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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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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)

mailto:Malaria_rdt%40who.int?subject=

mailto:info%40finddiagnostics.org?subject=


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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200 parasites/µl (HRP2)

200 parasites/µl (non-HRP2)



False-positive Plasmodium spp. rate (%)

Invalid rate (%)

Sum

mar

y r

ou

nd

S 1-

4


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 (%)


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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mas

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irst

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n™

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55

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IND

ON

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ICT

Dia

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al

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r M

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50

40

20

25

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sett

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PN

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LA

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asse

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MP

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On

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ick

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, P

f) T

est

53

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lear

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® M

alar

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ual

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t D

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irst

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n™

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est

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r M

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03

20

02

5Tr

ust

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gen

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test

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31

00

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AL

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33

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Po

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nd

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mal

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ecie

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59

89

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ago

n M

alar

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om

bi 5

80

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Tes

t M

AL

-W2

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-00

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P-2

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alit

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AM

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Sum

mar

y r

ou

nd

S 1-

4


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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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)


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

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.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


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)


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

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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

Results of WHO product testing of malaria RDTs: Round 4 ... · malaria, and considered close to the...

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Transcript of Results of WHO product testing of malaria RDTs: Round 4 ... · malaria, and considered close to the...