

/AN

/AN

/AN

/AAD

VAN

CED

QUAL

ITY

TM O

ne S

tep

Mal

aria

(p.f.

) Tes

t (w

hole

blo

od)

InTe

c Pr

oduc

ts, I

nc.

1617

920

1920

N/A

N/A

N/A

N/A

N/A

N/A

Adva

ntag

e P.

f. M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

1920

2020

2020

N/A

N/A

N/A

N/A

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MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)19

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MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)2 0

10.2. PHASE 1 - P. FALCIPARUM CULTURE PANEL

The majority (73%) of tests consistently detected ≥ 95% of P. falciparum cultured parasites at high parasite densities; however, detection rate was highly variable at low parasite densities (0-100%). At low parasite densities, the top ten products all targeted HRP2 (Figure 7).

Table 3a illustrates detection rates at low and high parasite densities based on a delayed second reading if it was specifically indicated in the package insert following initial negative results at the specified reading time. For 3 products, results were unchanged and for 4 products detection rates increased.

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Figure 7: Phase 1 P. falciparum detection rate of malaria RDTs at low (200) and high (2000 or 5000) parasite densities (parasites/μl) according to target antigen type (HRP2 or pLDH)†

† - Phase 1 Evaluation Panel : 20 P. falciparum culture samples. RDTs - 2 tests x 2 lots at 200 parasites/μl ; 1 test x 2 lots at 2000 parasites/μl.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)21

10.3. PHASE 2 - WILD TYPE P. FALCIPARUM AND P. VIVAX AND PLASMODIUM SPP. NEGATIVE SAMPLES

10.3.1. P. falciparum detection rateCompared to the P. falciparum cultured parasite panel, P. falciparum detection rates of wild type samples were generally higher, reflecting the increased antigen content of wild type samples. As in Phase 1, the majority of tests (35; 85%) detected ≥ 95% of P. falciparum samples at high

parasite densities but only 6 tests (15%) had this high level of detection at low parasite density (200 parasites/μl). All of these 6 products targeted HRP2; however 3 products targeting pLDH detected > 60% of P. falciparum samples. (Figure 8).

Table 4a illustrates detection rates at low and high parasite densities based on a delayed second reading if it was specifically indicated in the package insert following initial negative results at the specified reading time. At the low parasite density (200 parasites/μl), the P. falciparum detection rate increased for 5 of the 7 products, based on the delayed reading.

Figure 8: Phase 2 P. falciparum detection rate of malaria RDTs at low (200) and high (2000 or 5000) parasite density (parasites/μl) according to target antigen type (HRP2 or pLDH)†

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†- Phase 2 Evaluation Panel included 79 blood samples containing wild type P. falciparum. RDTs - 2 tests x 2 lots at 200 parasites/μl and 1 test x 2 lots at 2000 parasites/μl

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)22

10.3.2. P. vivax detection rate P. vivax was generally less well detected than P. falciparum in clinical samples. As Figure 9 illustrates, even at high parasite densities (2000 or 5000 parasites/μl) several products failed to consistently detect clinical samples infected with P. vivax samples and detection rates dropped at low parasite density, with only 5 products (25%) detecting > 90% of samples. Products targeting pLDH performed better than those targeting aldolase. One product had a higher detection rate at 200 parasites/μl compared to 2000 parasites/μl because false positive P. falciparum specific test lines at 2000 parasites/μl were counted as incorrect or negative results.

10.3.3. Combined detection of P. falciparum and P. vivax

Considering combination tests, 3 products had detection rates > 60% for both P. falciparum and P. vivax at the low parasite density (200 parasites/μl) (Tables 4. 4a). However, several performed well at high parasite densities. Two pan-specific tests showed high detection rates of both P. falciparum and P. vivax.

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aria

Com

biIC

T M

alar

ia C

ombo

Cas

sett

e Te

st (M

L02)

Mal

aria

P.F

/Viv

axM

alas

can

Rapi

d Te

st fo

r Mal

aria

Pf/

Pan

(Dev

ice)

One

Ste

p M

alar

ia A

ntig

en S

trip

Para

hit-

Tota

l Dev

ice

Rapi

d te

st fo

r P. f

alci

paru

m a

nd P

an m

alar

ial s

peci

esQ

uick

stic

k M

alar

ia A

ntig

en T

est

0

25

50

75

100

200 (aldolase)

200 (pLDH)

2000 (aldolase)

2000 (pLDH)

200 (pLDH + aldolase)

2000 (pLDH + aldolase)

Dete

ctio

n ra

te (

%)

†- Phase 2 Evaluation Panel included 20 blood samples containing wild type P. vivax. RDTs - 2 tests x 2 lots at 200 parasites/μl and 1 test x 2 lots at 2000 parasites/μl

Figure 9: Phase 2 P. vivax detection rate of malaria RDTs at low (200) and high (2000 or 5000) parasite densities (parasites/μl) according to target antigen type (aldolase, pLDH, aldolase + pLDH)†

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)23

10.3.4. P. falciparum and P. vivax positivity rate In addition to detection rate, positivity rate was also measured. This puts aside test and lot differences captured in detection rate and simply measures the total number of times a test returned a positive result. As expected,

positivity rate was higher but mirrored detection rate of wild type P. falciparum and P. vivax samples (Figs 10, 11) with one exception. In this exceptional case, the product had a very high invalid rate against P. falciparum samples (Table 4) and invalid test results were included in the calculation of positivity rate but excluded from detection rate.

†- Phase 2 Evaluation Panel included 79 blood samples containing wild type P. falciparum. RDTs - 2 tests x 2 lots at 200 parasites/μl and 1 test x 2 lots at 2000 parasites/μl

Firs

t Res

pons

e M

alar

ia A

g Co

mbo

(PLD

H/H

RP2)

Firs

t Res

pons

e M

alar

ia A

g H

RP2

Care

Star

t Mal

aria

HRP

2 (P

f)Ad

vant

age

P.f.

Mal

aria

Car

dCa

reSt

art M

alar

ia H

RP2/

pLDH

(Pf/

PAN

) COM

BOSD

BIO

LIN

E M

alar

ia A

g Pf

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

anIm

mun

oqui

ck M

alar

ia +

4Ca

reSt

art M

alar

ia p

LDH

(PAN

)M

alar

ia P

lasm

odiu

m fa

lcip

arum

Rap

id te

st D

evic

e (W

hole

blo

od)

Bina

x N

ow M

alar

iaIm

mun

oqui

ck M

alar

ia F

alci

paru

mM

alar

ia R

apid

Com

boIC

T M

alar

ia C

ombo

Cas

sett

e Te

st (M

L02)

ICT

Mal

aria

Pf C

asse

tte

Test

(ML0

1)Pa

rahi

t-f D

IPST

ICK

FOR

FALC

IPAR

UM M

ALAR

IAAZ

OG M

alar

ia p

f (H

RP-I

I) /p

v (p

LDH

) Ant

igen

Det

ectio

n Te

st D

evic

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alar

ia R

apid

Dua

lPa

rach

eck

Pf R

apid

test

for P

.falc

ipar

um M

alar

ia (D

ipst

ick)

Mal

aria

P.F

/Viv

axAd

vant

age

Pan

Mal

aria

Car

dM

alar

ia R

apid

Pf

ADVA

NCE

D Q

UALI

TY T

M O

ne S

tep

Mal

aria

(p.f.

) Tes

t (w

hole

blo

od)

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ad

vant

age

Mal

Car

dW

ondf

o On

e St

ep M

alar

ia P

f/Pa

n W

hole

Blo

od T

est

OnSi

ght –

Par

aQui

ck (P

an)

ADVA

NCE

D Q

UALI

TY T

M M

ALAR

IA (p

.f) P

OCT

Para

chec

k Pf

Rap

id te

st fo

r P. f

alci

paru

m M

alar

ia (D

evic

e)Pa

rasc

reen

Rap

id T

est f

or M

alar

ia P

an/P

f (De

vice

)Fi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Car

d Te

stH

exag

on M

alar

ia C

ombi

Hex

agon

Mal

aria

Para

hit-

f TES

T DE

VICE

FOR

FAL

CIPA

RUM

MAL

ARIA

OptiM

AL-I

TPa

rahi

t-To

tal D

evic

e Ra

pid

test

for P

. fal

cipa

rum

and

Pan

mal

aria

l spe

cies

Firs

tSig

n –

Mal

aria

Pf C

ard

Test

SD B

IOLI

NE

Mal

aria

Ag

One

Step

Mal

aria

Ant

igen

Str

ipPa

raba

nk R

apid

Tes

t for

Mal

aria

Pan

(Dev

ice)

Qui

ckst

ick

Mal

aria

Ant

igen

Tes

t

0

25

50

75

100

Positivity rate (HRP2)

Detection rate (HRP2)

Detection rate (pLDH)

Rate

(%)

Positivity rate (pLDH)

Figure 10: Phase 2† wild type P. falciparum detection rate and positivity rate at 200 parasites/μl

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)24

Adva

ntag

e M

al C

ard

Adva

ntag

e Pa

n M

alar

ia C

ard

Care

Star

t M

alar

ia p

LDH

(PAN

)O

ptiM

AL-I

TCa

reSt

art

Mal

aria

HRP

2/pL

DH (P

f/PA

N) C

OM

BOFi

rst

Resp

onse

Mal

aria

Ag

Com

bo (P

LDH

/HRP

2)O

nSig

ht –

Par

aQui

ck (P

an P

f) T

est

SD B

IOLI

NE

Mal

aria

Ag

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

anAZ

OG

Mal

aria

pf (

HRP

-II)

/pv

(pLD

H) A

ntig

en D

etec

tion

Test

Dev

ice

Imm

unoq

uick

Mal

aria

+4

Para

bank

Rap

id T

est

for M

alar

ia P

an (D

evic

e)W

ondf

o O

ne S

tep

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tPa

rasc

reen

Rap

id T

est

for M

alar

ia P

an/P

f (De

vice

)Bi

nax

Now

Mal

aria

Mal

aria

Rap

id C

ombo

Mal

aria

Rap

id D

ual

Firs

tSig

n –

Para

View

-2 (P

v +

Pf) C

ard

Test

Hex

agon

Mal

aria

Com

biIC

T M

alar

ia C

ombo

Cas

sett

e Te

st (M

L02)

Mal

aria

P.F

/Viv

axM

alas

can

Rapi

d Te

st fo

r Mal

aria

Pf/

Pan

(Dev

ice)

One

Ste

p M

alar

ia A

ntig

en S

trip

Para

hit-

Tota

l Dev

ice

Rapi

d te

st fo

r P.

falc

ipar

um a

nd P

an m

alar

ial s

peci

esQ

uick

stic

k M

alar

ia A

ntig

en T

est

0

25

50

75

100

Positiv ity rate

Detection rate

Rate

(%)

†- Phase 2 Evaluation Panel included 20 blood samples containing wild type P. vivax . RDTs - 2 tests x 2 lots at 200 parasites/μl and 1 test x 2 lots at 2000 parasites/μl

Figure 11: Phase 2† wild type P. vivax detection rate and positivity rate at 200 parasites/μl

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)25

10.3.5. Band intensity Although RDTs are not quantitative, technicians did grade positive results according to a standard chart and mean band intensity (for positive results) was calculated (Annex 4 - Tables A4.4, A4.5). There was a positive correlation between detection rate and band intensity and reader agreement; suggesting that, as expected, strong test bands are interpreted more reliably.

10.3.6. False positive ratesOverall false positive rates were modest, rarely > 10% on parasite-free blood bank specimens or Plasmodium spp. negative samples containing potentially cross-reacting factors (Figs 12-15). False positive results were seen on both P. falciparum and pan/P. vivax test lines. No consistently higher rate of false positive was seen with blood abnormalities compared to infectious pathogens; however, sample sizes were small. For detailed information regarding the blood abnormality or pathogen that generated false positive results for a specific product refer to Annex 4 (Tables A4.10-A4.12).

Figure 12: P. falciparum (P. falciparum test line*) false positive rate against clean negative samples†

ADVA

NCE

D Q

UAL

ITY

TM M

ALAR

IA (p

.f) P

OCT

ADVA

NCE

D Q

UAL

ITY

TM O

ne S

tep

Mal

aria

(p.f.

) Tes

t (w

hole

blo

od)

Adva

ntag

e M

al C

ard

Adva

ntag

e P.

f. M

alar

ia C

ard

Adva

ntag

e Pa

n M

alar

ia C

ard

AZO

G M

alar

ia p

f (H

RP-I

I) /p

v (p

LDH

) Ant

igen

Det

ectio

n Te

st D

evic

eBi

nax

Now

Mal

aria

Care

Star

t M

alar

ia H

RP2

(Pf)

Care

Star

t M

alar

ia H

RP2/

pLDH

(Pf/

PAN

) CO

MBO

Care

Star

t M

alar

ia p

LDH

(PAN

)Fi

rst

Resp

onse

Mal

aria

Ag

Com

bo (P

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/HRP

2)Fi

rst

Resp

onse

Mal

aria

Ag

HRP

2Fi

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ign

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alar

ia P

f Car

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stFi

rstS

ign

– Pa

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ew-2

(Pv

+ Pf

) Car

d Te

stH

exag

on M

alar

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exag

on M

alar

ia C

ombi

ICT

Mal

aria

Com

bo C

asse

tte

Test

(ML0

2)IC

T M

alar

ia P

f Cas

sett

e Te

st (M

L01)

Imm

unoq

uick

Mal

aria

+4

Imm

unoq

uick

Mal

aria

Fal

cipa

rum

Mal

aria

P.F

/Viv

axM

alar

ia P

lasm

odiu

m fa

lcip

arum

Rap

id t

est

Devi

ce (W

hole

blo

od)

Mal

aria

Rap

id C

ombo

Mal

aria

Rap

id D

ual

Mal

aria

Rap

id P

fM

alas

can

Rapi

d Te

st fo

r Mal

aria

Pf/

Pan

(Dev

ice)

One

Ste

p M

alar

ia A

ntig

en S

trip

OnS

ight

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araQ

uick

(Pan

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ptiM

AL-I

TPa

raba

nk R

apid

Tes

t fo

r Mal

aria

Pan

(Dev

ice)

Para

chec

k Pf

Rap

id t

est

for P

. fal

cipa

rum

Mal

aria

(Dev

ice)

Para

chec

k Pf

Rap

id t

est

for P

.falc

ipar

um M

alar

ia (D

ipst

ick)

Para

hit-

f DIP

STIC

K FO

R FA

LCIP

ARU

M M

ALAR

IAPa

rahi

t-f T

EST

DEVI

CE F

OR

FALC

IPAR

UM

MAL

ARIA

Para

hit-

Tota

l Dev

ice

Rapi

d te

st fo

r P. f

alci

paru

m a

nd P

an m

alar

ial s

peci

esPa

rasc

reen

Rap

id T

est

for M

alar

ia P

an/P

f (De

vice

)Q

uick

stic

k M

alar

ia A

ntig

en T

est

SD B

IOLI

NE

Mal

aria

Ag

SD B

IOLI

NE

Mal

aria

Ag

PfSD

BIO

LIN

E M

alar

ia A

g Pf

/Pan

Won

dfo

One

Ste

p M

alar

ia P

f/Pa

n W

hole

Blo

od T

est

10

20

30

40

50

HRP2

pLDHFals

e po

sitiv

e ra

te (%

)

0

†- Phase 2 Evaluation Panel included 90 Plasmodium spp. negative samples of which 42 were "clean" negatives. RDTs - 2 tests x 2 lots at 200 parasites/μl and 1 test x 2 lots at 2000 parasites/μl*- includes Pf specific lines on combination tests and pan-specific lines on pan-specific only products.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)26

ADVA

NCE

D Q

UAL

ITY

TM M

ALAR

IA (p

.f) P

OCT

ADVA

NCE

D Q

UAL

ITY

TM O

ne S

tep

Mal

aria

(p.f.

) Tes

t (w

hole

blo

od)

Adva

ntag

e M

al C

ard

Adva

ntag

e P.

f. M

alar

ia C

ard

Adva

ntag

e Pa

n M

alar

ia C

ard

AZO

G M

alar

ia p

f (H

RP-I

I) /p

v (p

LDH

) Ant

igen

Det

ectio

n Te

st D

evic

eBi

nax

Now

Mal

aria

Care

Star

t M

alar

ia H

RP2

(Pf)

Care

Star

t M

alar

ia H

RP2/

pLDH

(Pf/

PAN

) CO

MBO

Care

Star

t M

alar

ia p

LDH

(PAN

)Fi

rst

Resp

onse

Mal

aria

Ag

Com

bo (P

LDH

/HRP

2)Fi

rst

Resp

onse

Mal

aria

Ag

HRP

2Fi

rstS

ign

– M

alar

ia P

f Car

d Te

stFi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Car

d Te

stH

exag

on M

alar

iaH

exag

on M

alar

ia C

ombi

ICT

Mal

aria

Com

bo C

asse

tte

Test

(ML0

2)IC

T M

alar

ia P

f Cas

sett

e Te

st (M

L01)

Imm

unoq

uick

Mal

aria

+4

Imm

unoq

uick

Mal

aria

Fal

cipa

rum

Mal

aria

P.F

/Viv

axM

alar

ia P

lasm

odiu

m fa

lcip

arum

Rap

id t

est

Devi

ce (W

hole

blo

od)

Mal

aria

Rap

id C

ombo

Mal

aria

Rap

id D

ual

Mal

aria

Rap

id P

fM

alas

can

Rapi

d Te

st fo

r Mal

aria

Pf/

Pan

(Dev

ice)

One

Ste

p M

alar

ia A

ntig

en S

trip

OnS

ight

– P

araQ

uick

(Pan

Opt

iMAL

-IT

Para

bank

Rap

id T

est

for M

alar

ia P

an (D

evic

e)Pa

rach

eck

Pf R

apid

tes

t fo

r P. f

alci

paru

m M

alar

ia (D

evic

e)Pa

rach

eck

Pf R

apid

tes

t fo

r P.fa

lcip

arum

Mal

aria

(Dip

stic

k)Pa

rahi

t-f D

IPST

ICK

FOR

FALC

IPAR

UM

MAL

ARIA

Para

hit-

f TES

T DE

VICE

FO

R FA

LCIP

ARU

M M

ALAR

IAPa

rahi

t-To

tal D

evic

e Ra

pid

test

for P

. fal

cipa

rum

and

Pan

mal

aria

l spe

cies

Para

scre

en R

apid

Tes

t fo

r Mal

aria

Pan

/Pf (

Devi

ce)

Qui

ckst

ick

Mal

aria

Ant

igen

Tes

tSD

BIO

LIN

E M

alar

ia A

gSD

BIO

LIN

E M

alar

ia A

g Pf

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

anW

ondf

o O

ne S

tep

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

t

0

10

20

30

40

50

Non malaria infectious pathogens (HRP2)

Immunological abnormalities (HRP2)

Non malaria infectious pathogens (pLDH)

Immunological abnormalities (pLDH)

Fal

se p

ositi

ve ra

te (%

)

†- Phase 2 Evaluation Panel included 90 Plasmodium spp. negative samples - 42 clean negatives; 27 samples with blood immunological abnormalities and 21 with non Plasmodium spp. infectious pathogens. RDTs - 2 tests x 2 lots at 200 parasites/μl and 1 test x 2 lots at 2000 parasites/μl*- includes Pf specific lines on combination tests and pan-specific lines on pan-specific only products.

Figure 13: P. falciparum (P. falciparum test line*) false positive rate against Plasmodium spp. negative samples containing potentially cross-reacting blood immunological abnormalities or infectious pathogens†

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)27

Adva

ntag

e M

al C

ard

Adva

ntag

e Pa

n M

alar

ia C

ard

AZO

G M

alar

ia p

f (H

RP-I

I) /p

v (p

LDH

) Ant

igen

Det

ectio

n Te

st D

evic

eBi

nax

Now

Mal

aria

Care

Star

t M

alar

ia H

RP2/

pLDH

(Pf/

PAN

) CO

MBO

Care

Star

t M

alar

ia p

LDH

(PAN

)Fi

rst

Resp

onse

Mal

aria

Ag

Com

bo (P

LDH

/HRP

2)Fi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Car

d Te

stH

exag

on M

alar

ia C

ombi

ICT

Mal

aria

Com

bo C

asse

tte

Test

(ML0

2)Im

mun

oqui

ck M

alar

ia +

4M

alar

ia P

.F/V

ivax

Mal

aria

Rap

id C

ombo

Mal

aria

Rap

id D

ual

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)O

ne S

tep

Mal

aria

Ant

igen

Str

ipO

nSig

ht –

Par

aQui

ck (P

an)

Opt

iMAL

-IT

Para

bank

Rap

id T

est

for M

alar

ia P

an (D

evic

e)Pa

rahi

t-To

tal D

evic

e Ra

pid

test

for P

. fal

cipa

rum

and

Pan

mal

aria

l spe

cies

Para

scre

en R

apid

Tes

t fo

r Mal

aria

Pan

/Pf (

Devi

ce)

Qui

ckst

ick

Mal

aria

Ant

igen

Tes

tSD

BIO

LIN

E M

alar

ia A

gSD

BIO

LIN

E M

alar

ia A

g Pf

/Pan

Won

dfo

One

Ste

p M

alar

ia P

f/Pa

n W

hole

Blo

od T

est

0

10

20

30

40

50

pLDH

Aldolase

pLDH + aldolase

Fals

e po

sitiv

e ra

te (%

)

†- Phase 2 Evaluation Panel included 90 Plasmodium spp. negative samples - 42 clean negatives; 27 samples with blood immunological abnormalities and 21 with non Plasmodium spp. infectious pathogens. RDTs - 2 tests x 2 lots at 200 parasites/μl and 1 test x 2 lots at 2000 parasites/μl*- includes pan of pv line on combination tests and pan-specific line on pan-specific only products.

Figure 14: Plasmodium spp. (pan or P. vivax test line*) false positive rate against clean negatives†

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)28

Adva

ntag

e M

al C

ard

Adva

ntag

e Pa

n M

alar

ia C

ard

AZO

G M

alar

ia p

f (H

RP-I

I) /p

v (p

LDH

) Ant

igen

Det

ectio

n Te

st D

evic

eBi

nax

Now

Mal

aria

Care

Star

t M

alar

ia H

RP2/

pLDH

(Pf/

PAN

) CO

MBO

Care

Star

t M

alar

ia p

LDH

(PAN

)Fi

rst

Resp

onse

Mal

aria

Ag

Com

bo (P

LDH

/HRP

2)Fi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Car

d Te

stH

exag

on M

alar

ia C

ombi

ICT

Mal

aria

Com

bo C

asse

tte

Test

(ML0

2)Im

mun

oqui

ck M

alar

ia +

4M

alar

ia P

.F/V

ivax

Mal

aria

Rap

id C

ombo

Mal

aria

Rap

id D

ual

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)O

ne S

tep

Mal

aria

Ant

igen

Str

ipO

nSig

ht –

Par

aQui

ck (P

an)

Opt

iMAL

-IT

Para

bank

Rap

id T

est

for M

alar

ia P

an (D

evic

e)Pa

rahi

t-To

tal D

evic

e Ra

pid

test

for P

. fal

cipa

rum

and

Pan

mal

aria

l spe

cies

Para

scre

en R

apid

Tes

t fo

r Mal

aria

Pan

/Pf (

Devi

ce)

Qui

ckst

ick

Mal

aria

Ant

igen

Tes

tSD

BIO

LIN

E M

alar

ia A

gSD

BIO

LIN

E M

alar

ia A

g Pf

/Pan

Won

dfo

One

Ste

p M

alar

ia P

f/Pa

n W

hole

Blo

od T

est

0

10

20

30

40

50

Non malaria infectious pathogens (pLDH)

Immunological abnormalities (pLDH)

Non malaria infectious pathogens (pLDH + aldolase)

Immunological abnormalities (pLDH + aldolase)

Non malaria infectious pathogens (aldolase)

Immunological abnormalities (aldolase)

% f

alse

pos

itiv

e

†- Phase 2 Evaluation Panel included 90 Plasmodium spp. negative samples - 42 clean negatives; 27 samples with blood immunological abnormalities and 21 with non Plasmodium spp. infectious pathogens. RDTs - 2 tests x 2 lots at 200 parasites/μl and 1 test x 2 lots at 2000 parasites/μl*- includes pan of pv line on combination tests and pan-specific line on pan-specific only products.

Figure 15: Plasmodium spp. (pan or P. vivax test line*) false positive rate against Plasmodium spp. negative samples containing potentially cross-reacting blood immunological abnormalities or infectious pathogens†

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)29

Figure 16 and 17 illustrates that high rates of detection of P. falciparum or of P. vivax were not associated with a significant overall increase in false positive rates.

0 25 50 75 1000

10

20

30

40

50

HRP2

pLDH

P. falciparum detection rate (%) at 200 parasites/µl

Fals

e po

sitiv

e ra

te (%

)Figure 16: P. falciparum false positive rate19 versus P. falciparum detection rate at low (200) parasite density (parasites/μl)

0 25 50 75 1000

10

20

30

40

50

pLDH

Aldolase

P. vivax detection rate (%) at 200 parasites/µl

Fals

e po

sitiv

e ra

te (%

)

Figure 17: P. vivax false positive rate versus P. vivax detection rate at low (200) parasite density (parasites/μl)

10.3.7. Inter-reader variability Each RDT result was read twice, the first, according to the manufacturers minimum reading time and a second reading was performed by a different technician within one hour. The mean time between readings for each product can be found in Tables A4.2, A4.3 (Annex 4). Figures 18 and 19 illustrate that for many products, the second reading yielded more positive results. However, for two products Reader 2 results returned fewer positive results secondary

to the fading of weak test band signals. In the case of 7 products20 manufacturers specifically indicated that a second reading should be performed if the initial results were negative. Results are therefore reported on the basis of the delayed reading in Tables 3a, 4a and in Annex 4 (Tables A4.1a, A4.4a-A4.12a)

20 Parascreen Rapid Test for Malaria (Pan/Pf) Device, Parabank Rapid Test for Malaria Pan (Device), Malascan Rapid Test for Malaria Pf/Pan (Device), ImmunoQuick Malaria + 4, Malaria Pf/vivax, Wondfo One Step Malaria Pf/Pan Whole Blood Test, FirstSign – ParaView-2 (Pv + Pf) Card Test.

19

19 On the clean negative panel, only.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)3 0

AD

VAN

CED

QU

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Y TM

MAL

ARIA

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ia (p

.f.) T

est

(who

le b

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)Ad

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aria

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aria

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aria

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*Firs

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View

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agon

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agon

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ivax

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apid

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apid

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ia R

apid

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ne S

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igen

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apid

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ce)

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id t

est

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um M

alar

ia (

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ARIA

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tal D

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. fal

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rum

and

Pan

mal

aria

l spe

cies

.*P

aras

cree

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pid

Test

for

Mal

aria

Pan

/Pf (

Devi

ce)

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ick

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aria

Ant

igen

Tes

tSD

BIO

LIN

E M

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NE

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aria

Ag

Pf/P

an*W

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o O

ne S

tep

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

t

0

25

50

75

100

Reader 1

Reader 2

Dete

ctio

n Ra

te (

%)

Figure 18: Wild type P. falciparum detection rate according to first and second readings at 200 parasites/μl

*- Manufacturers recommend a delayed reading if initial test results are negative.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)31

Figure 19: Wild type P. vivax detection rate according to first and second readings at 200 parasites/μl

Ad

vant

age

Mal

Car

dAd

vant

age

Pan

Mal

aria

Car

dAZ

OG

Mal

aria

pf (

HRP

-II)

/pv

(pLD

H) A

ntig

en D

etec

tion

Test

Dev

ice

Bina

x N

ow M

alar

iaCa

reSt

art

Mal

aria

HRP

2/pL

DH (P

f/PA

N) C

OM

BOCa

reSt

art

Mal

aria

pLD

H (P

AN)

Firs

t Re

spon

se M

alar

ia A

g Co

mbo

(PLD

H/H

RP2)

*Firs

tSig

n –

Para

View

-2 (P

v +

Pf) C

ard

Test

Hex

agon

Mal

aria

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biIC

T M

alar

ia C

ombo

Cas

sett

e Te

st (M

L02)

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unoq

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Mal

aria

+4

* Mal

aria

P.F

/Viv

axM

alar

ia R

apid

Com

boM

alar

ia R

apid

Dua

l*M

alas

can

Rapi

d Te

st fo

r Mal

aria

Pf/

Pan

(Dev

ice)

One

Ste

p M

alar

ia A

ntig

en S

trip

OnS

ight

– P

araQ

uick

(Pan

)O

ptiM

AL-I

T*P

arab

ank

Rapi

d Te

st fo

r Mal

aria

Pan

(Dev

ice)

Para

hit-

Tota

l Dev

ice

Rapi

d te

st fo

r P. f

alci

paru

m a

nd P

an m

alar

ial s

peci

es*P

aras

cree

n Ra

pid

Test

for M

alar

ia P

an/P

f (De

vice

)Q

uick

stic

k M

alar

ia A

ntig

en T

est

SD B

IOLI

NE

Mal

aria

Ag

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

an*W

ondf

o O

ne S

tep

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

t

0

25

50

75

100

Reader 1

Reader 2

Dete

ctio

n Ra

te (

%)

*- Manufacturers recommend a delayed reading if initial test results are negative.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)32

11. HEAT STABILITY

A single P. falciparum culture sample was used as the reference sample for heat stability testing. Variations in baseline performance reflect inter-test variation as the sample at 200 parasites/μl was at the limit of detection of some products.

Several products were stable, meaning that they detected a P. falciparum cultured sample the same number of times at baseline and following incubation for 2 months (75% humidity) at 4°C, 35°C and 45°C. Detailed results are presented in Tables A4.13-A4.15 (Annex 4); in Table 5 and Figs 20-29, the results of both lots are combined (maximum score 20; 10 tests per lot).

Overall products (including HRP2 and pan test lines) were significantly more stable against samples with high (2000 or 5000) compared to low parasite densities, Figures 21, 23, 25 and Figures 20, 22, 24, respectively. For several, P. falciparum and combination tests, HRP2 test lines showed a high degree of stability at 35°C but several dropped off at 45°C. Some products showed an improved performance with incubation (Figs 22, 26). Baseline detection based on pan test lines was lower than baseline HRP2 test line results and the pan test lines of many products had poorer stability than HRP2 test lines.

Ultimately, there are products in each test category (Pf only, combination, pan only) that show good consistent baseline detection and heat stability up to 45°C for 2 months.

The summary results of heat/thermal stability testing are presented in Table 5.

11.1. P. FALCIPARUM TEST LINES Figure 20: Heat stability of P. falciparum specific (HRP2) test line of P. falciparum only tests against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.

0

5

10

15

20

Parahit-f TEST DEVICE FOR FALCIPARUM MALARIAParacheck Pf Rapid Test for P. falciparum Malaria (Dipstick)Paracheck Pf Rapid Test for P. falciparum Malaria (Device)Malaria Rapid PfICT Malaria Pf Rapid Test (ML01)Hexagon MalariaFirstSign – Malaria Pf Card Test

CareStart Malaria HRP2 (Pf)First Response Malaria Ag HRP2Immunoquick Malaria FalciparumMalaria Plasmodium falciparum Rapid test Device (Whole blood)Parahit-f DIPSTICK FOR FALCIPARUM MALARIASD BIOLINE Malaria Ag Pf

Advantage P.f. Malaria CardADVANCED QUALITY TM One Step Malaria (p.f.) Test (whole blood)ADVANCED QUALITY TM MALARIA (p.f) POCT 45°C35°CBaseline

No. of positive results from two lots

Figure 21: Heat stability of P. falciparum (HRP2) test specific line of P. falciparum tests against a high density P. falciparum sample (2000 parasites/μl) . Positivity rate at baseline, and after 60 days incubation.

15

20

Parahit-f TEST DEVICE FOR FALCIPARUM MALARIAParacheck Pf Rapid Test for P. falciparum Malaria (Device)Hexagon MalariaFirstSign – Malaria Pf Card TestADVANCED QUALITY TM One Step Malaria (p.f.) Test (whole blood)

ADVANCED QUALITY TM MALARIA (p.f) POCTAdvantage P.f. Malaria CardCareStart Malaria HRP2 (Pf)First Response Malaria Ag HRP2ICT Malaria Pf Rapid Test (ML01)Immunoquick Malaria FalciparumMalaria Plasmodium falciparum Rapid test Device (Whole blood)Malaria Rapid PfParacheck Pf Rapid Test for P. falciparum Malaria (Dipstick)Parahit-f DIPSTICK FOR FALCIPARUM MALARIASD BIOLINE Malaria Ag Pf

45°C35°CBaseline

No. of positive results from two lots

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)33

Figure 22: Heat stability of P. falciparum specific (HRP2) test line in combination tests against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.

0

5

10

15

20

Wondfo One Step Malaria Pf/Pan Whole Blood TestCareStart Malaria HRP2/pLDH (Pf/PAN) COMBO

SD BIOLINE Malaria Ag Pf/PanBinax Now MalariaFirst Response Malaria Ag Combo (PLDH/HRP2)ICT Malaria Combo Cassette Test (ML02)Immunoquick Malaria +4Malaria Rapid ComboMalaria Rapid Dual

SD BIOLINE Malaria AgQuickstick Malaria Antigen TestOne Step Malaria Antigen StripParascreen Rapid Test for Malaria Pan/Pf (Device)ParahitTotal Device Rapid Test for P. falciparum and Pan Malarial SpeciesOptiMAL- ITOnSight – ParaQuick (Pan, Pf)Malascan Rapid Test for Malaria Pf/Pan (Device)

Malaria P.F/VIVAXHexagon Malaria CombiFirstSign – ParaView-2 (Pv + Pf) Card TestAdvantage Mal CardAZOG Malaria pf (HRP-II)/pv (pLDH) Antigen Detection Test Device

45°C35°CBaseline

No. of positive results from two lots

Figure 23: Heat stability of P. falciparum (HRP2) test specific line in combination tests against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation.

0

5

10

15

20

Quickstick Malaria Antigen TestOne Step Malaria Antigen Strip

Parascreen Rapid Test for Malaria Pan/Pf (Device)SD BIOLINE Malaria Ag Pf/PanBinax Now Malaria

ParahitTotal Device Rapid Test for P. falciparum and Pan Malarial SpeciesWondfo One Step Malaria Pf/Pan Whole Blood Test

OptiMAL- IT

Malaria P.F/VIVAXHexagon Malaria CombiFirstSign – ParaView-2 (Pv + Pf) Card Test

Advantage Mal CardCareStart Malaria HRP2/pLDH (Pf/PAN) COMBOFirst Response Malaria Ag Combo (PLDH/HRP2)ICT Malaria Combo Cassette Test (ML02)Immunoquick Malaria +4Malaria Rapid ComboMalaria Rapid DualMalascan Rapid Test for Malaria Pf/Pan (Device)OnSight – ParaQuick (Pan, Pf)SD BIOLINE Malaria Ag

AZOG Malaria pf (HRP-II)/pv (pLDH) Antigen Detection Test Device

45°C35°CBaseline

No. of positive results from two lots

Figure 24: Heat stability of pan-line of pan-specific tests against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.

0

5

10

15

20Parabank Rapid Test for Malaria Pan (Device)

CareStart Malaria pLDH (PAN)

Advantage Pan Malaria Card

45°C35°CBaseline

No. of positive results from two lots

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)3 4

Figure 25: Heat stability of pan-line of pan-specific tests against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation.

10

15

20Parabank Rapid Test for Malaria Pan (Device)

CareStart Malaria pLDH (PAN)Advantage Pan Malaria Card

45°C35°CBaseline

No. of positive results from two lots

11.2. PAN TEST LINESFigure 26: Heat stability of pan-line of combination tests against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.

0

5

10

15

20Wondfo One Step Malaria Pf/Pan Whole Blood TestSD BIOLINE Malaria Ag Pf/PanSD BIOLINE Malaria Ag

OptiMAL- ITOne Step Malaria Antigen StripQuickstick Malaria Antigen TestMalascan Rapid Test for Malaria Pf/Pan (Device)

Malaria Rapid DualMalaria Rapid ComboICT Malaria Combo Cassette Test (ML02)First Response Malaria Ag Combo (PLDH/HRP2)CareStart Malaria HRP2/pLDH (Pf/PAN) COMBO

Binax Now MalariaParascreen Rapid Test for Malaria Pan/Pf (Device)ParahitTotal Device Rapid Test for P. falciparum and Pan Malarial Species

Advantage Mal CardAZOG Malaria pf (HRP-II)/pv (pLDH) Antigen Detection Test Device

Hexagon Malaria CombiImmunoquick Malaria +4Malaria P.F/VIVAXOnSight – ParaQuick (Pan, Pf)

45°C35°CBaseline

No. of positive results from two lots

Figure 27: Heat stability of pan-line of combination tests against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation.

0

5

10

15

20 Wondfo One Step Malaria Pf/Pan Whole Blood TestSD BIOLINE Malaria Ag Pf/PanSD BIOLINE Malaria AgQuickstick Malaria Antigen TestOne Step Malaria Antigen StripParascreen Rapid Test for Malaria Pan/Pf (Device)ParahitTotal Device Rapid Test for P. falciparum and Pan Malarial SpeciesMalaria P.F/VIVAXHexagon Malaria Combi

OptiMAL- ITOnSight – ParaQuick (Pan, Pf)Malascan Rapid Test for Malaria Pf/Pan (Device)Malaria Rapid DualMalaria Rapid ComboImmunoquick Malaria +4ICT Malaria Combo Cassette Test (ML02)Binax Now MalariaAZOG Malaria pf (HRP-II)/pv (pLDH) Antigen Detection Test Device

Advantage Mal CardCareStart Malaria HRP2/pLDH (Pf/PAN) COMBOFirst Response Malaria Ag Combo (PLDH/HRP2)

45°C35°CBaseline

No. of positive results from two lots

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)35

Figure 28: Heat stability of pan-line of pan-specific tests only against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.

0

5

10

15

20Parabank Rapid Test for Malaria Pan (Device)CareStart Malaria pLDH (PAN)Advantage Pan Malaria Card

45°C35°CBaseline

No. of positive results from two lots

Figure 29: Heat stability of pan-line of pan-specific tests only against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation.

10

15

20Parabank Rapid Test for Malaria Pan (Device)

Advantage Pan Malaria CardCareStart Malaria pLDH (PAN)

45°C35°CBaseline

No. of positive results from two lots

12. EASE OF USE DESCRIPTION

After becoming proficient at using a product, two technicians jointly produced an agreed assessment of product usability. The results are presented in Table 6.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)3 6

Tabl

e 6:

Eas

e of

use

des

crip

tion

of

41 m

alar

ia r

apid

dia

gnos

tic

test

s

Prod

uct

Man

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ture

r

Bloo

d sa

fety

†In

stru

ctio

n qu

alit

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mbi

ned

scor

e (m

ax. 5

)

Num

ber

of t

imed

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eps

Tota

l ti

me

to

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lt

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d tr

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er

devi

ce

Form

at

Lang

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of

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ed in

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in

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) N

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MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)37

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MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)3 8

13. DISCUSSION OF KEY FINDINGS

This report describes the performance of many of the available malaria antigen-detecting RDTs manufactured under the ISO-13485 quality standard. Malaria RDTs have the potential to provide a huge step forward in the management of febrile illness in malaria-endemic areas. To be useful in this context, malaria RDTs must have adequate:

1. sensitivity, to detect nearly all clinically-significant cases of malaria;

2. specificity, to accurately discriminate non-malarial febrile illness from malaria, to ensure appropriate management and accurate disease monitoring;

3. stability, for accuracy to be maintained after transport and storage in ambient conditions;

4. ease of use and safety, to allow safe and correct preparation, and correct interpretation of results.

In order to assist national malaria control programmes, and other procurement agencies to select products appropriate to their needs, malaria RDTs were evaluated in terms of these four major requirements. The blood panel used successfully discriminated between the RDTs evaluated, showing a considerable range of performance. Importantly, a number of products demonstrated a high rate of antigen detection combined with a low false-positive rate and good heat (thermal) stability, attributes essential if they are to be relied on as a basis for malaria treatment decisions in most endemic populations.

The principal results in this report are presented in Tables 3, 3a, 4, 4a. The table groups the RDTs by type, depending on what they aim to detect, e.g. P. falciparum only, P. falciparum and non-falciparum species, or all malaria species without discrimination. Detection rates at both high and low concentrations are presented, as are false-positive rates, and the percentage of invalid test results. Tests in each category are listed alphabetically, but the results are colour-coded to assist the reader in quick interpretation of the data. These colour codes are intended to be used to quickly compare performance in the different categories and not as performance cut-offs to guide test selection or procurement. When choosing an appropriate product, it is important to also review the stability results (Table 5) in the context of the expected conditions of transport and storage of the RDTs in the field.

This evaluation is performed against a standardized panel of frozen blood samples by experienced technicians in a research laboratory and is not a field evaluation of RDT accuracy in a specific epidemiological context in the hands of intended users. The panel is designed to mimic fresh blood samples from real cases as closely as possible, while allowing direct comparison of a large number of products

simultaneously in a manner that controls for confounding factors and is calibrated to a level likely to discriminate performance differences of various products. In interpreting the results, it is therefore important that the following notes are taken into account.

13.1. PARASITE DETECTION AND ITS RELATIONSHIP TO SENSITIVITY

Evaluation of the RDTs against the parasite-positive panel with parasite densities of 200 parasites/μL (Figs 8, 9) revealed a wide range of detection rates between products. Testing at higher parasite densities (2000 or 5000 parasites/μL) was less able to demonstrate small differences in performance. As two tests each from two different lots were tested, and as all four results had to be positive for a sample to be considered detected by an RDT, a positive result indicated both the ability of a product to detect the target antigen in the sample, and to do this consistently (both tests from both lots).

The rate of detection against the panel used in this evaluation is expected to differ from the sensitivity for detection of malaria in a specific clinical setting. There are five main reasons for this:

i. Performance may vary between lots or batches of the same product. Variability in lot performance is an issue with all diagnostics, and it can not be guaranteed that the results found here will predict results from different RDT lots that are purchased. It is important to test lots prior to distribution to the field, to ensure that expected performance is maintained (Section 14.2).

ii. In clinical settings, patients show a wide variety of parasite densities, the range of which will depend on the local epidemiology of the disease. The magnitude of the parasite density in the population tested affects the clinical sensitivity of the test. Detection rates in the test panel of blood samples diluted to 200 parasites/μL are likely to underestimate the clinical sensitivity of an RDT in many situations, especially in high-transmission areas where symptomatic patients often have much higher parasite densities in their blood. Many tests that showed only moderate sensitivity against the 200 parasite/μL panel may perform very well in such settings, as shown by the high performance of most products against the panel set at 2000 parasites/μL.

Importantly, when interpreting Figs E1, 7, 8 and 9 and the colour coding in Tables 3, 3a, 4, 4a the small differences in detection rates found among the better-performing RDTs in this evaluation are unlikely to result in noticeable differences in clinical sensitivity, and other issues such as stability, cost, or ease of use and manufacturing capacity may be more important factors in test selection.

When considering the parasite density of the target populations and the likely field sensitivity of RDTs, it is important to note that, even in areas with high transmission and strong malaria immunity, populations may include individuals with low parasite densities but

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)39

clinically significant infections (e.g. young children, pregnant women, others with low immunity). The ability to detect low parasite density infections reliably therefore remains important in these cases.

iii. Performance of tests against the challenge panel may not directly relate to sensitivity in clinical testing as there is variability in the amino acid sequence of the HRP2 antigen of P. falciparum that may affect the ability of RDTs to detect it. In certain P. falciparum parasites the HRP2 antigen may not be detectable at all. Specifically, there is evidence that P. falciparum strains in some areas of South America may express HRP2 antigens very poorly or not at all.21 If a significant proportion of parasites in a given area do not express HRP2, it is necessary to use tests detecting other target antigens (pLDH or aldolase). The distribution of such strains is currently being mapped.

iv. The methods used to transport and store tests can affect their field sensitivity. All the tests used in this evaluation were shipped and stored under conditions intended to safeguard against degradation caused by high temperature or other extreme conditions. If similar precautions are not taken with purchased RDTs, loss of performance could result. Ambient temperatures of storage conditions vary widely in settings where these tests are commonly used, as do temperatures during transport, and requirements for heat stability of a product will therefore differ.

v. Diagnostic sensitivity and specificity are dependent on the quality of preparation and interpretation of the tests. Highly trained individuals performed all the testing in this product evaluation. In clinical settings, malaria RDTs will often be used by health workers with limited training and supervision. Simplicity of design and clearly-interpretable results will have an influence on ensuring that the technical proficiency of a product translates into accurate diagnosis in the field.

13.2. FALSE POSITIVE RATE AND SPECIFICITY False positive rates are reported here against a panel of 'clean' negative samples taken from blood donated in low-transmission settings by people without malaria symptoms. Also calculated were false positive rates against a smaller number of samples with specific characteristics that affect the likelihood of a false-positive result from an immuno-diagnostic test (e.g. rheumatoid factor, anti-nuclear antibody), or that may be of significance in a specific population (e.g. leishmaniasis, dengue). The importance of these results will vary with the intended area of use. High false positive rates against samples of blood from dengue patients, for example, may not be a significant factor to consider in regions where dengue does not occur. In view of the small number of samples in each category in this evaluation, the results should be considered primarily as a guide, to highlight potential cross-reactions that will require

21 WHO 2009, unpublished data. Clarification of these findings will be made in following publications of the WHO-FIND malaria RDT evaluation programme.

close monitoring if relevant to the target population.

In general, it is preferable to procure a product with a low rate of false-positive reactions. In the case of many diagnostic tests, a trade-off must be made between a preference for a high rate of antigen detection (sensitivity) and a low false positive rate (specificity). The context in which the test will be used will guide the relative importance of these two factors in choosing one product over another. In this evaluation there was no correlation of loss of sensitivity associated with high specificity, with a number of products attaining both a high detection rate (predicting a high sensitivity) and a low false-positive rate (predicting a high specificity).

13.3. HEAT (THERMAL) STABILITY RDTs in this evaluation were held for two months at 35°C and 45°C and then retested to evaluate stability at these temperatures. The importance of thermal stability will vary according to the ambient conditions under which a product is expected to be transported and stored. Thus, stability at high temperatures will be vital if an RDT is to be stored at clinic level in a country where ambient temperatures can reach 45°C in the hot season, but less critical in a high-altitude or cooler tropical environment where temperatures rarely rise above 35°C. Most of the commercial RDTs list 30°C as the maximal storage temperature. Higher temperatures were used for this evaluation because it is unusual for malaria–endemic countries to have maximum ambient temperatures less than 35°C, though the use of cool storage methods will also allow the use of less heat-stable products. Where transport and storage of RDTs is likely to occur at high ambient temperatures, heat (thermal) stability should be seen as a significant factor in ensuring maintenance of sensitivity.

High humidity will accelerate the degradation of malaria RDTs and other lateral flow tests. All the products in this evaluation were packaged in individual envelopes that contain a desiccant and are designed to be moisture-proof. This allows the user to open the envelope of a specific test at the time of use, limiting exposure to high humidity. During the stability testing phase of this evaluation, RDTs were stored at 75% humidity. The packaging should, if in good condition, protect the contents from exposure to high humidity during storage. As such, the stability testing results presented here provide an assessment of both the stability of the RDT and the quality of its packaging.

Several products showed high stability at the temperatures and time periods used in this evaluation. In general, pan-specific lines (pLDH and aldolase) were less stable than HRP2 test lines, but there was overlap between the antibodies against these targets with some pLDH tests maintaining high positivity rates after 2 months at 45°C. A small number of products showed a consistent improvement in positivity rate after incubation, for reasons which are not clear.

Though temperature and humidity were held constant in this evaluation, in the field temperatures fluctuate with time of day and season. While two months’ storage at a set temperature can not accurately predict long-term stability

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)4 0

under field conditions, loss of parasite detection over this period indicates a likelihood that significant sensitivity will be lost when similar or higher storage temperatures comprise a significant amount of the storage time, and indicates likelihood of a higher susceptibility to degradation during short periods of exposure to much higher temperatures, such as during transport (12, 13).

13.4. EASE OF USE DESCRIPTIONThe sensitivity and specificity of RDT results will depend to some extent on the quality of preparation and interpretation of the test. In general, a simpler format with fewer steps or fewer extraneous materials is likely to be prepared and interpreted more reliably. Thus, cassette-format RDTs are generally more reliably prepared and interpreted than products in dip-stick format (14). The extra cost involved in such a format may be offset by the advantages of increased accuracy and, in some cases, less additional equipment required to perform them.

The method of blood transfer from the patient to the test is important for the safety of the user, and for the accuracy of volume of blood transferred. Devices for blood transfer are supplied with RDTs, and vary widely in design. The performance of blood transfer devices was not formally assessed in this evaluation, as blood was transferred from a tube by a micro-pipette to ensure the manufacturer-specified volume was used. Programmes procuring RDTs should consider the adequacy of the blood transfer device supplied, including previous experience of health workers and the costs and time required for re-training. It may often be appropriate to discuss with manufacturers changing the blood transfer device from that normally supplied.

Clarity of results is important to test interpretation. A clearly visible (intense) test line is less likely to be overlooked than a line that is barely visible. While reading proficiency and adequate work places should always be ensured, health workers may sometimes have sub-optimal vision or work in conditions of inadequate lighting. The intensity of the line of the test band is closely associated with error rate and with the detection rate found in this report (Tables A4.4, A4.4a, A4.5, A4.5a).

The importance of format and simplicity of test design will depend on the intended end-users. Trained laboratory technicians may handle a complicated procedure more reliably than village-level volunteers with limited supervision. In all cases, specific proficiency-based training and adequate supervision should be included in any RDT-based diagnostic programme, and clear instructions should be provided in a language and format appropriate for the end-user22(14-16).

13.5. INTER-LOT VARIABILITY This testing programme evaluated only two production lots of each product. Malaria RDTs are complex biological

22 See www.wpro.who.int/sites/rdt for generic examples

products made of components commonly supplied from multiple sources, and subject to various conditions during manufacture that may affect the quality of the final product. All manufacturers entered in this evaluation have current ISO 13485:2003 certification, a standard designed to give assurance of consistency of quality of final product if correctly implemented. The results presented here indicate that inter-lot variability does occur, and WHO strongly recommends that a sample of RDTs from each production lot be tested prior to dissemination to the field to ensure it meets an appropriate standard. This can be facilitated by WHO (see section 14.2).

Since inter-test variability also occurs, this will be detected to some extent by routine lot testing. Ensuring manufacturers have good manufacturing standards should minimize the likelihood of inconsistencies due to poor practice in the manufacturing process.

13.6. INTER-READER VARIABILITYAll RDTs in this evaluation were interpreted by two technicians, blinded to the other technicians' results. The first reading was performed at the minimum time specified by the manufacturer to obtain a result, and this reading is used as the primary determinant of RDT performance. The second reading was obtained later, usually within 45 minutes, always within 90 minutes. Where a manufacturer specifically instructed in the product insert that interpretation be deferred if a result was not visible at the time of the initial reading, the result of the second reader was also reported.

The difference between the two readings reported here was therefore subject to the stability of the result: if a test became positive after the minimum time specified by a manufacturer to obtain a result, this appeared as a discrepancy between the two readers. The intensity of the test lines of antigen-detecting RDTs was also dependent on the amount of available antigen. Therefore, at the low parasite-densities used in this evaluation where a test line intensity was close to the limit of human visual perception (i.e. close to the operational limits of the product), inter-reader discrepancies were more likely to occur.

Early, accurate and stable RDT results are important in the context of busy clinical work. Specifying a single reading time at which the result can be determined to be negative or positive is also an advantage in terms of training and consistency of use. It is recommended that low inter-reader variability and early availability of result be considered in making decisions on procurement, but that the stability of the result (an adequate time period during which the result may be read) is also ensured.

13.7. TARGET ANTIGENS AND SPECIESMalaria RDTs included in this evaluation detect one or more of three parasite antigens (HRP2, pLDH, and aldolase) in various combinations. HRP2 is present only in P. falciparum, whereas aldolase and pLDH are present in all four species

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)41

and may be used as pan or all-species targets. Some tests use differences in pLDH sequences between species as a means to differentiate P. falciparum from P. vivax and other species. There is considerable overlap in the detection rates of products targeting the different antigens in this evaluation. While the products with the highest detection rates for P. falciparum targeted HRP2, a number of pLDH-detecting products demonstrated high detection rates against P. falciparum and P. vivax. The stability of tests targeting these different antigens also overlapped.

The choice of RDT should take target antigen into account: HRP2-detecting RDTs should not be used in areas where high rates of HRP2 non-expression occur. Tests detecting only HRP2 (without pLDH or aldolase lines) will have limited utility where non-falciparum malaria is common. pLDH (and possibly aldolase) RDTs may have further advantages where antigen persistence (common with HRP2) may result in a high false-positive rate in areas where early re-testing in the weeks soon after treatment is common.

The required sensitivity of a test may also vary with species; a less sensitive test may be acceptable for detection of P. vivax compared to detection of P. falciparum, as severe outcomes due to missed diagnoses are less likely. Use of a sufficiently sensitive pan-specific test may be appropriate in areas where both P. falciparum and P. vivax occur, if all infections were to be managed initially as a P. falciparum infection with artemisinin-based combination therapy (ACT).

It should be noted that pan-species tests were not evaluated for detection of P. ovale or P. malariae due to lack of sources of suitable mono-species infections of these parasites.

14. ADDITIONAL MEASURES TO ENSURE QUALITY AND UTILITY OF RDT TESTING

This report provides data to guide programmes in selecting products likely to perform to a high standard in the particular contexts in which the programme operates. The final decision on product selection requires that this data be considered in a systematic way, often with other data obtained from the manufacturer and other sources. An algorithm to guide this process, adapted from the quality assurance guide of the WHO Global Malaria Programme (found at www.wpro.who.int/sites/rdt) is given in Annex 5.

While malaria RDTs have application in a number of settings, the area in which they have the greatest impact on public health is in extension of access to accurate, parasite-based diagnosis of malaria to regions and populations where good quality microscopy-based analysis is impractical to maintain. This currently applies to most people at risk of malaria in endemic countries (1). In many settings where RDTs have been introduced, the true rate of parasitaemia has been found to be dramatically lower than expected, allowing health systems to save on wasted RDTs and to focus

appropriately on the management of non-malarial causes of fever, including pneumonia and sepsis. A successful RDT programme must therefore address not just malaria but also the management of other common and severe febrile illness that occur locally as differential diagnoses of malaria, if the potential full public health impact of an RDT programme is to be achieved.

14.1. BEYOND PROCUREMENTRDTs are often added to a procurement list that includes mainly chemical agents such as pharmaceuticals, bednets, and insecticides. Unlike these products, however, diagnostic tests are relatively more complex to implement, not least because they represent the starting point, not the end point, in a health system intervention, and their use presumes that appropriate patient management, based on testing, will follow. Thus, successful introduction of RDTs requires careful planning going beyond rational procurement to ensure consistent supplies of all necessary materials (including gloves, sharps disposal containers, and supplies required for further case management), training of users, and community sensitization. This extends beyond malaria management to management of other febrile diseases and health service delivery systems.

This report provides information to guide procurement of RDTs within this framework. A number of factors beyond performance characteristics reported here must influence procurement decisions. An example algorithm to guide these decisions is given in Annex 5. Details of implementation will vary widely between programmes according to local capacity and needs. Further recommendations on budgeting, planning and implementation can be found in Annex 6.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)42

14.2. LOT TESTING Complementary to the product testing programme, WHO and FIND currently support three laboratories that perform continual quality assurance of RDTs in the form of lot testing. These lot testing facilities respond to formal requests from national malaria programmes, manufacturers, and procurement bodies and assess the quality of RDT lots when they arrive in country, before distribution. Testing is performed with carefully prepared blood panels such as those used for this evaluation. A number of other national institutions have also developed this capacity. Lot-testing reassures countries that the product they have purchased is performing to a high standard and helps to ensure that manufacturers produce consistently good lots and improve their products.

Countries and/or manufacturers ship between 125-175 RDTs to the regional lot testing centre where they are evaluated against a small panel of parasites at high and low parasite

densities and negative samples. They are subsequently incubated at a temperature close to the manufacturer's specified storage temperature and retested every three months until their expiry date. Initial results are available after five days and then sent at regular intervals. Details of the protocol can be found in a published methods manual for lot testing.23

All countries and procuring agencies are encouraged to participate in the lot testing programme and in the near future it is intended to publish overall performance of products submitted for lot testing.

23 WHO, Rapid Diagnostic Tests for Malaria: Methods Manual for Laboratory Quality Control Testing. Version 5a. 2008, WHO - Regional Office for the Western Pacific. Available at: www.wpro.who.int/sites/rdt/documents/list.htm

15. CONCLUSIONS

This study is a landmark in the field of malaria RDT evaluations because of the number of products evaluated and its comprehensiveness including, samples with low and high parasite densities, detailed parasite characterization (antigen quantification, HRP 2,3 characterization) multiple test lots and heat stability assessment. New laboratory methods were developed and validated to support parasite characterization and this work generated new findings regarding the variation in antigen content at similar parasite densities and the variation in the structure and expression of HRP proteins. The latter will critically inform RDT selection in several endemic countries.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)43

16. REFERENCES

1. WHO, World Malaria Report 2008. 2008, WHO - Global Malaria Programme: Geneva.

2. WHO, WHO Technical Consultation to review the role of parasitological diagnosis to support malaria disease management: focus on the use of RDTs in areas of high transmission deploying ACT treatments. 2005, World Health Organization: Geneva.

3. Kolaczinski, J., et al., Comparison of the OptiMAL rapid antigen test with field microscopy for the detection of Plasmodium vivax and P. falciparum: considerations for the application of the rapid test in Afghanistan. Ann Trop Med Parasitol, 2004. 98(1): p. 15-20.

4. Richter, J., et al., Co-reactivity of plasmodial histidine-rich protein 2 and aldolase on a combined immuno-chromographic-malaria dipstick (ICT) as a potential semi-quantitative marker of high Plasmodium falciparum parasitaemia. Parasitol Res, 2004. 94(5): p. 384-5.

5. Huong, N.M., et al., Comparison of three antigen detection methods for diagnosis and therapeutic monitoring of malaria: a field study from southern Vietnam. Trop Med Int Health, 2002. 7(4): p. 304-8.

6. Mason, D.P., et al., A comparison of two rapid field immunochromatographic tests to expert microscopy in the diagnosis of malaria. Acta Trop, 2002. 82(1): p. 51-9.

7. Van den Broek, I., et al., Evaluation of three rapid tests for diagnosis of P. falciparum and P. vivax malaria in Colombia. Am J Trop Med Hyg, 2006. 75(6): p. 1209-15.

8. McMorrow, M.L., et al., Challenges in routine implementation and quality control of rapid diagnostic tests for malaria--Rufiji District, Tanzania. Am J Trop Med Hyg, 2008. 79(3): p. 385-90.

9. Wanji, S., et al., Performance and usefulness of the Hexagon rapid diagnostic test in children with asymptomatic malaria living in the Mount Cameroon region. Malar J, 2008. 7: p. 89.

10. Willcox, M.L., et al., Rapid diagnostic tests for the home-based management of malaria, in a high-transmission area. Ann Trop Med Parasitol, 2009. 103(1): p. 3-16.

11. Belizario, V.Y., et al., Field evaluation of malaria rapid diagnostic tests for the diagnosis of P. falciparum and non-P. falciparum infections. Southeast Asian J Trop Med Public Health, 2005. 36(3): p. 552-61.

12. Jorgensen, P., et al., Malaria rapid diagnostic tests in tropical climates: The need for a cool chain. American Journal of Tropical Medicine and Hygiene, 2006. 74(5).

13. Chiodini, P.L., et al., The heat stability of Plasmodium lactate dehydrogenase-based and histidine-rich protein 2-based malaria rapid diagnostic tests. Trans R Soc Trop Med Hyg, 2007. 101(4): p. 331-7.

14. Rennie, W., et al., Minimising human error in malaria rapid diagnosis: clarity of written instructions and health worker performance. Trans R Soc Trop Med Hyg, 2007. 101(1): p. 9-18.

15. Harvey, S.A., et al., Improving community health worker use of malaria rapid diagnostic tests in Zambia: package instructions, job aid and job aid-plus-training. Malar J, 2008. 7(1): p. 160.

16. Tavrow, P., E Knebel, L Cogswell, Using quality design to improve malaria rapid diagnostic tests in Malawi, in Operations Research Results 1(4). 2000, Published for the United States Agency for International Development (USAID) by the Quality Assurance Project (QAP): Bethesda, Maryland.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)4 4

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)45

ANNEXES

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)4 6

ANNE

X 1:

CHAR

ACTE

RISTIC

S OF

RAP

ID M

ALAR

IA TE

STS

IN TH

E EV

ALUA

TION

Man

ufac

ture

rPr

oduc

t na

me

Plas

mod

ium

sp

ecie

s ta

rget

ed(F

=P.

fa

lcip

arum

V

=P.

viv

ax

O =

P. o

vale

M =

P. m

alar

iae

P =

PAN

; maj

or

Plas

mod

ium

sp

ecie

s)

Targ

et

Ant

igen

1Fo

rmat

Sequ

ence

and

typ

e of

bou

nd a

ntib

ody2

Requ

ired

vo

lum

e (μ

l) of

w

hole

bl

ood

Buff

er

volu

me

(dro

ps)

Inte

rmed

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St

ep

Tim

e to

re

sult

s3 (m

ins)

Max

imum

re

adin

g ti

me3

Resu

lts

Inte

rpre

-ta

tion

(T

ype

A-E

)4

Resu

lts

Inte

rpre

tati

on (

Type

A-E

)4

CT1

T2

Acce

ss B

io, I

nc.

Care

Star

t M

alar

ia p

LDH

(P

AN)

PpL

DH

Cass

ette

√pL

DH

52

drop

s -

20

-

B

CT

SA

Care

Star

t M

alar

ia H

RP2/

pLD

H (P

f/PA

N) C

OM

BO

F, P

pLD

H/H

RP2

Cass

ette

√pL

DH

HRP

25

2 dr

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-

20 -

C

CT1

T2S

A

Care

Star

t M

alar

ia H

RP2

(Pf)

FH

RP2

Cass

ette

√H

RP2

52

drop

s -

20

-

A

CT

SA

ACO

N

Labo

rato

ries,

In

c.

Mal

aria

Pl

asm

odiu

m

falc

ipar

um

Rapi

d Te

st

Dev

ice

(Who

le

Bloo

d)

FH

RP2

Cass

ette

√H

RP2

203

drop

sM

ixin

g tim

e 1

min

, squ

eeze

tu

be 5

tim

es

1020

A

CT

S

Amge

nix

Inte

rnat

iona

l, In

c.

OnS

ight

-

Para

Qui

ck

(Pan

, Pf)

Tes

tP,

FpL

DH

,HRP

2Ca

sset

te√

pLD

HH

RP2

56

drop

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15

15C

CT1

T2A

B

AZO

G, I

nc.

AZO

G M

alar

ia

pf (H

RP-I

I) /

pv (p

LDH

) An

tigen

D

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tion

Test

D

evic

e

F,P"H

RP2,

pL

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Cass

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20 -

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Imm

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M

alar

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Falc

ipar

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HRP

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√H

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20

adul

ts/5

ch

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drop

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10

15A

CT

Imm

unoq

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M

alar

ia +

4F,

PH

RP2/

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ipst

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√pL

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HRP

220

ad

ults

/5

child

ren

6 dr

ops

Buff

er in

tube

, Bl

ood

on s

tick,

st

ick

in tu

be15

30C

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T1

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)47

Man

ufac

ture

rPr

oduc

t na

me

Plas

mod

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sp

ecie

s ta

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Ant

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Sequ

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typ

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bou

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Requ

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l) of

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Buff

er

volu

me

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ps)

Inte

rmed

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St

ep

Tim

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sult

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ins)

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imum

re

adin

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me3

Resu

lts

Inte

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-ta

tion

(T

ype

A-E

)4

Resu

lts

Inte

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on (

Type

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Dia

gnos

tics

Auto

mat

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Inc.

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aria

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vax

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2Al

dola

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1 dr

ops

1 dr

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bl

ood

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drop

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min

(30

min

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an,

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k√

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(pf

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ifi c)

pLD

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l

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co

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stic

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l, w

ait 5

min

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was

hing

wel

l, w

ait 1

0 m

in"

15 -

C

CT2

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MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)4 8

Man

ufac

ture

rPr

oduc

t na

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ecie

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=P.

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or

Plas

mod

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ence

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bou

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lum

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l) of

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hole

bl

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er

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me

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sult

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ins)

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re

adin

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lts

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ype

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vate

k M

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c.

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ckst

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aria

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tigen

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(pan

, pf

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ick

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spec

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te

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l,3

drop

s w

ashi

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wel

l

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njug

ate

wel

l, m

ix a

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wai

t 1 m

in,

stic

k in

wel

l, w

ait 5

min

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ick

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l, w

ait 1

0 m

in

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c Pr

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ts,

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D Q

UAL

ITY

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p M

alar

ia (p

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(who

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d)

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/str

ip

look

s lik

e a

cass

ette

!

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RP2

103

drop

s (4

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ops)

-

-

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TC

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NCE

D Q

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ITY

TM

MAL

ARIA

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sepa

rate

pr

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t in

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edic

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ow

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aria

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tigen

Cass

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√H

RP2

pan

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an

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drop

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D

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MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)49

Man

ufac

ture

rPr

oduc

t na

me

Plas

mod

ium

sp

ecie

s ta

rget

ed(F

=P.

fa

lcip

arum

V

=P.

viv

ax

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alar

iae

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or

Plas

mod

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sp

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s)

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et

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nd a

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ired

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l) of

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hole

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volu

me

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rmed

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ep

Tim

e to

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sult

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ins)

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imum

re

adin

g ti

me3

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lts

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rpre

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tion

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ype

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Resu

lts

Inte

rpre

tati

on (

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)4

CT1

T2

J. M

itra

& C

o.

Pvt.

Ltd.

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ntag

e P.

f. M

alar

ia C

ard

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√H

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55

drop

s -

20

+

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52

drop

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20

-

A

TC

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)50

Man

ufac

ture

rPr

oduc

t na

me

Plas

mod

ium

sp

ecie

s ta

rget

ed(F

=P.

fa

lcip

arum

V

=P.

viv

ax

O =

P. o

vale

M =

P. m

alar

iae

P =

PAN

; maj

or

Plas

mod

ium

sp

ecie

s)

Targ

et

Ant

igen

1Fo

rmat

Sequ

ence

and

typ

e of

bou

nd a

ntib

ody2

Requ

ired

vo

lum

e (μ

l) of

w

hole

bl

ood

Buff

er

volu

me

(dro

ps)

Inte

rmed

iate

St

ep

Tim

e to

re

sult

s3 (m

ins)

Max

imum

re

adin

g ti

me3

Resu

lts

Inte

rpre

-ta

tion

(T

ype

A-E

)4

Resu

lts

Inte

rpre

tati

on (

Type

A-E

)4

CT1

T2

ICT

Dia

gnos

tics

ICT

Mal

aria

Pf

Cass

ette

Tes

t (M

L01)

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Cass

ette

√H

RP2

55

drop

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15

15A

TC

ICT

Mal

aria

Co

mbo

Ca

sset

te T

est

(ML0

2)

F, P

HRP

2/pa

n m

alar

ia

Antig

enCa

sset

te√

HRP

2pa

n m

alar

ia

antig

en5

5 dr

ops

-

1515

D

CT1

T1

Span

Dia

gnot

ics

Ltd.

Para

hit-

f D

IPST

ICK

FOR

FALC

IPAR

UM

M

ALAR

IA

FH

RP2

Dip

stic

k√

HRP

28

4 dr

ops

Buff

er in

tu

be, b

lood

on

stic

k,St

ick

in tu

be

1530

A

CT

Para

hit-

f TES

T D

EVIC

E FO

R FA

LCIP

ARU

M

MAL

ARIA

FH

RP2

Cass

ette

√H

RP2

84

drop

s15

30A

CT

Para

hit-

Tota

l D

evic

e Ra

pid

test

for P

. fa

lcip

arum

an

d Pa

n m

alar

ial

spec

ies

F, P

HRP

2/pL

DH

/al

dola

seCa

sset

te√

HRP

2pL

DH

/ad

olas

e 8

4 dr

ops

1530

D

CT1

T2

Stan

dard

D

iagn

ostic

s In

c.

SD B

IOLI

NE

Mal

aria

Ag

F, P

pLD

H"C

asse

tte

√pL

DH

(p

an)

pLD

H

(Pf)

54

drop

s -

15

30C

CT1

T2A

B

Dip

stic

k"√

pLD

H (p

an)

pLD

H (P

f)5

HRP

25

4 dr

ops

-

1530

A

CT1

AB

SD B

IOLI

NE

Mal

aria

Ag

Pf/

Pan

FH

RP2

Cass

ette

√H

RP2

54

drop

s -

15

30C

CT1

T2A

B

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)51

Man

ufac

ture

rPr

oduc

t na

me

Plas

mod

ium

sp

ecie

s ta

rget

ed(F

=P.

fa

lcip

arum

V

=P.

viv

ax

O =

P. o

vale

M =

P. m

alar

iae

P =

PAN

; maj

or

Plas

mod

ium

sp

ecie

s)

Targ

et

Ant

igen

1Fo

rmat

Sequ

ence

and

typ

e of

bou

nd a

ntib

ody2

Requ

ired

vo

lum

e (μ

l) of

w

hole

bl

ood

Buff

er

volu

me

(dro

ps)

Inte

rmed

iate

St

ep

Tim

e to

re

sult

s3 (m

ins)

Max

imum

re

adin

g ti

me3

Resu

lts

Inte

rpre

-ta

tion

(T

ype

A-E

)4

Resu

lts

Inte

rpre

tati

on (

Type

A-E

)4

CT1

T2

Uni

med

In

tern

atio

nal,

Inc.

Firs

tSig

n –

Mal

aria

Pf

Card

Tes

tF

HRP

2Ca

sset

te√

HRP

25

6 dr

ops

-

1515

A

CT

SR

Firs

tSig

n –

Para

View

-2

(Pv

+ Pf

) Car

d Te

st

F, V

pLD

H/H

RP2

Cass

ette

√pL

DH

(s

peci

fi c

Pv)

HRP

25

4 dr

ops

-

1515

E

CT1

T2S

R

Visi

on B

iote

ch

(Pty

) Ltd

.

Mal

aria

Rap

id

PfF

HRP

2Ca

sset

te√

HRP

25

5 dr

ops

-

15 -

A

CT

Mal

aria

Rap

id

Com

boP,

FH

RP2/

Aldo

lase

Cass

ette

√H

RP2

Aldo

lase

55

drop

s -

15

-

D

CT1

T2

Mal

aria

Rap

id

Dua

l P,

FH

RP2/

pLD

HCa

sset

te√

HRP

2pL

DH

55

drop

s -

15

-

D

CT1

T2

Gua

ngzh

ou

Won

dfo

Biot

ech

Co. L

td.

Won

dfo

One

St

ep M

alar

ia

Pf/P

an W

hole

Bl

ood

Test

F, P

pLD

H/

HRP

2Ca

sset

te√

pLD

HH

RP2

53

drop

s -

15

30C

CT1

T2A

B

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)52

Man

ufac

ture

rPr

oduc

t na

me

Plas

mod

ium

sp

ecie

s ta

rget

ed(F

=P.

fa

lcip

arum

V

=P.

viv

ax

O =

P. o

vale

M =

P. m

alar

iae

P =

PAN

; maj

or

Plas

mod

ium

sp

ecie

s)

Targ

et

Ant

igen

1Fo

rmat

Sequ

ence

and

typ

e of

bou

nd a

ntib

ody2

Requ

ired

vo

lum

e (μ

l) of

w

hole

bl

ood

Buff

er

volu

me

(dro

ps)

Inte

rmed

iate

St

ep

Tim

e to

re

sult

s3 (m

ins)

Max

imum

re

adin

g ti

me3

Resu

lts

Inte

rpre

-ta

tion

(T

ype

A-E

)4

Resu

lts

Inte

rpre

tati

on (

Type

A-E

)4

CT1

T2

Zeph

yr

Biom

edic

als

Para

scre

en

Rapi

d Te

st fo

r M

alar

ia P

an/

Pf (D

evic

e)

P, F

pLD

H, H

RP2

Cass

ette

√pL

DH

HRP

25

4 dr

ops

-

15-3

0 -

C

CT1

T2A

B

Para

bank

Ra

pid

Test

for

Mal

aria

Pan

(D

evic

e)

PpL

DH

Cass

ette

√pL

DH

54

drop

s *

15-3

0 -

B

CT

AB

Mal

asca

n Ra

pid

Test

for

Mal

aria

Pf/

Pan

(Dev

ice)

F, P

HRP

2, P

an

spec

ifi c

aldo

lase

Cass

ette

√Al

dola

seH

RP2

54

drop

s -

15

-30

-

C

CT1

T2A

B

1 -

pLD

H =

plas

mod

ium

lact

ate

dehy

drog

enas

e ; H

RP =

hist

idin

e ric

h pr

otei

n 2

- Se

quen

ce w

hen

test

hel

d In

a h

oriz

onta

l pos

ition

and

the

sam

ple

wel

l at f

ar ri

ght a

nd c

ontr

ol li

ne f

ar le

ft3

- Fr

om p

lace

men

t of b

uffe

r, or

fro

m 'i

nter

med

iate

ste

p' if

this

is p

rese

nt4

- Se

e An

nex

2Ea

ch p

rodu

ct s

houl

d id

eally

be

acco

mpa

nied

by

all r

equi

red

mat

eria

ls (l

ance

t, pi

pett

e et

c.) P

artic

ular

ly w

hen

used

at t

he v

illag

e he

alth

wor

ker l

evel

; how

ever

, thi

s is

oft

en n

ot th

e ca

se a

nd th

e co

nten

ts d

epen

d on

the

requ

est o

f pro

curin

g ag

ent.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)53

ANNEX 2: MALARIA RDT GUIDE TO RESULTS INTERPRETATION

Type A: Malaria Generic Pf RDT Results Guide

Results Window: C=control line; T=test line with bound HRP-2 antibody.

C T

Negative Results: One line 'C' appears in the results window

C T

positive Results: P. falciparum infection. Two lines 'C' and 'T' appear in the results window. Test is positive even if the test line is faint

C T

C T

Invalid Results: No 'C' line appears in the results window. Repeat the test using a new RDT if no control line appears.

C T

C T

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)54

Type B: Malaria Generic Major Plasmodium species (PAN) RDT Results Guide

Results Window: C=control line; T=test line with bound HRP2 antibody.

C T

Negative Results: One line 'C' appears in the results window

C T

positive Results: Plasmodium species (P. falciparum, P. vivax, P.malariae, P.ovale) infection. Two lines 'C' and 'T' appear in the results window. Test is positive even is the test line is faint

C T

C T

Invalid Results: No 'C' line appears in the results window. Repeat the test using a new RDT if no control line appears.

C T

C T

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)55

Type C: Malaria Generic Pan-Pf RDT Results Guide

Results Window: C=control line; T1=test line with bound pLDH or aldolase antibody; T2=test line with bound HRP2 or Pf specifi c pLDH antibody.

C T2T1

Negative Results: Only one line 'C' appears in the results window.

C T1 T2

positive Results:

P. falciparum: Two lines 'C' and 'T2" appear in the results window.

C T1 T2

C T1 T2

Non-falciparum infection (P. vivax, P.ovale, P.malariae) or mixed infection of these: Two lines 'C' and 'T1" appear in the results window.

C T1 T2

P. falciparum or mixed infection. Three lines 'C', 'T1' and 'T2' appear in the results window.

C T1 T2

Invalid Results: No 'C' line appears in the results window. Repeat the test using a new RDT if no control line appears.

C T1 T2

C T1 T2

C T1 T2

C T1 T2

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)56

Type D: Malaria Generic Pf-Pan RDT Results Guide

Results Window: C=control line; T1=test line with bound HRP2 or Pf specifi c LDH antibody; T2=test line with bound pLDH or aldolase antibody

C T2T1

Negative Results: Only one line 'C' appears in the results window.

C T

positive Results:

P. falciparum infection. Two lines 'C' and 'T1" appear in the results window.

C T1 T2

Non-falciparum infection (P. vivax, P.ovale, P.malariae) or mixed infection of these. Two lines 'C' and 'T2" appear in the results window

C T1 T2

P. falciparum or mixed infection. Three lines 'C', 'T1' and 'T2' appear in the results window.

C T1 T2

Invalid Results: No 'C' line appears in the results window. Repeat the test using a new RDT if no control line appears.

C T1 T2

C T1 T2

C T1 T2

C T1 T2

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)57

Type E: Malaria Generic Pv-Pf RDT Results Guide

Results Window: C=control line; T1=test line with bound P. vivax specifi c pLDH; T2=test line with bound HRP-2 antibody.

C T2T1

Negative Results: Only one line 'C' appears in the results window.

C T

positive Results:

P. falciparum infection. Two lines 'C' and 'T2" appear in the results window

C T1 T2

C T1 T2

P. vivax infection. Two lines 'C' and 'T1" appear in the results window

C T1 T2

P. falciparum and P. vivax mixed infection. Three lines 'C', 'T1' and 'T2' appear in the results window.

C T1 T2

Invalid Results: No 'C' line appears in the results window. Repeat the test using a new RDT if no control line appears.

C T1 T2

C T1 T2

C T1 T2

C T1 T2

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)58

ANN

EX 3:

PHAS

E 1

RESU

LTS

Tabl

e A

3.1:

Lot

var

iabi

lity

in p

osit

ive

resu

lts†

agai

nst

P. f

alci

paru

m c

ultu

re s

ampl

es a

t lo

w (

200)

and

hig

h (2

000

or 5

000)

par

asit

e de

nsit

ies

(par

asit

es/μ

l)

Prod

uct

Man

ufac

ture

r

P. f

alci

paru

m s

ampl

es (

n=20

)

Tot

al p

osit

ive

resu

lts

retu

rned

200

para

site

s/μl

2,00

0 or

5,0

00 p

aras

ites

/μl

Lot

1 Lo

t 2

Lot

1 Lo

t 2

Test

1

Test

2N

o. p

osit

ive

agre

emen

ts

(max

=20)

*Te

st 1

Te

st 2

No.

pos

itiv

e ag

reem

ents

(m

ax=2

0)*

Test

1Te

st 1

Pf o

nly

ADVA

NCE

D QU

ALIT

Y TM

MAL

ARIA

(p.f)

POC

T In

Tec

Prod

ucts

, Inc

.7

74

69

419

19AD

VAN

CED

QUAL

ITY

TM O

ne S

tep

Mal

aria

(p.f.

) Tes

t (w

hole

bl

ood)

InTe

c Pr

oduc

ts, I

nc.

912

77

74

2018

Adva

ntag

e P.

f. M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

1919

1818

1817

2020

Care

Star

t Mal

aria

HRP

2 (P

f)Ac

cess

Bio

, Inc

.20

2020

2020

2020

20Fi

rst R

espo

nse

Mal

aria

Ag

HRP

2Pr

emie

r Med

ical

Cor

pora

tion

Ltd.

2020

2020

2020

2020

Firs

tSig

n –

Mal

aria

Pf C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.7

20

12

116

18H

exag

on M

alar

iaH

uman

Gm

bH6

11

47

419

20IC

T M

alar

ia P

f Cas

sett

e Te

st (M

L01)

ICT

Diag

nost

ics

1918

1814

1511

2020

Imm

unoq

uick

Mal

aria

Fal

cipa

rum

Bios

ynex

1515

1414

1212

2020

Mal

aria

Pla

smod

ium

falc

ipar

um R

apid

test

Dev

ice

(Who

le

bloo

d)AC

ON L

abor

ator

ies,

Inc.

1919

1917

1917

2019

Mal

aria

Rap

id P

fVi

sion

Bio

tech

(Pty

) Ltd

.17

1715

1817

1720

20Pa

rach

eck

Pf R

apid

test

for P

. fal

cipa

rum

Mal

aria

(Dev

ice)

Or

chid

Bio

med

ical

Sys

tem

s7

7 (1

9)3

1412

1019

18 (1

8)Pa

rach

eck

Pf R

apid

test

for P

. fal

cipa

rum

Mal

aria

(Dip

stic

k)

Orch

id B

iom

edic

al S

yste

ms

1215

1216

1413

2020

Para

hit-

f DIP

STIC

K FO

R FA

LCIP

ARU

M M

ALAR

IASp

an D

iagn

ostic

s Lt

d.16

1515

149

920

20Pa

rahi

t-f T

EST

DEVI

CE F

OR F

ALCI

PARU

M M

ALAR

IASp

an D

iagn

ostic

s Lt

d.2

42

66

320

18SD

BIO

LIN

E M

alar

ia A

g Pf

St

anda

rd D

iagn

ostic

s, In

c.19

1818

1919

1920

20Pf

& P

an/P

f &

Pv

Adva

ntag

e M

al C

ard

J. M

itra

& C

o. P

vt. L

td.

45

10

10

2020

AZOG

Mal

aria

pf (

HRP

-II)/

pv (p

LDH

) Ant

igen

Det

ectio

n Te

st D

evic

eAZ

OG, I

nc.

1818

1718

1918

2020

Bina

x N

ow M

alar

ia

Inve

rnes

s M

edic

al In

nova

tions

, Inc

.17

1717

1716

1620

20Ca

reSt

art M

alar

ia H

RP2/

pLDH

(Pf/

PAN

) COM

BOAc

cess

Bio

, Inc

.20

1919

2020

2020

20Fi

rst R

espo

nse

Mal

aria

Ag

Com

bo (P

LDH

/HRP

2)Pr

emie

r Med

ical

Cor

pora

tion

Ltd.

2020

2019

2019

2020

Firs

tSig

n –

Para

View

-2 (P

v +

Pf) C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.9

64

99

720

19H

exag

on M

alar

ia C

ombi

Hum

an G

mbH

43

29

127

1920

ICT

Mal

aria

Com

bo C

asse

tte

Test

(ML0

2)IC

T Di

agno

stic

s18

1716

1918

1720

20Im

mun

oqui

ck M

alar

ia +

4Bi

osyn

ex17

1717

1920

1920

20

Mal

aria

P.F

/Viv

axDi

agno

stic

Aut

omat

ion

/ Cor

tez

Diag

nost

ics,

Inc.

0 (1

5)0

(11)

0 (1

8)0

(15)

0 (1

1)0

(16)

2(10

)0

(14)

Mal

aria

Rap

id C

ombo

Visi

on B

iote

ch (P

ty) L

td.

1413

1116

1513

2019

Mal

aria

Rap

id D

ual

Visi

on B

iote

ch (P

ty) L

td.

1817

1617

1816

2020

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s10

87

55

320

20On

e St

ep M

alar

ia A

ntig

en S

trip

IND

Diag

nost

ic In

c.0

00

00

015

17On

Sigh

t – P

araQ

uick

(Pan

, Pf)

Test

Amge

nix

Inte

rnat

iona

l, In

c.15

1513

1617

1620

20Op

tiMAL

-IT

DiaM

ed A

G0

00

00

020

20Pa

rahi

t-To

tal D

evic

e Ra

pid

test

for P

. fal

cipa

rum

and

Pan

m

alar

ial s

peci

es.

Span

Dia

gnos

tics

Ltd.

55

35

41

1819

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf (

Devi

ce)

Zeph

yr B

iom

edic

als

810

614

1212

2020

Quic

kstic

k M

alar

ia A

ntig

en T

est

Inno

vate

k M

edic

al In

c.0

00

00

015

17SD

BIO

LIN

E M

alar

ia A

gSt

anda

rd D

iagn

ostic

s, In

c.0

00

02

018

19SD

BIO

LIN

E M

alar

ia A

g Pf

/Pan

St

anda

rd D

iagn

ostic

s, In

c.17

1817

1718

1720

20W

ondf

o On

e St

ep M

alar

ia P

f/Pa

n W

hole

Blo

od T

est

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d13

129

119

818

19

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)59

Tabl

e A

3.1a

: Lot

var

iabi

lity

in p

osit

ive

resu

lts

agai

nst

P. f

alci

paru

m c

ultu

re s

ampl

es a

t lo

w (

200)

and

hig

h (2

000

or 5

000)

par

asit

e de

nsit

ies

(par

asit

es/μ

l) ba

sed

on a

de

laye

d re

adin

g w

hen

spec

ified

by

the

man

ufac

ture

r

Prod

uct

Man

ufac

ture

r

P. f

alci

paru

m s

ampl

es (

n=20

)

Tot

al p

osit

ive

resu

lts

retu

rned

200

para

site

s/μl

2,00

0 or

5,0

00 p

aras

ites

/μl

Lot

1 Lo

t 2

Lot

1 Lo

t 2

Test

1

Test

2N

o. p

osi-

tive

agr

eem

ents

(m

ax=2

0)*

Test

1

Test

2N

o. p

osi-

tive

agr

eem

ents

(m

ax=2

0)*

Test

1Te

st 1

Pf &

Pan

/Pf

& P

vFi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Car

d Te

stU

nim

ed In

tern

atio

nal,

Inc.

1315

1115

1313

2019

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

1919

1819

1918

2020

Mal

aria

P.F

/Viv

axDi

agno

stic

s Au

tom

atio

n/Co

rtez

Dia

-gn

ostic

s, In

c.1

(16)

0 (1

1)1

(18)

1(15

)2

(11)

1 (1

6)1

(12)

0 (1

4)

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s10

107

915

820

20Pa

rasc

reen

Rap

id T

est f

or M

alar

ia P

an/P

f (De

vice

)Ze

phyr

Bio

med

ical

s18

1414

1717

1720

20W

ondf

o On

e St

ep M

alar

ia P

f/Pa

n W

hole

Blo

od T

est

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d11

128

1616

1518

19Pa

n on

lyPa

raba

nk R

apid

Tes

t for

Mal

aria

Pan

(Dev

ice)

Zeph

yr B

iom

edic

als

41

01

31

2019

Pf -

Pla

smod

ium

falc

ipar

um

Pv -

Pla

smod

ium

viv

axpa

n -

Plas

mod

ium

spe

cies

* N

umbe

r of s

ampl

es th

at re

turn

ed a

pos

itive

resu

lt fo

r bot

h te

sts.

Whe

re o

ne te

st w

as in

valid

and

the

othe

r pos

itive

, pos

itive

agr

eem

ent w

as re

cord

ed.

Prod

uct

Man

ufac

ture

r

P. f

alci

paru

m s

ampl

es (

n=20

)

Tot

al p

osit

ive

resu

lts

retu

rned

200

para

site

s/μl

2,00

0 or

5,0

00 p

aras

ites

/μl

Lot

1 Lo

t 2

Lot

1 Lo

t 2

Test

1

Test

2N

o. p

osit

ive

agre

emen

ts

(max

=20)

*Te

st 1

Te

st 2

No.

pos

itiv

e ag

reem

ents

(m

ax=2

0)*

Test

1Te

st 1

Pan

only

Adva

ntag

e Pa

n M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

138

62

21

2019

Care

Star

t Mal

aria

pLD

H (P

AN)

Acce

ss B

io, I

nc.

1818

1717

1513

2020

Para

bank

Rap

id T

est f

or M

alar

ia P

an (D

evic

e)Ze

phyr

Bio

med

ical

s0

00

00

018

14Pf

- P

lasm

odiu

m fa

lcip

arum

Pv

- P

lasm

odiu

m v

ivax

pan

- Pl

asm

odiu

m s

peci

es

† res

ults

are

bas

ed o

n th

e fir

st re

ader

s in

terp

reta

tion

acco

rdin

g to

man

ufac

ture

rs in

stru

ctio

ns.

* Num

ber o

f sam

ples

that

retu

rned

a p

ositi

ve re

sult

for b

oth

test

s. W

here

one

test

was

inva

lid a

nd th

e ot

her p

ositi

ve, p

ositi

ve a

gree

men

t was

reco

rded

.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)6 0

Tabl

e A

3.2:

Det

ecti

on ra

te o

f 20

P. fa

lcip

arum

cul

ture

line

s at l

ow a

nd h

igh

para

site

den

siti

es b

ased

on

init

ial r

eadi

ng a

ccor

ding

to m

anuf

actu

rers

inst

ruct

ions

and

a d

elay

ed

seco

nd r

eadi

ng p

erfo

rmed

wit

hin

1 ho

ur.

Prod

uct

Man

ufac

ture

r

Dete

ctio

n ra

te‡

200

para

site

s/μl

2,00

0 -

5,00

0 pa

rasi

tes/

μl

Read

er

1† (n=

80)

Read

er 2

(n

=80)

Perc

ent

agre

emen

t be

twee

n re

a-de

rs (

n=80

)

Mea

n ti

me

betw

een

read

ings

Read

er 1

† (n

=40)

Read

er

2(n=

40)

Mea

n ti

me

betw

een

read

ings

Pf o

nly

Adva

nced

Qua

lity

One

Step

Mal

aria

(pf)

Test

(Who

le B

lood

) ITP

1100

2TC1

Inte

c Pr

oduc

ts In

c.43

.75

62.5

68.7

50:

19:5

295

97.5

0:19

:33

Adva

nced

Qua

lity

One

Step

Mal

aria

(Pf)

Test

(Who

le B

lood

) ITP

1100

2TC4

0In

tec

Prod

ucts

Inc.

36.2

557

.568

.75

0:22

:18

9597

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21:3

9Ad

vant

age

P.f.

Mal

aria

Car

dJ.

Mitr

a Co

mpa

ny P

vt L

td92

.595

950:

16:2

810

010

00:

19:0

0Ca

reSt

art M

alar

ia H

RP2

(Pf)

Acce

ss B

io, I

nc.

100

100

100

0:13

:44

100

100

0:13

:13

Firs

t Res

pons

e M

alar

ia A

g H

RP2

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.10

010

010

00:

20:1

610

010

00:

22:3

4Fi

rstS

ign

– M

alar

ia P

f Car

d Te

stU

nim

ed In

tern

atio

nal,

Inc.

158.

7583

.75

0:20

:10

8582

.50:

19:0

3H

exag

on M

alar

iaH

uman

Gm

bH22

.538

.75

78.7

50:

20:5

897

.595

0:20

:13

ICT

Mal

aria

Pf C

asse

tte

Test

(ML0

1)IC

T Di

agno

stic

s82

.586

.25

86.2

50:

17:3

210

010

00:

17:1

2Im

mun

oqui

ck M

alar

ia F

alci

paru

mBi

osyn

ex70

9080

0:13

:06

100

100

0:15

:36

Mal

aria

Pla

smod

ium

falc

ipar

um R

apid

test

Dev

ice

(Who

le b

lood

)AC

ON L

abor

ator

ies,

Inc.

92.5

87.5

92.5

0:20

:16

97.5

100

0:24

:18

Mal

aria

Rap

id P

fVi

sion

Bio

tech

86.2

598

.75

87.5

0:11

:18

100

100

0:10

:37

Para

chec

k Pf

Rap

id te

st fo

r P. f

alci

paru

m M

alar

ia (D

evic

e)

Orch

id B

iom

edic

al S

yste

ms

50.6

3 (7

9)72

.15

(79)

65.3

8 (7

8)0:

15:0

497

.37

(38)

100

0:13

:26

Para

chec

k Pf

Rap

id te

st fo

r P. f

alci

paru

m M

alar

ia (D

ipst

ick)

Or

chid

Bio

med

ical

Sys

tem

s71

.25

51.2

580

0:15

:47

100

100

0:17

:32

Para

hit-

f DIP

STIC

K FO

R FA

LCIP

ARU

M M

ALAR

IASp

an D

iagn

ostic

s67

.562

.582

.50:

20:1

310

010

00:

21:5

7Pa

rahi

t-f T

EST

DEVI

CE F

OR F

ALCI

PARU

M M

ALAR

IASp

an D

iagn

ostic

s22

.538

.75

81.2

50:

22:4

795

100

0:20

:36

SD B

IOLI

NE

Mal

aria

Ag

Pf

Stan

dard

Dia

gnos

tics,

Inc.

93.7

590

96.2

50:

28:4

910

010

00:

32:1

8Pf

& P

an/P

f &

Pv

Adva

ntag

e M

al C

ard

J. M

itra

Com

pany

Pvt

Ltd

12.5

36.2

568

.75

0:18

:13

100

100

0:20

:12

AZOG

Mal

aria

pf (

HRP

-II)

/pv

(pLD

H) A

ntig

en D

etec

tion

Test

Dev

ice

AZOG

, Inc

.91

.25

97.5

93.7

50:

12:2

610

010

00:

13:0

0Bi

nax

Now

Mal

aria

In

vern

ess

Med

ical

Inno

vatio

ns83

.75

77.5

86.2

50:

20:5

810

010

00:

25:0

7Ca

reSt

art M

alar

ia H

RP2/

pLDH

(Pf/

PAN

) COM

BOAc

cess

Bio

, Inc

.98

.75

98.7

597

.50:

09:5

010

010

00:

09:2

0Fi

rst R

espo

nse

Mal

aria

Ag

Com

bo (P

LDH

/HRP

2)Pr

emie

r Med

ical

Cor

pora

tion

Ltd.

98.7

598

.75

100

0:29

:34

100

100

0:29

:54

Firs

tSig

n –

Para

View

-2 (P

v +

Pf) C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.41

.25

7071

.25

0:16

:33

97.5

97.5

0:15

:28

Hex

agon

Mal

aria

Com

biH

uman

Gm

bH35

33.7

566

.25

0:23

:23

97.5

97.5

0:22

:40

ICT

Mal

aria

Com

bo C

asse

tte

Test

(ML0

2)IC

T Di

agno

stic

s90

91.2

596

.25

0:19

:00

100

100

0:19

:17

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

91.2

595

91.2

50:

23:2

510

010

00:

22:3

6M

alar

ia P

.F/V

ivax

Diag

nost

ic A

utom

atio

n/Co

rtez

Dia

gnos

tics,

Inc.

0

(52)

7.55

(53)

92.3

1 (5

2)0:

24:2

98.

33 (2

4)3.

85 (2

6)0:

23:5

1M

alar

ia R

apid

Com

boVi

sion

Bio

tech

72.5

87.5

850:

16:2

897

.510

00:

15:4

5M

alar

ia R

apid

Dua

l Vi

sion

Bio

tech

87.5

96.2

591

.25

0:19

:24

100

100

0:18

:40

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s35

5575

0:33

:02

100

100

0:33

:00

One

Step

Mal

aria

Ant

igen

Str

ipIN

D Di

agno

stic

Inc.

00

100

0:06

:21

8067

.50:

06:1

9On

Sigh

t – P

araQ

uick

(Pan

, Pf)

Test

Amge

nix

Inte

rnat

iona

l, In

c.78

.75

8593

.75

0:19

:04

100

100

0:18

:51

OptiM

AL-I

TDi

aMed

021

.25

78.7

50:

23:0

410

010

00:

24:1

3Pa

rahi

t-To

tal D

evic

e Ra

pid

test

for P

. fal

cipa

rum

and

Pan

mal

aria

l spe

cies

.Sp

an D

iagn

ostic

s23

.75

32.5

86.2

50:

23:4

892

.595

0:22

:22

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf (

Devi

ce)

Zeph

yr B

iom

edic

als

5582

.572

.5N

/A10

010

0N

/AQu

icks

tick

Mal

aria

Ant

igen

Tes

tIn

nova

tek

Med

ical

Inc.

00

100

0:06

:21

8067

.50:

06:1

9SD

BIO

LIN

E M

alar

ia A

gSt

anda

rd D

iagn

ostic

s, In

c.2.

53.

7596

.25

0:23

:37

92.5

97.5

0:25

:51

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

an

Stan

dard

Dia

gnos

tics,

Inc.

87.5

87.5

100

N/A

100

100

N/A

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

56.2

568

.75

77.5

0:13

:31

92.5

92.5

0:10

:14

Pan

only

Adva

ntag

e Pa

n M

alar

ia C

ard

J. M

itra

Com

pany

Pvt

Ltd

31.2

561

.25

47.5

0:18

:25

97.5

100

0:19

:52

Care

Star

t Mal

aria

pLD

H (P

AN)

Acce

ss B

io, I

nc.

8586

.25

76.2

50:

13:4

010

097

.50:

12:3

6Pa

raba

nk R

apid

Tes

t for

Mal

aria

Pan

(Dev

ice)

Zeph

yr B

iom

edic

als

011

.25

88.7

50:

32:5

280

97.5

0:32

:29

Pf -

Pla

smod

ium

falc

ipar

um

Pv -

Pla

smod

ium

viv

axpa

n -

Plas

mod

ium

spe

cies

† -

Rea

d ac

cord

ing

to m

anuf

actu

rers

inst

ruct

ions

‡ - A

sam

ple

is c

onsi

dere

d de

tect

ed o

nly

if al

l RDT

s fr

om b

oth

lots

read

by

the

first

tech

nici

an, a

t min

imum

spe

cifie

d re

adin

g tim

e, a

re p

ositi

veTh

ose

test

s in

whi

ch a

man

ufac

ture

rs re

com

men

ded

a de

laye

d re

adin

g if

initi

al re

sults

wer

e ne

gativ

e.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)61

Tabl

e A

3.2:

Det

ecti

on ra

te o

f 20

P. fa

lcip

arum

cul

ture

line

s at l

ow a

nd h

igh

para

site

den

siti

es b

ased

on

init

ial r

eadi

ng a

ccor

ding

to m

anuf

actu

rers

inst

ruct

ions

and

a d

elay

ed

seco

nd r

eadi

ng p

erfo

rmed

wit

hin

1 ho

ur.

Prod

uct

Man

ufac

ture

r

Dete

ctio

n ra

te‡

200

para

site

s/μl

2,00

0 -

5,00

0 pa

rasi

tes/

μl

Read

er

1† (n=

80)

Read

er 2

(n

=80)

Perc

ent

agre

emen

t be

twee

n re

a-de

rs (

n=80

)

Mea

n ti

me

betw

een

read

ings

Read

er 1

† (n

=40)

Read

er

2(n=

40)

Mea

n ti

me

betw

een

read

ings

Pf o

nly

Adva

nced

Qua

lity

One

Step

Mal

aria

(pf)

Test

(Who

le B

lood

) ITP

1100

2TC1

Inte

c Pr

oduc

ts In

c.43

.75

62.5

68.7

50:

19:5

295

97.5

0:19

:33

Adva

nced

Qua

lity

One

Step

Mal

aria

(Pf)

Test

(Who

le B

lood

) ITP

1100

2TC4

0In

tec

Prod

ucts

Inc.

36.2

557

.568

.75

0:22

:18

9597

.50:

21:3

9Ad

vant

age

P.f.

Mal

aria

Car

dJ.

Mitr

a Co

mpa

ny P

vt L

td92

.595

950:

16:2

810

010

00:

19:0

0Ca

reSt

art M

alar

ia H

RP2

(Pf)

Acce

ss B

io, I

nc.

100

100

100

0:13

:44

100

100

0:13

:13

Firs

t Res

pons

e M

alar

ia A

g H

RP2

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.10

010

010

00:

20:1

610

010

00:

22:3

4Fi

rstS

ign

– M

alar

ia P

f Car

d Te

stU

nim

ed In

tern

atio

nal,

Inc.

158.

7583

.75

0:20

:10

8582

.50:

19:0

3H

exag

on M

alar

iaH

uman

Gm

bH22

.538

.75

78.7

50:

20:5

897

.595

0:20

:13

ICT

Mal

aria

Pf C

asse

tte

Test

(ML0

1)IC

T Di

agno

stic

s82

.586

.25

86.2

50:

17:3

210

010

00:

17:1

2Im

mun

oqui

ck M

alar

ia F

alci

paru

mBi

osyn

ex70

9080

0:13

:06

100

100

0:15

:36

Mal

aria

Pla

smod

ium

falc

ipar

um R

apid

test

Dev

ice

(Who

le b

lood

)AC

ON L

abor

ator

ies,

Inc.

92.5

87.5

92.5

0:20

:16

97.5

100

0:24

:18

Mal

aria

Rap

id P

fVi

sion

Bio

tech

86.2

598

.75

87.5

0:11

:18

100

100

0:10

:37

Para

chec

k Pf

Rap

id te

st fo

r P. f

alci

paru

m M

alar

ia (D

evic

e)

Orch

id B

iom

edic

al S

yste

ms

50.6

3 (7

9)72

.15

(79)

65.3

8 (7

8)0:

15:0

497

.37

(38)

100

0:13

:26

Para

chec

k Pf

Rap

id te

st fo

r P. f

alci

paru

m M

alar

ia (D

ipst

ick)

Or

chid

Bio

med

ical

Sys

tem

s71

.25

51.2

580

0:15

:47

100

100

0:17

:32

Para

hit-

f DIP

STIC

K FO

R FA

LCIP

ARU

M M

ALAR

IASp

an D

iagn

ostic

s67

.562

.582

.50:

20:1

310

010

00:

21:5

7Pa

rahi

t-f T

EST

DEVI

CE F

OR F

ALCI

PARU

M M

ALAR

IASp

an D

iagn

ostic

s22

.538

.75

81.2

50:

22:4

795

100

0:20

:36

SD B

IOLI

NE

Mal

aria

Ag

Pf

Stan

dard

Dia

gnos

tics,

Inc.

93.7

590

96.2

50:

28:4

910

010

00:

32:1

8Pf

& P

an/P

f &

Pv

Adva

ntag

e M

al C

ard

J. M

itra

Com

pany

Pvt

Ltd

12.5

36.2

568

.75

0:18

:13

100

100

0:20

:12

AZOG

Mal

aria

pf (

HRP

-II)

/pv

(pLD

H) A

ntig

en D

etec

tion

Test

Dev

ice

AZOG

, Inc

.91

.25

97.5

93.7

50:

12:2

610

010

00:

13:0

0Bi

nax

Now

Mal

aria

In

vern

ess

Med

ical

Inno

vatio

ns83

.75

77.5

86.2

50:

20:5

810

010

00:

25:0

7Ca

reSt

art M

alar

ia H

RP2/

pLDH

(Pf/

PAN

) COM

BOAc

cess

Bio

, Inc

.98

.75

98.7

597

.50:

09:5

010

010

00:

09:2

0Fi

rst R

espo

nse

Mal

aria

Ag

Com

bo (P

LDH

/HRP

2)Pr

emie

r Med

ical

Cor

pora

tion

Ltd.

98.7

598

.75

100

0:29

:34

100

100

0:29

:54

Firs

tSig

n –

Para

View

-2 (P

v +

Pf) C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.41

.25

7071

.25

0:16

:33

97.5

97.5

0:15

:28

Hex

agon

Mal

aria

Com

biH

uman

Gm

bH35

33.7

566

.25

0:23

:23

97.5

97.5

0:22

:40

ICT

Mal

aria

Com

bo C

asse

tte

Test

(ML0

2)IC

T Di

agno

stic

s90

91.2

596

.25

0:19

:00

100

100

0:19

:17

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

91.2

595

91.2

50:

23:2

510

010

00:

22:3

6M

alar

ia P

.F/V

ivax

Diag

nost

ic A

utom

atio

n/Co

rtez

Dia

gnos

tics,

Inc.

0

(52)

7.55

(53)

92.3

1 (5

2)0:

24:2

98.

33 (2

4)3.

85 (2

6)0:

23:5

1M

alar

ia R

apid

Com

boVi

sion

Bio

tech

72.5

87.5

850:

16:2

897

.510

00:

15:4

5M

alar

ia R

apid

Dua

l Vi

sion

Bio

tech

87.5

96.2

591

.25

0:19

:24

100

100

0:18

:40

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s35

5575

0:33

:02

100

100

0:33

:00

One

Step

Mal

aria

Ant

igen

Str

ipIN

D Di

agno

stic

Inc.

00

100

0:06

:21

8067

.50:

06:1

9On

Sigh

t – P

araQ

uick

(Pan

, Pf)

Test

Amge

nix

Inte

rnat

iona

l, In

c.78

.75

8593

.75

0:19

:04

100

100

0:18

:51

OptiM

AL-I

TDi

aMed

021

.25

78.7

50:

23:0

410

010

00:

24:1

3Pa

rahi

t-To

tal D

evic

e Ra

pid

test

for P

. fal

cipa

rum

and

Pan

mal

aria

l spe

cies

.Sp

an D

iagn

ostic

s23

.75

32.5

86.2

50:

23:4

892

.595

0:22

:22

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf (

Devi

ce)

Zeph

yr B

iom

edic

als

5582

.572

.5N

/A10

010

0N

/AQu

icks

tick

Mal

aria

Ant

igen

Tes

tIn

nova

tek

Med

ical

Inc.

00

100

0:06

:21

8067

.50:

06:1

9SD

BIO

LIN

E M

alar

ia A

gSt

anda

rd D

iagn

ostic

s, In

c.2.

53.

7596

.25

0:23

:37

92.5

97.5

0:25

:51

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

an

Stan

dard

Dia

gnos

tics,

Inc.

87.5

87.5

100

N/A

100

100

N/A

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

56.2

568

.75

77.5

0:13

:31

92.5

92.5

0:10

:14

Pan

only

Adva

ntag

e Pa

n M

alar

ia C

ard

J. M

itra

Com

pany

Pvt

Ltd

31.2

561

.25

47.5

0:18

:25

97.5

100

0:19

:52

Care

Star

t Mal

aria

pLD

H (P

AN)

Acce

ss B

io, I

nc.

8586

.25

76.2

50:

13:4

010

097

.50:

12:3

6Pa

raba

nk R

apid

Tes

t for

Mal

aria

Pan

(Dev

ice)

Zeph

yr B

iom

edic

als

011

.25

88.7

50:

32:5

280

97.5

0:32

:29

Pf -

Pla

smod

ium

falc

ipar

um

Pv -

Pla

smod

ium

viv

axpa

n -

Plas

mod

ium

spe

cies

† -

Rea

d ac

cord

ing

to m

anuf

actu

rers

inst

ruct

ions

‡ - A

sam

ple

is c

onsi

dere

d de

tect

ed o

nly

if al

l RDT

s fr

om b

oth

lots

read

by

the

first

tech

nici

an, a

t min

imum

spe

cifie

d re

adin

g tim

e, a

re p

ositi

veTh

ose

test

s in

whi

ch a

man

ufac

ture

rs re

com

men

ded

a de

laye

d re

adin

g if

initi

al re

sults

wer

e ne

gativ

e.

Tabl

e A

3.3:

Dis

trib

utio

n of

tes

t ba

nd in

tens

ity

scor

es (

0-4)

aga

inst

20

P. fa

lcip

arum

cul

ture

d pa

rasi

tes

at lo

w (

200)

and

hig

h (2

000

or 5

000)

par

asit

e de

nsit

ies

(par

asit

es/μ

l)

Prod

uct

Man

ufac

ture

r

200

para

site

s/μl

sam

ples

(n=

20)

2,00

0 or

5,0

00 p

aras

ites

/μl s

ampl

es (

n=20

) 2

00 p

aras

ites

/μl s

ampl

es (

n=20

)2,

000

or 5

,000

par

asit

es/μ

l sam

ples

(n

=20)

Perc

enta

ge d

istr

ibut

ion

of t

est

Pf b

and

inte

nsit

y† (n

=80)

Perc

enta

ge d

istr

ibut

ion

of t

est

Pf b

and

inte

nsit

y† (n

=40)

Perc

enta

ge d

istr

ibut

ion

of P

an t

est

band

inte

nsit

y (n

=80)

Perc

enta

ge d

istr

ibut

ion

of P

an t

est

band

inte

nsit

y (n

=40)

0*1

23

40

12

34

01

23

40

12

34

Pf o

nly

ADVA

NCE

D QU

ALIT

Y TM

MAL

ARIA

(p.f)

POC

T In

Tec

Prod

ucts

, Inc

.63

.75

32.5

2.5

1.25

05

17.5

2015

42.5

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

ADVA

NCE

D QU

ALIT

Y TM

One

Ste

p M

alar

ia (p

.f.)

Test

(who

le b

lood

)In

Tec

Prod

ucts

, Inc

.56

.25

37.5

6.25

00

515

22.5

22.5

35N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

Adva

ntag

e P.

f. M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

7.5

46.2

535

8.75

2.5

02.

55

1577

.5N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

Care

Star

t Mal

aria

HRP

2 (P

f)Ac

cess

Bio

, Inc

.0

2532

.536

.25

6.25

00

2.5

12.5

85N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

Firs

t Res

pons

e M

alar

ia A

g H

RP2

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.0

36.2

535

208.

750

02.

510

87.5

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Firs

tSig

n –

Mal

aria

Pf C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.85

12.5

1.25

1.25

015

3515

2510

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Hex

agon

Mal

aria

Hum

an G

mbH

77.5

17.5

3.75

1.25

02.

537

.525

1520

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

ICT

Mal

aria

Pf C

asse

tte

Test

(ML0

1)IC

T Di

agno

stic

s17

.550

28.7

53.

750

05

12.5

27.5

55N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

Imm

unoq

uick

Mal

aria

Fal

cipa

rum

Bios

ynex

3063

.75

6.25

00

015

27.5

2532

.5N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

Mal

aria

Pla

smod

ium

falc

ipar

um R

apid

test

Dev

ice

(Who

le b

lood

)AC

ON L

abor

ator

ies,

Inc.

7.5

5530

6.25

1.25

2.5

010

4047

.5N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

Mal

aria

Rap

id P

fVi

sion

Bio

tech

(Pty

) Ltd

.13

.75

76.2

510

00

012

.510

37.5

40N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

Para

chec

k Pf

Rap

id te

st fo

r P. f

alci

paru

m M

alar

ia

(Dev

ice)

Or

chid

Bio

med

ical

Sys

tem

s50

37.5

11.2

51.

250

7.5

1020

4517

.5N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

Para

chec

k Pf

Rap

id te

st fo

r P. f

alci

paru

m M

alar

ia

(Dip

stic

k)

Orch

id B

iom

edic

al S

yste

ms

28.7

555

13.7

52.

50

010

3042

.517

.5N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

Para

hit-

f DIP

STIC

K FO

R FA

LCIP

ARU

M M

ALAR

IASp

an D

iagn

ostic

s Lt

d.32

.550

12.5

3.75

1.25

02.

527

.525

45N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

Para

hit-

f TES

T DE

VICE

FOR

FAL

CIPA

RUM

MAL

ARIA

Span

Dia

gnos

tics

Ltd.

77.5

201.

250

1.25

527

.520

27.5

20N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

SD B

IOLI

NE

Mal

aria

Ag

Pf

Stan

dard

Dia

gnos

tics,

Inc.

6.25

23.7

542

.525

2.5

00

7.5

7.5

85N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

Pf &

Pan

/Pf

& P

vAd

vant

age

Mal

Car

dJ.

Mitr

a &

Co.

Pvt

. Ltd

.87

.512

.50

00

027

.547

.525

091

.25

8.75

00

00

42.5

507.

50

AZOG

Mal

aria

pf (

HRP

-II)

/pv

(pLD

H) A

ntig

en

Dete

ctio

n Te

st D

evic

eAZ

OG, I

nc.

8.75

66.2

517

.57.

50

05

1032

.552

.561

.25

38.7

50

00

2.5

82.5

150

0

Bina

x N

ow M

alar

ia

Inve

rnes

s M

edic

al In

nova

tions

, Inc

.16

.25

67.5

13.7

52.

50

010

1545

3010

00

00

012

.587

.50

00

Care

Star

t Mal

aria

HRP

2/pL

DH (P

f/PA

N) C

OMBO

Acce

ss B

io, I

nc.

1.25

21.2

547

.525

50

05

1085

2.5

96.2

51.

250

00

035

4520

Firs

t Res

pons

e M

alar

ia A

g Co

mbo

(PLD

H/H

RP2)

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.1.

2516

.25

4032

.510

00

2.5

17.5

8037

.562

.50

00

2.5

050

407.

5

Firs

tSig

n –

Para

View

-2 (P

v +

Pf) C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.58

.75

22.5

12.5

6.25

02.

57.

55

3055

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Hex

agon

Mal

aria

Com

biH

uman

Gm

bH65

33.7

51.

250

02.

527

.522

.522

.525

100

00

00

100

00

00

ICT

Mal

aria

Com

bo C

asse

tte

Test

(ML0

2)IC

T Di

agno

stic

s10

3540

13.7

51.

250

07.

515

77.5

97.5

2.5

00

022

.567

.510

00

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

8.75

36.2

543

.75

7.5

3.75

00

7.5

2072

.510

00

00

020

707.

52.

50

Mal

aria

P.F

/Viv

axDi

agno

stic

Aut

omat

ion

/ Cor

tez

Diag

nost

ics,

Inc.

100

00

00

955

00

045

11.2

525

153.

7532

.55

12.5

7.5

42.5

Mal

aria

Rap

id C

ombo

Visi

on B

iote

ch (P

ty) L

td.

27.5

61.2

58.

752.

50

2.5

7.5

1040

4098

.75

1.25

00

020

800

00

Mal

aria

Rap

id D

ual

Visi

on B

iote

ch (P

ty) L

td.

12.5

52.5

26.2

57.

51.

250

512

.510

72.5

88.7

511

.25

00

027

.572

.50

00

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s65

31.2

53.

750

00

2035

27.5

17.5

100

00

00

52.5

3512

.50

0

One

Step

Mal

aria

Ant

igen

Str

ipIN

D Di

agno

stic

Inc.

100

00

00

2072

.57.

50

010

00

00

022

.570

7.5

00

OnSi

ght –

Par

aQui

ck (P

an, P

f) Te

stAm

geni

x In

tern

atio

nal,

Inc.

21.2

547

.522

.55

3.75

02.

510

2067

.598

.75

1.25

00

02.

547

.535

12.5

2.5

OptiM

AL-I

TDi

aMed

AG

100

00

00

067

.525

7.5

098

.75

1.25

00

00

6527

.57.

50

Para

hit-

Tota

l Dev

ice

Rapi

d te

st fo

r P. f

alci

paru

m

and

Pan

mal

aria

l spe

cies

.Sp

an D

iagn

ostic

s Lt

d.76

.25

21.2

51.

250

1.25

7.5

2027

.522

.522

.510

00

00

010

00

00

0

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf (

Devi

ce)

Zeph

yr B

iom

edic

als

4528

.75

22.5

1.25

2.5

010

2530

3510

00

00

035

4515

50

Quic

kstic

k M

alar

ia A

ntig

en T

est

Inno

vate

k M

edic

al In

c.10

00

00

020

72.5

7.5

00

100

00

00

22.5

707.

50

0

SD B

IOLI

NE

Mal

aria

Ag

Stan

dard

Dia

gnos

tics,

Inc.

97.5

2.5

00

07.

555

32.5

50

100

00

00

7525

00

0

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

an

Stan

dard

Dia

gnos

tics,

Inc.

12.5

57.5

252.

52.

50

55

1080

100

00

00

5545

00

0

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Te

stG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

43.7

551

.25

50

07.

512

.527

.532

.520

9010

00

010

4530

12.5

2.5

Pan

only

Adva

ntag

e Pa

n M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

68.7

530

1.25

00

2.5

2055

202.

568

.75

301.

250

02.

520

5520

2.5

Care

Star

t Mal

aria

pLD

H (P

AN)

Acce

ss B

io, I

nc.

1583

.75

1.25

00

02.

545

37.5

1515

83.7

51.

250

00

2.5

4537

.515

Para

bank

Rap

id T

est f

or M

alar

ia P

an (D

evic

e)Ze

phyr

Bio

med

ical

s10

00

00

020

47.5

27.5

50

100

00

00

2047

.527

.55

0

* den

otes

no

band

Pf

- P

lasm

odiu

m fa

lcip

arum

Pv

- P

lasm

odiu

m v

ivax

pan

- Pl

asm

odiu

m s

peci

es

† thi

s in

clud

es P

an li

ne in

tens

ity o

nly

for P

an-o

nly

test

s

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)62

Tabl

e A

3.3a

: Dis

trib

utio

n of

tes

t ban

d in

tens

ity

(0-4

) sco

res a

gain

st 2

0 P.

falc

ipar

um c

ultu

red

para

site

s at l

ow (2

00) a

nd h

igh

(200

0 or

500

0) p

aras

ite

dens

itie

s (pa

rasi

tes/

μl)

base

d on

a d

elay

ed r

eadi

ng w

hen

spec

ified

by

the

man

ufac

ture

r

Prod

uct

Man

ufac

ture

r

200

para

site

s/μl

sam

ples

(n=

20)

2,00

0 or

5,0

00 p

aras

ites

/μl

sam

ples

(n=

20)

200

par

asit

es/μ

l sam

ples

(n=

20)

2,00

0 or

5,0

00 p

aras

ites

/μl s

ampl

es

(n=2

0)

Perc

enta

ge d

istr

ibut

ion

of t

est

Pf

band

inte

nsit

y† (n

=80)

Perc

enta

ge d

istr

ibut

ion

of t

est

Pf

band

inte

nsit

y† (n

=40)

Perc

enta

ge d

istr

ibut

ion

of P

an t

est

band

inte

nsit

y (n

=80)

Perc

enta

ge d

istr

ibut

ion

of P

an t

est

band

in

tens

ity

(n=4

0)

0*1

23

40

12

34

No

band

12

34

No

band

12

34

Pf &

Pan

/Pf

& P

v

Firs

tSig

n –

Para

View

-2 (P

v +

Pf) C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.30

56.2

510

2.5

1.25

2.5

7.5

7.5

2557

.5N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

536

.25

3520

3.75

02.

55

12.5

8098

.75

1.25

00

02.

570

252.

50

Mal

aria

P.F

/Viv

axDi

agno

stic

s Au

tom

atio

n/Co

rtez

Dia

gnos

tics,

Inc.

955

00

097

.50

2.5

00

43.7

513

.75

17.5

17.5

7.5

32.5

57.

512

.542

.5

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s45

46.2

57.

50

1.25

020

3035

1596

.25

3.75

00

025

62.5

12.5

00

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf (

Devi

ce)

Zeph

yr B

iom

edic

als

17.5

41.2

533

.75

6.25

1.25

02.

515

2557

.591

.25

8.75

00

015

4032

.512

.50

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Te

stG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

31.2

560

6.25

2.5

07.

57.

530

2035

53.7

543

.75

2.5

00

7.5

3032

.512

.517

.5

Pan

only

Para

bank

Rap

id T

est f

or M

alar

ia P

an (D

evic

e)Ze

phyr

Bio

med

ical

s88

.75

11.2

50

00

2.5

42.5

4510

088

.75

11.2

50

00

2.5

42.5

4510

0† =

this

incl

udes

Pan

line

inte

nsity

onl

y fo

r Pan

-onl

y te

sts

* den

otes

no

band

Pf

- P

lasm

odiu

m fa

lcip

arum

Pv

- P

lasm

odiu

m v

ivax

pan

- Pl

asm

odiu

m s

peci

es

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)63

ANNE

X 4:

PHAS

E 2

RESU

LTS

Tabl

e A4

.1: L

ot v

aria

bilit

y in

pos

itiv

e re

sult

s† ag

ains

t P.

fal

cipa

rum

and

P. v

ivax

sam

ples

at

low

(20

0) a

nd h

igh

(200

0 or

500

0) p

aras

ite

dens

itie

s (p

aras

ites

/μl)

Prod

uct

Man

ufac

ture

r

P. f

alci

paru

m s

ampl

es (

n=79

)P.

viv

ax s

ampl

es (

n=20

)

Tot

al p

osit

ive

resu

lts

retu

rned

Tot

al p

osit

ive

resu

lts

retu

rned

200

para

site

s/μl

2,00

0 or

5,

000

para

site

s/μl

200

para

site

s/μl

2,00

0 or

5,

000

para

site

s/μl

Lot

1 Lo

t 2

Lot

1 Lo

t 2

Lot

1 Lo

t 2

Lot

1 Lo

t 2

Test

1

Test

2N

o. p

osit

ive

agre

emen

ts

(max

=79)

*Te

st 1

Te

st 2

No.

pos

itiv

e ag

reem

ents

(m

ax=7

9)*

Test

1Te

st 1

Test

1

Test

2N

o. p

osit

ive

agre

emen

ts

(max

=20)

*Te

st 1

Te

st 2

No.

pos

itiv

e ag

reem

ents

(m

ax=2

0)*

Test

1

Test

1

Pf o

nly

ADVA

NCE

D QU

ALIT

Y TM

MAL

ARIA

(p.f)

PO

CT

InTe

c Pr

oduc

ts, I

nc.

5961

5163

6054

7979

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

ADVA

NCE

D QU

ALIT

Y TM

One

Ste

p M

alar

ia

(p.f.

) Tes

t (w

hole

blo

od)

InTe

c Pr

oduc

ts, I

nc.

6770

6272

6962

7979

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Adva

ntag

e P.

f. M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

7877

7778

7978

7979

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Care

Star

t Mal

aria

HRP

2 (P

f)Ac

cess

Bio

, Inc

.79

7979

7879

7878

79N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

Firs

t Res

pons

e M

alar

ia A

g H

RP2

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.79

7979

7979

7979

79N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

Firs

tSig

n –

Mal

aria

Pf C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.38

4431

3936

3175

71N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

Hex

agon

Mal

aria

Hum

an G

mbH

46

(78)

44

(78)

3447

(7

8)46

(7

8)40

76

(78)

76

(78)

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

ICT

Mal

aria

Pf C

asse

tte

Test

(ML0

1)IC

T Di

agno

stic

s73

7369

7376

7279

77N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AIm

mun

oqui

ck M

alar

ia F

alci

paru

mBi

osyn

ex75

7673

7776

7579

79N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AM

alar

ia P

lasm

odiu

m fa

lcip

arum

Rap

id

test

Dev

ice

(Who

le b

lood

)AC

ON L

abor

ator

ies,

Inc.

7477

7376

7876

7979

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Mal

aria

Rap

id P

fVi

sion

Bio

tech

(Pty

) Ltd

.61

6255

7677

7477

79N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/APa

rach

eck

Pf R

apid

test

for

P. fa

lcip

arum

M

alar

ia (D

evic

e)

Orch

id B

iom

edic

al S

yste

ms

53

(75)

48

(77)

4555

(7

6)54

(7

8)51

72

(74)

78

(78)

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Para

chec

k Pf

Rap

id te

st fo

r P. f

alci

paru

m

Mal

aria

(Dip

stic

k)

Orch

id B

iom

edic

al S

yste

ms

6866

(7

8)62

7067

6578

(7

8)78

(7

8)N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

Para

hit-

f DIP

STIC

K FO

R FA

LCIP

ARU

M

MAL

ARIA

Span

Dia

gnos

tics

Ltd.

6972

6772

6967

7979

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Para

hit-

f TES

T DE

VICE

FOR

FAL

CIPA

RUM

M

ALAR

IASp

an D

iagn

ostic

s Lt

d.54

4543

4543

3879

77N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

SD B

IOLI

NE

Mal

aria

Ag

Pf

Stan

dard

Dia

gnos

tics,

Inc.

7979

7978

7877

7978

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Pf &

Pan

/Pf

& P

vAd

vant

age

Mal

Car

dJ.

Mitr

a &

Co.

Pvt

. Ltd

.60

6358

5962

5579

7920

2020

2020

2020

20AZ

OG M

alar

ia p

f (H

RP-I

I) /p

v (p

LDH

) An

tigen

Det

ectio

n Te

st D

evic

eAZ

OG, I

nc.

7070

6470

7369

7979

1110

713

1511

2019

Bina

x N

ow M

alar

ia

Inve

rnes

s M

edic

al In

nova

tions

, In

c.78

7776

7675

7278

(7

8)79

5 2

(19)

26

64

2017

Care

Star

t Mal

aria

HRP

2/pL

DH (P

f/PA

N)

COM

BOAc

cess

Bio

, Inc

.79

7878

7779

7779

7920

1818

2020

2020

19

Firs

t Res

pons

e M

alar

ia A

g Co

mbo

(PLD

H/

HRP

2)Pr

emie

r Med

ical

Cor

pora

tion

Ltd.

7979

7979

7979

7979

1919

1818

1817

1517

Firs

tSig

n –

Para

View

-2 (P

v +

Pf) C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.54

5147

5648

4378

790

00

33

110

19

Hex

agon

Mal

aria

Com

biH

uman

Gm

bH50

5043

5149

4578

(7

8)77

00

00

1 (1

9)0

10

(19)

13

(19)

ICT

Mal

aria

Com

bo C

asse

tte

Test

(ML0

2)IC

T Di

agno

stic

s74

7571

7577

7479

795

73

40

019

19Im

mun

oqui

ck M

alar

ia +

4Bi

osyn

ex77

7777

7677

7678

7912

1412

1210

820

20

Mal

aria

P.F

/Viv

axDi

agno

stic

Aut

omat

ion

/ Co

rtez

Dia

gnos

tics,

Inc.

22

(29)

19

(27)

28 (3

9)14

(2

1)17

(2

0)26

(36)

30

(31)

16

(17)

0 (7

)0

(7)

0 (9

)0

(9)

0 (7

)0

(14)

3 (1

0)3

(8)

Mal

aria

Rap

id C

ombo

Visi

on B

iote

ch (P

ty) L

td.

7273

7078

7776

7979

59

38

85

1918

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)6 4

Prod

uct

Man

ufac

ture

r

P. f

alci

paru

m s

ampl

es (

n=79

)P.

viv

ax s

ampl

es (

n=20

)

Tot

al p

osit

ive

resu

lts

retu

rned

Tot

al p

osit

ive

resu

lts

retu

rned

200

para

site

s/μl

2,00

0 or

5,

000

para

site

s/μl

200

para

site

s/μl

2,00

0 or

5,

000

para

site

s/μl

Lot

1 Lo

t 2

Lot

1 Lo

t 2

Lot

1 Lo

t 2

Lot

1 Lo

t 2

Test

1

Test

2N

o. p

osit

ive

agre

emen

ts

(max

=79)

*Te

st 1

Te

st 2

No.

pos

itiv

e ag

reem

ents

(m

ax=7

9)*

Test

1Te

st 1

Test

1

Test

2N

o. p

osit

ive

agre

emen

ts

(max

=20)

*Te

st 1

Te

st 2

No.

pos

itiv

e ag

reem

ents

(m

ax=2

0)*

Test

1

Test

1

Mal

aria

Rap

id D

ual

Visi

on B

iote

ch (P

ty) L

td.

7169

6575

7471

7879

12

110

33

1820

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s64

6156

6363

5878

781

20

11

017

16

One

Step

Mal

aria

Ant

igen

Str

ipIN

D Di

agno

stic

Inc.

109

413

199

5766

23

14

10

1316

OnSi

ght –

Par

aQui

ck (P

an, P

f) Te

stAm

geni

x In

tern

atio

nal,

Inc.

6066

5755

5951

7979

1415

1312

1210

2020

OptiM

AL-I

TDi

aMed

AG

4747

3639

3733

7777

1920

1920

2020

2020

Para

hit-

Tota

l Dev

ice

Rapi

d te

st fo

r P.

falc

ipar

um a

nd P

an m

alar

ial s

peci

es.

Span

Dia

gnos

tics

Ltd.

4247

3748

(7

8)39

3775

780

10

01

013

14

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf

(Dev

ice)

Zeph

yr B

iom

edic

als

5453

4650

5448

7979

1313

109

10

(19)

620

19

Quic

kstic

k M

alar

ia A

ntig

en T

est

Inno

vate

k M

edic

al In

c.10

94

1319

957

662

31

41

013

16SD

BIO

LIN

E M

alar

ia A

gSt

anda

rd D

iagn

ostic

s, In

c.46

4432

3839

3077

7716

1412

1214

1120

20

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

an

Stan

dard

Dia

gnos

tics,

Inc.

74

(76)

7877

76

(77)

78

(78)

7879

7911

(1

9)10

910

99

18

(19)

20

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le

Bloo

d Te

stG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

62

(77)

5954

68

(78)

67

(78)

6478

(7

8)76

(7

7)13

12 (1

9)10

14

(18)

13 /

1210

2018

(1

9)Pa

n on

lyAd

vant

age

Pan

Mal

aria

Car

dJ.

Mitr

a &

Co.

Pvt

. Ltd

.65

6862

7268

6679

7920

2020

2020

2020

20Ca

reSt

art M

alar

ia p

LDH

(PAN

)Ac

cess

Bio

, Inc

.77

7775

7777

7679

7920

2020

2020

2020

20Pa

raba

nk R

apid

Tes

t for

Mal

aria

Pan

(D

evic

e)Ze

phyr

Bio

med

ical

s8

165

1011

473

7211

108

89

720

20

Pf -

Pla

smod

ium

falc

ipar

umPv

- P

lasm

odiu

m v

ivax

† Res

ults

are

bas

ed o

n th

e fir

st re

ader

s in

terp

reta

tion

acco

rdin

g to

man

ufac

ture

rs in

stru

ctio

ns.

* Num

ber o

f sam

ples

that

retu

rned

a p

ositi

ve re

sult

for b

oth

test

s. W

here

one

test

was

inva

lid a

nd th

e ot

her p

ositi

ve, p

ositi

ve a

gree

men

t was

reco

rded

.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)65

Tabl

e A4

.1a:

Lot

var

iabi

lity

in p

osit

ive

resu

lts

agai

nst

P. f

alci

paru

m a

nd P

. viv

ax s

ampl

es a

t lo

w (

200)

and

hig

h (2

000

or 5

000)

par

asit

e de

nsit

ies

(par

asit

es/μ

l) ba

sed

on

dela

yed

read

ings

whe

n sp

ecifi

ed b

y th

e m

anuf

actu

rer

Prod

uct

Man

ufac

ture

r

P. f

alci

paru

m s

ampl

es (

n=79

)P.

viv

ax s

ampl

es (

n=20

)

Tot

al p

osit

ive

resu

lts

retu

rned

Tot

al p

osit

ive

resu

lts

retu

rned

200

para

site

s/μl

2,00

0 or

5,

000

para

site

s/μl

200

para

site

s/μl

2,00

0 or

5,0

00

para

site

s/μl

Lot

1 Lo

t 2

Lot

1 Lo

t 2

Lot

1 Lo

t 2

Lot

1 Lo

t 2

Test

1

Test

2N

o. p

osit

ive

agre

emen

ts

(max

=79)

*Te

st 1

Te

st 2

No.

pos

itiv

e ag

reem

ents

(m

ax=7

9)*

Test

1Te

st

1Te

st 1

Te

st 2

No.

pos

itiv

e ag

reem

ents

(m

ax=2

0)*

Test

1

Test

2N

o. p

osit

ive

agre

emen

ts

(max

=20)

*Te

st 1

Te

st 1

Pf &

Pan

/Pf

& P

vFi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Car

d Te

stU

nim

ed In

tern

atio

nal,

Inc.

6663

6064

5855

7979

23

10

40

2020

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

7677

7479

7979

78 (7

8)79

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Tabl

e A4

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r va

riabi

lity

in d

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tion

rat

e‡ of

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paru

m s

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sed

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AZOG

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11

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agon

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20

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79.4

382

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00

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53.8

46.8

40

00:

18:5

297

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00:

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e Ra

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test

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an D

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Para

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66.7

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SD B

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Mal

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Ag

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00

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97.4

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LIN

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299

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n on

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Mal

aria

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dJ.

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a &

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Pvt

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14.2

430

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00:

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291

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97.4

70

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m fa

lcip

arum

Pv

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lasm

odiu

m v

ivax

pan

- Pl

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m s

peci

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‡ - A

sam

ple

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tect

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nly

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l RDT

s fr

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oth

lots

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by

the

first

tech

nici

an, a

t min

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spe

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e, a

re p

ositi

ve

Tabl

e A4

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eade

r va

riabi

lity

in d

etec

tion

rat

e‡ fo

r P.

viv

ax s

ampl

es (

n=20

) ba

sed

on in

itia

l rea

ding

acc

ordi

ng t

o m

anuf

actu

rers

inst

ruct

ions

and

sec

ond

read

ing

wit

hin

1 ho

ur

Prod

uct

Man

ufac

ture

r

Dete

ctio

n ra

te f

or P

. viv

ax s

ampl

es

200

para

site

s/μl

2,00

0 or

5,0

00 p

aras

ites

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Read

er 1

(n

=80)

Read

er 2

(n

=80)

No.

inva

lid

test

s Re

ader

1

No.

inva

lid

test

s Re

ader

2

Mea

n ti

me

betw

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read

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(h

:m:s

)

Read

er 1

(n

=40)

Read

er 2

(n

=40)

No.

inva

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test

s Re

ader

1

No.

inva

lid

test

s Re

ader

2

Mea

n ti

me

betw

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read

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(h

:m:s

)

Pf &

Pan

/Pf

& P

vAd

vant

age

Mal

Car

dJ.

Mitr

a &

Co.

Pvt

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098

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0:12

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100

950

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6AZ

OG M

alar

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f (H

RP-I

I) /p

v (p

LDH

) Ant

igen

Det

ectio

n Te

st D

evic

eAZ

OG, I

nc.

61.2

567

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00:

11:3

097

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00:

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9

Bina

x N

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alar

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s M

edic

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nova

tions

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51

00:

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592

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00

0:12

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Care

Star

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aria

HRP

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f/PA

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Acce

ss B

io, I

nc.

97.5

950

00:

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297

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92.5

93.7

50

00:

14:5

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82.5

00

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n –

Para

View

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v +

Pf) C

ard

Test

Uni

med

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l, In

c.7.

511

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00

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7H

exag

on M

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Hum

an G

mbH

1.27

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1.27

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11

0:20

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60.5

3 (3

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22

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ICT

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asse

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Test

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50

00:

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595

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6071

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00

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100

97.5

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Mal

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5050

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Mal

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37.5

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692

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Mal

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ual

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9597

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alas

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6.25

100

00:

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282

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c.66

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50

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110

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1Op

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88.7

50

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an

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an D

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52.

50

00:

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467

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00

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Para

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56.9

6 (7

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11

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97.5

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50

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00:

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alar

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c.50

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997

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4 (3

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10:

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3

Won

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Step

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Who

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4 (3

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11

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only

Adva

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n M

alar

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ard

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itra

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vt. L

td.

100

100

00

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100

100

00

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Care

Star

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H (P

AN)

Acce

ss B

io, I

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100

100

00

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100

97.5

00

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Para

bank

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est f

or M

alar

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an (D

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phyr

Bio

med

ical

s47

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00

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100

100

00

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Pf -

Pla

smod

ium

falc

ipar

um

Pv -

Pla

smod

ium

viv

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n -

Plas

mod

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spe

cies

‡ -

A s

ampl

e is

con

side

red

dete

cted

onl

y if

all R

DTs

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bot

h lo

ts re

ad b

y th

e fir

st te

chni

cian

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inim

um s

peci

fied

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ing

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are

pos

itive

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)6 8

Tabl

e A4

.4: D

istr

ibut

ion

of t

est

band

int

ensi

ty (

0-4)

sco

res

agai

nst

wild

typ

e P.

fal

cipa

rum

sam

ples

(n=

79)

at l

ow (

200)

and

hig

h (2

000

or 5

000)

par

asit

e de

nsit

ies

(par

asit

es/μ

l)

Prod

uct

Man

ufac

ture

r

200

par

asit

es/μ

l 2

,000

or

5,00

0 pa

rasi

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μl 2

00 p

aras

ites

/μl

2,00

0 or

5,0

00 p

aras

ites

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Perc

enta

ge d

istr

ibut

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of P

f te

st b

and

inte

nsit

y† (n

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rcen

tage

dis

trib

utio

n of

Pf

test

ban

d in

tens

ity†

(n=1

58)

Perc

enta

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an t

est

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in

tens

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16)

Perc

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in

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58)

0*1

23

40*

12

34

No

band

12

34

No

band

12

34

Pf o

nly

ADVA

NCE

D QU

ALIT

Y TM

MAL

ARIA

(p

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OCT

InTe

c Pr

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ts. I

nc.

23.1

32.9

134

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7.59

1.9

01.

2729

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N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

ADVA

NCE

D QU

ALIT

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One

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vt. L

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342

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30.3

814

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00

1.9

22.1

575

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N/A

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N/A

N/A

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N/A

N/A

Care

Star

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Firs

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RP2

Prem

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orpo

ratio

n Lt

d.0

6.33

32.9

127

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33.2

30

0.63

1.27

10.1

387

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N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Firs

tSig

n –

Mal

aria

Pf C

ard

Test

Uni

med

Inte

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iona

l. In

c.50

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25.9

516

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6.01

1.58

7.59

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327

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31.6

523

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N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Hex

agon

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Hum

an G

mbH

42.0

929

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111.

583.

86.

9632

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37.3

419

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N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

ICT

Mal

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asse

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Test

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6527

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33.8

634

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9.81

00

11.3

925

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odiu

m fa

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arum

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id

test

Dev

ice

(Who

le b

lood

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ON L

abor

ator

ies.

Inc.

3.48

19.3

37.6

632

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00.

636.

9632

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/AN

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Mal

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fVi

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tech

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22.1

539

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20.8

94.

751.

271.

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rach

eck

Pf R

apid

test

for P

. fal

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-ru

m M

alar

ia (D

evic

e)

Orch

id B

iom

edic

al S

yste

ms

33.2

315

.51

22.4

720

.89

7.91

3.16

4.43

10.1

325

.95

56.3

3N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

Para

chec

k Pf

Rap

id te

st fo

r P.

falc

ipar

um M

alar

ia (D

ipst

ick)

Or

chid

Bio

med

ical

Sys

tem

s14

.24

24.0

543

.67

12.9

75.

061.

270.

6315

.82

53.8

28.4

8N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

Para

hit-

f DIP

STIC

K FO

R FA

LCIP

ARU

M

MAL

ARIA

Span

Dia

gnos

tics

Ltd.

10.7

622

.47

37.9

720

.57

8.23

00

6.33

26.5

867

.09

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Para

hit-

f TES

T DE

VICE

FOR

FAL

CIPA

-RU

M M

ALAR

IASp

an D

iagn

ostic

s Lt

d.40

.82

21.8

431

.01

5.38

0.95

1.27

4.43

34.8

129

.1130

.38

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

SD B

IOLI

NE

Mal

aria

Ag

Pf

Stan

dard

Dia

gnos

tics.

Inc.

0.63

2.53

36.7

137

.34

22.7

80.

630

012

.66

86.7

1N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/APf

& P

an/P

f &

Pv

Adva

ntag

e M

al C

ard

J. M

itra

& C

o. P

vt. L

td.

22.7

851

.58

22.4

72.

850.

320

1.9

24.0

556

.96

17.0

931

.01

52.8

514

.56

1.58

00

4.43

53.1

631

.65

10.7

6AZ

OG M

alar

ia p

f (H

RP-I

I) /p

v (p

LDH

) An

tigen

Det

ectio

n Te

st D

evic

eAZ

OG. I

nc.

10.4

420

.57

36.3

922

.78

9.81

00.

634.

4331

.65

63.2

957

.91

37.0

35.

060

03.

832

.91

46.8

412

.03

4.43

Bina

x N

ow M

alar

ia

Inve

rnes

s M

edic

al In

nova

-tio

ns. I

nc.

3.16

17.0

945

.89

25.6

38.

230

08.

2327

.22

64.5

673

.42

18.0

48.

230.

320

6.33

15.8

258

.86

17.7

21.

27

Care

Star

t Mal

aria

HRP

2/pL

DH (P

f/PA

N) C

OMBO

Acce

ss B

io. I

nc.

0.95

7.59

30.7

37.9

722

.78

00

2.53

15.1

982

.28

0.95

30.0

657

.28

10.1

31.

580

0.63

7.59

41.1

450

.63

Firs

t Res

pons

e M

alar

ia A

g Co

mbo

(P

LDH

/HRP

2)Pr

emie

r Med

ical

Cor

pora

tion

Ltd.

04.

4320

.25

29.11

46.2

00

0.63

8.23

91.1

45.

736

.08

44.6

212

.03

1.58

01.

2715

.82

32.2

850

.63

Firs

tSig

n –

Para

View

-2 (P

v +

Pf) C

ard

Test

Uni

med

Inte

rnat

iona

l. In

c.33

.86

17.4

125

.63

14.2

48.

860.

632.

5312

.66

24.6

859

.49

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Hex

agon

Mal

aria

Com

biH

uman

Gm

bH36

.71

28.1

624

.05

9.81

1.27

1.9

4.43

27.8

536

.71

29.11

99.6

80.

320

00

80.3

817

.72

1.9

00

ICT

Mal

aria

Com

bo C

asse

tte

Test

(M

L02)

ICT

Diag

nost

ics

4.75

14.5

635

.76

25.6

319

.30

02.

5316

.46

81.0

174

.68

21.5

23.

480.

320

8.23

30.3

839

.87

18.9

92.

53

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

2.85

7.28

28.8

35.4

425

.63

0.63

00

13.2

986

.08

74.5

221

.34

3.5

0.64

04.

4614

.65

42.0

437

.58

1.27

Mal

aria

P.F

/Viv

axDi

agno

stic

Aut

omat

ion

/ Co

rtez

Dia

gnos

tics.

Inc.

56.9

610

.76

14.5

612

.97

4.75

31.6

57.

5914

.56

18.3

527

.85

98.1

1.58

0.32

00

88.6

14.

435.

71.

270

Mal

aria

Rap

id C

ombo

Visi

on B

iote

ch (P

ty) L

td.

5.06

22.7

841

.46

20.2

510

.44

00.

638.

2322

.15

68.9

961

.71

29.11

8.86

0.32

03.

827

.85

44.3

20.2

53.

8M

alar

ia R

apid

Dua

l Vi

sion

Bio

tech

(Pty

) Ltd

.8.

5423

.42

44.9

415

.51

7.59

0.63

2.53

11.3

923

.42

62.0

371

.84

26.5

81.

580

019

.62

27.8

543

.67

7.59

1.27

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s20

.57

28.1

639

.56

10.7

60.

951.

271.

919

.62

43.0

434

.18

91.7

76.

961.

270

018

.99

32.2

831

.01

16.4

61.

27

One

Step

Mal

aria

Ant

igen

Str

ipIN

D Di

agno

stic

Inc.

83.8

615

.19

0.63

0.32

022

.15

27.2

234

.81

15.8

20

83.2

315

.82

0.95

00

23.4

230

.38

34.1

812

.03

0On

Sigh

t – P

araQ

uick

(Pan

. Pf)

Test

Amge

nix

Inte

rnat

iona

l. In

c.24

.05

13.6

125

.32

21.8

415

.19

00.

633.

822

.78

72.7

877

.53

14.2

46.

961.

270

8.86

6.33

32.2

826

.58

25.9

5

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)69

Prod

uct

Man

ufac

ture

r

200

par

asit

es/μ

l 2

,000

or

5,00

0 pa

rasi

tes/

μl 2

00 p

aras

ites

/μl

2,00

0 or

5,0

00 p

aras

ites

/μl

Perc

enta

ge d

istr

ibut

ion

of P

f te

st b

and

inte

nsit

y† (n

=316

)Pe

rcen

tage

dis

trib

utio

n of

Pf

test

ban

d in

tens

ity†

(n=1

58)

Perc

enta

ge d

istr

ibut

ion

of P

an t

est

band

in

tens

ity

(n=3

16)

Perc

enta

ge d

istr

ibut

ion

of P

an t

est

band

in

tens

ity

(n=1

58)

0*1

23

40*

12

34

No

band

12

34

No

band

12

34

OptiM

AL-I

TDi

aMed

AG

46.2

41.7

711

.08

0.95

02.

5310

.13

39.2

432

.91

15.1

949

.05

40.1

99.

810.

950

2.53

13.2

940

.51

31.6

512

.03

Para

hit-

Tota

l Dev

ice

Rapi

d te

st fo

r P.

falc

ipar

um a

nd P

an m

alar

ial s

peci

es.

Span

Dia

gnos

tics

Ltd.

44.3

20.5

725

.63

7.59

1.9

3.16

6.33

28.4

827

.22

34.8

199

.68

0.32

00

072

.78

17.7

29.

490

0

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf

(Dev

ice)

Zeph

yr B

iom

edic

als

33.2

314

.56

26.9

16.1

49.

180

0.63

15.8

220

.89

62.6

686

.08

7.59

5.7

0.63

010

.13

13.2

942

.41

21.5

212

.66

Quic

kstic

k M

alar

ia A

ntig

en T

est

Inno

vate

k M

edic

al In

c.83

.86

15.1

90.

630.

320

22.1

527

.22

34.8

115

.82

083

.23

15.8

20.

950

023

.42

30.3

834

.18

12.0

30

SD B

IOLI

NE

Mal

aria

Ag

Stan

dard

Dia

gnos

tics,

Inc.

47.1

540

.82

11.7

10.

320

2.53

3.8

57.5

931

.65

4.43

96.2

3.8

00

026

.58

44.3

29.11

00

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

an

Stan

dard

Dia

gnos

tics,

Inc.

3.16

14.2

438

.92

26.2

717

.41

00

3.8

14.5

681

.65

91.1

47.

910.

950

012

.03

37.3

446

.84

3.8

0W

ondf

o On

e St

ep M

alar

ia P

f/Pa

n W

hole

Blo

od T

est

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d18

.99

37.3

429

.1110

.13

4.43

2.53

3.8

18.9

935

.44

39.2

434

.81

45.5

714

.56

4.75

0.32

3.16

6.33

36.0

834

.18

20.2

5

Pan

only

Adva

ntag

e Pa

n M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

13.6

147

.15

34.4

94.

750

00

17.7

256

.33

25.9

513

.61

47.1

534

.49

4.75

00

017

.72

56.3

325

.95

Care

Star

t Mal

aria

pLD

H (P

AN)

Acce

ss B

io, I

nc.

2.53

34.8

155

.76.

010.

950

0.63

12.0

341

.77

45.5

72.

5334

.81

55.7

6.01

0.95

00.

6312

.03

41.7

745

.57

Para

bank

Rap

id T

est f

or M

alar

ia P

an

(Dev

ice)

Zeph

yr B

iom

edic

als

85.7

611

.39

1.58

0.95

0.32

8.23

15.1

928

.48

32.2

815

.82

85.7

611

.39

1.58

0.95

0.32

8.23

15.1

928

.48

32.2

815

.82

Pf -

Pla

smod

ium

falc

ipar

um

Pv -

Pla

smod

ium

viv

axpa

n -

Plas

mod

ium

spe

cies

Tabl

e A4

.4a:

Dis

trib

utio

n of

tes

t ba

nd i

nten

sity

(0-

4) s

core

s ag

ains

t w

ild t

ype

P. f

alci

paru

m s

ampl

es (

n=79

) at

low

(20

0) a

nd h

igh

(200

0 or

500

0) p

aras

ite

dens

itie

s (p

aras

ites

/μl)

base

d on

a d

elay

ed r

eadi

ng w

hen

spec

ified

by

the

man

ufac

ture

r

Prod

uct

Man

ufac

ture

r

200

par

asit

es/μ

l 2

,000

or

5,00

0 pa

rasi

tes/

μl 2

00 p

aras

ites

/μl

2,00

0 or

5,0

00 p

aras

ites

/μl

Perc

enta

ge d

istr

ibut

ion

of P

f te

st b

and

inte

nsit

y† (n

=316

)Pe

rcen

tage

dis

trib

utio

n of

Pf

test

ban

d in

tens

ity†

(n=1

58)

Perc

enta

ge d

istr

ibut

ion

of P

an t

est

band

in

tens

ity

(n=3

16)

Perc

enta

ge d

istr

ibut

ion

of P

an t

est

band

in

tens

ity

(n=1

58)

0*1

23

40*

12

34

No

band

12

34

No

band

12

34

Pf &

Pan

/Pf

& P

vFi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Ca

rd T

est

Uni

med

Inte

rnat

iona

l, In

c.20

.57

14.2

425

25.6

314

.56

01.

273.

1622

.78

72.7

8N

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/AN

/A

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

1.58

4.75

27.2

239

.87

26.5

80.

630

0.63

15.1

983

.54

55.7

335

.03

7.96

0.96

0.32

1.27

8.92

33.1

250

.96

5.73

Mal

aria

P.F

/Viv

axDi

agno

stic

Aut

omat

ion

/ Co

rtez

Dia

gnos

tics,

Inc.

59.8

16.

0113

.61

13.9

26.

6535

.44

2.53

10.7

624

.05

27.2

299

.68

0.32

00

084

.81

5.06

8.23

1.9

0

Mal

asca

n Ra

pid

Test

for M

alar

ia

Pf/P

an (D

evic

e)Ze

phyr

Bio

med

ical

s17

.41

21.2

46.2

13.2

91.

90.

630.

6319

.62

30.3

848

.73

78.8

17.4

13.

80

010

.13

17.7

244

.94

24.0

53.

16

Para

scre

en R

apid

Tes

t for

Mal

aria

Pa

n/Pf

(Dev

ice)

Zeph

yr B

iom

edic

als

18.3

511

.71

34.8

120

.89

14.2

40.

630

7.59

16.4

675

.32

69.3

20.8

98.

231.

580

4.43

12.0

331

.65

31.0

120

.89

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

17.7

233

.54

30.7

11.0

86.

962.

532.

5318

.35

27.2

249

.37

28.4

841

.46

253.

161.

92.

533.

1625

.95

36.7

131

.65

Pan

only

Para

bank

Rap

id T

est f

or M

alar

ia

Pan

(Dev

ice)

Zeph

yr B

iom

edic

als

69.3

20.8

98.

540

1.27

2.53

6.96

29.11

32.9

128

.48

69.3

20.8

98.

540

1.27

2.53

6.96

29.11

32.9

128

.48

Pf -

Pla

smod

ium

falc

ipar

um

Pv -

Pla

smod

ium

viv

axpa

n -

Plas

mod

ium

spe

cies

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)70

Tabl

e A4

.5: D

istr

ibut

ion

of p

an/P

v te

st b

and

inte

nsit

y (0

-4)

scor

es f

or P

. viv

ax (

n=20

) sa

mpl

es a

t lo

w (

200)

and

hig

h (2

000

or 5

000)

par

asit

e de

nsit

ies

(par

asit

es/μ

l)

Prod

uct

Man

ufac

ture

r

200

para

site

s/μl

2,00

0 or

5,0

00 p

aras

ites

/μl

Perc

enta

ge d

istr

ibut

ion

of P

an t

est

band

inte

nsit

y (n

=80)

Perc

enta

ge d

istr

ibut

ion

of P

an t

est

band

inte

nsit

y (n

=80)

01

23

40

12

34

Pf &

Pan

/Pf

& P

vAd

vant

age

Mal

Car

dJ.

Mitr

a &

Co.

Pvt

. Ltd

.0

1.25

46.2

551

.25

1.25

00

05

95AZ

OG M

alar

ia p

f (H

RP-I

I) /p

v (p

LDH

) Ant

igen

Det

ectio

n Te

st D

evic

eAZ

OG, I

nc.

38.7

548

.75

11.2

51.

250

02.

512

.560

25Bi

nax

Now

Mal

aria

In

vern

ess

Med

ical

Inno

vatio

ns, I

nc.

7523

.75

1.25

00

55

42.5

452.

5Ca

reSt

art M

alar

ia H

RP2/

pLDH

(Pf/

PAN

) COM

BOAc

cess

Bio

, Inc

.1.

2513

.75

71.2

513

.75

00

05

22.5

72.5

Firs

t Res

pons

e M

alar

ia A

g Co

mbo

(PLD

H/H

RP2)

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.3.

7518

.75

66.2

510

1.25

00

022

.577

.5Fi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Car

d Te

stU

nim

ed In

tern

atio

nal,

Inc.

92.5

6.25

1.25

00

105

52.5

32.5

0H

exag

on M

alar

ia C

ombi

Hum

an G

mbH

98.7

51.

250

00

4037

.522

.50

0IC

T M

alar

ia C

ombo

Cas

sett

e Te

st (M

L02)

ICT

Diag

nost

ics

77.5

22.5

00

00

2.5

52.5

37.5

7.5

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

4043

.75

16.2

50

00

010

7515

Mal

aria

P.F

/Viv

axDi

agno

stic

Aut

omat

ion

/ Cor

tez

Diag

nost

ics,

Inc.

100

00

00

850

150

0M

alar

ia R

apid

Com

boVi

sion

Bio

tech

(Pty

) Ltd

.55

37.5

7.5

00

02.

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Tabl

e A4

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Dis

trib

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n of

pan

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d in

tens

ity

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ores

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ples

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MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)71

Tabl

e A4

.6 D

etec

tion

rat

e‡ of

P. f

alci

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MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)72

Prod

uct

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ufac

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y th

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pos

itive

Tabl

e A4

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Det

ecti

on r

ate

of P

. fal

cipa

rum

in lo

w (

200)

and

hig

h (2

000

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000)

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asit

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nsit

ies

(par

asit

es/μ

l) by

con

tine

nt b

ased

on

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man

ufac

ture

r

Prod

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ufac

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r

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or

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of s

ampl

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tect

ion

rate

by

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inen

t of

sam

ple

orig

in

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a (n

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h Am

eric

a (n

=8)

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a (n

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Pf &

Pan

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& P

v

Firs

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n –

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View

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v +

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ard

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med

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l, In

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350

100

100

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100

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stic

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fied

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itive

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)73

Tabl

e A4

.7 P

. fal

cipa

rum

tes

t lin

e fa

lse

posi

tive

res

ults

for

P. v

ivax

sam

ples

(n=

20)

at lo

w (

200)

and

hig

h (2

000

or 5

000)

par

asit

e de

nsit

ies

(par

asit

es/μ

l)

Prod

uct

Man

ufac

ture

r

P. v

ivax

sam

ples

(n=

20)

200

para

site

s/μl

2000

or

5000

par

asit

es/μ

l

Fals

e po

siti

ve P

f in

fect

ion◊

Fals

e po

siti

ve P

f in

fect

ion◊

Lot

1 (n

=40)

Lot

2 (n

=40)

Ove

rall

(n=8

0)Lo

t 1

(n=2

0)Lo

t 2

(n=2

0)O

vera

ll (n

=40)

Pf o

nly

ADVA

NCE

D QU

ALIT

Y TM

MAL

ARIA

(p.f)

POC

T In

Tec

Prod

ucts

, Inc

.7.

517

.512

.520

1517

.5AD

VAN

CED

QUAL

ITY

TM O

ne S

tep

Mal

aria

(p.f.

) Tes

t (w

hole

blo

od)

InTe

c Pr

oduc

ts, I

nc.

52.5

4548

.75

5040

45Ad

vant

age

P.f.

Mal

aria

Car

dJ.

Mitr

a &

Co.

Pvt

. Ltd

.2.

50

1.25

50

2.5

Care

Star

t Mal

aria

HRP

2 (P

f)Ac

cess

Bio

, Inc

.10

05

105

7.5

Firs

t Res

pons

e M

alar

ia A

g H

RP2

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.0

00

00

0Fi

rstS

ign

– M

alar

ia P

f Car

d Te

stU

nim

ed In

tern

atio

nal,

Inc.

520

12.5

1515

15H

exag

on M

alar

iaH

uman

Gm

bH5.

41 (3

7)10

.26

(39)

7.89

(76)

05

2.5

ICT

Mal

aria

Pf C

asse

tte

Test

(ML0

1)IC

T Di

agno

stic

s0

(39)

2.5

1.27

(79)

50

2.5

Imm

unoq

uick

Mal

aria

Fal

cipa

rum

Bios

ynex

00

00

00

Mal

aria

Pla

smod

ium

falc

ipar

um R

apid

test

Dev

ice

(Who

le b

lood

)AC

ON L

abor

ator

ies,

Inc.

00

00

00

Mal

aria

Rap

id P

fVi

sion

Bio

tech

(Pty

) Ltd

.0

00

00

0Pa

rach

eck

Pf R

apid

test

for P

. fal

cipa

rum

Mal

aria

(Dev

ice)

Or

chid

Bio

med

ical

Sys

tem

s2.

63 (3

8)5.

26 (3

8)3.

95 (7

6)5

55

Para

chec

k Pf

Rap

id te

st fo

r P. f

alci

paru

m M

alar

ia (D

ipst

ick)

Or

chid

Bio

med

ical

Sys

tem

s7.

525

.64

(39)

16.4

6 (7

9)10

1010

Para

hit-

f DIP

STIC

K FO

R FA

LCIP

ARU

M M

ALAR

IASp

an D

iagn

ostic

s Lt

d.0

00

00

0Pa

rahi

t-f T

EST

DEVI

CE F

OR F

ALCI

PARU

M M

ALAR

IASp

an D

iagn

ostic

s Lt

d.0

00

00

0SD

BIO

LIN

E M

alar

ia A

g Pf

St

anda

rd D

iagn

ostic

s, In

c.0

00

00

0Pf

& P

an/P

f &

Pv

Adva

ntag

e M

al C

ard

J. M

itra

& C

o. P

vt. L

td.

00

00

00

AZOG

Mal

aria

pf (

HRP

-II)

/pv

(pLD

H) A

ntig

en D

etec

tion

Test

Dev

ice

AZOG

, Inc

.0

00

05

2.5

Bina

x N

ow M

alar

ia

Inve

rnes

s M

edic

al In

nova

tions

, Inc

.2.

56 (3

9)5

3.8

(79)

010

5Ca

reSt

art M

alar

ia H

RP2/

pLDH

(Pf/

PAN

) COM

BOAc

cess

Bio

, Inc

.2.

50

1.25

05

2.5

Firs

t Res

pons

e M

alar

ia A

g Co

mbo

(PLD

H/H

RP2)

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.2.

55

3.75

2515

20Fi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Car

d Te

stU

nim

ed In

tern

atio

nal,

Inc.

07.

53.

750

105

Hex

agon

Mal

aria

Com

biH

uman

Gm

bH0

0 (3

9)0

(79)

5.26

(19)

0 (1

9)2.

63 (3

8)IC

T M

alar

ia C

ombo

Cas

sett

e Te

st (M

L02)

ICT

Diag

nost

ics

52.

53.

755

55

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

00

00

00

Mal

aria

P.F

/Viv

axDi

agno

stic

Aut

omat

ion

/ Cor

tez

Diag

nost

ics,

Inc.

0 (1

4)0

(16)

0 (3

0)0

(10)

0 (8

)0

(18)

Mal

aria

Rap

id C

ombo

Visi

on B

iote

ch (P

ty) L

td.

7.5

7.5

7.5

510

7.5

Mal

aria

Rap

id D

ual

Visi

on B

iote

ch (P

ty) L

td.

00

00

00

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s5

7.5

6.25

1520

17.5

One

Step

Mal

aria

Ant

igen

Str

ipIN

D Di

agno

stic

Inc.

07.

53.

750

00

OnSi

ght –

Par

aQui

ck (P

an, P

f) Te

stAm

geni

x In

tern

atio

nal,

Inc.

02.

51.

250

00

OptiM

AL-I

TDi

aMed

AG

00

00

00

Para

hit-

Tota

l Dev

ice

Rapi

d te

st fo

r P. f

alci

paru

m a

nd P

an m

alar

ial s

peci

es.

Span

Dia

gnos

tics

Ltd.

00

05

02.

5Pa

rasc

reen

Rap

id T

est f

or M

alar

ia P

an/P

f (De

vice

)Ze

phyr

Bio

med

ical

s5

2.56

(39)

3.8

(79)

00

0Qu

icks

tick

Mal

aria

Ant

igen

Tes

tIn

nova

tek

Med

ical

Inc.

07.

53.

750

00

SD B

IOLI

NE

Mal

aria

Ag

Stan

dard

Dia

gnos

tics,

Inc.

2.5

01.

250

00

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

an

Stan

dard

Dia

gnos

tics,

Inc.

0 (3

9)0

0 (7

9)5.

26 (1

9)0

2.56

(39)

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

0 (3

9)2.

63 (3

8)1.

3 (7

7)0

5.26

(19)

2.56

(39)

Pan

only

Adva

ntag

e Pa

n M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

N/A

N/A

N/A

N/A

N/A

N/A

Care

Star

t Mal

aria

pLD

H (P

AN)

Acce

ss B

io, I

nc.

N/A

N/A

N/A

N/A

N/A

N/A

Para

bank

Rap

id T

est f

or M

alar

ia P

an (D

evic

e)Ze

phyr

Bio

med

ical

sN

/AN

/AN

/AN

/AN

/AN

/APf

- P

lasm

odiu

m fa

lcip

arum

Pv

- P

lasm

odiu

m v

ivax

pan

- Pl

asm

odiu

m s

peci

es

◊ - P

f lin

e po

sitiv

e in

dica

tes

a fa

lse

posi

tive

P. fa

lcip

arum

infe

ctio

n

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)74

Tabl

e A4

.7a:

P. f

alci

paru

m t

est

line

fals

e po

siti

ve r

esul

ts f

or P

. viv

ax s

ampl

es (

n=20

) at

low

(20

0) a

nd h

igh

(200

0 or

500

0) p

aras

ite

dens

itie

s (p

aras

ites

/μl)

base

d on

a

dela

yed

read

ing

whe

n sp

ecifi

ed b

y th

e m

anuf

actu

rer

Prod

uct

Man

ufac

ture

r

P. v

ivax

sam

ples

(n=

20)

200

para

site

s/μl

2000

or

5000

par

asit

es/μ

l

Fals

e po

siti

ve P

f in

fect

ion◊

Fals

e po

siti

ve P

f in

fect

ion◊

Lot

1 (n

=40)

Lot

2 (n

=40)

Ove

rall

(n=8

0)

Lot

1 (n

=20)

Lot

2 (n

=20)

Ove

rall

(n=4

0)

Pf &

Pan

/Pf

& P

v

Firs

tSig

n –

Para

View

-2 (P

v +

Pf) C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.2.

52.

52.

50

52.

5

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

02.

51.

250

52.

5

Mal

aria

P.F

/Viv

axDi

agno

stic

Aut

omat

ion

/ Cor

tez

Diag

nost

ics,

Inc.

0 (1

6)0

(14)

0 (3

0)0

(10)

0 (5

)0

(15)

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s5

107.

515

1012

.5

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf (

Devi

ce)

Zeph

yr B

iom

edic

als

00

(39)

0 (7

9)0

00

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

2.56

(39)

5.26

(38)

3.9

(77)

100

(19)

5.13

(39)

Pan

only

Para

bank

Rap

id T

est f

or M

alar

ia P

an (D

evic

e)Ze

phyr

Bio

med

ical

sN

/AN

/AN

/AN

/AN

/AN

/A

Pf -

Pla

smod

ium

falc

ipar

um

Pv -

Pla

smod

ium

viv

axpa

n -

Plas

mod

ium

spe

cies

◊ -

Pf l

ine

posi

tive

indi

cate

s a

fals

e po

sitiv

e P.

falc

ipar

um in

fect

ion

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)75

Tabl

e A4

.8: C

ombi

nati

on t

est

pan

line

fals

e po

siti

ve n

on P

f in

fect

ion

on P

f sa

mpl

es (

n=79

) at

low

and

hig

h pa

rasi

te d

ensi

ties

(pa

rasi

tes/

μl)

Prod

uct

Man

ufac

ture

r

P. f

alci

paru

m s

ampl

es (

n=79

)

200

para

site

s/μl

2000

or

5000

par

asit

es/μ

l

Fals

e po

siti

ve n

on P

f in

fect

ion†

Fals

e po

siti

ve n

on P

f in

fect

ion†

Lot

1 (n

=158

)Lo

t 2

(n=1

58)

Ove

rall

(n=3

16)

Lot

1 (n

=79)

Lot

2 (n

=79)

Ove

rall

(n=1

58)

Pf &

Pan

/Pf

& P

vAd

vant

age

Mal

Car

dJ.

Mitr

a &

Co.

Pvt

. Ltd

.2.

532.

532.

530

00

AZOG

Mal

aria

pf (

HRP

-II)

/pv

(pLD

H) A

ntig

en D

etec

tion

Test

Dev

ice

AZOG

, Inc

.1.

91.

91.

90

00

Bina

x N

ow M

alar

ia

Inve

rnes

s M

edic

al In

nova

tions

, Inc

.0.

630

0.32

0 (7

8)0

0 (1

57)

Care

Star

t Mal

aria

HRP

2/pL

DH (P

f/PA

N) C

OMBO

Acce

ss B

io, I

nc.

00.

630.

320

00

Firs

t Res

pons

e M

alar

ia A

g Co

mbo

(PLD

H/H

RP2)

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.0

00

00

0Fi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Car

d Te

stU

nim

ed In

tern

atio

nal,

Inc.

01.

90.

950

00

Hex

agon

Mal

aria

Com

biH

uman

Gm

bH0

00

0 (7

8)0

0 (1

57)

ICT

Mal

aria

Com

bo C

asse

tte

Test

(ML0

2)IC

T Di

agno

stic

s0

0.63

0.32

00

0Im

mun

oqui

ck M

alar

ia +

4Bi

osyn

ex0

0 (1

56)

0 (3

14)

00

(78)

0 (1

57)

Mal

aria

P.F

/Viv

axDi

agno

stic

Aut

omat

ion

/ Cor

tez

Diag

nost

ics,

Inc.

1.79

(56)

0 (4

1)1.

03 (9

7)0

(31)

5.88

(17)

2.08

(48)

Mal

aria

Rap

id C

ombo

Visi

on B

iote

ch (P

ty) L

td.

0.63

00.

320

00

Mal

aria

Rap

id D

ual

Visi

on B

iote

ch (P

ty) L

td.

0.63

1.9

1.27

00

0M

alas

can

Rapi

d Te

st fo

r Mal

aria

Pf/

Pan

(Dev

ice)

Zeph

yr B

iom

edic

als

0.63

0.63

0.63

00

0On

e St

ep M

alar

ia A

ntig

en S

trip

IND

Diag

nost

ic In

c.1.

92.

532.

221.

272.

531.

9On

Sigh

t – P

araQ

uick

(Pan

, Pf)

Test

Amge

nix

Inte

rnat

iona

l, In

c.0

00

00

0Op

tiMAL

-IT

DiaM

ed A

G4.

433.

163.

80

1.27

0.63

Para

hit-

Tota

l Dev

ice

Rapi

d te

st fo

r P. f

alci

paru

m a

nd P

an m

alar

ial s

peci

es.

Span

Dia

gnos

tics

Ltd.

00

(315

)0

(315

)0

00

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf (

Devi

ce)

Zeph

yr B

iom

edic

als

0.63

0.63

0.63

00

0Qu

icks

tick

Mal

aria

Ant

igen

Tes

tIn

nova

tek

Med

ical

Inc.

1.9

2.53

2.22

1.27

2.53

1.9

SD B

IOLI

NE

Mal

aria

Ag

Stan

dard

Dia

gnos

tics,

Inc.

00

00

00

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

an

Stan

dard

Dia

gnos

tics,

Inc.

00

(155

)0

(310

)0

00

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

3.21

(156

)3.

85 (1

56)

3.52

(312

)0

(78)

0 (7

7)0

(155

)Pf

- P

lasm

odiu

m fa

lcip

arum

Pv

- P

lasm

odiu

m v

ivax

pan

- Pl

asm

odiu

m s

peci

es

† - F

or c

ombi

natio

n te

sts,

Pan

or P

v lin

e, o

nly,

posi

tive

indi

cate

s a

fals

e po

sitiv

e no

n P.

falc

ipar

um in

fect

ion

Tabl

e A4

.8a:

Com

bina

tion

tes

t pa

n lin

e fa

lse

posi

tive

non

Pf

infe

ctio

n on

Pf

sam

ples

(n=

79)

at lo

w a

nd h

igh

para

site

den

siti

es (

para

site

s/μl

) ba

sed

on a

del

ayed

rea

ding

w

hen

spec

ified

by

the

man

ufac

ture

r

Prod

uct

Man

ufac

ture

r

P. f

alci

paru

m s

ampl

es (

n=79

)

200

para

site

s/μl

2000

or

5000

par

asit

es/μ

l

Fals

e po

siti

ve n

on P

f in

fect

ion†

Fals

e po

siti

ve n

on P

f in

fect

ion†

Lot

1 (n

=158

)Lo

t 2

(n=1

58)

Ove

rall

(n=3

16)

Lot

1 (n

=79)

Lot

2 (n

=79)

Ove

rall

(n=1

58)

Pf &

Pan

/Pf

& P

v

Firs

tSig

n –

Para

View

-2 (P

v +

Pf) C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.0

00

00

0

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

00

(156

)0

(314

)0

(78)

0 (7

8)0

(156

)

Mal

aria

P.F

/Viv

axDi

agno

stic

Aut

omat

ion

/ Cor

tez

Diag

nost

ics,

Inc.

0 (5

8)0

(44)

0 (1

02)

3.23

(31)

5.88

(17)

4.17

(48)

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s1.

91.

271.

580

00

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf (

Devi

ce)

Zeph

yr B

iom

edic

als

0.63

0.63

0.63

1.27

00.

63

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

2.56

(156

)1.

28 (1

56)

1.92

(312

)0

(78)

0 (7

7)0

(155

)

Pf -

Pla

smod

ium

falc

ipar

um

Pv -

Pla

smod

ium

viv

axpa

n -

Plas

mod

ium

spe

cies

† -

For

com

bina

tion

test

s, Pa

n or

Pv

line,

onl

y, po

sitiv

e in

dica

tes

a fa

lse

posi

tive

non

P. fa

lcip

arum

infe

ctio

n

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)76

Tabl

e A4

.9: F

alse

pos

itiv

e ra

te o

f P.

fal

cipa

rum

(or

pan

† ) t

est

line

resu

lts

on a

ll m

alar

ia-n

egat

ive

sam

ples

Prod

uct

Man

ufac

ture

r

Perc

enta

ge o

f fa

lse

posi

tive

Pf

(or

Pan† )

tes

t lin

es o

n”cl

ean”

neg

ativ

e sa

mpl

es

Perc

enta

ge o

f fa

lse

posi

tive

Pf

(or

Pan† )

tes

t lin

es o

n sa

mpl

es c

onta

inin

g no

n-Pl

asm

odiu

m

spp.

infe

ctio

us a

gent

s

Perc

enta

ge o

f fa

lse

posi

tive

Pf

(or

Pan† )

tes

t lin

es o

n sa

mpl

es c

onta

i-ni

ng im

mun

olog

ical

fac

tors

Lot

1 (n

=84)

Lot

2 (n

=84)

Ove

rall

(n=1

68)

Lot

1 (n

=42)

Lot

2 (n

=42)

Ove

rall

(n=8

4)Lo

t 1

(n=5

4)Lo

t 2

(n=5

4)O

vera

ll (n

=108

)

Pf o

nly

ADVA

NCE

D QU

ALIT

Y TM

MAL

ARIA

(p.f)

POC

T In

Tec

Prod

ucts

, Inc

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11.9

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711

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835

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ALIT

Y TM

One

Ste

p M

alar

ia (p

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est (

who

le b

lood

)In

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Prod

ucts

, Inc

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22.6

227

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42.8

621

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(41)

32.5

3 (8

3)53

.729

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41.6

7Ad

vant

age

P.f.

Mal

aria

Car

dJ.

Mitr

a &

Co.

Pvt

. Ltd

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00

00

03.

71.

852.

78Ca

reSt

art M

alar

ia H

RP2

(Pf)

Acce

ss B

io, I

nc.

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850

0.93

Firs

t Res

pons

e M

alar

ia A

g H

RP2

Prem

ier M

edic

al C

orpo

ratio

n Lt

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4.76

2.38

00

0Fi

rstS

ign

– M

alar

ia P

f Car

d Te

stU

nim

ed In

tern

atio

nal,

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(83)

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(166

)0

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141.

850

(53)

0.93

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exag

on M

alar

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uman

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0 (3

9)1.

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T M

alar

ia P

f Cas

sett

e Te

st (M

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nost

ics

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1.19

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mun

oqui

ck M

alar

ia F

alci

paru

mBi

osyn

ex1.

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0.6

00

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851.

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85M

alar

ia P

lasm

odiu

m fa

lcip

arum

Rap

id te

st D

evic

e (W

hole

blo

od)

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Lab

orat

orie

s, In

c.0

00

00

05.

561.

853.

7M

alar

ia R

apid

Pf

Visi

on B

iote

ch (P

ty) L

td.

1.19

00.

60

00

00

0Pa

rach

eck

Pf R

apid

test

for P

. fal

cipa

rum

Mal

aria

(Dev

ice)

Or

chid

Bio

med

ical

Sys

tem

s0

(81)

2.53

(79)

1.25

(160

)0

(39)

5 (4

0)2.

53 (7

9)1.

89 (5

3)1.

89 (5

3)1.

89 (1

06)

Para

chec

k Pf

Rap

id te

st fo

r P. f

alci

paru

m M

alar

ia (D

ipst

ick)

Or

chid

Bio

med

ical

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tem

s7.

147.

23 (8

3)7.

19 (1

67)

7.14

9.52

8.33

1.85

15.0

9 (5

3)8.

41 (1

07)

Para

hit-

f DIP

STIC

K FO

R FA

LCIP

ARU

M M

ALAR

IASp

an D

iagn

ostic

s Lt

d.0

1.19

0.6

2.38

01.

190

1.85

0.93

Para

hit-

f TES

T DE

VICE

FOR

FAL

CIPA

RUM

MAL

ARIA

Span

Dia

gnos

tics

Ltd.

00

00

00

00

0SD

BIO

LIN

E M

alar

ia A

g Pf

St

anda

rd D

iagn

ostic

s, In

c.2.

382.

382.

384.

767.

145.

950

00

Pf &

Pan

/Pf

& P

vAd

vant

age

Mal

Car

dJ.

Mitr

a &

Co.

Pvt

. Ltd

.2.

383.

572.

982.

380

1.19

1.85

1.85

1.85

AZOG

Mal

aria

pf (

HRP

-II)

/pv

(pLD

H) A

ntig

en D

etec

tion

Test

Dev

ice

AZOG

, Inc

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191.

792.

382.

382.

380

00

Bina

x N

ow M

alar

ia

Inve

rnes

s M

edic

al In

nova

tions

, Inc

.0

00

07.

143.

570

00

Care

Star

t Mal

aria

HRP

2/pL

DH (P

f/PA

N) C

OMBO

Acce

ss B

io, I

nc.

1.19

00.

62.

380

1.19

00

0Fi

rst R

espo

nse

Mal

aria

Ag

Com

bo (P

LDH

/HRP

2)Pr

emie

r Med

ical

Cor

pora

tion

Ltd.

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3.57

3.57

4.76

02.

380

3.7

1.85

Firs

tSig

n –

Para

View

-2 (P

v +

Pf) C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.7.

142.

41 (8

3)4.

79 (1

67)

7.14

4.76

5.95

5.56

7.41

6.48

Hex

agon

Mal

aria

Com

biH

uman

Gm

bH2.

382.

41 (8

3)2.

4 (1

67)

00

00

00

ICT

Mal

aria

Com

bo C

asse

tte

Test

(ML0

2)IC

T Di

agno

stic

s1.

190

0.6

2.38

2.38

2.38

7.41

3.7

5.56

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

00

00

2.38

1.19

00

0M

alar

ia P

.F/V

ivax

Diag

nost

ic A

utom

atio

n / C

orte

z Di

agno

stic

s, In

c.0

(35)

0 (2

9)0

(64)

9.09

(11)

0 (1

5)3.

85 (2

6)11

.54

(26)

5.26

(19)

8.89

(45)

Mal

aria

Rap

id C

ombo

Visi

on B

iote

ch (P

ty) L

td.

4.76

5.95

5.36

9.76

(41)

7.14

8.43

(83)

5.56

5.56

5.56

Mal

aria

Rap

id D

ual

Visi

on B

iote

ch (P

ty) L

td.

03.

571.

790

4.76

2.38

01.

850.

93M

alas

can

Rapi

d Te

st fo

r Mal

aria

Pf/

Pan

(Dev

ice)

Zeph

yr B

iom

edic

als

5.95

4.76

5.36

4.76

02.

3811

.119.

2610

.19

One

Step

Mal

aria

Ant

igen

Str

ipIN

D Di

agno

stic

Inc.

1.19

2.41

(83)

1.8

(167

)0

(41)

2.38

1.2

(83)

3.7

1.85

2.78

OnSi

ght –

Par

aQui

ck (P

an, P

f) Te

stAm

geni

x In

tern

atio

nal,

Inc.

00

00

(41)

00

(83)

0 (5

3)0

(53)

0 (1

06)

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AL-I

TDi

aMed

AG

0 (8

3)0

0 (1

67)

0 (4

1)0

0 (8

3)3.

85 (5

2)1.

852.

83 (1

06)

Para

hit-

Tota

l Dev

ice

Rapi

d te

st fo

r P. f

alci

paru

m a

nd P

an m

alar

ial s

peci

es.

Span

Dia

gnos

tics

Ltd.

00

02.

380

1.19

01.

850.

93Pa

rasc

reen

Rap

id T

est f

or M

alar

ia P

an/P

f (De

vice

)Ze

phyr

Bio

med

ical

s0

2.38

1.19

02.

381.

191.

853.

77 (5

3)2.

8 (1

07)

Quic

kstic

k M

alar

ia A

ntig

en T

est

Inno

vate

k M

edic

al In

c.1.

192.

41 (8

3)1.

8 (1

67)

0 (4

1)2.

381.

2 (8

3)3.

71.

852.

78SD

BIO

LIN

E M

alar

ia A

gSt

anda

rd D

iagn

ostic

s, In

c.2.

381.

191.

790

00

3.7

3.7

3.7

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

an

Stan

dard

Dia

gnos

tics,

Inc.

01.

190.

62.

56 (3

9)4.

763.

7 (8

1)0

(53)

00

(107

)W

ondf

o On

e St

ep M

alar

ia P

f/Pa

n W

hole

Blo

od T

est

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ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d2.

41 (8

3)4.

763.

59 (1

67)

7.32

(41)

11.9

9.64

(83)

3.85

(52)

7.41

5.66

(106

)Pa

n on

lyAd

vant

age

Pan

Mal

aria

Car

dJ.

Mitr

a &

Co.

Pvt

. Ltd

.1.

192.

381.

790

00

00

0Ca

reSt

art M

alar

ia p

LDH

(PAN

)Ac

cess

Bio

, Inc

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768.

336.

552.

3811

.97.

143.

71.

852.

78Pa

raba

nk R

apid

Tes

t for

Mal

aria

Pan

(Dev

ice)

Zeph

yr B

iom

edic

als

3.61

(83)

2.38

2.99

(167

)2.

380

1.19

7.55

(53)

3.7

5.61

(107

)Pf

- P

lasm

odiu

m fa

lcip

arum

Pv

- P

lasm

odiu

m v

ivax

pan

- Pl

asm

odiu

m s

peci

es

† - F

or P

an-o

nly

test

s

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)77

Tabl

e A4

.9a:

Fal

se p

osit

ive

rate

of

P. f

alci

paru

m (

or p

an† )

tes

t lin

e re

sult

s on

all

mal

aria

-neg

ativ

e sa

mpl

es b

ased

on

a de

laye

d re

adin

g w

here

spe

cifie

d by

the

m

anuf

actu

rer

Prod

uct

Man

ufac

ture

r

Perc

enta

ge o

f fa

lse

posi

tive

Pf

or P

an t

est

lines

on”

clea

n” n

egat

ive

sam

ples

Perc

enta

ge o

f fa

lse

posi

tive

Pf

or P

an t

est

lines

on

sam

ples

con

tain

ing

non-

Plas

mo-

dium

infe

ctio

us a

gent

s

Perc

enta

ge o

f fa

lse

posi

tive

Pf

or P

an t

est

lines

on

sam

ples

con

tain

ing

imm

unol

ogic

al

fact

ors

Lot

1 (n

=84)

Lot

2 (n

=84)

Ove

rall

(n=1

68)

Lot

1 (n

=42)

Lot

2 (n

=42)

Ove

rall

(n=8

4)Lo

t 1

(n=5

4)Lo

t 2

(n=5

4)O

vera

ll (n

=108

)

Pf &

Pan

/Pf

& P

vFi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Car

d Te

stU

nim

ed In

tern

atio

nal,

Inc.

5.95

0 (8

3)2.

99 (1

67)

00

01.

850

0.93

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

1.19

13.1

7.14

011

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951.

8524

.07

12.9

6M

alar

ia P

.F/V

ivax

Diag

nost

ic A

utom

atio

n / C

orte

z Di

agno

stic

s, In

c.6.

45 (3

1)0

(31)

3.23

(62)

0 (9

)0

(14)

0 (2

3)10

.71

(28)

5.26

(19)

8.51

(47)

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

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334.

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557.

140

3.57

14.8

13.

79.

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rasc

reen

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id T

est f

or M

alar

ia P

an/P

f (De

vice

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phyr

Bio

med

ical

s0

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1.19

00

00

1.85

0.93

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

3.66

(82)

5.95

4.82

(166

)9.

76 (4

1)4.

767.

23 (8

3)4

(50)

9.26

6.73

(104

)Pa

n on

lyPa

raba

nk R

apid

Tes

t for

Mal

aria

Pan

(Dev

ice)

Zeph

yr B

iom

edic

als

1.22

(82)

1.19

1.2

(166

)2.

380

1.19

7.41

03.

7Pf

- P

lasm

odiu

m fa

lcip

arum

Pv

- P

lasm

odiu

m v

ivax

pan

- Pl

asm

odiu

m s

peci

es

† - fo

r Pan

-onl

y te

sts

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)78

Tabl

e A4

.10

Fals

e po

siti

ve r

ate

of P

. fal

cipa

rum

(or

pan

† ) t

est

line

resu

lts

for

sam

ples

con

tain

ing

spec

ific

non-

mal

aria

l inf

ecti

ous

path

ogen

s

Prod

uct

Man

ufac

ture

r

Perc

enta

ge o

f fa

lse

posi

tive

Pf

(or

Pan)

tes

t lin

es b

y in

fect

ious

pat

hoge

n

Deng

ueSc

hist

osom

iasi

s Le

ishm

ania

Chag

as

Lot

1 (n

=8)

Lot

2 (

n=8)

Lot

1 (n

=20)

Lot

2 (

n=20

)Lo

t 1

(n=1

0)Lo

t 2

(n=1

0)Lo

t 1

(n=4

)Lo

t 2

(n=4

)

Pf o

nly

ADVA

NCE

D QU

ALIT

Y TM

MAL

ARIA

(p.f)

POC

T In

Tec

Prod

ucts

, Inc

.0

010

1030

300

75AD

VAN

CED

QUAL

ITY

TM O

ne S

tep

Mal

aria

(p.f.

) Tes

t (w

hole

blo

od)

InTe

c Pr

oduc

ts, I

nc.

500

405.

26 (

19)

3050

7575

Adva

ntag

e P.

f. M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

00

00

00

00

Care

Star

t Mal

aria

HRP

2 (P

f)Ac

cess

Bio

, Inc

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00

010

00

0Fi

rst R

espo

nse

Mal

aria

Ag

HRP

2Pr

emie

r Med

ical

Cor

pora

tion

Ltd.

00

00

010

025

Firs

tSig

n –

Mal

aria

Pf C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.0

12.5

05

010

075

Hex

agon

Mal

aria

Hum

an G

mbH

12.5

00

(19)

0 (1

9)0

0 (9

)0

0IC

T M

alar

ia P

f Cas

sett

e Te

st (M

L01)

ICT

Diag

nost

ics

00

00

010

00

Imm

unoq

uick

Mal

aria

Fal

cipa

rum

Bios

ynex

00

00

00

00

Mal

aria

Pla

smod

ium

falc

ipar

um R

apid

test

Dev

ice

(Who

le b

lood

)AC

ON L

abor

ator

ies,

Inc.

00

00

00

00

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aria

Rap

id P

fVi

sion

Bio

tech

(Pty

) Ltd

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00

00

00

0Pa

rach

eck

Pf R

apid

test

for P

. fal

cipa

rum

Mal

aria

(Dev

ice)

Or

chid

Bio

med

ical

Sys

tem

s0

00

(18)

0 (1

8)0

(9)

100

25Pa

rach

eck

Pf R

apid

test

for P

. fal

cipa

rum

Mal

aria

(Dip

stic

k)

Orch

id B

iom

edic

al S

yste

ms

012

.55

520

200

0Pa

rahi

t-f D

IPST

ICK

FOR

FALC

IPAR

UM

MAL

ARIA

Span

Dia

gnos

tics

Ltd.

00

00

100

00

Para

hit-

f TES

T DE

VICE

FOR

FAL

CIPA

RUM

MAL

ARIA

Span

Dia

gnos

tics

Ltd.

00

00

00

00

SD B

IOLI

NE

Mal

aria

Ag

Pf

Stan

dard

Dia

gnos

tics,

Inc.

00

00

2030

00

Pf &

Pan

/Pf

& P

vAd

vant

age

Mal

Car

dJ.

Mitr

a &

Co.

Pvt

. Ltd

.0

00

010

00

0AZ

OG M

alar

ia p

f (H

RP-I

I) /p

v (p

LDH

) Ant

igen

Det

ectio

n Te

st D

evic

eAZ

OG, I

nc.

00

50

010

00

Bina

x N

ow M

alar

ia

Inve

rnes

s M

edic

al In

nova

tions

, Inc

.0

00

00

300

0Ca

reSt

art M

alar

ia H

RP2/

pLDH

(Pf/

PAN

) COM

BOAc

cess

Bio

, Inc

.0

05

00

00

0Fi

rst R

espo

nse

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aria

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Com

bo (P

LDH

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emie

r Med

ical

Cor

pora

tion

Ltd.

12.5

05

00

00

0Fi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Car

d Te

stU

nim

ed In

tern

atio

nal,

Inc.

12.5

010

00

100

25H

exag

on M

alar

ia C

ombi

Hum

an G

mbH

00

00

00

00

ICT

Mal

aria

Com

bo C

asse

tte

Test

(ML0

2)IC

T Di

agno

stic

s12

.512

.50

00

00

0Im

mun

oqui

ck M

alar

ia +

4Bi

osyn

ex0

00

50

00

0M

alar

ia P

.F/V

ivax

Diag

nost

ic A

utom

atio

n / C

orte

z Di

agno

stic

s, In

c.0

(2)

0 (3

)25

(4)

0 (9

)0

(4)

0 (3

)0

(1)

N/A

Mal

aria

Rap

id C

ombo

Visi

on B

iote

ch (P

ty) L

td.

012

.55.

26 (

19)

020

2025

0M

alar

ia R

apid

Dua

l Vi

sion

Bio

tech

(Pty

) Ltd

.0

00

00

100

25M

alas

can

Rapi

d Te

st fo

r Mal

aria

Pf/

Pan

(Dev

ice)

Zeph

yr B

iom

edic

als

250

00

00

00

One

Step

Mal

aria

Ant

igen

Str

ipIN

D Di

agno

stic

Inc.

0 (7

)0

00

010

00

OnSi

ght –

Par

aQui

ck (P

an, P

f) Te

stAm

geni

x In

tern

atio

nal,

Inc.

00

0 (1

9)0

00

00

OptiM

AL-I

TDi

aMed

AG

00

0 (1

9)0

00

00

Para

hit-

Tota

l Dev

ice

Rapi

d te

st fo

r P. f

alci

paru

m a

nd P

an m

alar

ial s

peci

es.

Span

Dia

gnos

tics

Ltd.

00

50

00

00

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf (

Devi

ce)

Zeph

yr B

iom

edic

als

00

00

010

00

Quic

kstic

k M

alar

ia A

ntig

en T

est

Inno

vate

k M

edic

al In

c.0

(7)

00

00

100

0SD

BIO

LIN

E M

alar

ia A

gSt

anda

rd D

iagn

ostic

s, In

c.0

00

00

00

0SD

BIO

LIN

E M

alar

ia A

g Pf

/Pan

St

anda

rd D

iagn

ostic

s, In

c.0

00

(19)

012

.520

00

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

00

5.26

(19

)10

2020

025

Pan

only

Adva

ntag

e Pa

n M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

00

00

00

00

Care

Star

t Mal

aria

pLD

H (P

AN)

Acce

ss B

io, I

nc.

00

05

1030

025

Para

bank

Rap

id T

est f

or M

alar

ia P

an (D

evic

e)Ze

phyr

Bio

med

ical

s0

00

010

00

0Pf

- P

lasm

odiu

m fa

lcip

arum

Pv

- P

lasm

odiu

m v

ivax

pan

- Pl

asm

odiu

m s

peci

es

† -fo

r Pan

-onl

y te

sts

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)79

Tabl

e A4

.10a

: Fal

se p

osit

ive

rate

of

P. f

alci

paru

m (

or p

an† )

tes

t lin

e re

sult

s fo

r sa

mpl

es c

onta

inin

g sp

ecifi

c no

n-m

alar

ial i

nfec

tiou

s pa

thog

ens

base

d on

a d

elay

ed s

econ

d re

adin

g w

hen

spec

ified

by

the

man

ufac

ture

r

Prod

uct

Man

ufac

ture

r

Perc

enta

ge o

f fa

lse

posi

tive

Pf

(or

Pan)

tes

t lin

es b

y in

fect

ious

pat

hoge

n

Deng

ueSc

hist

osom

iasi

s Le

ishm

ania

Chag

as

Lot

1 (n

=8)

Lot

2 (n

=8)

Lot

1 (n

=20)

Lot

2 (n

=20)

Lot

1 (n

=10)

Lot

2 (n

=10)

Lot

1 (n

=4)

Lot

2 (n

=4)

Pf &

Pan

/Pf

& P

vFi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Car

d Te

stU

nim

ed In

tern

atio

nal,

Inc.

00

00

00

00

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

012

.50

150

100

0M

alar

ia P

.F/V

ivax

Diag

nost

ic A

utom

atio

n / C

orte

z Di

agno

stic

s, In

c.0

(2)

0 (3

)0

(2)

00

(4)

0 (3

)0

(1)

N/A

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s37

.50

00

00

00

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf (

Devi

ce)

Zeph

yr B

iom

edic

als

00

00

00

00

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

00

15.7

9 (1

9)0

1010

025

Pan

only

Para

bank

Rap

id T

est f

or M

alar

ia P

an (D

evic

e)Ze

phyr

Bio

med

ical

s0

00

010

00

0Pf

- P

lasm

odiu

m fa

lcip

arum

Pv

- P

lasm

odiu

m v

ivax

pan

- Pl

asm

odiu

m s

peci

es

† -fo

r Pan

-onl

y te

sts

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)8 0

Tabl

e A4

.11: F

alse

pos

itiv

e ra

te o

f P.

fal

cipa

rum

(or

pan

† ) t

est

line

resu

lts

for

sam

ples

con

tain

ing

pote

ntia

lly c

ross

-rea

ctin

g bl

ood

imm

unol

ogic

al f

acto

rs

Prod

uct

Man

ufac

ture

r

Perc

enta

ge o

f fa

lse

posi

tive

Pf

(or

Pan)

tes

t lin

es b

y bl

ood

imm

unol

ogic

al f

acto

r

Rheu

mat

oid

fact

orAn

ti-n

ucle

ar a

ntib

odie

sAn

ti-m

ouse

ant

ibod

ies

Rapi

d pl

asm

a re

agin

(RP

R)

posi

tive

Lot

1 (n

=8)

Lot

2 (n

=8)

Lot

1 (n

=26)

Lot

2 (n

=26)

Lot

1 (n

=2)

Lot

2 (n

=2)

Lot

1 (n

=18)

Lot

2 (n

=18)

Pf o

nly

ADVA

NCE

D QU

ALIT

Y TM

MAL

ARIA

(p.f)

POC

T In

Tec

Prod

ucts

, Inc

.25

2530

.77

00

050

11.11

ADVA

NCE

D QU

ALIT

Y TM

One

Ste

p M

alar

ia (p

.f.) T

est (

who

le b

lood

)In

Tec

Prod

ucts

, Inc

.62

.562

.546

.15

19.2

350

5061

.1127

.78

Adva

ntag

e P.

f. M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

00

00

100

500

0Ca

reSt

art M

alar

ia H

RP2

(Pf)

Acce

ss B

io, I

nc.

12.5

00

00

00

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rst R

espo

nse

Mal

aria

Ag

HRP

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emie

r Med

ical

Cor

pora

tion

Ltd.

00

00

00

00

Firs

tSig

n –

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aria

Pf C

ard

Test

Uni

med

Inte

rnat

iona

l, In

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850

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00

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Hex

agon

Mal

aria

Hum

an G

mbH

2512

.50

00

00

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T M

alar

ia P

f Cas

sett

e Te

st (M

L01)

ICT

Diag

nost

ics

00

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050

05.

56Im

mun

oqui

ck M

alar

ia F

alci

paru

mBi

osyn

ex12

.50

03.

850

00

0M

alar

ia P

lasm

odiu

m fa

lcip

arum

Rap

id te

st D

evic

e (W

hole

blo

od)

ACON

Lab

orat

orie

s, In

c.12

.50

00

100

500

0M

alar

ia R

apid

Pf

Visi

on B

iote

ch (P

ty) L

td.

00

00

00

00

Para

chec

k Pf

Rap

id te

st fo

r P. f

alci

paru

m M

alar

ia (D

evic

e)

Orch

id B

iom

edic

al S

yste

ms

12.5

12.5

00

(25)

00

0 (1

7)0

Para

chec

k Pf

Rap

id te

st fo

r P. f

alci

paru

m M

alar

ia (D

ipst

ick)

Or

chid

Bio

med

ical

Sys

tem

s0

12.5

3.85

8 (2

5)0

500

22.2

2Pa

rahi

t-f D

IPST

ICK

FOR

FALC

IPAR

UM

MAL

ARIA

Span

Dia

gnos

tics

Ltd.

00

00

050

00

Para

hit-

f TES

T DE

VICE

FOR

FAL

CIPA

RUM

MAL

ARIA

Span

Dia

gnos

tics

Ltd.

00

00

00

00

SD B

IOLI

NE

Mal

aria

Ag

Pf

Stan

dard

Dia

gnos

tics,

Inc.

00

00

00

00

Pf &

Pan

/Pf

& P

vAd

vant

age

Mal

Car

dJ.

Mitr

a &

Co.

Pvt

. Ltd

.12

.50

03.

850

00

0AZ

OG M

alar

ia p

f (H

RP-I

I) /p

v (p

LDH

) Ant

igen

Det

ectio

n Te

st D

evic

eAZ

OG, I

nc.

00

00

00

00

Bina

x N

ow M

alar

ia

Inve

rnes

s M

edic

al In

nova

tions

, Inc

.0

00

00

00

0Ca

reSt

art M

alar

ia H

RP2/

pLDH

(Pf/

PAN

) COM

BOAc

cess

Bio

, Inc

.0

00

00

00

0Fi

rst R

espo

nse

Mal

aria

Ag

Com

bo (P

LDH

/HRP

2)Pr

emie

r Med

ical

Cor

pora

tion

Ltd.

00

03.

850

00

5.56

Firs

tSig

n –

Para

View

-2 (P

v +

Pf) C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.0

07.

6915

.38

00

5.56

0H

exag

on M

alar

ia C

ombi

Hum

an G

mbH

00

00

00

00

ICT

Mal

aria

Com

bo C

asse

tte

Test

(ML0

2)IC

T Di

agno

stic

s12

.50

7.69

3.85

050

5.56

0Im

mun

oqui

ck M

alar

ia +

4Bi

osyn

ex0

00

00

00

0

Mal

aria

P.F

/Viv

axDi

agno

stic

Aut

omat

ion

/ Cor

tez

Diag

nost

ics,

Inc.

0 (7

)0

(4)

25 (1

2)0

(9)

0N

/A0

(5)

16.6

7 (6

)

Mal

aria

Rap

id C

ombo

Visi

on B

iote

ch (P

ty) L

td.

00

3.85

11.5

410

00

00

Mal

aria

Rap

id D

ual

Visi

on B

iote

ch (P

ty) L

td.

00

03.

850

00

0M

alas

can

Rapi

d Te

st fo

r Mal

aria

Pf/

Pan

(Dev

ice)

Zeph

yr B

iom

edic

als

00

23.0

815

.38

00

05.

56On

e St

ep M

alar

ia A

ntig

en S

trip

IND

Diag

nost

ic In

c.25

00

00

500

0On

Sigh

t – P

araQ

uick

(Pan

, Pf)

Test

Amge

nix

Inte

rnat

iona

l, In

c.0

00

(25)

0 (2

5)0

00

0Op

tiMAL

-IT

DiaM

ed A

G0

12.5

0 (2

4)0

100

00

0Pa

rahi

t-To

tal D

evic

e Ra

pid

test

for P

. fal

cipa

rum

and

Pan

mal

aria

l spe

cies

.Sp

an D

iagn

ostic

s Lt

d.0

00

00

00

5.56

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf (

Devi

ce)

Zeph

yr B

iom

edic

als

012

.50

3.85

00

5.56

0 (1

7)Qu

icks

tick

Mal

aria

Ant

igen

Tes

tIn

nova

tek

Med

ical

Inc.

250

00

050

00

SD B

IOLI

NE

Mal

aria

Ag

Stan

dard

Dia

gnos

tics,

Inc.

2525

00

00

00

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

an

Stan

dard

Dia

gnos

tics,

Inc.

00

0 (2

5)0

00

00

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

00

0 (2

5)11

.54

500

5.88

(17)

5.56

Pan

only

Adva

ntag

e Pa

n M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

00

00

00

00

Care

Star

t Mal

aria

pLD

H (P

AN)

Acce

ss B

io, I

nc.

12.5

00

00

05.

565.

56Pa

raba

nk R

apid

Tes

t for

Mal

aria

Pan

(Dev

ice)

Zeph

yr B

iom

edic

als

12.5

12.5

7.69

00

(1)

05.

565.

56Pf

- P

lasm

odiu

m fa

lcip

arum

Pv

- P

lasm

odiu

m v

ivax

pan

- Pl

asm

odiu

m s

peci

es

† - F

or P

an-o

nly

test

s

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)81

Tabl

e A4

.11: F

alse

pos

itiv

e ra

te o

f P.

fal

cipa

rum

(or

pan

† ) t

est

line

resu

lts

for

sam

ples

con

tain

ing

pote

ntia

lly c

ross

-rea

ctin

g bl

ood

imm

unol

ogic

al f

acto

rs

Prod

uct

Man

ufac

ture

r

Perc

enta

ge o

f fa

lse

posi

tive

Pf

(or

Pan)

tes

t lin

es b

y bl

ood

imm

unol

ogic

al f

acto

r

Rheu

mat

oid

fact

orAn

ti-n

ucle

ar a

ntib

odie

sAn

ti-m

ouse

ant

ibod

ies

Rapi

d pl

asm

a re

agin

(RP

R)

posi

tive

Lot

1 (n

=8)

Lot

2 (n

=8)

Lot

1 (n

=26)

Lot

2 (n

=26)

Lot

1 (n

=2)

Lot

2 (n

=2)

Lot

1 (n

=18)

Lot

2 (n

=18)

Pf o

nly

ADVA

NCE

D QU

ALIT

Y TM

MAL

ARIA

(p.f)

POC

T In

Tec

Prod

ucts

, Inc

.25

2530

.77

00

050

11.11

ADVA

NCE

D QU

ALIT

Y TM

One

Ste

p M

alar

ia (p

.f.) T

est (

who

le b

lood

)In

Tec

Prod

ucts

, Inc

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.562

.546

.15

19.2

350

5061

.1127

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Adva

ntag

e P.

f. M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

00

00

100

500

0Ca

reSt

art M

alar

ia H

RP2

(Pf)

Acce

ss B

io, I

nc.

12.5

00

00

00

0Fi

rst R

espo

nse

Mal

aria

Ag

HRP

2Pr

emie

r Med

ical

Cor

pora

tion

Ltd.

00

00

00

00

Firs

tSig

n –

Mal

aria

Pf C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.0

03.

850

(25)

00

00

Hex

agon

Mal

aria

Hum

an G

mbH

2512

.50

00

00

0IC

T M

alar

ia P

f Cas

sett

e Te

st (M

L01)

ICT

Diag

nost

ics

00

00

050

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56Im

mun

oqui

ck M

alar

ia F

alci

paru

mBi

osyn

ex12

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03.

850

00

0M

alar

ia P

lasm

odiu

m fa

lcip

arum

Rap

id te

st D

evic

e (W

hole

blo

od)

ACON

Lab

orat

orie

s, In

c.12

.50

00

100

500

0M

alar

ia R

apid

Pf

Visi

on B

iote

ch (P

ty) L

td.

00

00

00

00

Para

chec

k Pf

Rap

id te

st fo

r P. f

alci

paru

m M

alar

ia (D

evic

e)

Orch

id B

iom

edic

al S

yste

ms

12.5

12.5

00

(25)

00

0 (1

7)0

Para

chec

k Pf

Rap

id te

st fo

r P. f

alci

paru

m M

alar

ia (D

ipst

ick)

Or

chid

Bio

med

ical

Sys

tem

s0

12.5

3.85

8 (2

5)0

500

22.2

2Pa

rahi

t-f D

IPST

ICK

FOR

FALC

IPAR

UM

MAL

ARIA

Span

Dia

gnos

tics

Ltd.

00

00

050

00

Para

hit-

f TES

T DE

VICE

FOR

FAL

CIPA

RUM

MAL

ARIA

Span

Dia

gnos

tics

Ltd.

00

00

00

00

SD B

IOLI

NE

Mal

aria

Ag

Pf

Stan

dard

Dia

gnos

tics,

Inc.

00

00

00

00

Pf &

Pan

/Pf

& P

vAd

vant

age

Mal

Car

dJ.

Mitr

a &

Co.

Pvt

. Ltd

.12

.50

03.

850

00

0AZ

OG M

alar

ia p

f (H

RP-I

I) /p

v (p

LDH

) Ant

igen

Det

ectio

n Te

st D

evic

eAZ

OG, I

nc.

00

00

00

00

Bina

x N

ow M

alar

ia

Inve

rnes

s M

edic

al In

nova

tions

, Inc

.0

00

00

00

0Ca

reSt

art M

alar

ia H

RP2/

pLDH

(Pf/

PAN

) COM

BOAc

cess

Bio

, Inc

.0

00

00

00

0Fi

rst R

espo

nse

Mal

aria

Ag

Com

bo (P

LDH

/HRP

2)Pr

emie

r Med

ical

Cor

pora

tion

Ltd.

00

03.

850

00

5.56

Firs

tSig

n –

Para

View

-2 (P

v +

Pf) C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.0

07.

6915

.38

00

5.56

0H

exag

on M

alar

ia C

ombi

Hum

an G

mbH

00

00

00

00

ICT

Mal

aria

Com

bo C

asse

tte

Test

(ML0

2)IC

T Di

agno

stic

s12

.50

7.69

3.85

050

5.56

0Im

mun

oqui

ck M

alar

ia +

4Bi

osyn

ex0

00

00

00

0

Mal

aria

P.F

/Viv

axDi

agno

stic

Aut

omat

ion

/ Cor

tez

Diag

nost

ics,

Inc.

0 (7

)0

(4)

25 (1

2)0

(9)

0N

/A0

(5)

16.6

7 (6

)

Mal

aria

Rap

id C

ombo

Visi

on B

iote

ch (P

ty) L

td.

00

3.85

11.5

410

00

00

Mal

aria

Rap

id D

ual

Visi

on B

iote

ch (P

ty) L

td.

00

03.

850

00

0M

alas

can

Rapi

d Te

st fo

r Mal

aria

Pf/

Pan

(Dev

ice)

Zeph

yr B

iom

edic

als

00

23.0

815

.38

00

05.

56On

e St

ep M

alar

ia A

ntig

en S

trip

IND

Diag

nost

ic In

c.25

00

00

500

0On

Sigh

t – P

araQ

uick

(Pan

, Pf)

Test

Amge

nix

Inte

rnat

iona

l, In

c.0

00

(25)

0 (2

5)0

00

0Op

tiMAL

-IT

DiaM

ed A

G0

12.5

0 (2

4)0

100

00

0Pa

rahi

t-To

tal D

evic

e Ra

pid

test

for P

. fal

cipa

rum

and

Pan

mal

aria

l spe

cies

.Sp

an D

iagn

ostic

s Lt

d.0

00

00

00

5.56

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf (

Devi

ce)

Zeph

yr B

iom

edic

als

012

.50

3.85

00

5.56

0 (1

7)Qu

icks

tick

Mal

aria

Ant

igen

Tes

tIn

nova

tek

Med

ical

Inc.

250

00

050

00

SD B

IOLI

NE

Mal

aria

Ag

Stan

dard

Dia

gnos

tics,

Inc.

2525

00

00

00

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

an

Stan

dard

Dia

gnos

tics,

Inc.

00

0 (2

5)0

00

00

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

00

0 (2

5)11

.54

500

5.88

(17)

5.56

Pan

only

Adva

ntag

e Pa

n M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

00

00

00

00

Care

Star

t Mal

aria

pLD

H (P

AN)

Acce

ss B

io, I

nc.

12.5

00

00

05.

565.

56Pa

raba

nk R

apid

Tes

t for

Mal

aria

Pan

(Dev

ice)

Zeph

yr B

iom

edic

als

12.5

12.5

7.69

00

(1)

05.

565.

56Pf

- P

lasm

odiu

m fa

lcip

arum

Pv

- P

lasm

odiu

m v

ivax

pan

- Pl

asm

odiu

m s

peci

es

† - F

or P

an-o

nly

test

s

Tabl

e A4

.11a:

Fal

se p

osit

ive

rate

of P

. fal

cipa

rum

(or p

an† )

tes

t lin

e re

sult

s for

sam

ples

con

tain

ing

pote

ntia

lly c

ross

-rea

ctin

g bl

ood

imm

unol

ogic

al fa

ctor

s bas

ed o

n a

dela

yed

read

ing

whe

n sp

ecifi

ed b

y th

e m

anuf

actu

rer

Prod

uct

Man

ufac

ture

r

Perc

enta

ge o

f fa

lse

posi

tive

Pf

(or

Pan)

tes

t lin

es b

y bl

ood

imm

unol

ogic

al f

acto

r

Rheu

mat

oid

fact

orAn

ti-n

ucle

ar a

ntib

odie

sAn

ti-m

ouse

ant

ibod

ies

Rapi

d pl

asm

a re

agin

(RP

R)

posi

tive

Lot

1 (n

=8)

Lot

2 (n

=8)

Lot

1 (n

=26)

Lot

2 (n

=26)

Lot

1 (n

=2)

Lot

2 (n

=2)

Lot

1 (n

=18)

Lot

2 (n

=18)

Pf &

Pan

/Pf

& P

vFi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Car

d Te

stU

nim

ed In

tern

atio

nal,

Inc.

00

3.85

00

00

0Im

mun

oqui

ck M

alar

ia +

4Bi

osyn

ex0

00

19.2

350

500

38.8

9M

alar

ia P

.F/V

ivax

Diag

nost

ic A

utom

atio

n / C

orte

z Di

agno

stic

s, In

c.0

(7)

0 (4

)23

.08

(13)

0 (9

)0

N/A

0 (6

)16

.67

(6)

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s0

030

.77

7.69

00

00

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf (

Devi

ce)

Zeph

yr B

iom

edic

als

00

03.

850

00

0W

ondf

o On

e St

ep M

alar

ia P

f/Pa

n W

hole

Blo

od T

est

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d0

04.

35 (2

3)11

.54

00

5.88

(17)

11.11

Pan

only

Para

bank

Rap

id T

est f

or M

alar

ia P

an (D

evic

e)Ze

phyr

Bio

med

ical

s0

011

.54

050

00

0Pf

- P

lasm

odiu

m fa

lcip

arum

Pv

- P

lasm

odiu

m v

ivax

pan

- Pl

asm

odiu

m s

peci

es

† - F

or P

an-o

nly

test

s

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)82

Tabl

e A4

.12:

Fal

se p

osit

ive

rate

of

pan/

P. v

ivax

tes

t lin

e re

sult

s on

all

mal

aria

-neg

ativ

e sa

mpl

es

Prod

uct

Man

ufac

ture

r

Perc

enta

ge o

f fa

lse

posi

tive

pan

tes

t lin

es o

n ”c

lean

” ne

gati

ve s

ampl

es

Perc

enta

ge o

f fa

lse

posi

tive

pan

tes

t lin

es o

n sa

mpl

es c

onta

inin

g no

n-Pl

asm

odiu

m in

fect

ious

age

nts

Perc

enta

ge o

f fa

lse

posi

tive

pan

te

st li

nes

on s

ampl

es c

onta

inin

g im

mun

olog

ical

fac

tors

Lot

1 (n

=84)

Lot

2 (n

=84)

Ove

rall

(n=1

68)

Lot

1 (n

=42)

Lot

2 (n

=42)

Ove

rall

(n=8

4)Lo

t 1

(n=5

4)Lo

t 2

(n=5

4)O

vera

ll (n

=108

)

Pf &

Pan

/Pf

& P

v

Adva

ntag

e M

al C

ard

J. M

itra

& C

o. P

vt. L

td.

3.57

3.57

3.57

2.38

(42)

4.76

(42)

3.57

1.85

3.7

2.78

AZOG

Mal

aria

pf (

HRP

-II)

/pv

(pLD

H) A

ntig

en D

etec

tion

Test

Dev

ice

AZOG

, Inc

.2.

3814

.29

8.33

4.76

(42)

11.9

(42)

8.33

3.7

12.9

68.

33

Bina

x N

ow M

alar

ia

Inve

rnes

s M

edic

al In

nova

tions

, Inc

.0

00

0 (4

2)0

(42)

00

00

Care

Star

t Mal

aria

HRP

2/pL

DH (P

f/PA

N) C

OMBO

Acce

ss B

io, I

nc.

2.38

2.38

2.38

2.38

(42)

2.38

(42)

2.38

1.85

00.

93

Firs

t Res

pons

e M

alar

ia A

g Co

mbo

(PLD

H/H

RP2)

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.0

2.38

1.19

0 (4

2)0

(42)

00

00

Firs

tSig

n –

Para

View

-2 (P

v +

Pf) C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.5.

95 (8

4)3.

61 (8

3)4.

79 (1

67)

7.14

(42)

0 (4

2)3.

57 (8

4)3.

7 (5

4)7.

41 (5

4)5.

56 (1

08)

Hex

agon

Mal

aria

Com

biH

uman

Gm

bH0

1.2

(83)

0.6

(167

)0

(42)

0 (4

2)0

03.

71.

85

ICT

Mal

aria

Com

bo C

asse

tte

Test

(ML0

2)IC

T Di

agno

stic

s0

00

0 (4

2)0

(42)

05.

565.

565.

56

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

01.

190.

60

(42)

0 (4

2)0

5.56

3.7

4.63

Mal

aria

P.F

/Viv

axDi

agno

stic

Aut

omat

ion

/ Cor

tez

Diag

nost

ics,

Inc.

0 (3

5)3.

45 (2

9)1.

56 (6

4)0

(11)

0 (1

5)0

(26)

7.69

(26)

5.26

(19)

6.67

(45)

Mal

aria

Rap

id C

ombo

Visi

on B

iote

ch (P

ty) L

td.

5.95

7.14

6.55

9.76

(41)

7.14

(42)

8.43

(83)

7.41

7.41

7.41

Mal

aria

Rap

id D

ual

Visi

on B

iote

ch (P

ty) L

td.

020

.24

10.1

20

(42)

11.9

(42)

5.95

5.56

20.3

712

.96

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s0

00

2.38

(42)

0 (4

2)1.

193.

77.

415.

56

One

Step

Mal

aria

Ant

igen

Str

ipIN

D Di

agno

stic

Inc.

02.

41 (8

3)1.

2 (1

67)

0 (4

1)0

(42)

0 (8

3)1.

851.

851.

85

OnSi

ght –

Par

aQui

ck (P

an, P

f) Te

stAm

geni

x In

tern

atio

nal,

Inc.

00

00

(41)

0 (4

2)0

(83)

0 (5

3)1.

89 (5

3)0.

94 (1

06)

OptiM

AL-I

TDi

aMed

AG

0 (8

3)0

0 (1

67)

0 (4

1)0

(42)

0 (8

3)3.

85 (5

2)3.

73.

77 (1

06)

Para

hit-

Tota

l Dev

ice

Rapi

d te

st fo

r P. f

alci

paru

m a

nd P

an m

alar

ial s

peci

es.

Span

Dia

gnos

tics

Ltd.

00

00

(42)

0 (4

2)0

3.7

1.85

2.78

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf (

Devi

ce)

Zeph

yr B

iom

edic

als

00

00

(42)

0 (4

2)0

00

(53)

0 (1

07)

Quic

kstic

k M

alar

ia A

ntig

en T

est

Inno

vate

k M

edic

al In

c.0

2.41

(83)

1.2

(167

)0

(41)

0 (4

2)0

(83)

1.85

1.85

1.85

SD B

IOLI

NE

Mal

aria

Ag

Stan

dard

Dia

gnos

tics,

Inc.

1.19

00.

60

(42)

0 (4

2)0

00

0

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

an

Stan

dard

Dia

gnos

tics,

Inc.

01.

190.

60

(39)

0 (4

2)0

(81)

0 (5

3)0

0 (1

07)

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

2.41

(83)

5.95

4.19

(167

)0

(41)

2.38

(42)

1.2

(83)

5.77

(52)

7.41

6.6

(106

)

Pan

only

Adva

ntag

e Pa

n M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

1.19

2.38

1.79

0 (4

2)0

(42)

00

00

Care

Star

t Mal

aria

pLD

H (P

AN)

Acce

ss B

io, I

nc.

4.76

8.33

6.55

2.38

(42)

11.9

(42)

7.14

3.7

1.85

2.78

Para

bank

Rap

id T

est f

or M

alar

ia P

an (D

evic

e)Ze

phyr

Bio

med

ical

s3.

61 (8

3)2.

382.

99 (1

67)

2.38

(42)

0 (4

2)1.

197.

55 (5

3)3.

75.

61 (1

07)

Pf -

Pla

smod

ium

falc

ipar

um

Pv -

Pla

smod

ium

viv

axpa

n -

Plas

mod

ium

spe

cies

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)83

Tabl

e A4

.12a

: Fal

se p

osit

ive

rate

of

pan

test

line

res

ults

on

all m

alar

ia-n

egat

ive

sam

ples

bas

ed o

n a

dela

yed

seco

nd r

eadi

ng w

hen

spec

ified

by

the

man

ufac

ture

r

Prod

uct

Man

ufac

ture

r

Perc

enta

ge o

f fa

lse

posi

tive

pan

tes

t lin

es o

n ”c

lean

” ne

gati

ve s

ampl

es

Perc

enta

ge o

f fa

lse

posi

tive

pan

tes

t lin

es

on s

ampl

es c

onta

inin

g no

n-Pl

asm

odiu

m

infe

ctio

us a

gent

s

Perc

enta

ge o

f fa

lse

posi

tive

pan

tes

t lin

es o

n sa

mpl

es c

onta

inin

g im

mun

olog

ical

fac

tors

Lot

1

(n=8

4)Lo

t 2

(n

=84)

Ove

rall

(n=1

68)

Lot

1 (n

=42)

Lot

2 (n

=42)

Ove

rall

(n=8

4)Lo

t 1

(n=5

4)Lo

t 2

(n=5

4)O

vera

ll (n

=108

)

Pf &

Pan

/Pf

& P

v

Firs

tSig

n –

Para

View

-2 (P

v +

Pf) C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

1.19

11.9

6.55

016

.67

8.33

9.26

25.9

317

.59

Mal

aria

P.F

/Viv

axDi

agno

stic

Aut

omat

ion

/ Cor

tez

Diag

nost

ics,

Inc.

0 (3

1)0

(31)

0 (6

2)0

(9)

0 (1

4)0

(23)

7.14

(28)

10.5

3 (1

9)8.

51 (4

7)

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s1.

190

0.6

00

03.

77.

415.

56

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf (

Devi

ce)

Zeph

yr B

iom

edic

als

1.19

1.19

1.19

00

00

00

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

3.66

(82)

5.95

4.82

(166

)0

(41)

9.52

4.82

(83)

10 (5

0)9.

269.

62 (1

04)

Pan

only

Para

bank

Rap

id T

est f

or M

alar

ia P

an (D

evic

e)Ze

phyr

Bio

med

ical

s1.

22 (8

2)1.

191.

2 (1

66)

2.38

01.

197.

410

3.7

Pf -

Pla

smod

ium

falc

ipar

um

Pv -

Pla

smod

ium

viv

axpa

n -

Plas

mod

ium

spe

cies

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)8 4

Tabl

e A4

.13:

Hea

t st

abili

ty t

esti

ng r

esul

ts f

or P

f te

st li

ne o

n P.

fal

cipa

rum

sam

ples

at

low

par

asit

e de

nsit

y (2

00 p

aras

ites

/μl)

. Pos

itiv

ity

rate

at

base

line,

and

aft

er 6

0 da

ys

incu

bati

on a

t 35

°C a

nd 4

5°C.

Prod

uct

Man

ufac

ture

r

Base

line

test

ing

35°C

45°C

Lot

1 (n

=10)

Lot

2 (n

=10)

Lot

1 (n

=10)

Lot

2 (n

=10)

Lot

1 (n

=10)

Lot

2 (n

=10)

No.

po

si-ti

ve

No.

in

valid

Mea

n ba

nd

inte

nsit

y

No.

po

si-ti

ve

No.

in

valid

Mea

n ba

nd

inte

nsit

y

No.

po

si-ti

ve

No.

in

valid

Mea

n ba

nd

inte

nsit

y

No.

po

si-ti

ve

No.

in

valid

Mea

n ba

nd

inte

nsit

y

No.

po

si-ti

ve

No.

in

valid

Mea

n ba

nd

inte

nsit

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No.

po

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ve

No.

in

valid

Mea

n ba

nd

inte

nsit

y

Pf o

nly

test

sAD

VAN

CED

QUAL

ITY

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ALAR

IA (p

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nc.

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Mal

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Mitr

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100

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6Im

mun

oqui

ck M

alar

ia +

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osyn

ex10

02.

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910

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1

Mal

aria

P.F

/VIV

AXDi

agno

stic

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ion

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tez

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nost

ics,

Inc.

82

2.5

55

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42

83.

53

73

19

3

Mal

aria

Rap

id C

ombo

Visi

on B

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ch (P

ty) L

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100

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100

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02.

210

02.

110

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210

02.

2M

alar

ia R

apid

Dua

lVi

sion

Bio

tech

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) Ltd

.10

01.

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02.

110

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310

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9M

alas

can

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st fo

r Mal

aria

Pf/

Pan

(Dev

ice)

Zeph

yr B

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edic

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100

19

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apid

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Pan

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yr B

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kstic

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alar

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vate

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02

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aria

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aria

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01.

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02

100

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ep M

alar

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lasm

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asm

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peci

es

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)8 5

Tabl

e A4

.13a

: Hea

t st

abili

ty t

esti

ng r

esul

ts f

or p

an t

est

line

of c

ombi

nati

on R

DTs

on P

. fal

cipa

rum

sam

ples

at

low

par

asit

e de

nsit

y (2

00 p

aras

ites

/μl)

. Pos

itiv

ity

rate

at

base

line,

and

aft

er 6

0 da

ys in

cuba

tion

at

35°C

and

45°

C.

Prod

uct

Man

ufac

ture

r

Base

line

test

ing

35°C

45°C

Lot

1 (n

=10)

Lot

2 (n

=10)

Lot

1 (n

=10)

Lot

2 (n

=10)

Lot

1 (n

=10)

Lot

2 (n

=10)

No.

po

si-

tive

No.

in

valid

Mea

n ba

nd

inte

n-si

ty

No.

po

si-

tive

No.

in

valid

Mea

n ba

nd

inte

n-si

ty

No.

po

si-

tive

No.

in

valid

Mea

n ba

nd

inte

n-si

ty

No.

po

si-

tive

No.

in

valid

Mea

n ba

nd

inte

n-si

ty

No.

po

si-

tive

No.

in

valid

Mea

n ba

nd

inte

n-si

ty

No.

po

si-

tive

No.

in

valid

Mea

n ba

nd

inte

n-si

ty

Pf &

Pan

/Pv

& P

anAd

vant

age

Mal

Car

dJ.

Mitr

a &

Co.

Pvt

. Ltd

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30

15

01

40

18

01

00

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alar

ia p

f (H

RP-I

I)/pv

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H) A

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en

Dete

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st D

evic

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nc.

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01

00

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50

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ow M

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vern

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Care

Star

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aria

HRP

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f/PA

N)

COM

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01

100

19

11

100

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100

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100

1

Firs

t Res

pons

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alar

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g Co

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100

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v +

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Test

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med

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on M

alar

ia C

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Hum

an G

mbH

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01

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00

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00

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Mal

aria

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bo C

asse

tte

Test

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aria

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agno

stic

Aut

omat

ion

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gnos

tics,

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05

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09

N/A

08

N/A

07

N/A

09

N/A

Mal

aria

Rap

id C

ombo

Visi

on B

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ch (P

ty) L

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30

10

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01

40

10

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0N

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alar

ia R

apid

Dua

lVi

sion

Bio

tech

(Pty

) Ltd

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01.

333

00

N/A

00

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Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

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00

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00

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Step

Mal

aria

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igen

Str

ipIN

D Di

agno

stic

Inc.

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iona

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ed A

G6

01

00

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10

12

01

00

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09

N/A

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otal

Dev

ice

Rapi

d Te

st fo

r P. f

alci

pa-

rum

and

Pan

Mal

aria

l Spe

cies

Span

Dia

gnos

tics

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10

10

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0N

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scre

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apid

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t for

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aria

Pan

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Zeph

yr B

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edic

als

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Quic

kstic

k M

alar

ia A

ntig

en T

est

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vate

k M

edic

al In

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01

00

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00

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04

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00

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02

N/A

SD B

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NE

Mal

aria

Ag

Stan

dard

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gnos

tics,

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00

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40

15

01

90

16

01

SD B

IOLI

NE

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aria

Ag

Pf/P

anSt

anda

rd D

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ostic

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01

90

17

01.

43W

ondf

o On

e St

ep M

alar

ia P

f/Pa

n W

hole

Bl

ood

Test

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ngzh

ou W

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o Bi

otec

h Co

., Lt

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01

50

18

11

100

110

01

40

1.25

Pan

only

Adva

ntag

e Pa

n M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

80

12

01

60

17

01

90

15

01

Care

Star

t Mal

aria

pLD

H (P

AN)

Acce

ss B

io, I

nc.

100

1.1

100

1.1

100

110

01

80

110

01

Para

bank

Rap

id T

est f

or M

alar

ia P

an (D

evic

e)Ze

phyr

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med

ical

s0

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01

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00

N/A

01

N/A

00

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Pf -

Pla

smod

ium

falc

ipar

um

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Pla

smod

ium

viv

axpa

n -

Plas

mod

ium

spe

cies

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)8 6

Tabl

e A4

.14:

Hea

t st

abili

ty t

esti

ng r

esul

ts f

or P

f te

st li

ne o

n P.

fal

cipa

rum

sam

ples

at

high

par

asit

e de

nsit

y (2

000

para

site

s/μl

) Po

siti

vity

rat

e at

bas

elin

e, a

nd a

fter

60

days

incu

bati

on a

t 35

°C a

nd 4

5°C.

Prod

uct

Man

ufac

ture

r

Base

line

test

ing

35°C

45°C

Lot

1 (n

=10)

Lot

2 (n

=10)

Lot

1 (n

=10)

Lot

2 (n

=10)

Lot

1 (n

=10)

Lot

2 (n

=10)

No.

po

si-ti

ve

No.

in

valid

Mea

n ba

nd

inte

nsit

y

No.

po

si-ti

ve

No.

in

valid

Mea

n ba

nd

inte

nsit

y

No.

po

si-ti

ve

No.

in

valid

Mea

n ba

nd

inte

nsit

y

No.

po

si-ti

ve

No.

in

valid

Mea

n ba

nd

inte

nsit

y

No.

po

si-ti

ve

No.

in

valid

Mea

n ba

nd

inte

nsit

y

No.

po

si-ti

ve

No.

in

valid

Mea

n ba

nd

inte

nsit

y

Pf o

nly

test

sAD

VAN

CED

QUAL

ITY

TM M

ALAR

IA (p

.f) P

OCT

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c Pr

oduc

ts, I

nc.

100

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100

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100

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100

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100

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100

2.8

ADVA

NCE

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ALIT

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p M

alar

ia (p

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est

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le b

lood

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ucts

, Inc

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02.

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610

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110

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4

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ntag

e P.

f. M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

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100

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910

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100

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100

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t Mal

aria

HRP

2 (P

f)Ac

cess

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, Inc

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100

410

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100

410

04

100

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Firs

t Res

pons

e M

alar

ia A

g H

RP2

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ier M

edic

al C

orpo

ratio

n Lt

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04

100

410

03.

910

04

100

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100

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rstS

ign

– M

alar

ia P

f Car

d Te

stU

nim

ed In

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nal,

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100

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100

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90

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90

2.67

100

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90

2.67

Hex

agon

Mal

aria

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an G

mbH

90

2.11

100

2.6

100

2.3

100

2.5

100

2.3

100

2.9

ICT

Mal

aria

Pf R

apid

Tes

t (M

L01)

ICT

Diag

nost

ics

100

3.8

100

410

03.

710

04

100

3.2

100

3.5

Imm

unoq

uick

Mal

aria

Fal

cipa

rum

Bios

ynex

100

410

04

100

3.9

100

3.9

100

410

04

Mal

aria

Pla

smod

ium

falc

ipar

um R

apid

test

Dev

ice

(Who

le b

lood

)AC

ON L

abor

ator

ies,

Inc.

100

3.2

100

410

04

100

3.9

100

310

03.

9

Mal

aria

Rap

id P

fVi

sion

Bio

tech

(Pty

) Ltd

.10

03.

110

03.

810

02.

910

03.

210

02.

410

03.

1Pa

rach

eck

Pf R

apid

Tes

t for

P. f

alci

paru

m M

alar

ia

(Dev

ice)

Orch

id B

iom

edic

al S

yste

ms

100

1.9

100

3.7

73

3.71

100

3.5

100

3.1

100

3.8

Para

chec

k Pf

Rap

id T

est f

or P

. fal

cipa

rum

Mal

aria

(D

ipst

ick)

Orch

id B

iom

edic

al S

yste

ms

100

310

03

100

310

03.

310

02.

410

03.

4

Para

hit-

f DIP

STIC

K FO

R FA

LCIP

ARU

M M

ALAR

IASp

an D

iagn

ostic

s Lt

d.10

03.

910

03.

910

03

100

410

03.

310

04

Para

hit-

f TES

T DE

VICE

FOR

FAL

CIPA

RUM

MAL

ARIA

Span

Dia

gnos

tics

Ltd.

100

2.7

100

2.7

91

2.44

100

2.4

90

2.67

100

2.9

SD B

IOLI

NE

Mal

aria

Ag

Pf

Stan

dard

Dia

gnos

tics,

Inc.

100

410

04

100

410

04

100

410

04

Pf li

ne o

f co

mbi

nati

on t

ests

Adva

ntag

e M

al C

ard

J. M

itra

& C

o. P

vt. L

td.

91

3.33

100

3.8

100

3.9

100

3.8

90

2.44

100

3.2

AZO

G M

alar

ia p

f (H

RP-I

I)/pv

(pLD

H) A

ntig

en D

etec

-tio

n Te

st D

evic

eAZ

OG, I

nc.

100

210

02.

710

02.

210

02.

710

02.

910

02.

4

Bina

x N

ow M

alar

iaIn

vern

ess

Med

ical

Inno

vatio

ns, I

nc.

100

3.6

100

3.8

100

410

03.

810

03.

99

14

Care

Star

t Mal

aria

HRP

2/pL

DH (P

f/PA

N) C

OMBO

Acce

ss B

io, I

nc.

100

410

04

100

410

04

100

3.9

100

3.9

Firs

t Res

pons

e M

alar

ia A

g Co

mbo

(PLD

H/H

RP2)

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.10

04

100

410

04

100

410

04

100

4Fi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Car

d Te

stU

nim

ed In

tern

atio

nal,

Inc.

100

410

03.

49

12.

4410

03.

910

02.

35

12.

6H

exag

on M

alar

ia C

ombi

Hum

an G

mbH

100

2.7

100

2.8

100

3.1

72

2.57

100

2.1

90

3IC

T M

alar

ia C

ombo

Cas

sett

e Te

st (M

L02)

ICT

Diag

nost

ics

100

410

04

100

410

04

100

3.8

100

4Im

mun

oqui

ck M

alar

ia +

4Bi

osyn

ex10

04

100

410

04

100

410

03.

910

03.

7

Mal

aria

P.F

/VIV

AXDi

agno

stic

Aut

omat

ion

/ Cor

tez

Dia-

gnos

tics,

Inc.

64

47

34

36

3.67

64

3.67

19

10

9N

/A

Mal

aria

Rap

id C

ombo

Visi

on B

iote

ch (P

ty) L

td.

100

410

04

100

410

03.

910

03.

910

04

Mal

aria

Rap

id D

ual

Visi

on B

iote

ch (P

ty) L

td.

100

410

03.

810

03.

310

03.

210

03.

710

03.

4M

alas

can

Rapi

d Te

st fo

r Mal

aria

Pf/

Pan

(Dev

ice)

Zeph

yr B

iom

edic

als

100

2.8

100

310

03.

310

03.

310

03

100

3On

e St

ep M

alar

ia A

ntig

en S

trip

IND

Diag

nost

ic In

c.10

01

30

110

01

00

N/A

00

N/A

05

N/A

OnSi

ght –

Par

aQui

ck (P

an, P

f)Am

geni

x In

tern

atio

nal,

Inc.

100

3.8

100

3.9

100

3.8

100

410

03.

810

04

OptiM

AL-

ITDi

aMed

AG

100

210

01.

610

01.

99

01.

330

0N

/A0

8N

/APa

rahi

tTot

al D

evic

e Ra

pid

Test

for P

. fal

cipa

rum

and

Pa

n M

alar

ial S

peci

esSp

an D

iagn

ostic

s Lt

d.10

03.

49

02.

5610

03.

310

02.

510

01.

810

02.

7

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf (

Devi

ce)

Zeph

yr B

iom

edic

als

100

3.9

100

410

03.

610

03.

710

03.

49

13.

33Qu

icks

tick

Mal

aria

Ant

igen

Tes

tIn

nova

tek

Med

ical

Inc.

100

13

01

100

10

0N

/A0

0N

/A0

5N

/ASD

BIO

LIN

E M

alar

ia A

gSt

anda

rd D

iagn

ostic

s, In

c.10

02

100

1.9

100

210

01.

910

01.

910

02

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

anSt

anda

rd D

iagn

ostic

s, In

c.10

04

100

410

03.

910

04

91

410

04

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

100

49

12.

8910

03.

810

03.

910

02.

710

04

Pf -

Pla

smod

ium

falc

ipar

um

Pv -

Pla

smod

ium

viv

axpa

n -

Plas

mod

ium

spe

cies

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)87

Tabl

e A4

.14:

Hea

t st

abili

ty t

esti

ng r

esul

ts f

or P

f te

st li

ne o

n P.

fal

cipa

rum

sam

ples

at

high

par

asit

e de

nsit

y (2

000

para

site

s/μl

) Po

siti

vity

rat

e at

bas

elin

e, a

nd a

fter

60

days

incu

bati

on a

t 35

°C a

nd 4

5°C.

Prod

uct

Man

ufac

ture

r

Base

line

test

ing

35°C

45°C

Lot

1 (n

=10)

Lot

2 (n

=10)

Lot

1 (n

=10)

Lot

2 (n

=10)

Lot

1 (n

=10)

Lot

2 (n

=10)

No.

po

si-ti

ve

No.

in

valid

Mea

n ba

nd

inte

nsit

y

No.

po

si-ti

ve

No.

in

valid

Mea

n ba

nd

inte

nsit

y

No.

po

si-ti

ve

No.

in

valid

Mea

n ba

nd

inte

nsit

y

No.

po

si-ti

ve

No.

in

valid

Mea

n ba

nd

inte

nsit

y

No.

po

si-ti

ve

No.

in

valid

Mea

n ba

nd

inte

nsit

y

No.

po

si-ti

ve

No.

in

valid

Mea

n ba

nd

inte

nsit

y

Pf o

nly

test

sAD

VAN

CED

QUAL

ITY

TM M

ALAR

IA (p

.f) P

OCT

InTe

c Pr

oduc

ts, I

nc.

100

3.6

100

2.9

100

3.1

100

3.7

100

2.9

100

2.8

ADVA

NCE

D QU

ALIT

Y TM

One

Ste

p M

alar

ia (p

.f.) T

est

(who

le b

lood

)In

Tec

Prod

ucts

, Inc

.10

02.

510

03.

39

02.

6710

02.

610

03.

110

02.

4

Adva

ntag

e P.

f. M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

100

410

03.

910

04

100

410

04

100

3.9

Care

Star

t Mal

aria

HRP

2 (P

f)Ac

cess

Bio

, Inc

.10

04

100

410

04

100

410

04

100

3.8

Firs

t Res

pons

e M

alar

ia A

g H

RP2

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.10

04

100

410

03.

910

04

100

3.9

100

4Fi

rstS

ign

– M

alar

ia P

f Car

d Te

stU

nim

ed In

tern

atio

nal,

Inc.

100

2.8

100

2.8

90

1.11

90

2.67

100

1.4

90

2.67

Hex

agon

Mal

aria

Hum

an G

mbH

90

2.11

100

2.6

100

2.3

100

2.5

100

2.3

100

2.9

ICT

Mal

aria

Pf R

apid

Tes

t (M

L01)

ICT

Diag

nost

ics

100

3.8

100

410

03.

710

04

100

3.2

100

3.5

Imm

unoq

uick

Mal

aria

Fal

cipa

rum

Bios

ynex

100

410

04

100

3.9

100

3.9

100

410

04

Mal

aria

Pla

smod

ium

falc

ipar

um R

apid

test

Dev

ice

(Who

le b

lood

)AC

ON L

abor

ator

ies,

Inc.

100

3.2

100

410

04

100

3.9

100

310

03.

9

Mal

aria

Rap

id P

fVi

sion

Bio

tech

(Pty

) Ltd

.10

03.

110

03.

810

02.

910

03.

210

02.

410

03.

1Pa

rach

eck

Pf R

apid

Tes

t for

P. f

alci

paru

m M

alar

ia

(Dev

ice)

Orch

id B

iom

edic

al S

yste

ms

100

1.9

100

3.7

73

3.71

100

3.5

100

3.1

100

3.8

Para

chec

k Pf

Rap

id T

est f

or P

. fal

cipa

rum

Mal

aria

(D

ipst

ick)

Orch

id B

iom

edic

al S

yste

ms

100

310

03

100

310

03.

310

02.

410

03.

4

Para

hit-

f DIP

STIC

K FO

R FA

LCIP

ARU

M M

ALAR

IASp

an D

iagn

ostic

s Lt

d.10

03.

910

03.

910

03

100

410

03.

310

04

Para

hit-

f TES

T DE

VICE

FOR

FAL

CIPA

RUM

MAL

ARIA

Span

Dia

gnos

tics

Ltd.

100

2.7

100

2.7

91

2.44

100

2.4

90

2.67

100

2.9

SD B

IOLI

NE

Mal

aria

Ag

Pf

Stan

dard

Dia

gnos

tics,

Inc.

100

410

04

100

410

04

100

410

04

Pf li

ne o

f co

mbi

nati

on t

ests

Adva

ntag

e M

al C

ard

J. M

itra

& C

o. P

vt. L

td.

91

3.33

100

3.8

100

3.9

100

3.8

90

2.44

100

3.2

AZO

G M

alar

ia p

f (H

RP-I

I)/pv

(pLD

H) A

ntig

en D

etec

-tio

n Te

st D

evic

eAZ

OG, I

nc.

100

210

02.

710

02.

210

02.

710

02.

910

02.

4

Bina

x N

ow M

alar

iaIn

vern

ess

Med

ical

Inno

vatio

ns, I

nc.

100

3.6

100

3.8

100

410

03.

810

03.

99

14

Care

Star

t Mal

aria

HRP

2/pL

DH (P

f/PA

N) C

OMBO

Acce

ss B

io, I

nc.

100

410

04

100

410

04

100

3.9

100

3.9

Firs

t Res

pons

e M

alar

ia A

g Co

mbo

(PLD

H/H

RP2)

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.10

04

100

410

04

100

410

04

100

4Fi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Car

d Te

stU

nim

ed In

tern

atio

nal,

Inc.

100

410

03.

49

12.

4410

03.

910

02.

35

12.

6H

exag

on M

alar

ia C

ombi

Hum

an G

mbH

100

2.7

100

2.8

100

3.1

72

2.57

100

2.1

90

3IC

T M

alar

ia C

ombo

Cas

sett

e Te

st (M

L02)

ICT

Diag

nost

ics

100

410

04

100

410

04

100

3.8

100

4Im

mun

oqui

ck M

alar

ia +

4Bi

osyn

ex10

04

100

410

04

100

410

03.

910

03.

7

Mal

aria

P.F

/VIV

AXDi

agno

stic

Aut

omat

ion

/ Cor

tez

Dia-

gnos

tics,

Inc.

64

47

34

36

3.67

64

3.67

19

10

9N

/A

Mal

aria

Rap

id C

ombo

Visi

on B

iote

ch (P

ty) L

td.

100

410

04

100

410

03.

910

03.

910

04

Mal

aria

Rap

id D

ual

Visi

on B

iote

ch (P

ty) L

td.

100

410

03.

810

03.

310

03.

210

03.

710

03.

4M

alas

can

Rapi

d Te

st fo

r Mal

aria

Pf/

Pan

(Dev

ice)

Zeph

yr B

iom

edic

als

100

2.8

100

310

03.

310

03.

310

03

100

3On

e St

ep M

alar

ia A

ntig

en S

trip

IND

Diag

nost

ic In

c.10

01

30

110

01

00

N/A

00

N/A

05

N/A

OnSi

ght –

Par

aQui

ck (P

an, P

f)Am

geni

x In

tern

atio

nal,

Inc.

100

3.8

100

3.9

100

3.8

100

410

03.

810

04

OptiM

AL-

ITDi

aMed

AG

100

210

01.

610

01.

99

01.

330

0N

/A0

8N

/APa

rahi

tTot

al D

evic

e Ra

pid

Test

for P

. fal

cipa

rum

and

Pa

n M

alar

ial S

peci

esSp

an D

iagn

ostic

s Lt

d.10

03.

49

02.

5610

03.

310

02.

510

01.

810

02.

7

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf (

Devi

ce)

Zeph

yr B

iom

edic

als

100

3.9

100

410

03.

610

03.

710

03.

49

13.

33Qu

icks

tick

Mal

aria

Ant

igen

Tes

tIn

nova

tek

Med

ical

Inc.

100

13

01

100

10

0N

/A0

0N

/A0

5N

/ASD

BIO

LIN

E M

alar

ia A

gSt

anda

rd D

iagn

ostic

s, In

c.10

02

100

1.9

100

210

01.

910

01.

910

02

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

anSt

anda

rd D

iagn

ostic

s, In

c.10

04

100

410

03.

910

04

91

410

04

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

100

49

12.

8910

03.

810

03.

910

02.

710

04

Pf -

Pla

smod

ium

falc

ipar

um

Pv -

Pla

smod

ium

viv

axpa

n -

Plas

mod

ium

spe

cies

Tabl

e A4

.14a

: Hea

t st

abili

ty t

esti

ng r

esul

ts f

or p

an t

est

line

of c

ombi

nati

on R

DTs

on P

. fal

cipa

rum

sam

ples

at

high

par

asit

e de

nsit

y (2

000

para

site

s/μl

). P

osit

ivit

y ra

te a

t ba

selin

e, a

nd a

fter

60

days

incu

bati

on a

t 35

°C a

nd 4

5°C.

Prod

uct

Man

ufac

ture

r

Base

line

test

ing

35°C

45°C

Lot

1 (n

=10)

Lot

2 (n

=10)

Lot

1 (n

=10)

Lot

2 (n

=10)

Lot

1 (n

=10)

Lot

2 (n

=10)

No.

po

siti

ve

No.

in

valid

Mea

n ba

nd

inte

n-si

ty

No.

po

siti

ve

No.

in

valid

Mea

n ba

nd

inte

n-si

ty

No.

po

siti

ve

No.

in

valid

Mea

n ba

nd

inte

n-si

ty

No.

po

siti

ve

No.

in

valid

Mea

n ba

nd

inte

n-si

ty

No.

po

siti

ve

No.

in

valid

Mea

n ba

nd

inte

n-si

ty

No.

po

siti

ve

No.

in

valid

Mea

n ba

nd

inte

n-si

ty

Pan

line

of c

ombi

nati

on t

ests

Ad

vant

age

Mal

Car

dJ.

Mitr

a &

Co.

Pvt

. Ltd

.10

01.

610

01.

810

02

100

210

01.

910

02

AZO

G M

alar

ia p

f (H

RP-I

I)/pv

(pLD

H)

Antig

en D

etec

tion

Test

Dev

ice

AZOG

, Inc

.8

11

100

14

01

100

10

0N

/A4

02.

5

Bina

x N

ow M

alar

iaIn

vern

ess

Med

ical

Inno

vatio

ns,

Inc.

100

19

01.

569

01.

4410

01.

86

01

91

1.56

Care

Star

t Mal

aria

HRP

2/pL

DH (P

f/PA

N)

COM

BOAc

cess

Bio

, Inc

.10

02.

910

02.

410

02.

610

02

100

2.3

100

2.5

Firs

t Res

pons

e M

alar

ia A

g Co

mbo

(P

LDH

/HRP

2)Pr

emie

r Med

ical

Cor

pora

tion

Ltd.

100

2.9

100

2.8

100

1.8

100

2.4

100

2.2

100

2.4

Firs

tSig

n –

Para

View

-2 (P

v +

Pf) C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.0

0N

/A0

0N

/A0

1N

/A0

0N

/A0

0N

/A0

1N

/A

Hex

agon

Mal

aria

Com

biH

uman

Gm

bH0

0N

/A0

0N

/A0

0N

/A0

2N

/A0

0N

/A0

0N

/AIC

T M

alar

ia C

ombo

Cas

sett

e Te

st (M

L02)

ICT

Diag

nost

ics

90

19

01.

2210

01.

95

01

100

1.1

50

2Im

mun

oqui

ck M

alar

ia +

4Bi

osyn

ex10

01

100

19

01.

117

01

60

110

01.

7

Mal

aria

P.F

/VIV

AXDi

agno

stic

Aut

omat

ion

/ Cor

tez

Diag

nost

ics,

Inc.

04

N/A

03

N/A

06

N/A

04

N/A

09

N/A

09

N/A

Mal

aria

Rap

id C

ombo

Visi

on B

iote

ch (P

ty) L

td.

100

1.4

90

110

01.

410

01.

66

01.

339

01.

33M

alar

ia R

apid

Dua

lVi

sion

Bio

tech

(Pty

) Ltd

.9

01

30

12

01

30

1.33

00

N/A

30

3.33

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s5

01

80

16

01

50

11

01

20

5

One

Step

Mal

aria

Ant

igen

Str

ipIN

D Di

agno

stic

Inc.

100

13

01

100

10

0N

/A0

0N

/A1

55

OnSi

ght –

Par

aQui

ck (P

an, P

f)Am

geni

x In

tern

atio

nal,

Inc.

100

1.5

100

1.6

100

1.8

100

1.6

90

1.11

100

1.2

OptiM

AL-

ITDi

aMed

AG

100

210

01.

610

01.

610

01.

21

01

18

2Pa

rahi

tTot

al D

evic

e Ra

pid

Test

for P

. fa

lcip

arum

and

Pan

Mal

aria

l Spe

cies

Span

Dia

gnos

tics

Ltd.

00

N/A

00

N/A

00

N/A

00

N/A

00

N/A

00

N/A

Para

scre

en R

apid

Tes

t for

Mal

aria

Pan

/Pf

(Dev

ice)

Zeph

yr B

iom

edic

als

80

19

01.

676

01.

338

01.

58

01.

258

11.

5

Quic

kstic

k M

alar

ia A

ntig

en T

est

Inno

vate

k M

edic

al In

c.10

01

30

110

01

00

N/A

00

N/A

15

5SD

BIO

LIN

E M

alar

ia A

gSt

anda

rd D

iagn

ostic

s, In

c.7

01

40

110

01

100

110

01

90

1.2

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

anSt

anda

rd D

iagn

ostic

s, In

c.10

01

80

12

01

70

19

11

90

1.33

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le

Bloo

d Te

stG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

100

39

12

100

3.6

100

3.7

100

1.8

100

3

Pan

only

Adva

ntag

e Pa

n M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

100

2.4

100

2.6

100

2.1

100

2.7

100

2.8

100

2.8

Care

Star

t Mal

aria

pLD

H (P

AN)

Acce

ss B

io, I

nc.

100

2.8

100

3.4

100

2.4

100

2.5

100

210

02.

9Pa

raba

nk R

apid

Tes

t for

Mal

aria

Pan

(D

evic

e)Ze

phyr

Bio

med

ical

s7

01

100

1.8

100

1.4

80

1.25

81

1.62

60

1.5

Pf -

Pla

smod

ium

falc

ipar

um

Pv -

Pla

smod

ium

viv

axpa

n -

Plas

mod

ium

spe

cies

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)8 8

Tabl

e A4

.15:

Hea

t st

abili

ty t

esti

ng r

esul

ts f

or P

f (o

r pa

n† ) t

est

line

on p

aras

ite

nega

tive

sam

ples

. Pos

itiv

ity

rate

at

base

line,

and

aft

er 6

0 da

ys in

cuba

tion

at

35°C

and

45

°C.

Prod

uct

Man

ufac

ture

r

Base

line

test

ing

35°C

45°C

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

No.

po

siti

ve

No.

in

valid

No.

po

siti

ve

No.

in

valid

No.

po

siti

ve

No.

in

valid

No.

po

siti

ve

No.

in

valid

No.

po

siti

ve

No.

in

valid

No.

po

siti

ve

No.

in

valid

Pf o

nly

ADVA

NCE

D QU

ALIT

Y TM

MAL

ARIA

(p.f)

POC

T In

Tec

Prod

ucts

, Inc

.2

00

02

04

02

03

0AD

VAN

CED

QUAL

ITY

TM O

ne S

tep

Mal

aria

(p.f.

) Tes

t (w

hole

blo

od)

InTe

c Pr

oduc

ts, I

nc.

20

00

10

10

00

00

Adva

ntag

e P.

f. M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

00

00

00

00

00

00

Care

Star

t Mal

aria

HRP

2 (P

f)Ac

cess

Bio

, Inc

.0

00

00

00

00

00

0Fi

rst R

espo

nse

Mal

aria

Ag

HRP

2Pr

emie

r Med

ical

Cor

pora

tion

Ltd.

00

00

00

00

00

01

Firs

tSig

n –

Mal

aria

Pf C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.0

00

00

00

00

00

0H

exag

on M

alar

iaH

uman

Gm

bH0

00

00

00

00

00

1IC

T M

alar

ia P

f Cas

sett

e Te

st (M

L01)

ICT

Diag

nost

ics

00

00

00

00

00

00

Imm

unoq

uick

Mal

aria

Fal

cipa

rum

Bios

ynex

00

01

00

00

00

00

Mal

aria

Pla

smod

ium

falc

ipar

um R

apid

test

Dev

ice

(Who

le b

lood

)AC

ON L

abor

ator

ies,

Inc.

00

00

00

00

00

00

Mal

aria

Rap

id P

fVi

sion

Bio

tech

(Pty

) Ltd

.0

00

00

00

00

00

0Pa

rach

eck

Pf R

apid

test

for P

. fal

cipa

rum

Mal

aria

(Dev

ice)

Or

chid

Bio

med

ical

Sys

tem

s1

00

00

00

00

00

0Pa

rach

eck

Pf R

apid

test

for P

. fal

cipa

rum

Mal

aria

(Dip

stic

k)

Orch

id B

iom

edic

al S

yste

ms

20

00

10

00

00

00

Para

hit-

f DIP

STIC

K FO

R FA

LCIP

ARU

M M

ALAR

IASp

an D

iagn

ostic

s Lt

d.0

00

00

00

00

00

0Pa

rahi

t-f T

EST

DEVI

CE F

OR F

ALCI

PARU

M M

ALAR

IASp

an D

iagn

ostic

s Lt

d.0

00

00

10

00

00

0SD

BIO

LIN

E M

alar

ia A

g Pf

St

anda

rd D

iagn

ostic

s, In

c.0

00

00

00

00

00

0Pf

& P

an/P

f &

Pv

Adva

ntag

e M

al C

ard

J. M

itra

& C

o. P

vt. L

td.

10

00

00

00

00

00

AZOG

Mal

aria

pf (

HRP

-II)

/pv

(pLD

H) A

ntig

en D

etec

tion

Test

Dev

ice

AZOG

, Inc

.0

00

00

00

00

00

0Bi

nax

Now

Mal

aria

In

vern

ess

Med

ical

Inno

vatio

ns, I

nc.

00

00

00

00

00

10

Care

Star

t Mal

aria

HRP

2/pL

DH (P

f/PA

N) C

OMBO

Acce

ss B

io, I

nc.

00

00

00

00

00

00

Firs

t Res

pons

e M

alar

ia A

g Co

mbo

(PLD

H/H

RP2)

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.0

00

00

00

00

00

0Fi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Car

d Te

stU

nim

ed In

tern

atio

nal,

Inc.

00

00

00

00

00

02

Hex

agon

Mal

aria

Com

biH

uman

Gm

bH0

00

00

00

00

00

0IC

T M

alar

ia C

ombo

Cas

sett

e Te

st (M

L02)

ICT

Diag

nost

ics

00

00

00

00

00

00

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

00

00

00

00

00

00

Mal

aria

P.F

/Viv

axDi

agno

stic

Aut

omat

ion

/ Cor

tez

Diag

nos-

tics,

Inc.

00

00

04

03

03

02

Mal

aria

Rap

id C

ombo

Visi

on B

iote

ch (P

ty) L

td.

00

00

00

00

00

00

Mal

aria

Rap

id D

ual

Visi

on B

iote

ch (P

ty) L

td.

00

00

00

00

00

01

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s0

00

00

00

00

00

0On

e St

ep M

alar

ia A

ntig

en S

trip

IND

Diag

nost

ic In

c.0

00

00

00

40

00

1On

Sigh

t – P

araQ

uick

(Pan

, Pf)

Test

Amge

nix

Inte

rnat

iona

l, In

c.0

00

00

00

00

00

0Op

tiMAL

-IT

DiaM

ed A

G0

00

00

00

00

00

4Pa

rahi

t-To

tal D

evic

e Ra

pid

test

for P

. fal

cipa

rum

and

Pan

mal

aria

l spe

cies

.Sp

an D

iagn

ostic

s Lt

d.0

00

00

00

00

00

0Pa

rasc

reen

Rap

id T

est f

or M

alar

ia P

an/P

f (De

vice

)Ze

phyr

Bio

med

ical

s0

00

00

00

01

00

0Qu

icks

tick

Mal

aria

Ant

igen

Tes

tIn

nova

tek

Med

ical

Inc.

00

00

00

04

00

01

SD B

IOLI

NE

Mal

aria

Ag

Stan

dard

Dia

gnos

tics,

Inc.

00

00

00

00

00

00

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

an

Stan

dard

Dia

gnos

tics,

Inc.

00

00

00

00

00

00

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

00

00

20

10

01

10

Pan

only

Adva

ntag

e Pa

n M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

00

00

00

00

00

00

Care

Star

t Mal

aria

pLD

H (P

AN)

Acce

ss B

io, I

nc.

00

00

00

00

00

10

Para

bank

Rap

id T

est f

or M

alar

ia P

an (D

evic

e)Ze

phyr

Bio

med

ical

s0

00

00

00

00

00

0Pf

- P

lasm

odiu

m fa

lcip

arum

Pv

- P

lasm

odiu

m v

ivax

pan

- Pl

asm

odiu

m s

peci

es

† - F

or p

an-o

nly

test

s

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)89

Tabl

e A4

.15:

Hea

t st

abili

ty t

esti

ng r

esul

ts f

or P

f (o

r pa

n† ) t

est

line

on p

aras

ite

nega

tive

sam

ples

. Pos

itiv

ity

rate

at

base

line,

and

aft

er 6

0 da

ys in

cuba

tion

at

35°C

and

45

°C.

Prod

uct

Man

ufac

ture

r

Base

line

test

ing

35°C

45°C

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

No.

po

siti

ve

No.

in

valid

No.

po

siti

ve

No.

in

valid

No.

po

siti

ve

No.

in

valid

No.

po

siti

ve

No.

in

valid

No.

po

siti

ve

No.

in

valid

No.

po

siti

ve

No.

in

valid

Pf o

nly

ADVA

NCE

D QU

ALIT

Y TM

MAL

ARIA

(p.f)

POC

T In

Tec

Prod

ucts

, Inc

.2

00

02

04

02

03

0AD

VAN

CED

QUAL

ITY

TM O

ne S

tep

Mal

aria

(p.f.

) Tes

t (w

hole

blo

od)

InTe

c Pr

oduc

ts, I

nc.

20

00

10

10

00

00

Adva

ntag

e P.

f. M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

00

00

00

00

00

00

Care

Star

t Mal

aria

HRP

2 (P

f)Ac

cess

Bio

, Inc

.0

00

00

00

00

00

0Fi

rst R

espo

nse

Mal

aria

Ag

HRP

2Pr

emie

r Med

ical

Cor

pora

tion

Ltd.

00

00

00

00

00

01

Firs

tSig

n –

Mal

aria

Pf C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.0

00

00

00

00

00

0H

exag

on M

alar

iaH

uman

Gm

bH0

00

00

00

00

00

1IC

T M

alar

ia P

f Cas

sett

e Te

st (M

L01)

ICT

Diag

nost

ics

00

00

00

00

00

00

Imm

unoq

uick

Mal

aria

Fal

cipa

rum

Bios

ynex

00

01

00

00

00

00

Mal

aria

Pla

smod

ium

falc

ipar

um R

apid

test

Dev

ice

(Who

le b

lood

)AC

ON L

abor

ator

ies,

Inc.

00

00

00

00

00

00

Mal

aria

Rap

id P

fVi

sion

Bio

tech

(Pty

) Ltd

.0

00

00

00

00

00

0Pa

rach

eck

Pf R

apid

test

for P

. fal

cipa

rum

Mal

aria

(Dev

ice)

Or

chid

Bio

med

ical

Sys

tem

s1

00

00

00

00

00

0Pa

rach

eck

Pf R

apid

test

for P

. fal

cipa

rum

Mal

aria

(Dip

stic

k)

Orch

id B

iom

edic

al S

yste

ms

20

00

10

00

00

00

Para

hit-

f DIP

STIC

K FO

R FA

LCIP

ARU

M M

ALAR

IASp

an D

iagn

ostic

s Lt

d.0

00

00

00

00

00

0Pa

rahi

t-f T

EST

DEVI

CE F

OR F

ALCI

PARU

M M

ALAR

IASp

an D

iagn

ostic

s Lt

d.0

00

00

10

00

00

0SD

BIO

LIN

E M

alar

ia A

g Pf

St

anda

rd D

iagn

ostic

s, In

c.0

00

00

00

00

00

0Pf

& P

an/P

f &

Pv

Adva

ntag

e M

al C

ard

J. M

itra

& C

o. P

vt. L

td.

10

00

00

00

00

00

AZOG

Mal

aria

pf (

HRP

-II)

/pv

(pLD

H) A

ntig

en D

etec

tion

Test

Dev

ice

AZOG

, Inc

.0

00

00

00

00

00

0Bi

nax

Now

Mal

aria

In

vern

ess

Med

ical

Inno

vatio

ns, I

nc.

00

00

00

00

00

10

Care

Star

t Mal

aria

HRP

2/pL

DH (P

f/PA

N) C

OMBO

Acce

ss B

io, I

nc.

00

00

00

00

00

00

Firs

t Res

pons

e M

alar

ia A

g Co

mbo

(PLD

H/H

RP2)

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.0

00

00

00

00

00

0Fi

rstS

ign

– Pa

raVi

ew-2

(Pv

+ Pf

) Car

d Te

stU

nim

ed In

tern

atio

nal,

Inc.

00

00

00

00

00

02

Hex

agon

Mal

aria

Com

biH

uman

Gm

bH0

00

00

00

00

00

0IC

T M

alar

ia C

ombo

Cas

sett

e Te

st (M

L02)

ICT

Diag

nost

ics

00

00

00

00

00

00

Imm

unoq

uick

Mal

aria

+4

Bios

ynex

00

00

00

00

00

00

Mal

aria

P.F

/Viv

axDi

agno

stic

Aut

omat

ion

/ Cor

tez

Diag

nos-

tics,

Inc.

00

00

04

03

03

02

Mal

aria

Rap

id C

ombo

Visi

on B

iote

ch (P

ty) L

td.

00

00

00

00

00

00

Mal

aria

Rap

id D

ual

Visi

on B

iote

ch (P

ty) L

td.

00

00

00

00

00

01

Mal

asca

n Ra

pid

Test

for M

alar

ia P

f/Pa

n (D

evic

e)Ze

phyr

Bio

med

ical

s0

00

00

00

00

00

0On

e St

ep M

alar

ia A

ntig

en S

trip

IND

Diag

nost

ic In

c.0

00

00

00

40

00

1On

Sigh

t – P

araQ

uick

(Pan

, Pf)

Test

Amge

nix

Inte

rnat

iona

l, In

c.0

00

00

00

00

00

0Op

tiMAL

-IT

DiaM

ed A

G0

00

00

00

00

00

4Pa

rahi

t-To

tal D

evic

e Ra

pid

test

for P

. fal

cipa

rum

and

Pan

mal

aria

l spe

cies

.Sp

an D

iagn

ostic

s Lt

d.0

00

00

00

00

00

0Pa

rasc

reen

Rap

id T

est f

or M

alar

ia P

an/P

f (De

vice

)Ze

phyr

Bio

med

ical

s0

00

00

00

01

00

0Qu

icks

tick

Mal

aria

Ant

igen

Tes

tIn

nova

tek

Med

ical

Inc.

00

00

00

04

00

01

SD B

IOLI

NE

Mal

aria

Ag

Stan

dard

Dia

gnos

tics,

Inc.

00

00

00

00

00

00

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

an

Stan

dard

Dia

gnos

tics,

Inc.

00

00

00

00

00

00

Won

dfo

One

Step

Mal

aria

Pf/

Pan

Who

le B

lood

Tes

tG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd

00

00

20

10

01

10

Pan

only

Adva

ntag

e Pa

n M

alar

ia C

ard

J. M

itra

& C

o. P

vt. L

td.

00

00

00

00

00

00

Care

Star

t Mal

aria

pLD

H (P

AN)

Acce

ss B

io, I

nc.

00

00

00

00

00

10

Para

bank

Rap

id T

est f

or M

alar

ia P

an (D

evic

e)Ze

phyr

Bio

med

ical

s0

00

00

00

00

00

0Pf

- P

lasm

odiu

m fa

lcip

arum

Pv

- P

lasm

odiu

m v

ivax

pan

- Pl

asm

odiu

m s

peci

es

† - F

or p

an-o

nly

test

s

Tabl

e A4

.15a

: Hea

t st

abili

ty t

esti

ng r

esul

ts f

or p

an t

est

line

of c

ombi

nati

on R

DTs

on n

egat

ive

sam

ples

. Pos

itiv

ity

rate

at

base

line,

and

aft

er 6

0 da

ys in

cuba

tion

at

35°C

and

45

°C.

Prod

uct

Man

ufac

ture

r

Base

line

test

ing

35°C

45°C

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

No.

po

siti

veN

o.

inva

lidN

o.

posi

tive

No.

in

valid

No.

po

siti

veN

o.

inva

lidN

o.

posi

tive

No.

in

valid

No.

po

siti

veN

o.

inva

lidN

o.

posi

tive

No.

in

valid

Pan

line

of c

ombi

nati

on t

ests

Adva

ntag

e M

al C

ard

J. M

itra

& C

o. P

vt. L

td.

10

00

00

00

00

00

AZO

G M

alar

ia p

f (H

RP-I

I)/pv

(pLD

H) A

ntig

en D

etec

tion

Test

Dev

ice

AZOG

, Inc

.0

04

00

00

00

02

0Bi

nax

Now

Mal

aria

Inve

rnes

s M

edic

al In

nova

tions

, Inc

.0

00

00

00

00

00

0Ca

reSt

art M

alar

ia H

RP2/

pLDH

(Pf/

PAN

) COM

BOAc

cess

Bio

, Inc

.0

00

00

00

04

00

0Fi

rst R

espo

nse

Mal

aria

Ag

Com

bo (P

LDH

/HRP

2)Pr

emie

r Med

ical

Cor

pora

tion

Ltd.

00

00

00

00

00

00

Firs

tSig

n –

Para

View

-2 (P

v +

Pf) C

ard

Test

Uni

med

Inte

rnat

iona

l, In

c.0

00

00

00

00

00

2H

exag

on M

alar

ia C

ombi

Hum

an G

mbH

00

00

00

00

00

00

ICT

Mal

aria

Com

bo C

asse

tte

Test

(ML0

2)IC

T Di

agno

stic

s0

00

00

00

00

00

0Im

mun

oqui

ck M

alar

ia +

4Bi

osyn

ex0

00

00

00

00

00

0M

alar

ia P

.F/V

IVAX

Diag

nost

ic A

utom

atio

n / C

orte

z Di

agno

stic

s, In

c.0

00

00

40

30

30

2M

alar

ia R

apid

Com

boVi

sion

Bio

tech

(Pty

) Ltd

.0

00

00

01

00

00

0M

alar

ia R

apid

Dua

lVi

sion

Bio

tech

(Pty

) Ltd

.0

00

00

00

00

00

1M

alas

can

Rapi

d Te

st fo

r Mal

aria

Pf/

Pan

(Dev

ice)

Zeph

yr B

iom

edic

als

00

00

00

00

00

00

One

Step

Mal

aria

Ant

igen

Str

ipIN

D Di

agno

stic

Inc.

00

00

00

04

00

01

OnSi

ght –

Par

aQui

ck (P

an, P

f)Am

geni

x In

tern

atio

nal,

Inc.

00

00

00

00

00

00

OptiM

AL-

ITDi

aMed

AG

00

00

00

00

00

04

Para

hitT

otal

Dev

ice

Rapi

d Te

st fo

r P. f

alci

paru

m a

nd P

an M

alar

ial S

peci

esSp

an D

iagn

ostic

s Lt

d.0

00

00

00

00

00

0Pa

rasc

reen

Rap

id T

est f

or M

alar

ia P

an/P

f (De

vice

)Ze

phyr

Bio

med

ical

s0

00

00

00

01

00

0Qu

icks

tick

Mal

aria

Ant

igen

Tes

tIn

nova

tek

Med

ical

Inc.

00

00

00

04

00

01

SD B

IOLI

NE

Mal

aria

Ag

Stan

dard

Dia

gnos

tics,

Inc.

00

00

00

00

00

00

SD B

IOLI

NE

Mal

aria

Ag

Pf/P

anSt

anda

rd D

iagn

ostic

s, In

c.0

00

00

00

00

00

0W

ondf

o On

e St

ep M

alar

ia P

f/Pa

n W

hole

Blo

od T

est

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d0

00

00

00

00

10

0Pf

- P

lasm

odiu

m fa

lcip

arum

Pv

- P

lasm

odiu

m v

ivax

pan

- Pl

asm

odiu

m s

peci

es

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)9 0

ANNEX 5: EXAMPLE ALGORITHM FOR SELECTING A MALARIA RDT

Select (from Table 4, 4a) an RDT with sufficiently high detection rate,low false positive rate and invalid rate, then…

Parameter

Decision process

Decision

1. Plasmodium species to betargeted

2. Expected areas of use

3. Likelyclinicalscenarios

4. End-user

5. Other considerations: Box size: How many fever cases expected in 3 months(if less than one box, request reduced box size)

Next Step: Finalize short-list of suitable RDTs Sometimes preferences will be incompatible, in which case, prioritize the importance of the categories above for your programme.

Distinguish non-Pf from Pf or mixed?

Yes

No

Combination test HRP2 - pLDH HRP2 - aldolase pLDH - pLDH

Pf-only test HRP2 pLDH (may be combined with

pan-specific pLDH)

Store and use in tropical environment without temperature control

Yes No

High-stability High stability demonstrated, and specified temperature e.g. 35°C

Storage temperature less critical

Accept lower stability and <35°C specified storage

For use by health workers outside medical laboratories

Yes No

Simple format, all-inclusive

Cassette design , few steps, lancet, swabs etc. included in package

Design less critical Include dipsticks Test-only packaging

Likely to use for re-testing soon aftertreatment / treatment-monitoring

Yes No

Target non-persistent antigen

pLDH-detecting for P. falciparum

Antigen persistence not critical

HRP2 or pLDH for P. falciparum

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)91

1. Contact manufacturers and request:a. Quoted price (include necessary accessories, delivery to

country, and staggered delivery in 2-3 batches over 12 months)

b. Request heat stability data as evidence of manufacturer's stated storage temperature and shelf-life

c. Request sample of product to assess format, ease of use, compatibility of other materials with health system requirements

3. Options to improve implementation:a. Negotiate replacement of product if supplied product

fails lot-testing after delivery by a method approved by manufacturer / WHO-coordinated laboratory

b. Develop appropriately-formatted instructions in appro-priate language and consider their inclusion of these in kits at the manufacturing site

c. Negotiate delivery dates for staggered delivery to reduce in-country storage times, ensure long (e.g. 18 months) shelf-life after delivery

2. Assess experience of others:If possible, obtain written assessments of field experience from other countries / programmes that have experience in using the product

4. Organize lot-testing prior to dispersal to the field

Make preliminary procurement decision, then consider…

CHOOSING SPECIFIC PRODUCT FROM RDT SHORT-LIST

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)92

ANNEX 6: INTRODUCING RDT-BASED MALARIA DIAGNOSIS INTO NATIONAL PROGRAMMES

As parasite-based diagnosis is introduced at smaller clinics and village level for case management, a large number of challenges arise not only in logistical administration but also in managing the health-seeking and health-providing behaviour of patients and health workers. These can be addressed by a systematic approach to planning, implementation, monitoring and evaluation of the diagnostic programme; a process that must commence well before RDTs are procured. The following information is derived from existing WHO documents addressing this area.22 More information may be obtained at www.wpro.who.int/sites/rdt .

Many health workers and communities will have been taught that “fever equals malaria unless proven otherwise”. Introducing RDTs will demonstrate that this is not the case. To have an impact on anti-malarial diagnosis and treatment, RDTs must be seen to provide an accurate diagnosis by both health workers and patients alike, that is, they must be as good or better than those relied on previously. A health worker will also need a good alternative to anti-malarial medicines for the management of parasite-negative febrile patients. To achieve and maintain confidence in RDT-based diagnosis, a good quality assurance system must be in place (detailed elsewhere on this website). There must be satisfactory education of health workers, and widespread community sensitization. Knowledge of other causes of fever will be necessary to develop appropriate management algorithms for parasite-negative cases.

At the national level, regulatory requirements may need to be developed to control the importation and

22 Developed by WHO Regional Office for the Western Pacific and the WHO Global Malaria Programme, with support from the Uganda Ministry of Health (National Malaria Control Programme), Management Sciences for Health (MSH), and other partners.

use of malaria RDTs, and new procedures for storage, distribution and inventory management, such as those used for medicines, may need to be developed. If changing from a different product or mode of diagnosis, an adequate phase-out plan for this must also be developed.

This requires a clear strategic plan to be developed well in advance of RDT introduction, with a clear timeline to ensure that the various components of the RDT programme are in place at the right time. A focal person, or persons, will be needed to coordinate the overall implementation plan and ensure that the various agencies that may be involved understand the process and their particular roles. To achieve this, funding for the programme must include a significant component for planning and coordination, sensitization/IEC, training, quality assurance, monitoring and supervision, and logistics, in addition to procurement. Without this, much of the funds expended on RDTs may be wasted, and a loss of confidence in RDT-based diagnosis may hinder the process of strengthening appropriate malaria case management.

An example of a national implementation plan is shown below. This will need to be modified considerably for each programme, preferably through a collaborative process involving all the major agencies concerned in its implementation. Budgeting for all the components of the programme at the outset is vital. An example of components to be considered in an overall budget is shown in Figure A6.1.

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)93

Summary of introduction plan (see following page)

Program planning and management Identify key stakeholders, and secure commitment for introduction of RDTs Establish working group and develop terms of reference Identify specific focal person(s) responsible for day to day oversight of the implementation plan Develop a timeline, scope, and budget for implementation Identify human and other resource needs, and a strategy for accessing them Review and update, if needed, case-management algorithms for malaria and other causes of febrile illness

Policy and regulatory issues Develop appropriate regulatory documents if required Register RDT products

Procurement of RDTs Develop product specifications and packaging requirements Develop product short-list Conduct quantification (estimation of needs) Procure RDTs Procure sharps boxes, gloves etc.

Logistics Develop distribution plan Train logistics and storage personnel in handling and distribution of RDTs Implement a system for data collection and information flows Arrange for appropriate transport and storage Review and strengthen inventory management, as needed Develop a plan for discontinuation and disposal of other diagnostic supplies, if appropriate

Quality Assurance Develop mechanisms for assessing samples at a national level (lot-testing), and regular (and random) testing

at the level of use (e.g. microscopy-sentinel sites) Implement post-marketing surveillance

Training and communication Develop appropriate training and supervision materials Train health workers in case management and managing commodities Train in RDT use Develop and implement a program for community education/ sensitization

Monitoring and Evaluation Implement effective supervision and monitoring Strengthen recording and reporting procedures

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)94

Reco

mm

ende

d se

quen

ce o

f ac

tivi

ties

for

impl

emen

tatio

n of

RDT

-bas

ed d

iagn

osis

in a

nat

iona

l mal

aria

pro

gram

me

and

the

rela

tive

tim

e al

lotm

ent.

24

RDT

IMPL

EMEN

TATI

ON

TIM

ELIN

E

Prog

ram

me

plan

ning

and

man

agem

ent

Appo

int

mal

aria

dia

gnos

is c

oord

inat

or(s

)

Polic

y re

com

men

dati

ons

Writ

ten

MoH

end

ores

men

t

Guid

elin

esW

ritte

nM

oH e

ndor

sem

ent

Case

man

agem

ent

of f

ever

of

unkn

own

orig

in

Case

man

agem

ent

of m

alar

ia

RDT

(and

mic

rosc

opy)

qua

lity

assu

ranc

e

RDT

tran

spor

t an

d st

orag

e

Deci

de d

istr

icts

for

init

ial /

pha

sed

impl

emen

tati

on

Feve

r m

anag

emen

t al

gorit

hmW

ritte

nM

oH e

ndor

sem

ent

Dete

rmin

e/de

sign

ate

tran

spor

t an

d st

orag

e m

etho

ds

Regu

alto

ry is

sues

Writ

e Re

g. A

utho

rity

and

NM

CP r

oles

Writ

e re

gist

rati

on c

riter

ia

Regi

ster

RDT

proc

urem

ent

and

logi

stic

s

Sele

ct 3

-4 p

rodu

cts

Sam

ples

for

eas

e-of

-use

ass

essm

ent

Fina

l dec

isio

n on

RDT

Neg

otia

te s

peci

ficat

ions

wit

h m

anuf

actu

rer

Proc

urem

ent

Depe

nden

t on

reg

istr

atio

n pr

oces

s

Rece

ive

first

bat

ch (

of s

tagg

ered

del

iver

y)La

ter

batc

h

Dist

ribut

ion

to fi

eld

Proc

ure

glov

esPr

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e sh

arps

box

es

Proc

ure

othe

r as

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ated

mat

eria

ls

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lity

Assu

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e se

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el s

ite

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Dete

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e se

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el s

ites

Set-

up s

enti

nel s

ites

Set

upM

onit

orin

g

Lot-

test

ing

Post

-mar

keti

ng s

urve

illan

ce

Trai

ning

and

com

mun

icat

ion

Cond

uct

case

man

agem

ent

trai

ning

for

fev

erM

ay b

e co

nduc

ted

earli

er, o

r al

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y in

pla

ceM

odif

y RD

T in

stru

ctio

ns a

nd t

rain

ing

man

ual

Fiel

d-te

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odfie

d tr

aini

ng/in

stru

ctio

nsTr

aini

ng o

f tr

aine

rsCo

mm

unit

y se

nsit

izat

ion

Gene

ral h

ealt

h ca

re p

rovi

ders

edu

cati

on

Mon

itor

ing

and

eval

uati

on

Deve

lop

appr

opria

te r

ecor

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rms

and

proc

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r su

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st-i

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e re

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ts w

ill v

ary

betw

een

prog

ram

mes

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)95

Figure A6.1 Example malaria RDT implementation budget

Below is an example of major components of a programme budget to be considered when introducing RDTs into a malaria programme. Without adequate provision for each of these factors, it is likely that an RDT-based diagnostics programme will fail to achieve its goals. These components should therefore be addressed in proposals for programme funding, or provisions should be made for them in collaborating programmes.

Reco

mm

ende

d se

quen

ce o

f ac

tivi

ties

for

impl

emen

tatio

n of

RDT

-bas

ed d

iagn

osis

in a

nat

iona

l mal

aria

pro

gram

me

and

the

rela

tive

tim

e al

lotm

ent.

24

RDT

IMPL

EMEN

TATI

ON

TIM

ELIN

E

Prog

ram

me

plan

ning

and

man

agem

ent

Appo

int

mal

aria

dia

gnos

is c

oord

inat

or(s

)

Polic

y re

com

men

dati

ons

Writ

ten

MoH

end

ores

men

t

Guid

elin

esW

ritte

nM

oH e

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sem

ent

Case

man

agem

ent

of f

ever

of

unkn

own

orig

in

Case

man

agem

ent

of m

alar

ia

RDT

(and

mic

rosc

opy)

qua

lity

assu

ranc

e

RDT

tran

spor

t an

d st

orag

e

Deci

de d

istr

icts

for

init

ial /

pha

sed

impl

emen

tati

on

Feve

r m

anag

emen

t al

gorit

hmW

ritte

nM

oH e

ndor

sem

ent

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rmin

e/de

sign

ate

tran

spor

t an

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orag

e m

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ds

Regu

alto

ry is

sues

Writ

e Re

g. A

utho

rity

and

NM

CP r

oles

Writ

e re

gist

rati

on c

riter

ia

Regi

ster

RDT

proc

urem

ent

and

logi

stic

s

Sele

ct 3

-4 p

rodu

cts

Sam

ples

for

eas

e-of

-use

ass

essm

ent

Fina

l dec

isio

n on

RDT

Neg

otia

te s

peci

ficat

ions

wit

h m

anuf

actu

rer

Proc

urem

ent

Depe

nden

t on

reg

istr

atio

n pr

oces

s

Rece

ive

first

bat

ch (

of s

tagg

ered

del

iver

y)La

ter

batc

h

Dist

ribut

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to fi

eld

Proc

ure

glov

esPr

ocur

e sh

arps

box

es

Proc

ure

othe

r as

soci

ated

mat

eria

ls

Qua

lity

Assu

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e

Writ

e se

ntin

el s

ite

SOP

Dete

rmin

e se

ntin

el s

ites

Set-

up s

enti

nel s

ites

Set

upM

onit

orin

g

Lot-

test

ing

Post

-mar

keti

ng s

urve

illan

ce

Trai

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and

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icat

ion

Cond

uct

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man

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ual

Fiel

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ctio

nsTr

aini

ng o

f tr

aine

rsCo

mm

unit

y se

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izat

ion

Gene

ral h

ealt

h ca

re p

rovi

ders

edu

cati

on

Mon

itor

ing

and

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uati

on

Deve

lop

appr

opria

te r

ecor

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and

proc

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Procurement of RDTs

Training, drugs / supplies for non-malarial fever

Community education

Training and supervision

Monitoring accuracy in field

Testing and laboratory monitoringProcurement of gloves, sharps disposal containers etc.

Transport and storage

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)9 6

NOTES:

MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)97

NOTES:

98MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)

NOTES:

ISBN 978 92 4 159807 1

DOI: 10.2471/TDR.09.978-924-1598071

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