Malaria Rapid Diagnostic Test Performancestacks.cdc.gov/view/cdc/11959/cdc_11959_DS1.pdf · 2 mlaria a rapid diagnoStic teSt performance – Summary reSultS of WHo malaria rDt ProDuct

Malaria Rapid Diagnostic Test Performance

Summary results of WHO Malaria RDT Product Testing: Rounds 1-3 (2008-2011)

RDTMalariaRd3_Summary-03.indd 1 19/10/11 18:06

Malaria Rapid Diagnostic Test Performance

Summary results of WHO Malaria RDT Product Testing: Rounds 1-3 (2008-2011)


TDR/RDT/11.1

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malaria rapid diagnoStic teSt performance – Summary reSultS of WHo malaria rDt ProDuct teSting: rounDS 1-3 (2008-2011) 1

1. Summary performance of malaria rdtS: WHo product teSting: roundS 1-3

1.1. introductionThe World Health Organization estimates that half the world’s population are at risk of malaria, with 225 million people developing clinical malaria in 2009 (78% in Africa), and 781,000 deaths (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 identified, resulting in over-use of anti-malarial drugs and poor disease monitoring.1

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 as they provide 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. This data is guiding procurement decisions and helping to drive improvement in the quality of manufacturing. The results of the first and second rounds of Product Testing were published in 2009 and 2010, and now form the basis of procurement criteria of WHO and UN agencies and national governments.

This Summary presents an overview of the results of the first, second and third rounds of WHO Product Testing of malaria antigen-detecting RDTs completed in 2008, 2009 and 2011 respectively, and is published in conjunction with the release of the results of Round 3. The results of the three rounds of testing should be considered as a single data set. Concerning products re-submitted for evaluation, the results of earlier rounds are replaced by subsequent rounds and therefore only one set of results per product feature in

1 World Malaria Report 2010. Geneva, World Health Organization, 2010.2 Guidelines for the Treatment of Malaria, Second Edition. Geneva,

World Health Organization, 2010.

this summary. Separate 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 up to 3 tests 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 products from 13 manufacturers were evaluated in Round 2. In Round 3, 50 products were evaluated from 23 manufacturers, including 23 products re-submitted from earlier rounds (Table S3). Of these 120 total products, 118 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 118 fully evaluated products, 25 have been evaluated in more than one round. Of the 95 unique products tested by the programme, 29 detect P. falciparum alone, 57 detect and differentiate P. falciparum from non-P. falciparum malaria (either pan-specific or species-specific), 8 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 results published from the earlier round. Thus, the performance of many tests in the results below differ from those published in the Round 1 and Round 2 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. Product testing is part of a continuing programme of work to improve the quality of RDTs that are used, and to support broad imple-mentation of reliable malaria diagnosis in areas where malaria is prevalent. A fourth round of product testing began in June 2011.

3 See full reports of Rounds 1, 2 and 3 for full list of collaborating partners.4 Working definition of a product can be found here on page 13: http://

www.wpro.who.int/internet/resources.ashx/RDT/docs/pdf_version/web3_QARDTreport.pdf (accessed 8 September 2011)


malaria rapid diagnoStic teSt performance – Summary reSultS of WHo malaria rDt ProDuct teSting: rounDS 1-3 (2008-2011)2

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 settings.5 For the purposes of this report, the main measure of perform-ance is the ‘panel detection score (PDS)’6; 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 an RDT to detect malaria is highly dependent on the local conditions, including parasite density in the target population. Sensitivity of a test will therefore differ between populations with differing levels of transmission, as their different level of immunity will affect the parasite 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 perform-ance at 200 parasites/µl is particularly important. The results in this report show comparative performance between 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 management. 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 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 HRP27. In areas where HRP2-deleted parasites exist, HRP2-detecting

5 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

6 Termed ‘Detection Rate’ in the full report of Round 1, published in 2009. See the Round 3 report for a full explanation of the panel detection score (PDS).

7 Gamboa D et al. PLoS One, 2010: 5(1): e8091

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,8 and at www.wpro.who.int/sites/rdt. 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.9

8 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

9 Malaria RDT Interactive Guide : http://www.finddiagnostics.org/programs/malaria/find_activities/product_testing/malaria-rdt-product-testing/index.jsp (accessed 8 Sept.2011)


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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, an improvement was noted in the performance of products re-submitted to Round 3 (Table S3), indicating product improvement by the manufacturers. Furthermore, the proportion of tests achieving a PDS (>75%) at 200 parasites/µl is higher than that seen in previous reports.

Several RDTs from the three 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 between 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, but some tests targeting pLDH also exhibited high detection rates.

Test performance varied between lots, and widely between similar products, confi rming the advisability of lot-testing post-purchase and prior to use in the fi eld.

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 to manufacturers to assist in this process.

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 cases 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 variation, parasite densities, climate), as well as other important considerations, including fi eld-based ease of use assessments, 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 fi eld.10 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’.11

10 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 [email protected] and info@fi nddiagnostics.org.

11 Good Practices for selecting and procuring rapid diagnostic tests for malaria, Geneva, World Health Organization, 2011 ISBN 9789241501125

Reference to any company or product in this report, particularly in any of the fi gures or tables, does not in any way imply an endorsement, Reference to any company or product in this report, particularly in any of the fi gures or tables, does not in any way imply an endorsement, certifi cation, warranty of fi tness or recommendation by WHO of any company or product for any purpose, and does not imply preference over certifi cation, warranty of fi tness 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 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 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 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 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 refl ect those products which have been submitted for evaluation in Round 3 of the of RDTs are not an exhaustive list of malaria RDTs. Such lists refl ect those products which have been submitted for evaluation in Round 3 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 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’ 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 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.



Figure S1: Malaria RDT performance in Phase 2 of Rounds 1-3 against wild-type (clinical) samples containing P. falciparum at low (200) and high (2000 or 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. (see Figure S2)


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Figure S2: Malaria RDT performance in Phase 2 of Rounds 1-3 against wild-type (clinical) samples containing P. vivax at low (200) and high (2000 or 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.



Tabl

e S1

: Mal

aria

RDT

Pha

se 2

per

form

ance

in R

ound

s 1-

3 ag

ains

t w

ild t

ype

(clin

ical

) sa

mpl

es c

onta

inin

g P.

fal

cipa

rum

and

P. v

ivax

at

low

(20

0) a

nd

high

(20

00 o

r 50

00)

para

site

den

sitie

s (p

aras

ites

/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

pos

itive

ra

tesb

(%)

Inva

lid

rate

(%)

(n=1

204)

Roun

d

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

Pf o

nly

Adva

nced

Qua

lity™

One

Ste

p M

alar

ia P

.f Te

stj

ITP1

1002

TC40

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N/A

100.

0N

/AN

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.0N

/A35

.738

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13

Adva

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(p.f)

POC

TIT

P110

02TC

1In

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dIR

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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

N/A

N/A

N/A

N/A

1.8

0.0

1Ca

reSt

art™

Mal

aria

pLD

H (P

AN)

G01

11Ac

cess

Bio

, Inc

.92

.410

0.0

100.

010

0.0

N/A

N/A

N/A

N/A

6.6

0.0

1Cl

earv

iew

® M

alar

ia p

LDH

j 70

8840

25Or

geni

cs L

td.

81.8

85.7

99.0

100.

0N

/AN

/AN

/AN

/A13

.50.

53

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

N/A

N/A

N/A

N/A

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.

N/A

92.5

N/A

100.

00.

3N

/A1.

0N

/A1.

00.

02

Pf: P

lasm

odiu

m fa

lcip

arum

Pv

: Pla

smod

ium

viv

ax

pan:

Pla

smod

ium

spec

ies

a A

sam

ple

is c

onsi

dere

d de

tect

ed o

nly

if al

l RDT

s fr

om b

oth

lots

read

by

the

first

te

chni

cian

, at m

inim

um s

peci

fied

read

ing

time,

are

pos

itive

b Th

e to

tal n

umbe

r of t

imes

a p

ositi

ve re

sult

for m

alar

ia w

as g

ener

ated

whe

n it

shou

ld n

ot h

ave

been

c

Roun

d 1,

n=7

9; R

ound

2, n

=100

; Rou

nd 3

, n=9

9d

Roun

d 1,

n=2

0; R

ound

2, n

=40;

Rou

nd 3

, n=3

5e

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 P.

falc

ipar

um in

fect

ion

(Rou

nd 1

n=3

16; R

ound

2, n

=400

; Rou

nd 3

, n=3

96)

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;

Roun

d 2,

n=1

60; R

ound

3, n

=140

) 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 P.

falc

ipar

um in

fect

ion

(Rou

nd 1

, n=1

58, R

ound

2, n

=200

; Rou

nd 3

, n=1

98)

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=4

0;

Roun

d 2,

n=8

0, R

ound

3, n

=70)

i Ro

und

1, n

=168

; Rou

nd 2

, n=2

00; R

ound

3, n

=200

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

re

sults

. Ref

er to

Tab

le S

3.

k PD

S pr

esen

ted

in th

e ta

ble

is b

ased

on

a po

sitiv

e pf

test

line

(eith

er p

f-H

RP2

or

pf-p

LDH

). P.

falc

ipar

um P

DS b

ased

on

indi

vidu

al te

st li

nes

was

: pf

-pLD

H (1

7.2%

at

200p

/µl;

97%

at 2

000p

/µl)

and

pf-H

RP2

(87.

9% a

t 200

p/µl

; 100

% a

t 200

0p/µ

l)

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)


Sum

mar

y r

ou

nd

S 1-

3


Tabl

e S2

: Mal

aria

RDT

Rou

nds

1-3

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).

Posi

tivi

ty r

ate

at b

asel

ine,

and

aft

er 6

0 da

ys 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

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st r

esul

ts

for

P. f

alci

paru

m (P

an li

ne)

Roun

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µl20

0 pa

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00 p

aras

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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

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dLo

ts 1

and

2 c

ombi

ned

Lots

1 a

nd 2

com

bine

dLo

ts 1

and

2 c

ombi

ned

Pf o

nly

Adva

nced

Qua

lity™

One

Ste

p M

alar

ia P

.f Te

sta

ITP1

1002

TC40

InTe

c Pr

oduc

ts, I

nc.

100.

010

0.0

100.

010

0.0

100.

010

0.0

N/A

N/A

N/A

N/A

N/A

N/A

3Ad

vanc

ed Q

ualit

y™M

alar

ia (p

.f) P

OCT

ITP1

1002

TC1

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c Pr

oduc

ts, I

nc.

80.0

95.0

90.0

100.

010

0.0

100.

0N

/AN

/AN

/AN

/AN

/AN

/A1

Adva

ntag

e P.

f. M

alar

ia C

ard

IR01

6025

J. M

itra

& C

o. P

vt. L

td.

95.0

100.

010

0.0

100.

010

0.0

100.

0N

/AN

/AN

/AN

/AN

/AN

/A1

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

N/A

N/A

N/A

N/A

N/A

N/A

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

N/A

N/A

N/A

N/A

N/A

N/A

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

N/A

N/A

N/A

N/A

N/A

N/A

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

N/A

N/A

N/A

N/A

N/A

N/A

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

N/A

N/A

N/A

N/A

N/A

N/A

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

N/A

N/A

N/A

N/A

N/A

N/A

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

N/A

N/A

N/A

N/A

N/A

N/A

1H

exag

on M

alar

ia58

051

Hum

an G

mbH

50.0

35.0

60.0

95.0

100.

010

0.0

N/A

N/A

N/A

N/A

N/A

N/A

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

N/A

N/A

N/A

N/A

N/A

N/A

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

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/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

N/A

N/A

N/A

N/A

N/A

N/A

1M

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

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s, In

c.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

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/AN

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/A1

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

N/A

N/A

N/A

N/A

N/A

N/A

3On

e St

ep M

alar

ia P

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est (

cass

ette

)a 52

2352

Blue

Cro

ss B

io-M

edica

l (Be

ijing

) Co.

, Ltd

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00.

010

0.0

100.

010

0.0

N/A

N/A

N/A

N/A

N/A

N/A

3On

e St

ep M

alar

ia P

.f Te

sta

W37

-CG

uang

zhou

Won

dfo

Biot

ech

Co. L

td.

100.

093

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0.0

100.

010

0.0

N/A

N/A

N/A

N/A

N/A

N/A

3On

Sigh

t™ -

Mal

aria

Pf T

est

511-

25-D

BAm

geni

x In

tern

atio

nal,

Inc.

100.

095

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0.0

100.

065

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te P

f Ag

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sta

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K Bi

otec

h, In

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0.0

100.

010

0.0

100.

010

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N/A

N/A

N/A

N/A

N/A

N/A

3Pa

rach

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Pf D

evic

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apid

test

for P

. fal

cipa

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Mal

aria

Ver

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3030

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Orch

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iom

edic

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ms

100.

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100.

010

0.0

100.

010

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N/A

N/A

N/A

N/A

N/A

N/A

3Pa

rach

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Pf D

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Rap

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st fo

r P. f

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m M

alar

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a 30

3020

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Para

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f (De

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Span

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gnos

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Ltd.

100.

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0.0

100.

010

0.0

90.0

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N/A

N/A

N/A

N/A

N/A

3Pa

raH

IT®

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ipst

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a 55

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1-50

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Ltd.

100.

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SD B

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100.

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N/A

N/A

N/A

N/A

N/A

N/A

1Pf

and

Pan

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Mal

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Pan

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vant

age

Mal

Car

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2210

25J.

Mitr

a &

Co.

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. Ltd

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0.0

100.

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3Ca

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Mal

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Care

Star

t™ M

alar

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1Ca

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Prod

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Cata

logu

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mbe

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actu

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Perc

ent

posit

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test

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fo

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fal

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line)

Perc

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posit

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Perc

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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

N/A

N/A

N/A

N/A

N/A

N/A

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

Pf: P

lasm

odiu

m fa

lcip

arum

Pv

: Pla

smod

ium

viv

ax

pan:

Pla

smod

ium

spec

ies

a 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.

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

on

200p

/µl a

nd 2

000p

/µl s

ampl

es w

ere,

resp

ectiv

ely

: pf-

pLDH

(0%

; 33.

3% d

etec

ted

at b

asel

ine

and

0% ;

33.3

% d

etec

ted

post

60

d in

cuba

tion

at 3

5°C,

45°

C) a

nd p

f-H

RP2

(100

%; 1

00%

at b

asel

ine

and

100%

; 100

% p

ost 6

0 d

incu

batio

n at

35°

C, 4

5°C)



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

-3

Man

ufac

ture

rIn

itial

Tes

ting

Subs

eque

nt T

estin

g

Roun

dPr

oduc

t N

ame

Cata

logu

e N

o Ro

und

Prod

uct

Nam

eCa

talo

gue

No

AZOG

, Inc

.1

Mal

aria

Pf (

HRP

II)/p

v-LD

H) A

ntig

en D

etec

tion

Test

Dev

icea

MFV

-124

R3

Mal

aria

pf (

HRP

II) /

(PAN

-LDH

) Ant

igen

Det

ectio

n Te

st D

evic

eM

FV-1

24R

Blue

Cro

ss B

io-M

edic

al (B

eijin

g) C

o., L

td.

2On

e St

ep M

alar

ia P

f Tes

t (ca

sset

te)

5223

523

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

OnSi

te P

f/Pa

n M

alar

ia A

g Ra

pid

Test

R011

3C2

Onsi

te P

f/Pv

Ag

Rapi

d Te

st

R011

2C3

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)

3On

e St

ep M

alar

ia P

.f Te

st

W37

-C

ICT

Diag

nost

ics

1IC

T M

alar

ia C

ombo

Cas

sett

e Te

st

ML0

23

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

3Ad

vanc

ed Q

ualit

y™ O

ne S

tep

Mal

aria

P.f

Test

ITP1

1002

TC4

0

Orch

id B

iom

edic

al S

yste

ms

1Pa

rach

eck

Pf R

apid

test

for P

.falc

ipar

um M

alar

ia (D

evic

e)

3030

1025

3Pa

rach

eck®

Pf D

evic

e -

Rapi

d te

st fo

r P. f

alci

paru

m M

alar

ia (V

er. 3

)30

3010

251

Para

chec

k Pf

Rap

id te

st fo

r P.fa

lcip

arum

Mal

aria

(Dip

stic

k)

3030

2025

3Pa

rach

eck®

Pf D

ipst

ick

- Ra

pid

test

for P

. fal

cipa

rum

Mal

aria

(Ver

.3)

3030

2025

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.

1Fi

rst R

espo

nse

Mal

aria

Ag

Com

bo (p

LDH

/HRP

2)II6

FRC3

02

Firs

t Res

pons

e® M

alar

ia A

g Co

mbo

(pLD

H/H

RP2)

I16F

RC30

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.

(n

ow A

lere

Hea

lthca

re (P

ty) L

td)

1SD

BIO

LIN

E M

alar

ia A

g 0

5FK4

0-02

-5d

3SD

BIO

LIN

E M

alar

ia A

g05

FK40

1SD

BIO

LIN

E M

alar

ia A

g Pf

/Pan

05

FK60

-02-

3d3

SD B

IOLI

NE

Mal

aria

Ag

P.f/

Pan

05FK

60

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

3Pa

rasc

reen

™ D

evic

e -R

apid

test

for M

alar

ia P

an/P

f50

3100

25

a Ro

und

1 pr

oduc

t nam

e er

ror :

pub

lishe

d -

Mal

aria

Pf (

HRP

II)/p

v-LD

H) A

ntig

en D

etec

tion

Test

Dev

ice

Code

; co

rrec

ted

prod

uct n

ame:

Mal

aria

Pf (

HRP

II/PA

N-L

DH) A

ntig

en D

etec

tion

Test

Dev

ice

Code

. No

chan

ge in

pro

duct

cod

e.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

: pro

duct

cod

e (II

6FRC

30) s

houl

d ha

ve b

een

( I16

FRC3

0 ),

as in

Rou

nd 2

d 02

-05/

02-0

3 su

ffix

refe

rs to

ver

sion

of t

he p

acka

ge in

sert

se

New

com

pany

acq

uisi

tion

(Ale

re™

) -he

nce

nam

e ch

ange

s/pr

oduc

t cod

es. M

anuf

actu

rer c

onfir

med

com

plia

nce

with

pro

duct

defi

nitio

n.


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/11.1


Malaria Rapid Diagnostic Test Performancestacks.cdc.gov/view/cdc/11959/cdc_11959_DS1.pdf · 2 mlaria a rapid diagnoStic teSt performance – Summary reSultS of WHo malaria rDt ProDuct

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