About 3 - FIND · 2019. 4. 3. · Results – 2007 to 2015 - WHO-FIND malaria RDT lot testing...

Results – 2007 to 2015 - WHO-FIND malaria RDT lot testing programme 2

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

Summary of results 2007- 2015 ................................................................................................. 4

Malaria RDT lot failures are more frequently observed close to their expiry 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. ........... 6

Malaria RDT lot testing results: 2015 ......................................................................................... 4

Increased demand for malaria RDT lot testing ..........................................................................11

Requesters and recipient countries of lot tested malaria RDTs .................................................12

Performance of malaria RDTs submitted for lot testing from 2007 to 2015 ................................13

Evaporation of individual buffer vial ...........................................................................................14


The WHO-FIND lot testing programme for malaria rapid diagnostic tests (RDTs) is an independent quality control project designed to check lot to lot variation of 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 free of charge 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. RDT lots are tested within five days of receipt and at six months before expiry 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 several African countries.

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/quality-assurance-of-malaria-rdts/

http://www.finddiagnostics.org/export/sites/default/programs/malaria-afs/docs/Methods_manual_for_laboratory_qc_testing_malaria_RDTs_vers7.pdf

http://www.finddx.org/quality-assurance/quality-assurance-of-malaria-rdts/

http://www.finddx.org/quality-assurance/quality-assurance-of-malaria-rdts/


Manufacturer Catalog N° Product Name N° of lots

tested

N° of lots

passed

Access Bio, Inc. G0111 CareStart™ Malaria pLDH(Pan) 7 7

Access Bio, Inc. G0131 CareStart™ Malaria HRP2/pLDH(Pf/PAN) COMBO

60 60

Access Bio, Inc. G0131/-SK Carestart™ Malaria HRP2/pLDH(Pf/PAN) COMBO (Single kit)

1 1

Access Bio, Inc. G0141 CareStart™ Malaria HRP2(Pf) 115 115

Access Bio, Inc. G0161 Carestart™ Malaria HRP2(Pf 1 1

Access Bio, Inc. G0181 Carestart™ Malaria HRP2/pLDH(pf) 1 1

Access Bio, Inc. G0221 CareStart™ Malaria HRP2/ pLDH(Pf)

1 1

Biofootprints Healthcare Pvt. Ltd., Inc.

MTR00250 My test™ Malaria Ag P.f/Pan 2 2

Bionote, Inc. RG19-08 Bionote Malaria Pf/Pan Ag Rapid Test Kit

2 2

Deangel Biological Engineering Co., Ltd.

MAL-MD02 Malaria P.f/Pan Rapid Test Device 1 1

Hema MAL-PFV-CAS25

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

3 3

J.Mitra & Co.Pvt.Ltd. IR016025 Advantage Pf malaria Card 4 4

OBS (Orchid Biomedical System)

302030025 Paracheck Pf DEVICE 52 52

Premier Medical Corporation Ltd.

I13FRC25/30/35 First Response Malaria Ag. P. falciparum HRP2 Card Test

50 50


I13FRC25S/30S First Response Malaria Ag. P. falciparum HRP2 Card Test (Single kit)

2 2


P/I16FRC25 First Response Malaria Ag. pLDH/HRP2 Combo Card Test

18 17*


I16FRC30S First Response Malaria Ag. pLDH/HRP2 Combo Card Test (Single kit)

4 3*

Span Diagnostics Ltd. 55IC104-25 ParaHIT f Ver.1.0 24 24


Standard Diagnostics, Inc.

05FK50/58 SD Bioline Malaria Ag Pf 304 304


05FK53/57 SD Bioline Malaria Ag Pf 7 7


05FK60 SD BIOLINE Malaria Pf/Pan rapid test

106 106


05FK63 SD BIOLINE Malaria Pf/Pan rapid test

12 12


05FK65 SD BIOLINE Malaria P.f/Pan rapid test (*POCT)

2 2


05FK80/83/86/87 SD BIOLINE Malaria Pf/Pv rapid test 57 57


05FK90 SD Bioline Malaria Ag P.f/Pan 9 9


05FK93 SD BIOLINE Malaria Antigen P.f (HRP2/pLDH)

29 29


05FK120 SD Bioline Malaria Ag P.f/P.f/P.v 5 5

*Failure on Pv @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 during the 18 month testing period is counted in 2010 and not in the year when the failure was detected.


Malaria RDT lot failures are more frequently observed close to their expiry 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 N° new

products N° new

manufacturers N° RDT lots

tested N° initial failures

N° 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 -

Total 45 21 4498 12 19

* Manufacturer Catalog No

Product Names Number of lots tested

Year(s) tested Pass rate

Comment(s)

Access Bio, Inc. G0111 CareStart malaria pLDH (Pan) 12 2011, 2014, 2015

100%

Access Bio, Inc. G0121 Carestart Malaria pLDH 3 lines Test 5 2008, 2009 100%

Access Bio, Inc. G0131 CareStart Malaria HRp2/pLDH (Pf/PAN) COMBO

147 2007, 2008, 2009, 2010, 2011, 2012, 2013, 2014, 2015

100%

Access Bio, Inc. G0131/-

SK* CareStart Malaria HRp2/pLDH (Pf/PAN) COMBO (*SK: Single kit)

18 2011, 2012, 2013, 2014, 2015

100%

Access Bio, Inc. G0141 Carestart™ Malaria HRP2 (Pf) 399 2010, 2011,

2012, 2013, 2014, 2015

100%

Access Bio, Inc. G0141/-

SK* Carestart™ Malaria HRP2 (Pf) (*SK: Single kit)

66 2013, 2014 100%

Access Bio, Inc. G0161 Carestart™ Malaria HRP2(Pf) 5 2012, 2013, 2014, 2015

100%

Access Bio, Inc. G0181 CareStart™ Malaria HRP2/ pLDH(Pf) 1 2015 100% Access Bio, Inc. G0181-SK CareStart™ Malaria HRP2/ pLDH(Pf) 14 2013, 2014 100% Access Bio, Inc. G0221 CareStart™ Malaria HRP2/ pLDH(Pf) 1 2015 100%

Access Bio, Inc. G0231 CareStart Malaria Screen 16 2008, 2009 100% Advy Chemical Private limited, Factory, India

RK MAL 001

EzDx Malaria Pan/Pf Rapid test Detection Kit 9 2011, 2012, 2013

100%

Advy Chemical Private limited, Factory, India

RK MAL 003

EzDx™ Malaria Pv/Pf Rapid Test Detection Kit

2 2013 100%


Biofootprints Healthcare Pvt. Ltd.

MTR00250 My test™ Malaria Ag P.f/Pan 2 2015 100%

Bionote, Inc RG19-08 Bionote Malaria Pf/Pan Ag Rapid Test Kit 1 2014 100%

Bionote, Inc RG19-11 Bionote Malaria P.f Ag Rapid Test Kit 2 2015 100%

Clearview VB11 Clearview Malaria Combo 1 2010 100%

CTK Biotech, Inc. R0112C Onsite Malaria Pf/Pv Ag Rapid Test, Cs 8 2013, 2014 100%

CTK Biotech, Inc. R0113C OnSite Pf/Pan Malaria Ag Rapid Test 1 2012 100%

CTK Biotech, Inc. R0114C OnSite Pf Ag Rapid Test 6 2007, 2013, 2014

100%

Deangel Biological Engineering Co., Ltd.

MAL-MD02 Malaria P.f/Pan Rapid Test Device 1 2015 100%

Diamed AG 710024 OptiMAL-IT 1 2008 100%

Guangzhou Wondfo Biotech Co. Ltd.

W56-C (4.0 mm)

One step Malaria Pf/Pan whole blood test 4 2008, 2009 100%

Hema Diagnostic Systems, LCC

MAL-PFV-CAS25

Rapid 1-2-3 Hema Cassette Malaria (PFV) 3 2015 100%

Human Gmbh 58024 Hexagon Malaria Combi 1 2008 - Pv detection @200 parasites/µl failed at initial QC

ICT Diagnostics ML01 ICT Malaria Pf Cassette Test 249 2007, 2008, 2009, 2010, 2011, 2014

100%

ICT Diagnostics ML02 ICT Malaria Combo Cassette Test 68 2007, 2008, 2009, 2010, 2011, 2012

37% Failed against Pv QC panel @200 parasites/µl

ICT Diagnostics ML03 ICT Diagnostics Malaria Dual 2 2012, 2013, 2014

- 1 failure after 18 months of incubation at 37°C on Pv QC detection at @200 parasites/µl

J.Mitra & Co.Pvt.Ltd.

IR016025 Advantage Pf malaria Card 8 2013, 2014, 2015

100%

J.Mitra & Co.Pvt.Ltd.

IR211025 Advantage Malaria Card 1 2010 100%


Lumiquick Diagnostics, Inc.

71050 QUICK VIEW Malaria pf/pv Antigen Test Card

1 2013 100%

Nanong Egens Biotechnology Co., LTD.

Inf-73 Malaria P.f./Pv Antigen Test Cassette 2 2011, 2012, 2013

100%


Inf-76 Malaria P.f. Antigen Test Cassette 2 2011, 2012, 2013

100%


Nil QD Malaria Antigen P.f 1 2014 100%


30301025 Paracheck Pf DEVICE 987 2007 – 2014* 100%


302030025 Paracheck Pf DEVICE 52 2015 100%


I13FRC25/30/35

First Response Malaria Ag. P. falciparum HRP2 Card Test

235 2009, 2010, 2011, 2012, 2013, 2014, 2015

100%


I13FRC25/30S

First Response Malaria Ag. P. falciparum HRP2 Card Test (Single kit) (*25 or 30 tests/kit)

8 2013, 2014, 2015

100%


I16FRC25/30/40

First Response Malaria Ag. pLDH/HRP2 Combo Card Test

153 2010, 2011, 2012, 2013, 2014, 2015

1% Failure on Pv @200 parasites/µl during initial testing


I16FRC30S First Response Malaria Ag. pLDH/HRP2 Combo Card Test (Single kit)

5 2014, 2015 20% Failure on Pv @200 parasites/µl during initial testing


I16MMC10/25

Malacheck Malaria Ag (pLDH/HRP2) Combo Card Test

4 2012, 2013 100%


PI19FRC25 First Response Malaria Ag. P.f./P.v. Card Test

2 2014 100%

Span Diagnostics Ltd.

55IC102-10 Parahit-f (device) 7 2007, 2008, 2009

100%


55IC104 ParaHIT f Ver.1.0 86 2013, 2014, 2015

100%


55IC201-10 ParaHIT-Total (dipstick) 1 2008 - Pv detection @200 parasites/µl failed at initial QC



05FK40 SD Bioline Malaria Ag 14 2007, 2008, 2009, 2010

100%


05FK50/58 SD Bioline Malaria Ag Pf 893 2009 - 2015* 100%


05FK53*/57*

SD Bioline Malaria Ag Pf POCT 53 2014, 2015 100%


05FK60 SD BIOLINE Malaria P.f/Pan rapid test 539 2010, 2011, 2012, 2013, 2014, 2015

100%


05FK63* SD BIOLINE Malaria P.f/Pan rapid test (*POCT)

58 2010, 2011, 2012, 2013, 2014, 2015

100%



3 2011, 2012, 2014

100%



2 2015 100%


05FK66* SD BIOLINE Malaria P.f/Pan rapid test (*POCT)

5 2014 100%


05FK80/83/85/86/87*

SD BIOLINE Malaria Pf / Pv rapid test (*same tests)

254 2010, 2011, 2012, 2013, 2014, 2015

100%


05FK90 SD BIOLINE Malaria Ag P.f./Pan 28 2009, 2010, 2011, 2012, 2013, 2014, 2015

100%


05FK93* SD BIOLINE Malaria Antigen P.f (HRP2/pLDH) POCT*

29 2015 100%


05FK120 SD Bioline Malaria Ag P.f/P.f/P.v 6 2014, 2015 100%

Zephyr Biomedicals

50310025 Parascreen Device Rapid Test for Malaria Pan/Pf (Device)

14 2007 - 2008- 2009 - 2010

7% Received in 2007 & failed after 12 months of incubation at 37°C against Pv QC panels @200 parasites/µl

TOTAL 4498

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 of demands, 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 236365

567

1083

927

0

200

400

600

800

1000

1200

1400

1600

2007 2008 2009 2010 2011 2012 2013 2014 2015

Number of new Malaria RDT lots tested per year

Recom

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f th

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Pro

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In 2015, the malaria RDT lot testing service was requested by RDT manufacturers (43%), NGOs/international organizations (36%); procurement agencies (16%), and country programmes (5%). According to data collected from lot testing requesters, the RDT lots evaluated in 2015 represented about 262 million RDTs meant for distribution in about 46 countries (information about country distribution was not available for 42 million lot-tested RDTs). About 70% of the malaria RDT lot tested in 2015 were meant for distribution in Sub-Saharan countries.

NIGERIA16%

TANZANIA11%

UGANDA7%

DRC7%

MOZAMBIQUE5%

ZAMBIA5%

BURKINA FASO4%

MALAWI4%

MADAGASCAR2%

GUINEA2%

BURUNDI2%

ANGOLA2%

MYANMAR1%

NIGER1%

KENYA1%

CHAD1%

MALI1%

BENIN1%

GHANA1%

ZIMBABWE1%

COTE D'IVOIRE1%

CENTRAL AFRICA1%

SENEGAL1% LIBERIA

1%

SOUTH SUDAN1%

SUDAN1%

CAMEROON1%

OTHERS3%

UNKNOWN16%


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 2015, this percentage had decreased to 5.4%, with 93.6% 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.

In 2015 only two RDT lots failed initial testing on P. vivax. These RDT products also had panel detection scores below 75% when tested with P. vivax samples at 200 parasites/μl of blood. These results demonstrate consistency between product testing and lot testing results and a substantial increase in the quality of tests being procured.

1 http://www.finddx.org/quality-assurance/quality-assurance-of-malaria-rdts/

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

Not submitted to Product Testing 0.00% 0.00% 0.00% 0.00% 4.38% 0.35% 1.20% 0.22% 3.87%

PDS ≥75% (high performance criteria)

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

PDS ≥50% (WHO medium performance criteria)

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

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%

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 2015, 145 RDT lots from 11 different products and 3 different manufacturers could not undergo long term testing due to the insufficient volume of buffer available.

Table: RDT products with evaporation of individual buffer vials during lot testing

Manufacturer Catalog

number Description

Access Bio, Inc. G0141** Carestart™ Malaria HRP2 (Pf)

Access Bio, Inc. G0131** CareStart Malaria HRp2/pLDH (Pf/PAN) COMBO

Access Bio, Inc. G0131-SK CareStart Malaria HRp2/pLDH (Pf/PAN) COMBO

Access Bio, Inc. G0141-SK Carestart™ Malaria HRP2 (Pf) Single Kit Test

Premier Medical Corporation

Ltd. I16MCC10**

Malacheck Malaria Ag (pLDH/HRP2) Combo Card

Test


Ltd. I13FRC25S

First Response Malaria Ag. P. falciparum HRP2 Card

Test


Ltd. I16FRC30**

First Response Malaria Ag. pLDH/HRP2 Combo

Card Test

Standard Diagnostics, Inc. 05FK53/57 SD BIOLINE Malaria Ag Pf POCT

Standard Diagnostics, Inc. 05FK80-POCT SD BIOLINE Malaria Pf / Pv rapid test POCT

Standard Diagnostics, Inc. 05FK63 SD BIOLINE Malaria Pf/Pan rapid test POCT

Standard Diagnostics, Inc. 05FK64 SD Malaria Ag Pf/Pan POCT combo

** These products can be supplied either with individual buffer vials or with buffer bottles

About 3 - FIND · 2019. 4. 3. · Results – 2007 to 2015 - WHO-FIND malaria RDT lot testing...

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