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)
RDTMalariaRd3_Summary-03.indd 1 19/10/11 18:06
TDR/RDT/11.1
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Sum
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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)
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)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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malaria rapid diagnoStic teSt performance – Summary reSultS of WHo malaria rDt ProDuct teSting: rounDS 1-3 (2008-2011) 3
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.
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malaria rapid diagnoStic teSt performance – Summary reSultS of WHo malaria rDt ProDuct teSting: rounDS 1-3 (2008-2011)4
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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Sum
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malaria rapid diagnoStic teSt performance – Summary reSultS of WHo malaria rDt ProDuct teSting: rounDS 1-3 (2008-2011) 5
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.
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malaria rapid diagnoStic teSt performance – Summary reSultS of WHo malaria rDt ProDuct teSting: rounDS 1-3 (2008-2011)6
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
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13
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s92
.911
.499
.094
.30.
3 (3
91)
0.0
(137
)0.
0 (1
97)
1.4
3.5
(198
)1.
03
diag
nost
icks
MAL
ARIA
(Pan
/Pv/
Pf) C
asse
tte
MPN
VFC1
007.5
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
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)
RDTMalariaRd3_Summary-03.indd 8 19/10/11 18:06
Sum
mar
y r
ou
nd
S 1-
3
malaria rapid diagnoStic teSt performance – Summary reSultS of WHo malaria rDt ProDuct teSting: rounDS 1-3 (2008-2011) 9
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
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
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
InTe
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
/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
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
orie
s, In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
/AN
/AN
/AN
/AN
/AN
/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
.F T
est (
cass
ette
)a 52
2352
Blue
Cro
ss B
io-M
edica
l (Be
ijing
) Co.
, Ltd
.63
.30.
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
.390
.010
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
.090
.010
0.0
100.
065
.0N
/AN
/AN
/AN
/AN
/AN
/A2
OnSi
te P
f Ag
Rapi
d Te
sta
R011
4CCT
K Bi
otec
h, In
c.96
.710
0.0
100.
010
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
3Pa
rach
eck®
Pf D
evic
e- R
apid
test
for P
. fal
cipa
rum
Mal
aria
Ver
. 3a
3030
1025
Orch
id B
iom
edic
al 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
3Pa
rach
eck®
Pf D
ipst
ick-
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia V
er. 3
a 30
3020
25Or
chid
Bio
med
ical
Sys
tem
s10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
/AN
/AN
/AN
/AN
/AN
/A3
Para
HIT
® -
f (De
vice
)a 55
IC10
2-50
Span
Dia
gnos
tics
Ltd.
100.
096
.710
0.0
100.
010
0.0
90.0
N/A
N/A
N/A
N/A
N/A
N/A
3Pa
raH
IT®
-f (D
ipst
ick)
a 55
IC10
1-50
Span
Dia
gnos
tics
Ltd.
100.
010
0.0
56.7
100.
010
0.0
100.
0N
/AN
/AN
/AN
/AN
/AN
/A3
SD B
IOLI
NE
Mal
aria
Ag
P.f.
(HRP
2/pL
DH)b
05FK
90St
anda
rd D
iagn
ostic
s In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
/AN
/AN
/AN
/AN
/AN
/A3
SD B
IOLI
NE
Mal
aria
Ag
Pf05
FK50
Stan
dard
Dia
gnos
tics,
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
1Pf
and
Pan
ABON
Mal
aria
Pan
/P.f.
Rap
id T
est D
evic
e IM
A-B4
02AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td.
100.
080
.090
.010
0.0
100.
010
0.0
0.0
0.0
0.0
0.0
0.0
0.0
3Ad
vant
age
Mal
Car
dIR
2210
25J.
Mitr
a &
Co.
Pvt
. Ltd
.10
0.0
100.
055
.095
.010
0.0
95.0
55.0
45.0
40.0
100.
010
0.0
100.
01
Bina
x N
ow M
alar
ia T
est
IN66
0050
Inve
rnes
s M
edic
al In
nova
tions
, Inc
.10
0.0
100.
010
0.0
100.
010
0.0
95.0
5.0
0.0
0.0
95.0
95.0
75.0
1BI
ONOT
E M
ALAR
IA P
.f.&
Pan
Ag
Rapi
d Te
st K
it RG
19-0
8Bi
onot
e,In
c.10
0.0
100.
096
.710
0.0
100.
010
0.0
0.0
0.0
0.0
100.
010
0.0
90.0
3Ca
reSt
art™
Mal
aria
/Pre
gnan
cy C
ombo
(pLD
H/H
RP2/
HCG
) G
O221
Acce
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RDTMalariaRd3_Summary-03.indd 9 19/10/11 18:06
malaria rapid diagnoStic teSt performance – Summary reSultS of WHo malaria rDt ProDuct teSting: rounDS 1-3 (2008-2011)10
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Perc
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Num
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Num
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Dev
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LIN
E M
alar
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Inc.
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096
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080
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00.
00.
080
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Sure
step
™ E
asy
Mal
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Pf/
Pan
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d Te
st D
evic
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02AC
ON B
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Ltd
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010
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100.
010
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00.
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00.
00.
03
Pf a
nd P
vAd
vanc
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y™ O
ne S
tep
Mal
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P.f/
P.v
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Line
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03 T
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InTe
c Pr
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ts, I
nc.
96.7
100.
010
0.0
100.
010
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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
N/A
N/A
N/A
N/A
N/A
N/A
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
N/A
N/A
N/A
N/A
N/A
N/A
3Ca
reSt
art™
Mal
aria
HRP
2/PL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
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nc.
100.
010
0.0
95.0
100.
010
0.0
100.
0N
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/AN
/AN
/AN
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/A2
Tabl
e S2
(co
ntin
ued)
RDTMalariaRd3_Summary-03.indd 10 19/10/11 18:06
Sum
mar
y r
ou
nd
S 1-
3
malaria rapid diagnoStic teSt performance – Summary reSultS of WHo malaria rDt ProDuct teSting: rounDS 1-3 (2008-2011) 11
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
Care
Star
t™ M
alar
ia H
RP2/
PLDH
(Pf/
VOM
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BOG
0171
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
2Co
re™
Mal
aria
Pv/
PfM
AL-1
9002
2Co
re D
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s10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
/AN
/AN
/AN
/AN
/AN
/A3
diag
nost
icks
- M
alar
ia (P
v/Pf
) Cas
sett
eKM
VFC6
002
SSA
Diag
nost
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& B
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ch S
yste
ms
100.
095
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100.
095
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/AN
/AN
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/A2
Falc
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est f
or M
alar
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v/Pf
(dev
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5030
0025
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yr B
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als
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
rstS
ign™
– P
araV
iew
-2 (P
v +
Pf) C
ard
Test
2102
CB-2
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nim
ed In
tern
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nal,
Inc.
95.0
70.0
0.0
100.
095
.075
.0N
/AN
/AN
/AN
/AN
/AN
/A1
Mal
aria
pf (
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II) /
pv
(pLD
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ntig
en D
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tion
Test
Dev
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MFV
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OG, I
nc.
100.
010
0.0
96.7
100.
010
0.0
100.
0N
/AN
/AN
/AN
/AN
/AN
/A3
Mal
eris
can®
Mal
aria
Pf/
Pv
MAT
-50
Bhat
Bio
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h In
dia
(P) L
td10
0.0
60.0
30.0
100.
090
.095
.0N
/AN
/AN
/AN
/AN
/AN
/A2
OnSi
ght™
- P
araQ
uick
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v,Pf)
Mal
aria
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Amge
nix
Inte
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iona
l, In
c.10
0.0
100.
010
0.0
100.
010
0.0
85.0
N/A
N/A
N/A
N/A
N/A
N/A
2On
Site
Mal
aria
Pf/
Pv A
g Ra
pid
Test
a R0
112C
CTK
Biot
ech,
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
3SD
BIO
LIN
E M
alar
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g Pf
/Pv
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80St
anda
rd D
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s, In
c.10
0.0
100.
010
0.0
100.
010
0.0
95.0
N/A
N/A
N/A
N/A
N/A
N/A
2Pf
, Pv
and
Pan
Core
™ M
alar
ia P
an/P
v/Pf
M
AL-1
9002
6Co
re D
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0.0
100.
010
0.0
100.
090
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0.0
0.0
0.0
0.0
80.0
50.0
70.0
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stic
ks M
ALAR
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an/P
v/Pf
) Cas
sett
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PNVF
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7.5
SSA
Diag
nost
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ch S
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ms
96.7
100.
093
.310
0.0
100.
010
0.0
0.0
0.0
0.0
70.0
0.0
50.0
3Fi
rstS
ign™
- P
araV
iew
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an+P
v+Pf
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med
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0.0
100.
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0.0
100.
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0.0
100.
060
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0.0
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100.
02
Para
max
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apid
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t for
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Pf (d
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3200
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0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
25.0
30.0
100.
095
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0.0
2Pa
n O
nly
Adva
ntag
e Pa
n M
alar
ia C
ard
IR01
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itra
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vt. L
td.
N/A
N/A
N/A
N/A
N/A
N/A
50.0
65.0
70.0
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010
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01
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alar
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LDH
(PAN
)G
0111
Acce
ss B
io, I
nc.
N/A
N/A
N/A
N/A
N/A
N/A
100.
010
0.0
90.0
100.
010
0.0
100.
01
Clea
rvie
w®
Mal
aria
pLD
Ha
7088
4025
Orge
nics
Ltd
. 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
N/A
N/A
N/A
N/A
N/A
N/A
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.
N/A
N/A
N/A
N/A
N/A
N/A
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.
N/A
N/A
N/A
N/A
N/A
N/A
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
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)
RDTMalariaRd3_Summary-03.indd 11 19/10/11 18:06
malaria rapid diagnoStic teSt performance – Summary reSultS of WHo malaria rDt ProDuct teSting: rounDS 1-3 (2008-2011)12
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.
RDTMalariaRd3_Summary-03.indd 12 19/10/11 18:06
TDR/World Health Organization20, Avenue Appia1211 Geneva 27Switzerland
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RDTMalariaRd3_Summary-03.indd 14 19/10/11 18:06