About 3 · 2019. 4. 3. · Laboratorium Hepatika 1 2006 100% Quick Profile Malaria Pf/Pv Antigen...

Results – 2007 to 2016 - WHO-FIND malaria RDT lot testing programme 2

About ......................................................................................................................................... 3

Malaria RDT lot testing results in 2016 (initial testing) ................................................................ 4

Malaria RDT non-routine lot testing results in 2016 .................................................................... 5

Summary of results 2007 - 2016 ................................................................................................ 6

Malaria RDT lot testing results – Summary 2007 to December 2016 ......................................... 7

Annual demand for malaria RDT lot testing ...............................................................................12

Requesters and recipient countries of lot tested malaria RDTs .................................................13

Performance of malaria RDTs submitted for lot testing from 2007 to 2016 ................................14

Evaporation of individual buffer vial ...........................................................................................15


The WHO-FIND lot testing programme for malaria rapid diagnostic tests (RDTs) is an

independent quality control system designed to evaluate lot to lot variation in performance of

malaria RDTs. The purpose of this programme is to ensure that only the highest quality malaria

RDT lots are procured and used in endemic countries. Currently, two regional lot-testing

laboratories in Cambodia and Philippines have the capacity to evaluate RDT lots using well-

characterized and standardized parasite samples for quality control of malaria RDTs.

RDTs are sent from anywhere in the world on request by Ministries of Health, national malaria

control programmes, NGOs, RDT manufacturers, procurement agencies and other international

organizations. Lot testing is performed at the Institut Pasteur du Cambodge (Cambodia) and the

Research Institute for Tropical Medicine (The Philippines) according to procedures outlined in

the Methods Manual for Laboratory QC Testing of Malaria RDTs available at

http://who.int/malaria/publications/rdt-lab-quality-manual/en/. RDT lots are tested within five

days of receipt and at six months before the expiration date to provide long term stability data

after storage at high temperature and humidity conditions.

Malaria RDT lot testing results provide information about adequacy of RDTs for clinical use,

stability over their shelf life, and anomalies noted during testing that can also be encountered

during use in the field. Reports provided to lot testing requesters include photos of the RDTs

tested, observations (e.g. red background, faint test line, invalid result, etc.), and results of the

accessory assessment.

Lot testing has been mandatory for all recipients of grants from the Global Fund since 2011 and

has been adopted by all major procurers since then. With the support from UNITAID, WHO and

FIND are decentralizing the RDT lot testing programme to provide this capacity to countries in

other WHO regions.

Further information about procedures to request RDT lot testing services as well as other

related resources are available at http://www.finddx.org/quality-assurance/malaria-rdt-qa/.

http://www.finddiagnostics.org/export/sites/default/programs/malaria-afs/docs/Methods_manual_for_laboratory_qc_testing_malaria_RDTs_vers7.pdfhttp://who.int/malaria/publications/rdt-lab-quality-manual/en/http://www.finddx.org/quality-assurance/malaria-rdt-qa/


Product name Catalog N° Manufacturer N° of lots

tested

N° of lots

passed ADVANTAGE

MALARIA PAN+PF CARD

IR231025 J. Mitra & Co. Pvt. Ltd.

2 2

CareStart Malaria HRP2/pLDH (Pf/PAN)

COMBO

RMRM-02571 (G0131) Access Bio, Inc. 55 55

Carestart Pf/PAN (pLDH) Ag RDT

RMLM-05071 (G0121) Access Bio, Inc. 2 1*

CareStartTM Malaria HRP2/pLDH(Pf/Pv)

RMVM-02571 (G0161) Access Bio, Inc. 20 20

CareStartTM Malaria pLDH(Pan)

RMNM-02571 (G0111) Access Bio, Inc. 6 6

Carestart™ Malaria HRP2 (Pf)

RMOM-02571 (G0141) Access Bio, Inc. 101 101

CareStart™ Malaria HRP2/ pLDH(Pf)

RMPC-02571 (G0181) Access Bio, Inc. 22 22

First Response Malaria

HRP2/pLDH(Pf/Pan)

I16FRC-25/25CE/30 Premier Medical Corporation Ltd.

12 12

First Response Malaria Ag P.f. HRP2

Card test

I13FRC-25 Premier Medical Corporation Ltd.

35 35

First Response® Malaria Antigen P. falciparum (HRP2)

Card Test

PI13FRC-25 Premier Medical Corporation Ltd.

2 2

Malaria P.f/Pan (Mal Pf/Pan) Antigen Test

Kit

A03-18-322 Artron Laboratories Inc.

1 1

Malaria P.f/Pv (Mal Pf/Pv) Antigen Test

Kit

A03-12-322 Artron Laboratories Inc.

1 1

Paracheck Pf DEVICE

302030025 Orchid Biomedical Systems

107 107

ParaHIT f Ver.1.0 55IC104-25 Span Diagnostics Ltd.

7 7

Quick Profile Malaria Pf/Pan Antigen Test

71063 Lumiquick Diagnostics, Inc.

2 2

Quick Profile Malaria Pf/Pv Antigen Test


2 2

SD Bioline Malaria Ag P.f.

05FK50/51/52/53/54/55/56/57/58/59

Standard Diagnostics, Inc.

286 286

SD Bioloine Malaria Ag. P.f./Pan

05FK60/63/67 Standard Diagnostics, Inc.

56 56


SD Bioline Malaria Ag P.f/P.v

05FK80/87 Standard Diagnostics, Inc.

54 54

SD Bioline Malaria Ag P.f (HRP2/pLDH)

05FK90 Standard Diagnostics, Inc.

20 20

SD Bioline Malaria Ag P.f/P.f/P.v


4 4

*Failure with P. vivax samples at 200 parasites/µl during initial testing.

N.B. Since an RDT lot is counted Pass or Fail the year when it was received by the testing laboratory for quality control testing, the Pass rate may vary when a failure is detected during the interval testing; i.e. for an RDT lot received in 2010, a failure detected 6 months after expiration date is counted in 2010 and not in the year when the failure was detected.

Non routine testing is usually requested by national malaria control programmes and refers to

the testing of RDTs samples collected from lots that have been already deployed and after an

anomaly has been detected in the field.

Product name Catalog N° Manufacturer N° of lots

tested

N° of lots

passed CareStart Malaria

HRP2/pLDH (Pf/PAN) COMBO

RMRM-02571 (G0131) Access Bio, Inc. 28 19**

Carestart Pf/PAN (pLDH) Ag RDT

RMLM-05071 (G0121) Access Bio, Inc. 1 1

**Failures with P. vivax and/or P. falciparum samples at 200 parasites/µl during non-routine testing.


Malaria RDT lot failures are more frequently observed close to their expiration date. Failures

also occur mostly when testing RDTs on P. vivax samples at 200 parasites per microliter of

blood, while failures on P. falciparum samples are relatively rare at the same parasite density.

Year No of new products

No of new manufacturers

No of RDTs lots

No of initial failures

No of long term failures

2007 8 7 59 1 1

2008 6 4 139 3 1

2009 2 - 243 - 2

2010 7 3 236 - -

2011 4 2 365 2 9

2012 4 - 567 4 6

2013 6 1 1083 - -

2014 2 1 927 - -

2015 6 3 879 2 -

2016 14 2 797 1 -

Total 56 23 5395 13 19

Product name Cat No Manufacturer Number of lots tested

Year(s) tested PASS RATE

Comment (s)

Carestart Malaria pLDH 3 lines Test

G0121 Access Bio, Inc. 5 2008 - 2009 100%

Carestart TM Malaria/Pregnancy Combo (HRP2/pLDH/HCG)

G0221 Access Bio, Inc. 1 2015 100%

CareStart Malaria Screen

G0231 Access Bio, Inc. 18 2006 - 2008 - 2009 100%

CareStart™ Malaria Pf/PAN(pLDH)Ag RDT

RMLM-02571 Access Bio, Inc. 2 2016 50% Pv detection @ 200 parasites/µl failed at initial QC

CareStart™ Malaria Pf/Pan (HRP2/pLDH) Ag Combo RDT

RMNM-02571 (G0111)

Access Bio, Inc. 19 2011 - 2014 - 2015 - 2016

100%

Carestart™ Malaria HRP2 (Pf)

RMOM-02571 (G0141/141-SK)

Access Bio, Inc. 585 2010 - 2011 - 2012 - 2013 - 2014 - 2015 - 2016

100%

CareStart™ Malaria HRP2/ pLDH(Pf)

RMPC-02571 (G0181/181-SK)

Access Bio, Inc. 37 2013 -2014 - 2015 - 2016

100%

CareStart™ Malaria Pf/Pan (HRP2/pLDH) Ag Combo RDT

RMRM-02571 (G0131/131-SK)

Access Bio, Inc. 221 2006 - 2007- 2008 - 2009 - 2010 - 2011 - 2012 - 2013 - 2014 - 2015 - 2016

100%

CareStart™ Malaria P.f/P.v (HRP2/pLDH) Ag Combo RDT

RMVM-01071 (G0161)

Access Bio, Inc. 25 2012 - 2013 - 2014 - 2015 - 2016

100%

CareStart malaria pLDH (Pan)

Access Bio, Inc.


EzDx Malaria Pan/Pf Rapid test Detection Kit

RK MAL 001 Advy Chemical Private limited, Factory, India

9 2011 - 2013 100%

EzDx™ Malaria Pv/Pf Rapid Test Detection Kit

RK MAL 003 Advy Chemical Private limited, Factory, India

2 2013 100%

Malaria P.f/Pv (Mal Pf/Pv) Antigen Test Kit

A03-12-322 Artron Laboratories, Inc. 1 2016 100%

Malaria P.f/Pan (Mal Pf/Pan) Antigen Test Kit

A03-18-322 Artron Laboratories, Inc. 1 2016 100%

Artron Laboratories, Inc.

NOW Malaria Test IN660050 Binax Inc. USA 1 2005 100%

My test™ Malaria Ag P.f/Pan

MTR00250 Biofootprints Healthcare Pvt. Ltd.

2 2015 100%

Bionote Malaria Pf/Pan Ag Rapid Test Kit

RG19-08 BioNote Inc. Korea 1 2014 100%

Bionote Malaria P.f Ag Rapid Test Kit

RG19-11 BioNote Inc. Korea 2 2015 100%

Immunoquick Contact Falciparum

0502K25 Biosynex 1 2006 100%

Clearview Malaria Combo

VB11 Clearview 1 2010 100%

Onsite Malaria Pf/Pv Ag Rapid Test, Cs

R0112C CTK Biotech, Inc. 8 2013 -2014 100%

Malaria Pf/Pan Ag Rapid Test, Cs

R0113C CTK Biotech, Inc. 1 2012 100%

OnSite Malaria Pf Ag Rapid Test

R0114C CTK Biotech, Inc. 8 2006 -2007 - 2013 - 2014

100%

Malaria P.f/Pan Rapid Test Device

MAL-MD02 Deangel Biological Engineering Co., Ltd.

1 2015 100%

OptiMAL-IT 710024 Diamed AG 11 2003 - 2004 - 2008 100%

One step Malaria Pf/Pan whole blood test

W56-C (4.0 mm) Guangzhou Wondfo Biotech Co. Ltd.

5 2005 - 2008 - 2009 100%

Rapid 1-2-3 Hema Cassette Malaria (PFV)

MAL-PFV-CAS25 Hema Diagnostic Systems, LCC

3 2015 100%


Hexagon Malaria Combi

58024 Human Gmbh 1 2008 0% Pv detection @ 200 parasites/µl failed at initial QC

ICT Malaria Pf Cassette Test

ML01 ICT Diagnostics 251 2004 - 2007 - 2008 - 2009 -2010 - 2014

100%

ICT Malaria Combo Cassette Test

ML02 ICT Diagnostics 77 2005 - 2006 - 2007 - 2008 - 2009 - 2010 - 2011 - 2012

86% Pv detection @ 200 parasites/µl failed at initial QC

ICT Diagnostics Malaria Dual

ML03 ICT Diagnostics 2 2012 - 2014 100%

ADVANTAGE MALARIA PAN+PF CARD

IR231025 J MITRA & CO. PVT. LTD.

2 2016 100%

Advantage Pf malaria Card

IR016025 J.Mitra & Co.Pvt.Ltd. 8 2013 -2014 - 2015 100%

Advantage Malaria Card

IR211025 J.Mitra & Co.Pvt.Ltd. 7 2006 - 2010 100%

Entebe Malaria Strip Unspecified_Laboratorium Hepatika

Laboratorium Hepatika 1 2006 100%

Quick Profile Malaria Pf/Pv Antigen Test


3 2013 - 2016 100%

Quick Profile Malaria Pf/Pan Antigen Test


2 2016 100%

Malaria P.f./Pv Antigen Test Cassette

Inf-73 Nanong Egens Biotechnology Co., LTD.

2 2011 - 2013 100%

Malaria P.f. Antigen Test Cassette

Inf-76 Nanong Egens Biotechnology Co., LTD.

2 2012 - 2013 100%

QD Malaria Antigen P.f Nil Nanong Egens Biotechnology Co., LTD.

1 2014 100%

Paracheck Pf DEVICE 30301025/302030025

OBS (Orchid Biomedical System)

1200 2003 - 2004 - 2005 - 2006 - 2007 - 2008 - 2009 - 2010 - 2011 - 2012 - 2013 - 2014

100%

First Response Malaria Ag. P. falciparum HRP2 Card Test

I13FRC25/25S/30/30S/35

Premier Medical Corporation Ltd.

277 2009 -2010 - 2012 - 2013- 2014 - 2015 -2016

100%


First Response Malaria HRP2/pLDH(Pf/Pan)

I16FRC25/25S/25CE/30/30S/40

Premier Medical Corporation Ltd.

169 2005 - 2010 - 2011 - 2012 - 2013 - 2014 - 2015 - 2016

99% Pv detection @ 200 parasites/µl failed at initial QC

Malacheck Malaria Ag (pLDH/HRP2) Combo Card Test

I16MCC10/25 Premier Medical Corporation Ltd.

4 2012 - 2013 100%

First Response Malaria Ag. P. falciparum HRP2 Card Test

PI13FRC25 Premier Medical Corporation Ltd.

4 2014 - 2016 100%

First Response Malaria Ag. pLDH/HRP2 Combo Card Test


2 2014 100%

First Response Malaria Ag. P.f./P.v. Card Test


2 2014 100%

Parahit-f (device) 55IC102-10 Span Diagnostics Ltd. 8 2005 -2007 - 2009 100%

ParaHIT f Ver.1.0 55IC104-25/50 Span Diagnostics Ltd. 93 2013 - 2014 - 2015 -2016

100%

ParaHIT-Total (dipstick)

55IC201-10 Span Diagnostics Ltd. 1 2008 0% Pv detection @ 200 parasites/µl failed at initial QC

SD Bioline Malaria Ag P.f/P.f/P.v


10 2015 - 2016 100%

SD Bioline Malaria Ag 05FK40 Standard Diagnostics, Inc.

16 2006 - 2007 - 2008 - 2009 - 2010

100%

SD Bioline Malaria Ag Pf

05FK50/51/52/53/54/55/56/57/58/59


1235 2009 - 2010 - 2011 - 2012 - 2013 - 2014 - 2015 - 2016

100%

SD BIOLINE Malaria P.f/Pan rapid test

05FK60/63/64/65/66/67


669 2010 - 2011 - 2012 - 2013 - 2014 - 2015 - 2016

100%

SD Bioline Malaria Ag Pf/Pv

05FK80/83/85/86/87


307 2010 - 2011 - 2012 - 2013 - 2014 - 2015 - 2016

100%

SD BIOLINE Malaria Antigen P.f (HRP2/pLDH) POCT


77 2009 -2010 - 2012 - 2013- 2014 - 2015 -2016

100%


FirstSign - ParaView-2 (Pv +Pf) Card test

2102CB-25 Unimed International, Inc.

2 2005 50% Pv detection @ 200 parasites/µl failed at initial QC

Falciparum Unspecified_Vista Diagnostics

Vista Diagnostics 1 2005 100%

Parascreen Device Rapid Test for Malaria Pan/Pf (Device)

50310025 Zephyr Biomedicals 28 2005 - 2006 - 2007 - 2008 - 2009 - 2010

100%

The demand for testing malaria RDT lots has been increasing since its start in 2007. Lot testing has been mandatory for all recipients of grants from the Global Fund since 2011 and has been adopted by all major procurers since then. This new policy adoption led to a substantial increase in demand, reaching a peak in 2013. The apparent decrease that started in 2014 is mainly due to an increase in lot sizes, and actually corresponds to an increase in demand when considering the number of individual RDTs.

59139

243 236

365

567

1083

927

879797

0

200

400

600

800

1000

1200

1400

1600

2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Number of new Malaria RDT lots tested per year

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lot

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From January to December 2016, the malaria RDT lot testing service was requested by RDT manufacturers (34%), NGOs/international organizations (39%); procurement agencies (25%), and country programmes (2%). According to data collected from lot testing requesters, the RDT lots evaluated during this period represented about 225 million RDTs meant for distribution in about 58 countries (information about country distribution was not available for about 13 million RDTs tested).


In 2007, about 30% of the lot testing requests were for RDT products that were below the threshold of performance recommend by WHO for procurement (panel detection score below 75% in the WHO-FIND malaria RDT product testing programme). In 2016, this percentage had decreased to 18%, with 77.5% of the malaria RDTs lots tested from products with panel detection scores over 75%. This indicates that the majority of procurers selected their RDTs according to WHO procurement criteria, based on WHO Product Testing results1.

These results demonstrate consistency between the WHO-FIND malaria RDT product testing programme and lot testing results and a substantial increase in the quality of tests being procured. However, during the last two years there was an increase of lot testing of RDT products that don’t meet the WHO criteria (indicated in yellow in the figure below).

1 http://www.finddx.org/quality-assurance/malaria-rdt-qa/

0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

80.00%

90.00%

100.00%

2007 2008 2009Rd 1

2010 2011 2012 2013 2014 2015 2016

PDS ≥75% (high performance criteria)

71.19% 88.49% 93.42% 95.76% 89.04% 94.18% 98.61% 99.46% 93.63% 77.45%

PDS ≥50% (WHO medium performance criteria)

0.00% 1.44% 0.00% 0.00% 0.00% 0.35% 0.00% 0.22% 2.50% 17.94%

PDS ˂50% including False Positive (outside WHO criteria)

28.81% 10.07% 6.58% 4.24% 6.58% 5.11% 0.18% 0.11% 0.00% 0.12%

Panel Detection Score (PDS)

of Malaria RDTs submitted for lot-testing

http://www.finddiagnostics.org/programs/malaria-afs/malaria/current-projects/rdt_quality_control/product_testing/


Since 2014, the WHO-FIND Malaria RDT lot testing programme has observed buffer evaporation in single-use buffer vials for some RDT lots after heat stability testing. Therefore, buffer volumes were insufficient to conduct long term testing. Similar observations were also reported from end users in various countries. The WHO Prequalification of Diagnostics Programme has since then issued an “information notice for users” and is working closely with RDT manufacturers to address this issue.

Buffer evaporation has only been noted on individual buffer vials of RDT single test kits but not on buffer bottles from multi-test kits (e.g. packs of 25, 30 or 50 RDTs). Up until the end of December 2016, 24 RDT lots from 9 different products and 6 different manufacturers could not undergo long term testing due to the insufficient volume of buffer available.

Table: RDT products with evaporation of buffer vials during for long term lot testing

Product name Catalog number Manufacturer

OptiMAL-IT 710024 Diamed AG

Parascreen Device Rapid Test for Malaria Pan/Pf (Device)

50310025 Zephyr Biomedicals

SD Bioline Malaria P.f/Pan POCT Rapid Test


SD Bioline Malaria Ag P.f/P.v POCT


SD Bioline Malaria Ag P.f. (HRP2/pLDH) POCT


CareStart Malaria HRp2/pLDH (Pf/PAN) COMBO

G0131-SK Access Bio, Inc.

First Response Malaria Ag. pLDH/HRP2 Combo Card Test

I16FRC30/I16FRC30s Premier Medical Corporation Ltd.

ICT Malaria Combo Cassette Test ML02 ICT Diagnostics

ICT Diagnostics Malaria Dual ML03 ICT Diagnostics

About 3 · 2019. 4. 3. · Laboratorium Hepatika 1 2006 100% Quick Profile Malaria Pf/Pv Antigen...

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