Guidance for the use of approved COVID-19 Ag RDTs in Nigeria
Results of WHO product testing of malaria RDTs: Round 4 ... · malaria, and considered close to the...
Transcript of Results of WHO product testing of malaria RDTs: Round 4 ... · malaria, and considered close to the...
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Malaria Rapid Diagnostic Test Performance
Summary results of WHO product testing of malaria RDTs: Round 1-4 (2008-2012)
Malaria Rapid Diagnostic Test Performance
Summary results of WHO product testing of malaria RDTs: Round 1-4 (2008-2012)
WHO Library Cataloguing-in-Publication Data :Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 4 (2012).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 150472 0 (NLM classification: WC 750)
Copyright © World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases 2012
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Reference to any company or product in this report, particularly in any of the figures or tables, does not in any way imply an endorsement, certification, warranty of fitness or recommendation by WHO of any company or product for any purpose, and does not imply preference over products of a similar nature that are not mentioned. WHO furthermore does not warrant that: (1) any list of companies or products is complete and/or error free; and/or that (2) any products listed are of acceptable quality, have obtained regulatory approval in any country, or that their use is otherwise in accordance with the national laws and regulations of any country, including but not limited to patent laws. Inclusion in this report does not furthermore imply any approval by WHO of the products in question (which is the sole prerogative of national authorities). Any lists of RDTs are not an exhaustive list of malaria RDTs. Such lists reflect those products which have been submitted for evaluation in Round 4 of the WHO Malaria RDT Product Testing Programme. The fact that certain products are not included in any list means that they have not or not yet been submitted for evaluation in the WHO Malaria RDT Product Testing Programme and does not indicate anything in respect of such products’ performance. WHO will not accept any liability or responsibility whatsoever for any injury, death, loss, damage, or other prejudice of any kind that may arise as a result of or in connection with the procurement, distribution and use of any product whatsoever included in this report. This report may not be used by manufacturers and suppliers for commercial or promotional purposes.
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1malaria rapid diagnoStic teSt performance – Summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
1. Summary performance of malaria rdtS: WHo product teSting: roundS 1–4
1.1. introductionThe World Health Organization estimates that half the world’s population is at risk of malaria, with an estimated 216 million people (range 149–274 million) developing clinical malaria in 2010 (81% in Africa), and 655,000 deaths (range 537,000–907,000) due to malaria (91% in Africa, most being children). Malaria remains endemic in 106 countries, and while parasite-based diagnosis is increasing, most suspected cases of malaria are still not properly confirmed, resulting in over-use of anti-malarial drugs and poor disease monitoring1.
WHO recommends that malaria case management be based on parasite-based diagnosis in all cases2. The use of antigen-detecting rapid diagnostic tests (RDTs) forms a vital part of this strategy, forming the backbone of expansion of access to malaria diagnosis by providing parasite-based diagnosis in areas where good quality microscopy cannot 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 and epidemiology has limited the availability of good quality performance data that national malaria programmes require to make informed decisions on procurement and implementation, and limits the ability to extrapolate results of field trials to different populations and time periods. To this end, in 2006, the World Health Organization (WHO), Special Programme for Research and Training in Tropical Diseases (TDR) and the Foundation for Innovative New Diagnostics (FIND) launched an evalua-tion programme to assess the comparative performance of commercially available malaria RDTs. Currently, these data are guiding procurement decisions which are in turn shifting markets towards better-performing tests1 and helping to drive overall improvement in the quality of manufacturing. The results of WHO Malaria RDT Product Testing have been published annually since 2009 and form the basis of procurement criteria of WHO, other UN agencies, the Global Fund and national governments.
This Summary presents an overview of the results of the first through fourth rounds of WHO Malaria RDT Product Testing and is published in conjunction with the release of the full report on Round 4. The results of the four rounds of testing should be considered as a single data set. Separate
1 World Malaria Report 2011. Geneva, World Health Organization, 2011 2 Guidelines for the Treatment of Malaria, Second Edition. Geneva,
World Health Organization, 2010 (ISBN9789241547925)
full reports of all rounds should be consulted for further detail on product performance, and on the interpretation and use of these results.
1.2. the WHo product testing programmeThe RDT evaluations summarized here were performed as a collaboration between WHO, TDR, FIND, the US Centers for Disease Control and Prevention (CDC) and other partners3. All companies manufacturing under ISO 13485:2003 Quality System Standard were invited to submit a limited number of products (2–3) for evaluation under the programme. In the first round of testing, 41 products from 21 manufacturers were evaluated against prepared blood panels of cultured Plasmodium falciparum parasites, while 29, 50 and 48 products from 13, 23 and 27 manufacturers were evaluated in Round 2, 3 and 4, respectively. Many manufacturers have decided to voluntarily re-submit products to one or more rounds of testing, including 1, 23 and 13 resubmissions in Round 2, 3 and 4, respectively (Table S3). Of these 168 total products, 164 progressed to testing against panels of patient-derived P. falciparum and P. vivax parasites, and a parasite-negative panel. Thermal stability was assessed after two months of storage at elevated temperature and humidity, and a descriptive ease-of-use assessment was recorded. Of the 164 fully evaluated products, 21 have been evaluated twice, and 8 have been evaluated three times between Rounds 1-4. Of the 128 unique products tested by the programme, 35 detect P. falciparum alone, 83 detect and differentiate P. falciparum from non-P. falciparum malaria (either pan-specific or species-specific (Pv, Pvom), 9 detect P. falciparum and non-P. falciparum malaria without distinguishing between them, and one product was designed to detect P. vivax only. Manufacturers submitted two lots of each product for evaluation. Where the same products4 have been re-submitted in subsequent rounds of testing, the latter results replace those published from the earlier round. Thus, the performance of many tests in the results below differ from those published in the Rounds 1–3 reports.
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.
3 See full reports of Rounds 1–4 for full list of collaborating partners. 4 Informal Consultation on Laboratory Methods for Quality Assurance
of Malaria Rapid Diagnostic Tests. 20-22 July 2004. Manila. WHO Regional Office for the Western Pacific. 2004. (RS/2004/GE/26(PHL)
2 malaria rapid diagnoStic teSt performance – Summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
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 fifth round of product testing will begin in January 2013.
1.3. results of the evaluationThe results (summarized in Figures S1 and S2 and Tables S1 and S2) provide comparative data on two 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 well below the mean parasite density found in many populations with endemic malaria, and considered close to the threshold that tests must detect to reliably identify clinical malaria in many settings1. For the purposes of this report, the main measure of perform-ance is the ‘panel detection score (PDS)’2; 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 figures also show the false-positive rates against blood samples containing no malaria parasites or known markers of other diseases, and the rate at which invalid results occurred.
The clinical sensitivity of a RDT to detect malaria is highly dependent on the local conditions, including parasite density in the target population. Sensitivity of a test will therefore vary among populations with differing levels of transmis-sion, as their different levels of immunity affect the para-site density at which they exhibit symptoms warranting a diagnostic test. Where transmission rates are low, parasite densities in people with symptoms of malaria are likely to be lower, resulting in tests having a lower sensitivity. For this reason, test performance at 200 parasites/µl is particularly important. The results in this report show comparative performance among RDTs, and give an indication of which products are likely to provide higher sensitivity in the field, particularly in populations with low-density infections.
In general, as countries reduce malaria prevalence and even move towards malaria elimination, detection of low parasite densities becomes increasingly important in case manage-ment. 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. An important caveat when predicting field sensitivity from the PDS provided in this report is that the panels used in this
1 Parasitological Confirmation of Malaria Diagnosis. Report of a WHO technical consultation Geneva, 6–8 October 2009. Geneva, World Health Organization, 2010. (ISBN 978 92 4 159941 2)
2 Termed ‘Detection Rate’ in the full report of Round 1, published in 2009. See the Round 4 report for a full explanation of the panel detection score (PDS).
evaluation only include parasites known to express the target antigens. While non-expression of the target antigens has not been recorded for aldolase or pLDH, it is known that parasites infecting people in some areas of South America do not express HRP23. In areas where HRP2-deleted parasites exist, HRP2-detecting tests will have greatly reduced sensitivity or be incapable of detecting P. falciparum. In such populations, only tests detecting pLDH in P. falciparum parasites will be effective in diagnosing falciparum malaria.
Heat stability (summarized in Table S2) 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 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 may be placed on stability at high temperatures compared to other aspects of test quality.
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.
Detailed results of the evaluations can be found in the reports of each evaluation,4 and at www.wpro.who.int/sites/rdt. WHO provides guidance on the procurement and implementation of malaria RDTs5,6 . Furthermore, an interactive guide to assist in selecting products with performance characteristics most suitable for a particular country health programme is found on the FIND website.7
3 Gamboa, D., M. F. Ho, et al. A large proportion of P. falciparum isolates in the Amazon region of Peru lack pfhrp2 and pfhrp3: implications for malaria rapid diagnostic tests. PLoS One, 2010: 5(1): e8091.
4 Malaria Rapid Diagnostic Test Performance : Results of WHO product testing of malaria RDTs: Round 1 (2008). Geneva, World Health Organization, 2009. ISBN 978 92 4 1598071; Malaria Rapid Diagnostic Test Performance : Results of WHO product testing of malaria RDTs: Round 2 (2009). Geneva, World Health Organization, 2010. ISBN 978 92 4 1599467; Malaria Rapid Diagnostic Test Performance : Results of WHO product testing of malaria RDTs: Round 3 (2010-11). Geneva, World Health Organization, 2011. ISBN 978 92 4 150256 6.
5 Good practices for selecting and procuring rapid diagnostic tests for malaria. Geneva, World Health Organization , 2011 (ISBN 978 92 4 150112 5)
6 Universal Access to Malaria Diagnostic Testing: An operational manual. Geneva, World Health Organization, 2011 (ISBN 978 92 4 150209 )
7 Malaria RDT Interactive Guide : http://www.finddiagnostics.org/programs/malaria-afs/malaria/rdt_quality_control/product_testing/interactive-guide/index.jsp
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3malaria rapid diagnoStic teSt performance – Summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
1.4. Summary of outcomesThis laboratory-based evaluation provides a comparative measure of RDT performance in a standardized way to distinguish between well and poorly performing tests to inform procurement decisions of malaria control programmes and guide UN procurement policy.
Overall, the gains noted in the performance of products re-submitted to Round 3 were seen again in Round 4 for several products (Table S3), indicating product improvement by the manufacturers. Furthermore, in Round 4 the propor-tion of tests achieving a PDS (>75%) at 200 parasites/µl is comparable to Round 3 for P. falciparum at 73.9% and for P. vivax, the proportion is 47.2 %, representing an improve-ment over Rounds 1 and 3 combined (36.7%).
Several RDTs from the four rounds of testing 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 among products varied widely at low parasite density (200 parasites/µl); however, the majority of products showed a high level of detection at 2000 or 5000 parasites/µl.
P. falciparum tests targeting HRP2 antigen demonstrated the highest detection rates. In Round 4, both tests targeting pf-pLDH for detection of P. falciparum infection did not pass Phase 1. Thus, the range of choice for well-performing pLDH based P. falciparum tests remains limited, as it does for pan-only specific tests.
Test performance sometimes 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, offers quality standard panels of P. falciparum isolates to manufacturers to assist in this process and is planning to transition to malaria recombinant antigens panels by the end of 2014.
1.5. use of these resultsAccurate diagnosis is vital to good malaria case management, whether based on microscopy or RDTs. The results of this report should be used to short-list RDTs for procurement for use in settings where good microscopy is not available or appropriate. Additionally, 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 varia-tion, parasite densities, climate), as well as other important considerations, including field-based ease-of-use assess-ments, and training/retraining requirements. Furthermore, in order to ensure that the high performance demonstrated by the lots evaluated in the product testing programme is maintained, it is recommended that each lot of RDTs is also tested in a standardized way prior to dispersal to the field1. 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. The main report provides an algorithm (Annex 5a) to assist in this decision-making process and comprehensive guidance on several aspects of procurement can be found in ‘Good Practices for selecting and procuring rapid diagnostic tests for malaria’2.
1 The WHO-FIND Malaria RDT Evaluation Programme provides lot-testing capacity in a number of regional laboratories free of charge, and can be accessed through contacting [email protected] and [email protected].
2 Good Practices for selecting and procuring rapid diagnostic tests for malaria, Geneva, World Health Organization, 2011 (ISBN 9789241501125)
4 malaria rapid diagnoStic teSt performance – Summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Figure S1: Malaria RDT performance in Phase 2 of Rounds 1-4 against wild type (clinical) samples containing P. falciparum at low (200) and high (2000–5000) parasite densities (parasites/μl) and clean-negative samples
a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive. b Clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality. * Indicates tests that also detect other non-P. falciparum parasites
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Figure S1: Malaria RDT performance in Phase 2 of Rounds 1-4 against wild type (clinical) samples containing P. falciparum at low (200) and high (2000–5000) parasite densities (parasites/μl) and clean-negative samples
a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive. b Clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality. * Indicates tests that also detect other non-P. falciparum parasites
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False-positive Plasmodium spp. rate (%)
Invalid rate (%)
6 malaria rapid diagnoStic teSt performance – Summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Figure S2: Malaria RDT performance in Phase 2 of Rounds 1-4 against wild type (clinical) samples containing P. vivax at low (200) and high (2000–5000) parasite densities (parasites/μl)) and clean-negative samples
a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive. b Clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality.
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Sum
mar
y r
ou
nd
S 1-
4
7malaria rapid diagnoStic teSt performance – Summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Figure S2: Malaria RDT performance in Phase 2 of Rounds 1-4 against wild type (clinical) samples containing P. vivax at low (200) and high (2000–5000) parasite densities (parasites/μl)) and clean-negative samples
a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive. b Clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality.
Hu
mas
is M
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10
25
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E M
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E M
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D B
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AL
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dia
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Cle
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alar
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f (H
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N (
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nti
gen
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Mal
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HR
P2
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DH
Co
mb
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R-0
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Su
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Eas
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alar
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f/P
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MA
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Mal
aria
pf
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An
tig
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est
Dev
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M
FV
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On
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tep
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aria
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Tes
t (C
asse
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52
33
52
AZ
OG
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aria
pf
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AN
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tig
en D
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FV
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d T
est
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02
CB
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Mal
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can
® M
alar
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.f/P
AN
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v, P
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Po
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BO
N M
alar
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IM
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nd
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VM
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f/P
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Ad
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Qu
alit
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On
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AL
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25
200 parasites/µl2000 parasites/µlFalse-positive Plasmodium spp. rate (%)Invalid rate (%)
8 malaria rapid diagnoStic teSt performance – Summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Tabl
e S1
: Mal
aria
RDT
Pha
se 2
per
form
ance
in R
ound
s 1–
4 ag
ains
t w
ild t
ype
(clin
ical
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mpl
es c
onta
inin
g P.
fal
cipa
rum
and
P. v
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low
(20
0)
and
high
(20
00 o
r 50
00)
para
site
den
sitie
s (p
aras
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/μl)
and
clea
n-ne
gati
ve s
ampl
es
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Pane
l Det
ectio
n Sc
orea
False
-pos
itive
rat
es (%
)To
tal f
alse
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ra
tesb
(%)
Inva
lid
rate
(%)
(n=1
192)
Ro
und
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Clea
n-ne
gativ
e sa
mpl
es
Pf samplesc
Pv samplesd
Pf samplesc
Pv samplesd
Pf s
ampl
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sam
ples
Pf s
ampl
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Fals
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sitiv
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Pf
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ctio
ne
Fals
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Pf
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ctio
nf
Fals
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Pf
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ctio
ng
Fals
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sitiv
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Pf
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False
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Infe
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Pf o
nly
ABON
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Adva
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13
Adva
nced
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lity™
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f) PO
CTIT
P110
02TC
1In
Tec
Prod
ucts
, Inc
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A10
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NA
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17.5
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vant
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aria
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dIR
0160
25J.
Mitr
a &
Co.
Pvt
. Ltd
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A10
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NA
NA
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NA
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31)
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ONOT
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ALAR
IA P
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g Ra
pid
Test
Kit
RG19
-11
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NA
99.0
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NA
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0.1
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reSt
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2 (P
f)G
0141
Acce
ss B
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NA
98.7
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NA
5.0
NA
7.5
2.4
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reSt
art™
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aria
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2/pL
DH P
f tes
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0181
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ss B
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NA
100.
0N
AN
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6N
A1.
33.
00.
02
Clea
rvie
w®
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aria
P.f.
j VB
01Vi
sion
Bio
tech
(Pty
) Ltd
83.8
NA
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AN
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0N
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00.
00.
03
Core
™ M
alar
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f M
AL-1
9002
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A10
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NA
NA
0.0
NA
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1.0
(198
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33
diag
nost
icks
- M
alar
ia (P
f) Ca
sset
te
KMFC
6001
SSA
Diag
nost
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& B
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NA
99.0
NA
NA
1.9
NA
2.6
(77)
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0.9
2di
agno
stic
ks-
Mal
aria
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07SS
A Di
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s &
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82.
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02
Firs
t Res
pons
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g H
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RC30
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orpo
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03.
00.
01
Firs
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n™ –
Mal
aria
Pf C
ard
Test
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nim
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tern
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NA
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NA
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NA
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)0.
01
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tSig
n™ M
alar
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f21
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-25
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med
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NA
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1.47
2.2
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)0.
24
Hex
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uman
Gm
bH39
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AN
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9 (7
6)N
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2 (1
67)
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iSen
s M
alar
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g Pf
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HBI
Co.
, Ltd
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T Di
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alar
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AN
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0N
A0.
00.
00.
03
IMM
UN
OQU
ICK
CON
TACT
falc
ipar
um
0519
K25
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ynex
81.8
NA
100.
0N
AN
A3.
6 (1
39)
NA
1.4
4.0
(199
)0.
33
Imm
unoq
uick
Mal
aria
Fal
cipa
rum
0502
_K25
Bios
ynex
91.1
NA
100.
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AN
A0.
0N
A0.
00.
60.
01
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f 53
5-11
IND
Diag
nost
ics
Inc.
61.2
NA
99.0
NA
NA
2.2
NA
14.7
16
0.1
4M
alar
ia P
lasm
odiu
m fa
lcip
arum
Rap
id te
st D
evic
e (W
hole
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IMA-
402
ACON
Lab
orat
orie
s, In
c.92
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A10
0.0
NA
NA
0.0
NA
0.0
0.0
0.0
1M
aler
isca
n ®
Mal
aria
P.f
Antig
en T
est
MAT
-PF-
50Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
83.7
NA
98.0
NA
NA
1.5
NA
0.0
0.4
0.2
4N
anoS
ign
Mal
aria
Pf A
g RM
AF10
Biol
and,
Ltd
84.9
NA
100.
0N
AN
A0.
0N
A0.
00.
00.
33
One
Step
Mal
aria
P.F
Tes
t (Ca
sset
te)j
5223
52Bl
ue C
ross
Bio
-Med
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(Bei
jing)
Co
., Lt
d.94
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A99
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AN
A0.
0N
A1.
471.
30.
04
OnSi
ght™
- M
alar
ia P
f Tes
t51
1-25
-DB
Amge
nix
Inte
rnat
iona
l, In
c.74
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A99
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AN
A8.
1N
A2.
511
.00.
02
OnSi
te P
f Ag
Rapi
d Te
stj
R011
4CCT
K Bi
otec
h, In
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A10
0.0
NA
NA
0.7
NA
0.0
3.5
0.0
3Pa
rach
eck®
Pf-
Rapi
d Te
st fo
r P. f
alci
paru
m M
alar
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evic
e (V
er.3
)j30
3010
25Or
chid
Bio
med
ical
Sys
tem
s 95
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A98
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AN
A0.
0N
A0.
01.
30.
04
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipar
um M
alar
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ipst
ick (
Ver.3
)j30
3020
25Or
chid
Bio
med
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tem
s 70
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A99
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AN
A0.
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00.
90.
04
Para
HIT
® -
f (D
evic
e)j
55IC
102-
50Sp
an D
iagn
ostic
s Lt
d.84
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A10
0.0
NA
NA
0.0
NA
0.0
0.0
0.0
3Pa
raH
IT®
-f (D
ipst
ick)
j 55
IC10
1-50
Span
Dia
gnos
tics
Ltd.
80.8
NA
99.0
NA
NA
0.0
NA
1.4
2.5
0.0
3SD
BIO
LIN
E M
alar
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g P.
f. (H
RP2/
pLDH
)k05
FK90
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dard
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gnos
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Inc.
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NA
100.
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AN
A0.
0N
A0.
02.
00.
03
SD B
IOLI
NE
Mal
aria
Ag
Pf05
FK50
Stan
dard
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gnos
tics,
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NA
98.7
NA
NA
0.0
NA
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2.4
0.0
1Tr
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™ M
alar
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ntig
en P
.f. te
stA0
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abor
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AN
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4 (1
35)
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2.94
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74
Won
dfo
One
Step
Mal
aria
P.f
Test
jW
37-
CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
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NA
99.0
NA
NA
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A0
0.4
(231
)0.
24
Sum
mar
y r
ou
nd
S 1-
4
9malaria rapid diagnoStic teSt performance – Summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Pane
l Det
ectio
n Sc
orea
False
-pos
itive
rat
es (%
)To
tal f
alse
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ra
tesb
(%)
Inva
lid
rate
(%)
(n=1
192)
Ro
und
200
pa
rasit
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l20
00 o
r 50
00
para
sites
/μl
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pa
rasit
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r 50
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para
sites
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n-ne
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mpl
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ampl
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sam
ples
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ampl
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sam
ples
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sitiv
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ctio
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nf
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ctio
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nd P
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alar
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an/P
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apid
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gzho
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s M
alar
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pid
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vant
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Car
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2210
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Mitr
a &
Co.
Pvt
. Ltd
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34
Bina
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BION
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an A
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pid
Test
Kit
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Mal
aria
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ntig
en D
etec
tion
Test
Dev
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OG, I
nc.
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0.0
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094
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0 (3
95)
7.9
8.1
0.0
5.5
(199
)0.
33
Mal
aria
pf (
HRP
II)/P
AN (p
LDH
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igen
Det
ectio
n Te
st D
evic
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13-1
01-1
Uni
ted
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ech,
Inc.
63
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910
0.0
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0.0
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00.
00.
00.
14
Mal
aria
pf (
pLDH
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AN-p
LDH
Tes
t Dev
ice
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FV-1
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OG, I
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70.7
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0.0
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0 (1
39)
0.0
0.0
0.0
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43
Mal
aria
Pf/
PAN
GM
004
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mix
Mol
ecul
ar D
iagn
ostic
s Pvt
.Ltd.
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94.9
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0.7
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alas
can™
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ice
- Ra
pid
test
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alar
ia P
f/Pa
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phyr
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ical
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tem
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7 (1
36)
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0 (6
8)1.
0 (1
95)
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aler
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n® M
alar
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v, Pm
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ine
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en T
est
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at B
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ech
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a (P
te.)
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0.0
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076
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0 (3
91)
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0.0
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ro M
alar
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g H
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14
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n M
alar
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and
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4
Tabl
e S1
(co
ntin
ued)
10 malaria rapid diagnoStic teSt performance – Summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Pane
l Det
ectio
n Sc
orea
False
-pos
itive
rat
es (%
)To
tal f
alse
-pos
itive
ra
tesb
(%)
Inva
lid
rate
(%)
(n=1
192)
Ro
und
200
pa
rasit
es/μ
l20
00 o
r 50
00
para
sites
/μl
200
pa
rasit
es/μ
l20
00 o
r 50
00
para
sites
/μl
Clea
n-ne
gativ
e sa
mpl
es
Pf samplesc
Pv samplesd
Pf samplesc
Pv samplesd
Pf s
ampl
esPv
sam
ples
Pf s
ampl
esPv
sam
ples
Fals
e-po
sitiv
e
non
Pf
infe
ctio
ne
Fals
e-po
sitiv
e
Pf
infe
ctio
nf
Fals
e-po
sitiv
e
non
Pf
infe
ctio
ng
Fals
e-po
sitiv
e
Pf
infe
ctio
nh
False
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itive
Pl
asm
odiu
m sp
p.
Infe
ctio
ni
Nan
oSig
n M
alar
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f/Pv
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RMAD
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olan
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td6.
18.
689
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0.0
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00.
00.
00.
13
One
Step
Mal
aria
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igen
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ip82
0-1
IND
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nost
ic In
c.1.
30.
067
.160
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23.
81.
90.
01.
8 (1
67)
0.0
1On
e St
ep M
alar
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n Te
stj
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uang
zhou
Won
dfo
Biot
ech
Co. L
td.
37.4
85.7
95.0
100.
08.
4 (3
83)
0.0
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0 (1
94)
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)2.
43
OnSi
ght™
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araQ
uick
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536-
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nix
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rnat
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l, In
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00.
01.
30.
00.
00.
00.
01
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te P
f/Pa
n Ag
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id T
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otec
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IT -
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al V
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evic
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IC20
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gnos
tics
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84.7
82.4
99.0
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0.0
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3.0
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IT -
Tot
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ipst
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an D
iagn
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s Lt
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pstic
k)55
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Span
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64.0
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0.0
0.0
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rahi
t-To
tal D
evic
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pid
test
for P
. fal
cipa
rum
and
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m
alar
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093
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0 (3
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scre
en®
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pid
test
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alar
ia P
an/P
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3100
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phyr
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med
ical
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23.5
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050
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34
Quic
kstic
k M
alar
ia A
ntig
en T
est
--In
nova
tek
Med
ical
Inc.
1.3
0.0
67.1
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01
SD B
IOLI
NE
Mal
aria
Ag
P.f/
Panj
05FK
60St
anda
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s In
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0.0
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)0.
00.
50.
03.
5 (1
99)
0.3
3SD
BIO
LIN
E M
alar
ia A
g Pf
/ Pan
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anda
rd D
iagn
ostic
s In
c.
90.8
94.1
100.
010
0.0
1.0
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0 (1
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0 (6
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3 (2
26)
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LIN
E M
alar
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gj 05
FK40
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dard
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gnos
tics
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93.9
100.
00.
80.
00.
00.
00.
00.
03
Sure
step
™ E
asy
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aria
Pf/
Pan
Rapi
d Te
st D
evic
e IM
A-T4
02AC
ON B
iote
ch (H
angz
hou)
Co.
Ltd
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010
0.0
100.
00.
00.
00.
00.
01.
00.
03
Pf a
nd P
vAd
vanc
ed Q
ualit
y™ O
ne S
tep
Mal
aria
P.f/
P.v
Tri-
Line
Tes
t IT
P110
03 T
C40
InTe
c Pr
oduc
ts, I
nc.
86.9
0.0
100.
05.
715
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95)
5.7
8.1
(197
)4.
318
.50.
23
Adva
ntag
e M
alar
ia C
ard
IR21
1025
J. M
itra
& C
o. P
vt. L
td.
77.8
31.4
99.0
100.
00.
50.
70.
00.
00.
00.
03
BION
OTE
MAL
ARIA
P.f.
& P
.v. A
g Ra
pid
Test
Kit
RG19
-12
Bion
ote,
Inc.
92.9
97.1
98.0
100.
00.
30.
71.
5 (1
97)
0.0
4.0
0.0
3Ca
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOj
G01
61Ac
cess
Bio
, Inc
.90
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.110
0.0
100.
00.
30.
01.
01.
50.
00.
04
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOj
G01
71Ac
cess
Bio
, Inc
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.891
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0.0
100.
00.
30.
70.
52.
90.
00.
04
Core
™ M
alar
ia P
v/Pf
MAL
-190
022
Core
Dia
gnos
tics
98.0
60.0
100.
097
.10.
30.
00.
00.
04.
00.
13
diag
nost
icks
- M
alar
ia (P
v/Pf
) Cas
sett
eKM
VFC6
002
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
91.0
45.0
99.0
100.
00.
3 (3
99)
0.6
0.0
0.0
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0.1
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lciV
ax™
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apid
test
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alar
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v/Pf
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phyr
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30.
04
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n™ –
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aVie
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med
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iona
l, In
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098
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03.
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00.
0 (1
67)
0.0
1H
iSen
s M
alar
ia A
g P.
f/P.
v Co
mbo
Car
dH
R312
3H
BI C
o., L
td.
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79.4
100.
094
.10.
3 (3
91)
0.0
0.5
0.0
0.4
0.1
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iSen
s M
alar
ia A
g P.
f/VO
M C
ombo
Car
dH
R332
3H
BI C
o., L
td.
89.8
76.5
100.
091
.20.
00.
00.
50.
00.
00.
04
Hum
asis
Mal
aria
P.f/
P.v
Antig
en T
est
AMFV
-702
5H
umas
is, C
o., L
td.
92.9
100.
010
0.0
100.
00.
50.
70.
51.
51.
30.
04
Mal
aria
pf (
HRP
II) /
pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
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nite
d Bi
otec
h, In
c.
60.2
0.0
92.9
26.5
0.5
0.0
(135
)3.
1 (1
95)
1.5
0.0
(230
)0.
54
Mal
aria
pf (
HRP
II) /
pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
MFV
-124
VAZ
OG, I
nc.
79.8
0.0
100.
020
.00.
01.
40.
00.
00.
0 (1
99)
0.1
3M
alar
ia P
f/Pv
GM
002
Geno
mix
Mol
ecul
ar D
iagn
ostic
s Pvt
.Ltd.
40.8
0.0
94.9
5.9
0.8
0.7
0.5
0.0
0.9
0.0
4M
aler
isca
n® M
alar
ia P
f/Pv
M
AT-5
0Bh
at B
io-T
ech
Indi
a (P
) Ltd
52.0
0.0
97.0
60.0
1.8
(399
)2.
532
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5 (7
9)1.
5 (1
99)
0.4
2M
edis
enso
r Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOM
161
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isen
sor,
Inc.
90.8
94.1
100.
010
0.0
0.3
0.0
1.0
1.5
0.0
0.0
4M
edis
enso
r Mal
aria
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2/pL
DH (P
f/VO
M) C
OMBO
M17
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edis
enso
r, In
c.89
.891
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0.0
100.
00.
30.
70.
52.
90.
00.
04
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.50
.00.
095
.991
.20.
02.
90.
01.
51.
30.
04
OnSi
ght™
- P
araQ
uick
-2 (P
v,Pf)
Mal
aria
Tes
t53
7-25
-DB
Amge
nix
Inte
rnat
iona
l, In
c.92
.037
.510
0.0
100.
00.
51.
90.
00.
03.
50.
12
OnSi
te P
f/Pv
Ag
Rapi
d Te
stj
R011
2CCT
K Bi
otec
h, In
c.79
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0.0
100.
010
0.0
1.5
0.0
2.0
0.0
1.3
0.0
4
Tabl
e S1
(co
ntin
ued)
Sum
mar
y r
ou
nd
S 1-
4
11malaria rapid diagnoStic teSt performance – Summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Pane
l Det
ectio
n Sc
orea
False
-pos
itive
rat
es (%
)To
tal f
alse
-pos
itive
ra
tesb
(%)
Inva
lid
rate
(%)
(n=1
192)
Ro
und
200
pa
rasit
es/μ
l20
00 o
r 50
00
para
sites
/μl
200
pa
rasit
es/μ
l20
00 o
r 50
00
para
sites
/μl
Clea
n-ne
gativ
e sa
mpl
es
Pf samplesc
Pv samplesd
Pf samplesc
Pv samplesd
Pf s
ampl
esPv
sam
ples
Pf s
ampl
esPv
sam
ples
Fals
e-po
sitiv
e
non
Pf
infe
ctio
ne
Fals
e-po
sitiv
e
Pf
infe
ctio
nf
Fals
e-po
sitiv
e
non
Pf
infe
ctio
ng
Fals
e-po
sitiv
e
Pf
infe
ctio
nh
False
-pos
itive
Pl
asm
odiu
m sp
p.
Infe
ctio
ni
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io E
thio
pia
90.8
94.1
100.
010
0.0
0.3
0.0
1.0
1.5
0.0
0.0
4Pa
raCa
re M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOG
0171
Acce
ss B
io E
thio
pia
89.8
91.2
100.
010
0.0
0.3
0.7
0.5
2.9
0.0
0.0
4
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE M
ALAR
IA P
F/PV
TES
TM
AL-P
FV-
CAS/
25(1
00)
Hem
a Di
agno
stic
Sys
tem
s, LL
C92
.979
.410
0.0
100.
00.
00.
70.
01.
54.
30.
04
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
vk05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
96.9
97.1
100.
010
0.0
0.3
0.0
0.5
0.0
2.2
0.0
4SD
BIO
LIN
E M
alar
ia A
g Pf
/Pv
05FK
80St
anda
rd D
iagn
ostic
s, In
c.96
.095
.010
0.0
100.
00.
00.
0 (1
59)
0.0
(199
)0.
03.
50.
22
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v.
test
A03-
12-3
22Ar
tron
Lab
orat
orie
s In
c.88
.838
.299
.010
0.0
13.3
27.4
(135
)16
.0 (1
94)
19.4
(67)
32.0
(231
)0.
54
Pf, P
v an
d Pa
nCo
re™
Mal
aria
Pan
/Pv/
Pf
MAL
-190
026
Core
Dia
gnos
tics
92.9
11.4
99.0
94.3
0.3
(391
)0.
0 (1
37)
0.0
(197
)1.
43.
5 (1
98)
1.0
3di
agno
stic
ks M
ALAR
IA (P
an/P
v/Pf
) Cas
sett
eM
PNVF
C100
7.5
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
93.9
11.4
99.0
94.3
0.0
(389
)0.
0 (1
39)
0.0
(196
)2.
9 (6
9)4.
0 (1
99)
1.1
3Fi
rstS
ign™
- P
araV
iew
-3 (P
an+P
v+Pf
) Mal
aria
Tes
t21
03 C
B-25
Uni
med
Inte
rnat
iona
l Inc
.89
.045
.010
0.0
100.
00.
0 (3
99)
2.5
0.0
0.0
24.5
0.1
2Pa
ram
ax-3
Rap
id T
est f
or M
alar
ia P
an/P
v/Pf
(dev
ice)
5032
0025
Zeph
yr B
iom
edic
als
93.0
45.0
100.
010
0.0
0.0
(396
)0.
0 (1
59)
0.0
(199
)0.
037
.0 (1
98)
0.7
2Pa
n on
lyAd
vant
age
Pan
Mal
aria
Car
dIR
0130
25J.
Mitr
a &
Co.
Pvt
. Ltd
.72
.210
0.0
100.
010
0.0
NA
NA
NA
NA
1.8
0.0
1AZ
OG h
CG M
alar
ia D
etec
tion
Test
Dev
ice
MPT
-124
AZOG
, IN
C.61
.20
9955
.9N
AN
AN
AN
A2.
20.
24
Care
Star
t™ M
alar
ia p
LDH
(PAN
)G
0111
Acce
ss B
io, I
nc.
92.4
100.
010
0.0
100.
0N
AN
AN
AN
A6.
60.
01
Clea
rvie
w®
Mal
aria
pLD
Hj
7088
4025
Orge
nics
Ltd
. (In
vern
ess
Med
ical
In
nova
tions
)81
.885
.799
.010
0.0
NA
NA
NA
NA
13.5
0.5
3
diag
nost
icks
MAL
ARIA
(Pan
) Cas
sett
e M
PNW
BC10
07.3
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
16.2
54.3
92.9
100.
0N
AN
AN
AN
A0.
00.
33
Firs
t Res
pons
e® M
alar
ia A
g pL
DHI1
2FRC
30Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
31.0
92.5
98.0
100.
0N
AN
AN
AN
A0.
00.
02
Firs
tSig
n™ -
Pan
Chec
k (P
an) M
alar
ia T
est
2104
CB-
25U
nim
ed In
tern
atio
nal I
nc.
25.0
82.5
87.0
100.
0N
AN
AN
AN
A2.
50.
22
OnSi
ght™
- P
anSc
reen
(Pan
) Mal
aria
Tes
t53
9-25
-DB
Amge
nix
Inte
rnat
iona
l, In
c.22
.077
.596
.010
0.0
NA
NA
NA
NA
2.5
0.2
2Pa
raba
nk™
Dev
ice
- Ra
pid
test
for M
alar
ia P
anj
5030
1025
Zeph
yr B
iom
edic
al S
yste
ms
17.2
62.9
90.9
100.
0N
AN
AN
AN
A0.
50.
23
Pv o
nly
SD B
IOLI
NE
Mal
aria
Ag
Pv05
FK70
Stan
dard
Dia
gnos
tics,
Inc.
NA
92.5
NA
100.
00.
3N
A1.
0N
A1.
00.
02
NA,
not
app
licab
le
Pf, P
lasm
odiu
m fa
lcip
arum
P
v, Pl
asm
odiu
m v
ivax
p
an, P
lasm
odiu
m sp
ecie
sa
A sa
mpl
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
tech
nici
an, a
t min
imum
spe
cifie
d re
adin
g tim
e, a
re p
ositi
veb
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
no
t hav
e be
en
c Ro
und
1, n
=79;
Rou
nd 2
, n=1
00; R
ound
3, n
=99;
Rou
nd 4
, n=9
8d
Roun
d 1,
n=2
0; R
ound
2, n
=40;
Rou
nd 3
, n=3
5; R
ound
4, n
=34
e Fo
r com
bina
tion
test
s, Pa
n or
Pv
line,
only,
pos
itive
indi
cate
s a fa
lse-p
ositi
ve n
on P.
falci
paru
m
infe
ctio
n (R
ound
1 n
=316
; Rou
nd 2
, n=4
00; R
ound
3, n
=396
; Rou
nd 4
, n=3
92)
f Pf
line
pos
itive
indi
cate
s a
fals
e-po
sitiv
e P.
falc
ipar
um in
fect
ion
(Rou
nd 1
, n=8
0; R
ound
2,
n=1
60; R
ound
3, n
=140
; Rou
nd 4
, n=1
36)
g
For 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
(Rou
nd 1
, n=1
58, R
ound
2, n
=200
; Ro
und
3, n
=198
; Rou
nd 4
, n=1
96)
h Pf
line
pos
itive
indi
cate
s a
fals
e-po
sitiv
e P.
falc
ipar
um in
fect
ion
(Rou
nd 1
, n=
40; R
ound
2, n
=80,
Rou
nd 3
, n=7
0; R
ound
4, n
=68)
i Ro
und
1, n
=168
; Rou
nd 2
, n=2
00; R
ound
3, n
=200
; Rou
nd 4
, n=2
32
j Pr
oduc
t res
ubm
issi
on, r
esul
ts fr
om m
ost r
ecen
t rou
nd o
f tes
ting
repl
ace
prev
ious
resu
lts. R
efer
to T
able
S3.
k PD
S pr
esen
ted
in th
e ta
ble
is b
ased
on
a po
sitiv
e pf
test
line
(eith
er
pf-H
RP2
or p
f-pL
DH).
For t
est l
ine
spec
ific
resu
lts re
fer t
o th
e ta
bles
and
an
nexe
s in
the
full
repo
rts.
Dete
ctio
n ra
te (%
)≥9
585
-94
50-8
4<
50
Fals
e-po
sitiv
e ra
te (%
)<2
2-5
6 -1
0>1
0
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 S1
(co
ntin
ued)
12 malaria rapid diagnoStic teSt performance – Summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Tabl
e S2
: Mal
aria
RDT
Rou
nds
1—4
heat
sta
bilit
y re
sult
s on
a c
ultu
red
P. f
alci
paru
m s
ampl
e at
low
(20
0) a
nd h
igh
(200
0) p
aras
ite
dens
ity
(par
asit
es/μ
l). P
ositi
vity
rat
e at
bas
elin
e, a
nd a
fter
60
days
in
cuba
tion
at 3
5°C
and
45°C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pan
line
)Pe
rcen
t po
sitiv
e te
st r
esul
ts
for
P. f
alci
paru
m (P
an li
ne)
Roun
d20
0 pa
rasit
es/μ
l20
00 p
aras
ites/
μl20
0 pa
rasit
es/μ
l20
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
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
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
ABON
™ M
alar
ia P
.f. R
apid
Tes
t Dev
ice
(Who
le B
lood
)IM
A-40
2AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td15
.015
.017
.010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4Ad
vanc
ed Q
ualit
y™ O
ne S
tep
Mal
aria
P.f
Test
aIT
P110
02TC
40In
Tec
Prod
ucts
, Inc
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
Adva
nced
Qua
lity™
Mal
aria
(p.
f) PO
CTIT
P110
02TC
1In
Tec
Prod
ucts
, Inc
.80
.095
.090
.010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
1Ad
vant
age
P.f.
Mal
aria
Car
dIR
0160
25J.
Mitr
a &
Co.
Pvt
. Ltd
.95
.010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
1BI
OCRE
DIT
Mal
aria
pf(H
RP II
)H
R010
0Ra
piG
en In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
BION
OTE
MAL
ARIA
P.f.
Ag
Rapi
d Te
st K
it RG
19-1
1Bi
onot
e,In
c.10
0.0
100.
086
.710
0.0
90.0
80.0
NA
NA
NA
NA
NA
NA
3Ca
reSt
art™
Mal
aria
HRP
2 (P
f)G
0141
Acce
ss B
io, I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
1Ca
reSt
art™
Mal
aria
HRP
2/pL
DH P
f tes
tG
0181
Acce
ss B
io, I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
2Cl
earv
iew
® M
alar
ia P
.f.a
VB01
Visi
on B
iote
ch (P
ty) L
td10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
Core
™ M
alar
ia P
f M
AL-1
9002
0Co
re D
iagn
ostic
s10
0.0
100.
096
.710
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3di
agno
stic
ks-
Mal
aria
(Pf)
Cass
ette
KM
FC60
01SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s95
.070
.055
.095
.095
.095
.0N
AN
AN
AN
AN
AN
A2
diag
nost
icks
- M
alar
ia (P
f) Di
pstic
k K
MFD
6007
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
2Fi
rst R
espo
nse®
Mal
aria
Ag
HRP
2I1
3FRC
30Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
1Fi
rstS
ign™
– M
alar
ia P
f Car
d Te
st--
Uni
med
Inte
rnat
iona
l, In
c.20
.015
.00.
010
0.0
90.0
95.0
NA
NA
NA
NA
NA
NA
1Fi
rstS
ign™
Mal
aria
Pf
2100
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4H
exag
on M
alar
ia58
051
Hum
an G
mbH
50.0
35.0
60.0
95.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
1H
iSen
s M
alar
ia A
g Pf
HRP
2 Ca
rd
HR3
023
HBI
Co.
, Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A2
ICT
Diag
nost
ics
Mal
aria
P.f.
aM
L01
ICT
Diag
nost
ics
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3IM
MU
NOQ
UIC
K CO
NTA
CT fa
lcip
arum
05
19K2
5Bi
osyn
ex10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
Imm
unoq
uick
Mal
aria
Fal
cipa
rum
0502
_K25
Bios
ynex
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
1IN
D ON
E ST
EP M
ALAR
IA A
NTI
GEN
P.f
535-
11IN
D Di
agno
stic
s In
c.10
0.0
100.
086
.710
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4M
alar
ia P
lasm
odiu
m fa
lcip
arum
Rap
id te
st D
evic
e (W
hole
blo
od)
IMA-
402
ACON
Lab
orat
orie
s, In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A1
Mal
eris
can
® M
alar
ia P
.f An
tigen
Tes
tM
AT-P
F-50
Bhat
Bio
-Tec
h In
dia
(Pte
.) Lt
d.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Nan
oSig
n M
alar
ia P
f Ag
RMAF
10Bi
olan
d, L
td96
.710
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3On
e St
ep M
alar
ia P
.F T
est (
Cass
ette
)a 52
2352
Blue
Cro
ss B
io-M
edic
al (B
eijin
g) C
o., L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4On
Sigh
t™ -
Mal
aria
Pf T
est
511-
25-D
BAm
geni
x In
tern
atio
nal,
Inc.
100.
095
.090
.010
0.0
100.
065
.0N
AN
AN
AN
AN
AN
A2
OnSi
te P
f Ag
Rapi
d Te
sta
R0
114C
CTK
Biot
ech,
Inc.
96.7
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
Para
chec
k® P
f-Ra
pid
Test
for P
. fal
cipa
rum
Mal
aria
Dev
ice
(Ver
.3)j
3030
1025
Orch
id B
iom
edic
al S
yste
ms
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4Pa
rach
eck®
Pf-
Rapi
d Te
st fo
r P. f
alci
paru
m M
alar
ia D
ipst
ick
(Ver
.3)j
3030
2025
Orch
id B
iom
edic
al S
yste
ms
100.
096
.710
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Para
HIT
® -
f (D
evic
e)a
55
IC10
2-50
Span
Dia
gnos
tics
Ltd.
100.
096
.710
0.0
100.
010
0.0
90.0
NA
NA
NA
NA
NA
NA
3Pa
raH
IT®
-f (D
ipst
ick)
a 55
IC10
1-50
Span
Dia
gnos
tics
Ltd.
100.
010
0.0
56.7
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
SD B
IOLI
NE
Mal
aria
Ag
P.f.
(HRP
2/pL
DH)b
05FK
90St
anda
rd D
iagn
ostic
s In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
SD B
IOLI
NE
Mal
aria
Ag
Pf05
FK50
Stan
dard
Dia
gnos
tics,
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
1Tr
usty
™ M
alar
ia A
ntig
en P
.f. te
stA0
3-11
-322
Artr
on L
abor
ator
ies
Inc.
100.
010
0.0
56.7
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Won
dfo
One
Step
Mal
aria
P.f
Test
aW
37-
CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
100.
096
.710
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Pf a
nd P
anAB
ON M
alar
ia P
an/P
.f. R
apid
Tes
t Dev
ice
IM
A-B4
02AB
ON B
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arm
(Han
gzho
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o. L
td.
100.
080
.090
.010
0.0
100.
010
0.0
0.0
0.0
0.0
0.0
0.0
0.0
3AB
ON™
Plu
s M
alar
ia P
.f/Pa
n Ra
pid
Test
Dev
ice
(Who
le B
lood
)IM
A-T4
02AB
ON B
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arm
(Han
gzho
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o. L
td10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
00.
00.
00.
0
Sum
mar
y r
ou
nd
S 1-
4
13malaria rapid diagnoStic teSt performance – Summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pan
line
)Pe
rcen
t po
sitiv
e te
st r
esul
ts
for
P. f
alci
paru
m (P
an li
ne)
Roun
d20
0 pa
rasit
es/μ
l20
00 p
aras
ites/
μl20
0 pa
rasit
es/μ
l20
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
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
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
Adva
ntag
e M
al C
ard
IR22
1025
J. M
itra
& C
o. P
vt. L
td.
100.
010
0.0
55.0
95.0
100.
095
.055
.045
.040
.010
0.0
100.
010
0.0
1AZ
OG M
alar
ia p
f (H
RPII)
/pf (
LDH
)/ (P
AN-L
DH) A
ntig
en
Dete
ctio
n De
vice
b M
FV-1
24F
AZOG
, IN
C.96
.796
.710
0.0
100.
010
0.0
100.
03.
30.
00.
020
.00.
00.
04
Bina
x N
ow M
alar
ia T
est
IN66
0050
Inve
rnes
s M
edic
al In
nova
tions
, Inc
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0.0
100.
010
0.0
100.
010
0.0
95.0
5.0
0.0
0.0
95.0
95.0
75.0
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ONOT
E M
ALAR
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.f.&
Pan
Ag
Rapi
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it RG
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c.10
0.0
100.
096
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0.0
100.
010
0.0
0.0
0.0
0.0
100.
010
0.0
90.0
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reSt
art™
Mal
aria
/Pre
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cy C
ombo
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RP2/
HCG
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ss B
io In
c10
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
03
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/
PAN
) COM
BOG
0131
Acce
ss B
io, I
nc.
100.
095
.010
0.0
100.
010
0.0
100.
010
0.0
95.0
100.
010
0.0
100.
010
0.0
1Ca
reSt
art™
Mal
aria
pLD
H 3
Lin
e Te
st
GO1
21Ac
cess
Bio
, Inc
.10
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
03
Care
Star
t™ M
alar
ia S
cree
n G
O231
Acce
ss B
io, I
nc.
100.
010
0.0
93.3
100.
010
0.0
100.
010
0.0
100.
093
.310
0.0
100.
010
0.0
3Cl
earv
iew
® M
alar
ia C
ombo
a VB
11Vi
sion
Bio
tech
(Pty
) Ltd
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
90.0
20.0
0.0
3Cl
earv
iew
® M
alar
ia D
ual T
est D
evic
ea VB
20Vi
sion
Bio
tech
(Pty
) Ltd
100.
010
0.0
96.7
100.
010
0.0
100.
00.
00.
00.
050
.090
.020
.03
Core
Mal
aria
Pan
Pf
MAL
-190
024
Core
Dia
gnos
tics
Ltd.
100.
010
0.0
100.
010
0.0
100.
010
0.0
26.7
80.0
83.3
100.
010
0.0
100.
04
diag
nost
icks
MAL
ARIA
(Pan
/Pf)
Cass
ette
M
PNFW
BC10
07.4
SSA
Diag
nost
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& B
iote
ch S
yste
ms
100.
010
0.0
96.7
100.
010
0.0
100.
00.
00.
00.
010
0.0
90.0
90.0
3
EzDx
™ M
alar
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an/P
f Rap
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est D
etec
tion
kit
RK M
AL 0
01Ad
vy C
hem
ical
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Bha
rat
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ms
& V
acci
nes
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)10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
010
0.0
100.
070
.04
Firs
t Res
pons
e® M
alar
ia p
LDH
/HRP
2 Co
mbo
Tes
ta I1
6FRC
30Pr
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r Med
ical
Cor
pora
tion
Ltd.
100.
010
0.0
100.
010
0.0
100.
010
0.0
85.0
55.0
55.0
100.
010
0.0
100.
02
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tSig
n™ P
araV
iew
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nim
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tern
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nc.
96.7
100.
010
0.0
100.
010
0.0
100.
00.
00.
013
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0.0
100.
010
0.0
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exag
on M
alar
ia C
ombi
5802
4H
uman
Gm
bH65
.055
.050
.010
0.0
85.0
95.0
0.0
0.0
0.0
0.0
0.0
0.0
1H
iSen
s M
alar
ia A
g P.
f/P.
v Ca
rd
HR2
823
HBI
Co.
, Ltd
.35
.00.
05.
010
0.0
100.
010
0.0
0.0
0.0
0.0
35.0
0.0
0.0
2H
iSen
s M
alar
ia A
g Pf
/Pv
(HRP
2/pL
DH) C
ard
HR2
923
HBI
Co.
, Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
095
.010
0.0
100.
010
0.0
2H
umas
is M
alar
ia P
.f/Pa
n An
tigen
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tAM
AL-7
025
Hum
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Co.
, Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
076
.710
0.0
100.
010
0.0
100.
010
0.0
4IC
T Di
agno
stic
s M
alar
ia D
ual
ML0
3IC
T Dia
gnos
tics
100.
010
0.0
93.3
100.
010
0.0
100.
00.
00.
00.
010
0.0
80.0
0.0
3IC
T M
ALAR
IA C
OMBO
aM
L02
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INTE
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.310
0.0
100.
010
0.0
3.3
20.0
13.3
100.
050
.070
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IMM
UN
OQU
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CON
TACT
MAL
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+4
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K25
Bios
ynex
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
50.0
50.0
100.
03
Imm
unoq
uick
Mal
aria
+4
0506
_K25
Bios
ynex
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
100.
080
.080
.01
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f/Pa
n TE
ST53
5-10
IND
Diag
nost
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Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
20.0
3.3
33.3
100.
010
0.0
100.
04
Mal
aria
P.F
/Viv
ax17
211O
P-25
Diag
nost
ics
Auto
mat
ion/
Cort
ez
Diag
nost
ics,
Inc.
65.0
15.0
20.0
65.0
45.0
5.0
0.0
0.0
0.0
0.0
0.0
0.0
1
Mal
aria
Pan
Tes
t M
AL-W
23N
-001
Dim
a •
Gese
llsch
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ür D
iagn
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a m
bH60
.033
.323
.310
0.0
100.
090
.013
.353
.340
.010
.060
.040
.03
Mal
aria
pf (
HRP
II) /
(PAN
-pLD
H) A
ntig
en D
etec
tion
Test
Dev
icea
MFV
-124
RAZ
OG, I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
0.0
0.0
0.0
3M
alar
ia p
f (H
RP II
)/PAN
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
-1U
nite
d Bi
otec
h, In
c.
100.
096
.796
.710
0.0
100.
010
0.0
16.6
0.0
0.0
90.0
40.0
50.0
4M
alar
ia p
f (pL
DH) /
PAN
-pLD
H T
est D
evic
e
MFV
-124
AZOG
, Inc
.3.
30.
00.
040
.010
.00.
00.
00.
00.
00.
00.
00.
03
Mal
aria
Pf/
PAN
GM
004
Geno
mix
Mol
ecul
ar D
iagn
ostic
s Pvt
.Ltd.
56.7
23.3
26.7
100.
010
0.0
100.
00.
00.
00.
060
.090
.050
.04
Mal
asca
n™ D
evic
e -
Rapi
d te
st fo
r Mal
aria
Pf/
Pana
5040
2025
Zeph
yr B
iom
edic
al S
yste
ms
96.7
100.
096
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0.0
100.
010
0.0
0.0
0.0
6.7
100.
010
0.0
100.
03
Mal
eris
can®
Mal
aria
P.f/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
te.)
Ltd.
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
0.0
0.0
0.0
4M
eDiP
ro M
alar
ia A
g H
RP2/
pLDH
Com
boIR
-005
1KFo
rmos
a Bi
omed
ical
Tech
nolo
gy C
orp.
100.
096
.796
.710
0.0
100.
010
0.0
0.0
0.0
0.0
0.0
0.0
0.0
4N
anoS
ign
Mal
aria
pf/
pan
Ag 3
.0a
RMAP
10Bi
olan
d Lt
d.10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
010
0.0
100.
010
0.0
4N
anoS
ign
Mal
aria
Pf/
Pv A
g RM
AD10
Biol
and,
Ltd
0.0
0.0
0.0
20.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
3On
e St
ep M
alar
ia A
ntig
en S
trip
820-
1IN
D Di
agno
stic
Inc.
15.0
0.0
0.0
65.0
50.0
0.0
15.0
0.0
0.0
65.0
50.0
5.0
1On
e St
ep M
alar
ia P
.f/Pa
n Te
sta
W56
-CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
46.7
13.3
26.7
100.
010
0.0
100.
00.
036
.773
.370
.080
.010
0.0
3On
Sigh
t™ –
Par
aQui
ck (P
an, P
f) Te
st53
6-25
DBAm
geni
x In
tern
atio
nal,
Inc.
100.
090
.060
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0.0
100.
010
0.0
0.0
0.0
0.0
100.
010
0.0
95.0
1On
Site
Pf/
Pan
Ag R
apid
Tes
taR0
113C
CTK
Biot
ech,
Inc.
100.
010
0.0
93.3
100.
010
0.0
100.
00.
03.
30.
070
.020
.010
.04
Tabl
e S2
(co
ntin
ued)
14 malaria rapid diagnoStic teSt performance – Summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pan
line
)Pe
rcen
t po
sitiv
e te
st r
esul
ts
for
P. f
alci
paru
m (P
an li
ne)
Roun
d20
0 pa
rasit
es/μ
l20
00 p
aras
ites/
μl20
0 pa
rasit
es/μ
l20
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
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
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
OptiM
AL-I
T 71
0024
Diam
ed -
A D
ivis
ion
of B
io-R
ad0.
00.
00.
010
0.0
90.0
0.0
0.0
0.0
0.0
100.
090
.00.
03
Para
HIT
- T
otal
Ver
. 1.0
(Dev
ice)
55IC
204-
10Sp
an D
iagn
ostic
s Lt
d.10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
010
0.0
100.
010
0.0
4Pa
raH
IT -
Tot
al V
er. 1
.0 (D
ipst
ick)
55IC
203-
10Sp
an D
iagn
ostic
s Lt
d.10
0.0
93.3
46.7
100.
010
0.0
60.0
50.0
0.0
0.0
100.
090
.00.
04
Para
HIT
® to
tal (
dips
tick)
55IC
201-
10Sp
an D
iagn
ostic
s Lt
d55
.085
.055
.010
0.0
100.
095
.010
.00.
00.
050
.045
.070
.02
Para
hit-
Tota
l Dev
ice
Rapi
d te
st fo
r P. f
alci
paru
m a
nd P
an
mal
aria
l spe
cies
2598
9Sp
an D
iagn
ostic
s Lt
d.65
.075
.025
.095
.010
0.0
100.
05.
00.
00.
00.
00.
00.
01
Para
scre
en®
- Ra
pid
test
for M
alar
ia P
an/P
fa50
3100
25Ze
phyr
Bio
med
ical
s10
0.0
100.
010
0.0
100.
010
0.0
100.
086
.613
.383
.310
0.0
100.
010
0.0
4Qu
icks
tick
Mal
aria
Ant
igen
Tes
t--
Inno
vate
k M
edic
al In
c.15
.00.
00.
065
.050
.00.
015
.00.
00.
065
.050
.05.
01
SD B
IOLI
NE
Mal
aria
Ag
P.f/
Pana
05FK
60St
anda
rd D
iagn
ostic
s In
c.10
0.0
96.7
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
100.
070
.090
.03
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
an05
FK66
Stan
dard
Dia
gnos
tics
Inc.
96
.796
.710
0.0
90.0
100.
010
0.0
16.6
10.0
0.0
90.0
100.
010
0.0
4SD
BIO
LIN
E M
alar
ia A
ga 05
FK40
Stan
dard
Dia
gnos
tics
Inc.
0.0
0.0
0.0
100.
080
.090
.00.
00.
00.
080
.020
.090
.03
Sure
step
™ E
asy
Mal
aria
Pf/
Pan
Rapi
d Te
st D
evic
e IM
A-T4
02AC
ON B
iote
ch (H
angz
hou)
Co.
Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
00.
00.
00.
03
Pf a
nd P
vAd
vanc
ed Q
ualit
y™ O
ne S
tep
Mal
aria
P.f/
P.v
Tri-
Line
Tes
t IT
P110
03 T
C40
InTe
c Pr
oduc
ts, I
nc.
96.7
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
Adva
ntag
e M
alar
ia C
ard
IR21
1025
J. M
itra
& C
o. P
vt. L
td.
100.
096
.796
.710
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3BI
ONOT
E M
ALAR
IA P
.f.&
P.v.
Ag
Rapi
d Te
st K
it RG
19-1
2Bi
onot
e,In
c.10
0.0
96.7
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3Ca
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOa
G01
61Ac
cess
Bio
, Inc
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOa
G01
71Ac
cess
Bio
, Inc
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Core
™ M
alar
ia P
v/Pf
MAL
-190
022
Core
Dia
gnos
tics
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3di
agno
stic
ks-
Mal
aria
(Pv/
Pf) C
asse
tte
KMVF
C600
2SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s10
0.0
95.0
95.0
100.
010
0.0
95.0
NA
NA
NA
NA
NA
NA
2Fa
lciV
ax™
- R
apid
test
for M
alar
ia P
v/Pf
a50
3000
25Ze
phyr
Bio
med
ical
s10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Firs
tSig
n™ –
Par
aVie
w-2
(Pv
+ Pf
) Car
d Te
st21
02CB
-25
Uni
med
Inte
rnat
iona
l, In
c.95
.070
.00.
010
0.0
95.0
75.0
NA
NA
NA
NA
NA
NA
1H
iSen
s M
alar
ia A
g P.
f/P.
v Co
mbo
Car
dH
R312
3H
BI C
o., L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4H
iSen
s M
alar
ia A
g P.
f/VO
M C
ombo
Car
dH
R332
3H
BI C
o., L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4H
umas
is M
alar
ia P
.f/P.
v An
tigen
Tes
tAM
FV-7
025
Hum
asis,
Co.
, Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Mal
aria
pf (
HRP
II) /
pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
1-13
-101
-3U
nite
d Bi
otec
h, In
c.
100.
010
0.0
100.
090
.010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Mal
aria
pf (
HRP
II) /
pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
MFV
-124
VAZ
OG, I
nc.
100.
010
0.0
96.7
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
Mal
aria
Pf/
PvG
M00
2Ge
nom
ix M
olec
ular
Dia
gnos
tics P
vt.Lt
d.40
.033
.340
.010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4M
aler
isca
n® M
alar
ia P
f/Pv
M
AT-5
0Bh
at B
io-T
ech
Indi
a (P
) Ltd
100.
060
.030
.010
0.0
90.0
95.0
NA
NA
NA
NA
NA
NA
2M
edis
enso
r Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOM
161
Med
isen
sor,
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4M
edis
enso
r Mal
aria
HRP
2/pL
DH (P
f/VO
M) C
OMBO
M17
1M
edis
enso
r, In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
One
Step
Mal
aria
P.F
/P.V
Tes
t (Ca
sset
te)
5233
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.40
.06.
70.
010
0.0
100.
090
.0N
AN
AN
AN
AN
AN
A4
OnSi
ght™
- P
araQ
uick
-2 (P
v,Pf)
Mal
aria
Tes
t53
7-25
-DB
Amge
nix
Inte
rnat
iona
l, In
c.10
0.0
100.
010
0.0
100.
010
0.0
85.0
NA
NA
NA
NA
NA
NA
2On
Site
Pf/
Pv A
g Ra
pid
Test
aR0
112C
CTK
Biot
ech,
Inc.
100.
010
0.0
90.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Para
Care
Mal
aria
HRP
2/pL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io E
thio
pia
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4Pa
raCa
re M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOG
0171
Acce
ss B
io E
thio
pia
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4
RAPI
D 1-
2-3®
HEM
A CA
SSET
TE M
ALAR
IA P
F/PV
TES
TM
AL-P
FV-
CAS/
25(1
00)
Hem
a Di
agno
stic
Sys
tem
s, LL
C10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
vb05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
100.
010
0.0
96.7
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
v05
FK80
Stan
dard
Dia
gnos
tics,
Inc.
100.
010
0.0
100.
010
0.0
100.
095
.0N
AN
AN
AN
AN
AN
A2
Trus
ty™
Mal
aria
Ant
igen
P.f.
/p.v.
test
A03-
12-3
22Ar
tron
Lab
orat
orie
s In
c.10
0.0
100.
036
.710
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4
Tabl
e S2
(co
ntin
ued)
Sum
mar
y r
ou
nd
S 1-
4
15malaria rapid diagnoStic teSt performance – Summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pan
line
)Pe
rcen
t po
sitiv
e te
st r
esul
ts
for
P. f
alci
paru
m (P
an li
ne)
Roun
d20
0 pa
rasit
es/μ
l20
00 p
aras
ites/
μl20
0 pa
rasit
es/μ
l20
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
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
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, P
v an
d Pa
nCo
re™
Mal
aria
Pan
/Pv/
Pf
MAL
-190
026
Core
Dia
gnos
tics
100.
010
0.0
100.
010
0.0
90.0
100.
00.
00.
00.
080
.050
.070
.03
diag
nost
icks
MAL
ARIA
(Pan
/Pv/
Pf) C
asse
tte
MPN
VFC1
007.
5SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s96
.710
0.0
93.3
100.
010
0.0
100.
00.
00.
00.
070
.00.
050
.03
Firs
tSig
n™ -
Par
aVie
w-3
(Pan
+Pv+
Pf) M
alar
ia T
est
2103
CB-
25U
nim
ed In
tern
atio
nal I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
60.0
50.0
15.0
100.
090
.010
0.0
2Pa
ram
ax-3
Rap
id T
est f
or M
alar
ia P
an/P
v/Pf
(dev
ice)
5032
0025
Zeph
yr B
iom
edic
als
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
025
.030
.010
0.0
95.0
100.
02
Pan
Onl
yAd
vant
age
Pan
Mal
aria
Car
dIR
0130
25J.
Mitr
a &
Co.
Pvt
. Ltd
.N
AN
AN
AN
AN
AN
A50
.065
.070
.010
0.0
100.
010
0.0
1AZ
OG h
CG M
alar
ia D
etec
tion
Test
Dev
ice
MPT
-124
AZOG
, IN
C.N
AN
AN
AN
AN
AN
A10
0.0
100.
010
0.0
100.
010
0.0
100.
04
Care
Star
t™ M
alar
ia p
LDH
(PAN
)G
0111
Acce
ss B
io, I
nc.
NA
NA
NA
NA
NA
NA
100.
010
0.0
90.0
100.
010
0.0
100.
01
Clea
rvie
w®
Mal
aria
pLD
Ha
7088
4025
Orge
nics
Ltd
. (In
vern
ess
Med
ical
In
nova
tions
)N
AN
AN
AN
AN
AN
A96
.793
.310
0.0
100.
010
0.0
100.
03
diag
nost
icks
MAL
ARIA
(Pan
) Cas
sett
e M
PNW
BC10
07.3
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
NA
NA
NA
NA
NA
NA
0.0
0.0
0.0
80.0
100.
080
.03
Firs
t Res
pons
e® M
alar
ia A
g pL
DHI1
2FRC
30Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
NA
NA
NA
NA
NA
NA
50.0
80.0
55.0
100.
010
0.0
100.
02
Firs
tSig
n™ -
Pan
Chec
k (P
an) M
alar
ia T
est
2104
CB-
25U
nim
ed In
tern
atio
nal I
nc.
NA
NA
NA
NA
NA
NA
25.0
5.0
10.0
100.
010
0.0
100.
02
OnSi
ght™
- P
anSc
reen
(Pan
) Mal
aria
Tes
t53
9-25
-DB
Amge
nix
Inte
rnat
iona
l, In
c.N
AN
AN
AN
AN
AN
A5.
035
.015
.010
0.0
100.
010
0.0
2Pa
raba
nk™
Dev
ice
- Ra
pid
test
for M
alar
ia P
ana
5030
1025
Zeph
yr B
iom
edic
al S
yste
ms
NA
NA
NA
NA
NA
NA
0.0
0.0
0.0
90.0
100.
010
0.0
3Pv
onl
ySD
BIO
LIN
E M
alar
ia A
g Pv
05FK
70St
anda
rd D
iagn
ostic
s, In
c.N
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
AN
A2
NA,
not
app
licab
lePf
, Pla
smod
ium
falc
ipar
um
Pv,
Plas
mod
ium
viv
ax
pan
, Pla
smod
ium
spec
ies
a Pr
oduc
t res
ubm
issi
on,
resu
lts fr
om m
ost r
ecen
t rou
nd o
f tes
ting
repl
ace
prev
ious
resu
lts. R
efer
to T
able
S3.
b
Resu
lts p
rese
nted
in th
e ta
ble
are
base
d on
sta
bilit
y of
a p
f tes
t lin
e (e
ither
pf-
HRP
2 or
pf-
pLDH
). Re
sults
bas
ed o
n st
abili
ty o
f ind
ivid
ual t
est l
ines
is p
rese
nted
in th
e fo
llow
ing
tabl
e:
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
ent
posit
ive
test
res
ults
for
P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
for
P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
for
P.
fal
cipa
rum
(Pan
line
)Pe
rcen
t po
sitiv
e te
st r
esul
ts f
or
P. f
alci
paru
m (P
an li
ne)
Roun
d20
0 pa
rasit
es/μ
l20
00 p
aras
ites/
μl20
0 pa
rasit
es/μ
l20
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
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
Num
ber
of t
ests
pos
itive
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
SD B
IOLI
NE
Mal
aria
Ag
P.f.
(HRP
2/pL
DH) -
(PF(
HRP
2) li
ne)
05FK
90St
anda
rd D
iagn
ostic
s In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
SD B
IOLI
NE
Mal
aria
Ag
P.f.
(HRP
2/pL
DH)-
(PF(
pLDH
) lin
e)
05FK
90St
anda
rd D
iagn
ostic
s In
c.0.
00.
00.
033
.333
.333
.3N
AN
AN
AN
AN
AN
A3
AZOG
Mal
aria
pf (
HRP
II)/p
f (LD
H)/
(PAN
-LDH
) Ant
igen
De
tect
ion
Devi
ce -
(PF(
HRP
2) li
ne)
MFV
-124
FAZ
OG, I
NC.
96.7
96.7
100.
010
0.0
100.
010
0.0
3.3
0.0
0.0
20.0
0.0
0.0
4
AZOG
Mal
aria
pf (
HRP
II)/p
f (LD
H)/
(PAN
-LDH
) Ant
igen
De
tect
ion
Devi
ce -
(PF(
pLDH
) lin
e)M
FV-1
24F
AZOG
, IN
C.13
.33.
36.
750
.010
.050
.03.
30.
00.
020
.00.
00.
04
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
v -
(PF(
HRP
2) li
ne)
05FK
100
Stan
dard
Dia
gnos
tics
Inc.
10
0.0
100.
096
.710
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4
SD B
IOLI
NE
Mal
aria
Ag
Pf/ P
f/ P
v -
(PF(
pLDH
) lin
e)05
FK10
0St
anda
rd D
iagn
ostic
s In
c.
26.7
3.3
3.3
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Tabl
e S2
(co
ntin
ued)
16 malaria rapid diagnoStic teSt performance – Summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Tabl
e S3
: Pro
duct
Res
ubm
issi
ons:
WH
O M
alar
ia R
DT P
rodu
ct T
estin
g -
Roun
ds 1
—4
Man
ufac
ture
rIn
itial
Tes
ting
Subs
eque
nt T
estin
g
Roun
dPr
oduc
t N
ame
Cata
logu
e N
o.
Roun
dPr
oduc
t N
ame
Cata
logu
e N
o.
Acce
ss B
Io, I
nc.
2Ca
reSt
art™
Mal
aria
HRP
2/PL
DH (P
f/Pv
) COM
BOG
0161
4Ca
reSt
art™
Mal
aria
HRP
2/PL
DH (P
f/Pv
) COM
BOG
0161
2Ca
reSt
art™
Mal
aria
HRP
2/PL
DH (P
f/VO
M) C
OMBO
G01
714
Care
Star
t™ M
alar
ia H
RP2/
PLDH
(Pf/
VOM
) COM
BOG
0171
AZOG
1M
alar
ia P
f (H
RPII)
/pv-
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
eaM
FV-1
24R
3M
alar
ia p
f (H
RP II
) / (P
AN-L
DH) A
ntig
en D
etec
tion
Test
Dev
ice
MFV
-124
RBi
olan
d3
Nan
oSig
n M
alar
ia P
f/Pa
n Ag
RM
AP10
4N
anoS
ign
Mal
aria
Pf/
Pan
Ag
RMAP
10Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.2
One
Step
Mal
aria
Pf T
est (
cass
ette
)52
2352
3, 4
One
Step
Mal
aria
P.F
Tes
t (ca
sset
te)
5223
52
CTK
Biot
ech,
Inc.
2On
site
Pf A
g Ra
pid
Test
R0
114C
3On
Site
Pf A
g Ra
pid
Test
R011
4C2
Onsi
te P
f/Pa
n Ag
Rap
id T
est
R011
3C3,
4On
Site
Pf/
Pan
Mal
aria
Ag
Rapi
d Te
stR0
113C
2On
site
Pf/
Pv A
g Ra
pid
Test
R0
112C
3, 4
OnSi
te M
alar
ia P
f/Pv
Ag
Rapi
d Te
stR0
112C
DiaM
ed -
A D
ivis
ion
of B
io-R
ad1
OptiM
AL-I
T 71
0024
3Op
tiMAL
-IT
7100
24
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.1
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
t W
56-C
(4.0
mm
)3
One
Step
Mal
aria
P.f.
/Pan
Who
le B
lood
Tes
tW
56-C
2On
e St
ep M
alar
ia P
.f Te
stb
W37
-C (4
.0m
m)
3, 4
One
Step
Mal
aria
P.f
Test
W
37-C
ICT
Diag
nost
ics
(R &
R M
arke
ting
)1
ICT
Mal
aria
Com
bo C
asse
tte
Test
M
L02
3, 4
ICT
Diag
nost
ics
Mal
aria
Com
boM
L02
1IC
T M
alar
ia P
f Cas
sett
e Te
st
ML0
13
ICT
Diag
nost
ics
Mal
aria
P.f
ML0
1In
Tec
Prod
ucts
, Inc
.1
ADVA
NCE
D QU
ALIT
Y™ O
ne S
tep
Mal
aria
(p.f.
) Tes
t (w
hole
blo
od)
ITP1
1002
TC40
3 A
dvan
ced
Qual
ity™
One
Ste
p M
alar
ia P
.f Te
stIT
P110
02 T
C40
Orch
id B
iom
edic
al S
yste
ms
1Pa
rach
eck
Pf R
apid
test
for P
. fal
cipa
rum
Mal
aria
(Dev
ice)
30
3010
253,
4 P
arac
heck
® Pf
Dev
ice
- Ra
pid
test
for P
. fal
cipa
rum
Mal
aria
(Ver
. 3)
3030
1025
1Pa
rach
eck
Pf R
apid
test
for P
. fal
cipa
rum
Mal
aria
(Dip
stic
k)
3030
2025
3, 4
Para
chec
k® P
f Dip
stic
k -
Rapi
d te
st fo
r P. f
alci
paru
m M
alar
ia (V
er.3
)30
3020
25Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
1
Firs
t Res
pons
e M
alar
ia A
g Co
mbo
(pLD
H/H
RP2)
II6FR
C30
2Fi
rst R
espo
nse®
Mal
aria
Ag
Com
bo (p
LDH
/HRP
2)I1
6FRC
30
Span
Dia
gnot
ics
Ltd.
1Pa
rahi
t-f T
EST
DEVI
CE F
OR F
ALCI
PARU
M M
ALAR
IA
2597
53
Para
HIT
® -
f (De
vice
)55
IC10
2-10
1Pa
rahi
t-f D
IPST
ICK
FOR
FALC
IPAR
UM
MAL
ARIA
25
977
3Pa
raH
IT®
- f (
Dips
tick)
55IC
101-
10
Stan
dard
Dia
gnos
tics
Inc.
1
SD B
IOLI
NE
Mal
aria
Ag
05F
K40-
02-5
d3
SD
BIOL
INE
Mal
aria
Ag
05FK
401
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
an
05FK
60-0
2-3d
3SD
BIO
LIN
E M
alar
ia A
g P.
f/Pa
n05
FK60
Uni
med
Inte
rnat
iona
l Inc
.2
Firs
tSig
n™ -
Par
aVie
w (P
an+P
f) M
alar
ia T
est
2101
CB-
254
Firs
tSig
n™ -
Par
aVie
w (P
an+P
f) M
alar
ia T
est
2101
CB-
25
Visi
on B
iote
ch (P
ty) L
td
(now
Ale
re H
ealth
care
(Pty
) Ltd
)
1M
alar
ia R
apid
Com
bo
VB01
13
Clea
rvie
w®
Mal
aria
Com
boVB
11e
1M
alar
ia R
apid
Pf
VB01
3Cl
earv
iew
®M
alar
ia P
fVB
011
Mal
aria
Rap
id D
ual
VB02
03
Clea
rvie
w®
Mal
aria
Dua
l Tes
t Dev
ice
VB20
e
Zeph
yr B
iom
edic
al S
yste
ms
1M
alas
can
Rapi
d Te
st fo
r Mal
aria
Pf/
Pan
(Dev
ice)
50
4020
253
Mal
asca
n™ D
evic
e -
Rapi
d te
st fo
r Mal
aria
Pf/
Pan
5040
2025
1Pa
raba
nk R
apid
Tes
t for
Mal
aria
Pan
(Dev
ice)
50
3010
253
Para
bank
™ D
evic
e -
Rapi
d te
st fo
r Mal
aria
Pan
50
3010
251
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
5031
0025
3, 4
Para
scre
en™
Dev
ice
-Rap
id te
st fo
r Mal
aria
Pan
/Pf
5031
0025
2Fa
lciv
ax R
apid
Tes
t for
Mal
aria
Pv/
Pf (d
evic
e)50
3000
254
Falc
ivax
™ R
apid
Tes
t for
Mal
aria
Pv/
Pf (d
evic
e)50
3000
25a
Roun
d 1
prod
uct n
ame
erro
r : p
ublis
hed
- M
alar
ia P
f (H
RPII)
/pv-
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e Co
de ;
corr
ecte
d pr
oduc
t nam
e: M
alar
ia P
f (H
RPII/
PAN
-LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e. N
o ch
ange
in p
rodu
ct c
ode.
b
In R
ound
2, p
rodu
ct d
id n
ot p
ass
Phas
e 1,
ther
efor
e re
sults
do
not f
eatu
re in
sum
mar
y ta
bles
. c
Erro
r in
WH
O M
alar
ia R
DT P
rodu
ct T
estin
g: R
ound
1 re
port
: pr
oduc
t cod
e (II
6FRC
30) s
houl
d ha
ve b
een
( I16
FRC3
0 ),
as in
Rou
nd 2
d
02-0
5/02
-03
suffi
x re
fers
to v
ersi
on o
f the
pac
kage
inse
rts
e N
ew c
ompa
ny a
cqui
sitio
n (A
lere
™) -
hen
ce n
ame
and
prod
uct c
ode
chan
ges.
Man
ufac
ture
r con
firm
ed c
ompl
ianc
e w
ith p
rodu
ct d
efini
tion.
Mala
ria R
apid
Diag
nost
ic Te
st Pe
rform
ance
Re
sults
of W
HO p
rodu
ct te
sting
of m
alaria
RDT
s: Ro
und
4 (2
012)
TDR/World Health Organization20, Avenue Appia1211 Geneva 27Switzerland
Fax: (+41) 22 791 48 [email protected]/tdr
FINDAvenue de Budé 161202 GenevaSwitzerland
Fax: (+41) 22 710 05 [email protected]
TDR/World Health Organization20, Avenue Appia1211 Geneva 27Switzerland
Fax: (+41) 22 791 48 [email protected]/tdr
FINDAvenue de Budé 161202 GenevaSwitzerland
Fax: (+41) 22 710 05 [email protected]
TDR/RDT/12.1