summary results of who product testing of malaria rdts: round 1
TRANSCRIPT
Malaria Rapid Diagnostic Test Performance
Results of WHO product testing of malaria RDTs: Round 4 (2012)
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Malaria Rapid Diagnostic Test Performance
Summary results of WHO product testing of malaria RDTs: Round 1-5 (2008-2013)
Malaria Rapid Diagnostic Test Performance
Summary results of WHO product testing of malaria RDTs: Round 1-5 (2008-2013)
WHO Library Cataloguing-in-Publication Data:Malaria Rapid Diagnostic Test Performance: Summary results of WHO product testing of malaria RDTs: Round 1-5 (2008-2013)1.Diagnostic Techniques and Procedures. 2.Malaria - diagnosis. 3.Diagnostic Tests, Routine - methods. I.World Health Organization.
ISBN 978 92 4 150763 9 (NLM classification: WC 750)
© World Health Organization 2014
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The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use.
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Reference to any company or product in this report, particularly those listed in any of the figures and tables, does not constitute an endorsement, certification, or warranty of fitness by WHO of such company or product for any purpose, and does not imply any preference over companies or products of a similar nature that are not mentioned.
WHO does not furthermore warrant that: (1) the lists and figures are complete and/or error free; and/or that (2) any products included in the figures and tables 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 of any products in this report, particularly in any of the figures and tables listed on page IV, does not furthermore imply any approval by WHO of these products (which is the sole prerogative of national authorities).
The WHO Programme of Prequalification of Diagnostics and Medical Devices uses the results of the WHO Malaria RDT Product Testing Programme as the laboratory evaluation component of the prequalification process for malaria RDTs. Although not currently a requirement for WHO procurement, manufacturers are encouraged to apply for WHO prequalification. A regularly updated list of WHO-prequalified diagnostics, including malaria RDTs, is available at http://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/.
WHO recommendations for procurement of malaria RDTs are currently based on the attainment of a set of minimum performance criteria in the WHO Malaria RDT Product Testing Programme. These recommendations were established by the WHO Malaria Policy Advisory Committee in 2012 , are outlined in this report and presented in full in a WHO information note (available at http://www.who.int/malaria/publications/atoz/rdt_selection_criteria_en.pdf?ua=1).Products that do not meet the full set of minimum performance criteria are not eligible for procurement by WHO.
The lists of RDTs included in this report are not exhaustive lists of malaria RDTs. These lists reflect those products which have been submitted for evaluation in Rounds 2-5 of the WHO Malaria RDT Product Testing Programme, and indicate to what extent these products, as manufactured by the listed companies, were -at the time of their evaluation- found to meet the above mentioned set of minimum performance criteria. The evaluation results indicated in the figures and tables apply only to the specific product as listed with its unique product code / catalogue number and as manufactured by the listed company.
The improper storage, transport and handling of malaria RDTs may affect their level of performance.
The fact that certain products are not included in the lists and figures in this report indicates that they have not or not yet been submitted for evaluation in the WHO Malaria RDT Product Testing Programme, or that their evaluation has not yet been completed and published in [a new edition of this report]. It does not however indicate anything in respect of such products’ performance. The lists and figures are updated regularly, and malaria RDTs are added to the lists and figures as and when (following the voluntary participation in the WHO Malaria RDT Product Testing Programme) their evaluation against the above mentioned set of minimum performance criteria has been completed.
Although the malaria RDTs listed in the tables and figures are regularly re-evaluated, and updated evaluation results are published by WHO, WHO cannot represent that products included in the lists and figures will continue to meet the performance criteria in the same manner as indicated. WHO recommends therefore that before procurement of a malaria RDT, each lot of that product undergoes lot testing at one of the two following lot-testing laboratories: Institut Pasteur du Cambodge (IPC), Cambodia or Research Institute for Tropical Medicine (RITM), The Philippines.
WHO disclaims any and all liability and 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 included in this report and the figures and tables listed on page IV.
This report may not be used by manufacturers and suppliers for commercial or promotional purposes.
I I IMalaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Contents 1. sUMMarY of perforMance of rapid
diagnostic tests for Malaria: WHo prodUct testing roUnds 1–5 11.1. introduction 1
1.2. the WHo product testing programme 1
1.3. panel detection score and other results of the evaluation 2
1.4. summary of outcomes 4
1.5. How can product testing results inform rdt procurement and use? 5
1.6. product testing and WHo programme for prequalification of diagnostics and medical devices 5
2. references 20
annexes 21annex s1: characteristics of evaluation panels used in rounds 1–5 of WHo malaria rdt product testing, 2008–2013 22
annex s2: Malaria rdt field assessment and anomalies 25
annex s3: selection of an appropriate rdt 28
IV Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
figures
Figure S1: Malaria RDT performance in phase 2 of rounds 2–5 against wild-type (clinical) samples containing P. falciparum at low (200) and high (2000 or 5000) parasite density (parasites/µL) and clean-negative samples
Figure S2: Malaria RDT performance in phase 2 of rounds 2–5 against wild-type (clinical) samples containing P. vivax at low (200) and high (2000 or 5000) parasite density (parasites/µL) and clean-negative samples
Figure S3: Panel detection score of malaria combination and pan-only RDTs meeting WHO procurement criteria for false-positive and invalid rates, in phase 2 of rounds 2–5 against wild-type (clinical) samples containing P. falciparum and P. vivax at low parasite density (200 parasites/μL)
Figure AS1.1: Box-and-whisker plot of distribution of P. falciparum HRP2 concentration (ng/mL) in product testing phase 2 (wild-type) panels
Figure AS1.2: Box-and-whisker plot of distribution of P. falciparum pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels
Figure AS1.3: Box-and-whisker plot of distribution of P. vivax pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels
Figure AS1.4: Box-and-whisker plot of distribution of P. falciparum aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels
Figure AS1.5: Box-and-whisker plot of distribution of P. vivax aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels
Figure AS2.1: Malaria RDT anomalies encountered in production lots
Figure AS3.1: Selecting an appropriate RDT
tables
Table S1: Product resubmissions: WHO malaria RDT product testing rounds 1–5
Table S2 Malaria RDT phase-2 performance in rounds 2–5 against wild-type (clinical) samples containing P. falciparum and P. vivax at low (200) and high (2000 or 5000) parasite density (parasites/µL) and clean-negative samples
Table S3: Malaria RDT rounds 2–5 heat stability results on a cultured P. falciparum sample at low (200) and high (2000) parasite density (parasites/µL). Positivity rate at baseline and after 60 days’ incubation at 35 °C and 45 °C
Table AS1.1: Statistics for P. falciparum HRP2 concentration (ng/mL) in product testing phase 2 (wild-type) panels
Table AS1.2: Statistics for P. falciparum pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels
Table AS1.3: Statistics for P. vivax pLDH concentration (ng/mL) in wild-type product testing phase 2 (wild-type) panels.
Table AS1.4: Statistics for P. falciparum aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels
Table AS1.5: Statistics for P. vivax aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels
Table AS2.1: Field assessment of RDT packaging, safety and ease-of-use to guide product selection
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1IV Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
1. sUMMarY of perforMance of rapid diagnostic tests for Malaria: WHo prodUct testing roUnds 1–5
1.1. introductionWHO estimates that half the world’s population is at risk of malaria. In 2012, there were an estimated 207 million cases (with an uncertainty range of 135 million to 287 million) and an estimated 627 000 deaths (with an uncertainty range of 473 000 to 789 000). Approximately 90% of all malaria deaths occur in sub-Saharan Africa, and 77% occur in children under 5 years. Malaria remains endemic in 104 countries, and, while parasite-based diagnosis is increasing, most suspected cases of malaria are still not properly confirmed, resulting in over-use of antimalarial drugs and poor disease monitoring (1).
WHO recommends that malaria case management be based on parasite diagnosis in all cases (2). The use of antigen-detecting rapid diagnostic tests (RDTs) is a vital part of this strategy, forming the basis for extending 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 have increased rapidly over the past few years; however, limita-tions of field trials and the heterogeneous nature of malaria transmission have limited the availability of the good-quality data on performance that national malaria programmes require to make informed decisions on procurement and implementation, and it is difficult to extrapolate the results of field trials to different populations and times. Therefore, in 2006, the WHO Special Programme for Research and Training in Tropical Diseases (TDR) and the Foundation for Innovative New Diagnostics (FIND) launched a programme to systematically evaluate and compare the performance of commercially available malaria RDTs. The results of WHO’s malaria RDT product testing have been published annually since 2009 and form the basis of the procurement criteria of WHO, other United Nations agencies, the Global Fund to Fight AIDS, Tuberculosis and Malaria, national governments and nongovernmental organizations. The data have guided procurement decisions, which, in turn, have shifted markets towards better-performing tests1 and are driving overall improvements in the quality of manufacturing.
This summary presents an overview of the results of rounds 1–5 of malaria RDT product testing and key concepts for understanding and using the results. It is published in conjunction with the release of the full report on round 5. The results of all rounds of testing should be considered as a single data set. The separate, full reports of each round (3–6) should be consulted for further details of methods, product performance and interpretation of the results.
1.2. the WHo product testing programmeThe RDT evaluations summarized here were performed in collaboration by WHO, TDR, FIND, the United States Centers for Disease Control and Prevention (CDC) and other partners.1 All companies that manufacture according to the ISO 13485:2003 quality system standard were invited to submit one to three products for evaluation in the programme. In each round of testing, products are evaluated against geographically diverse, cryopreserved Plasmodium falci-parum and P. vivax clinical samples diluted to 200 and 2000 parasites/µL and with consistently comparable concen-tration ranges of histidine-rich protein II (HRP2), Plasmodium lactate dehydrogenase (pLDH) and aldolase determined by quantitative enzyme-linked immunosorbent assay (ELISA) (Annex S1). In the first round of testing, 41 products from 21 manufacturers were evaluated against prepared blood panels of cultured P. falciparum parasites, while 29, 50, 48 and 42 products from 13, 23, 27 and 34 manufacturers were evaluated in rounds 2, 3, 4 and 5, respectively. Of these 210 products, 206 progressed to testing against panels of patient-derived P. falciparum and P. vivax parasites and a parasite-negative panel. Thermal stability was assessed after 2 months of storage at elevated temperature and humidity, and a descriptive assessment of ease of use was made. Many manufacturers have decided voluntarily to submit products to one or more rounds of testing, and, in round 5, a require-ment was instituted to resubmit products for re-evaluation within 5 years of original testing (Table S1). Of the 206 fully evaluated products, 32 have been evaluated twice, 11 have been evaluated three times and two evaluated four times in rounds 1–5. Of the 147 unique products tested in the programme, 36 detect P. falciparum alone, 101 detect and differentiate P. falciparum from non-P. falciparum malaria (either pan-specific or species-specific for P. vivax or P. vivax, ovale and malariae), 9 detect P. falciparum and non-P. falci-parum malaria without distinguishing between them, and one product was designed to detect P. vivax only. Manufacturers submitted two lots of each product for evaluation. When the same products (7) were resubmitted in subsequent rounds of testing, the second set of results replaced those from the earlier round. Thus, the performance of some tests in the results below differs from that reported in rounds 1–4.
Of the 22 products due for compulsory retesting in round 5, 10 were submitted (Table S1). Round 1 products that were not
1 See full reports of rounds 1–5 (3–6) for lists of collaborating partners.
2 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
resubmitted have been removed from the figures and tables in this summary performance document.
The aim of the evaluation is to provide comparative data on the performance of the submitted production lots of each product. These data will be used to guide procure-ment decisions by WHO, other United Nations agencies and national governments and constitute the laboratory evaluation component of the WHO prequalification process for malaria RDTs (8). Product testing is part of a continuing programme of work to improve the quality of RDTs in use and to ensure reliable malaria diagnosis in areas where malaria is prevalent. A sixth round of product testing will begin in June 2014.
1.3. panel detection score and other results of the evaluationThe results (summarized in Figs S1–S3 and Tables S2 and S3) 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 is considered close to the threshold that must be detected in order reliably to identify clinical malaria in many settings (9). For the purposes of this report, the main measure of performance is the panel detection score (PDS);1 for each RDT evaluated, the PDS is measured separately at the
1 Termed “detection rate” in the full report of round 1, published in 2009.
Box 1: Example calculation of panel detection score and positivity rate for product A against a sample density of 200 parasites/µL
The first reading was at the minimum time specified by the manufacturer; the second reading was up to 30 min latera. A sample is considered detected only if all first test readings, from both lots, are positive, i.e. readings a, b, c and d must be positive.
Product A
c dReading
1Reading
1Reading
2Reading
2
Lot 2
Test 3 Test 4
a bReading
1Reading
1Reading
2Reading
2
Lot 1
Test 1 Test 2
Detected if 4 positive
first readings
a second reading results are for internal use only
P. falciparum sample a b c d
1 + - + + Sample NOT detected
2 + - - + Sample NOT detected
3 + + + + Sample detected
In this example, only one of three samples was positive all four times it was tested; the PDS is therefore 1/3 = 33%.
The positivity rate is calculated as the percentage of all tests of a particular product that returned a positive test result at the manufacturers’ recommended minimum reading time when tested against a P. falciparum or P. vivax sample.
In the above example, the positivity rate is: 9/12 = 75%.
The positivity rate is always greater than the PDS, except when the PDS and the positivity rate are both 100%.
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32 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
lower and the higher parasite density. The summary figures also show the false-positive rates against blood samples containing no malaria parasites or known markers of other diseases and the rate of invalid results.
The PDS is the percentage of malaria samples in the panel that give a positive result in two RDTs per lot at the lower parasite density or by a single RDT per lot at the higher parasite density. As each sample is tested with RDTs from two lots, for a sample to be positive at the lower parasite density, it must show a positive result in four tests (two RDTs per lot for two lots); at the higher parasite density, it must show a positive result in two tests (one RDT per lot for two lots). Thus, the PDS is a combined measure of positivity rate, incorporating inter-test and inter-lot consistency. As all tests performed on each sample must show a positive result for the sample to be considered positive, the PDS for a given RDT will usually be lower than a simple positivity rate per panel, measured by comparing the number of positive tests among all tests performed per panel. The PDS is also different from clinical sensitivity: the ability of the test to detect malaria infection in a given population of infected patients. Boxes 1 and 2 illustrate how the PDS is calculated and how it differs from a simple positivity rate for all samples tested and from clinical sensitivity in a population.
The PDS for a given RDT is different from the clinical sensi-tivity of that RDT (also called the true positive rate), which is a measure of the proportion of people known to have the disease who test positive for it. The sensitivity of malaria RDTs is highly dependent on local conditions, including the parasite density in the population; it therefore varies among populations with different levels of transmission, as their level of immunity affects the parasite density at which they exhibit symptoms that warrant a diagnostic test. Where transmission rates are low, the parasite densities in people with symptoms of malaria are likely to be low, and tests will be less sensitive. Test performance at 200 parasites/µL is therefore particularly important. The results in this report show the comparative performance of RDTs and indicate which products are likely to be more sensitive in the field, particularly in populations with low-density infections.
In general, as countries reduce the prevalence of malaria and even move towards malaria elimination, detection of low parasite densities becomes increasingly important in case management. As the high PDS at 2000 parasites/µL indicates, the sensitivity of many of these products is similar in populations with higher parasite densities and therefore it is not possible to discriminate RDTs with superior performance.
Box 2: Performance measures in WHO product testing and in field settings: PDS versus clinical sensitivity
WHO Malaria RDT Product TestingPrimary performance measure: PDS indicates which products are likely to be more sensitive in the field, particularly in populations with low‐density infections.
200 parasites/μL
2000 parasites/μL
Reference panels: two fixed parasite densities allows discrimination in RDT performance.
Malaria endemic settingPerformance measure: sensitivity is the proportion of the population studied who have malaria for whom the test is positive.
- high, moderate, low transmission- immune, non-immune- vulnerable groups
Patients have varying parasite density. Most RDTs for P. falciparum and P. vivax perform well for a parasite density > 2000 parasites/μL, but clinically significant densities < 200 parasites/μL may be missed. The “overall” test performance will nevertheless be classified as very good in a field evaluation.
4 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
An important caveat to estimating field sensitivity from the PDS provided in this report is that the panels used include only 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 that infect people in some areas of South America and India do not express HRP2 (10, 11). In areas where HRP2-deleted parasites exist, tests for HRP2 will have greatly reduced sensitivity or be incapable of detecting P. falciparum. In such populations, only tests for pLDH or aldolase in P. falciparum parasites will be effective for diagnosing falciparum malaria.
Heat stability (summarized in Table S3) is vital to maintaining the sensitivity of tests in the field. As a result, for procure-ment, careful consideration must be given to ensure that the products to be used in areas with high temperatures of transport and storage have demonstrated stability in the product testing programme. Requirements vary among countries; for example, if tests are to be deployed in areas where temperatures rarely rise above 30 °C, less emphasis is needed on stability at high temperatures than on other aspects of quality.
Ease-of-use requirements depend on the extent of training and the work environment of the users. Particularly in primary health care settings, the simpler the test, the easier it will be to avoid errors in preparation and interpretation.
Detailed results can be found in the report of each evalua-tion (3–6) and at http://www.who.int/malaria/publications/diagnostic_testing/en/.
1.4. summary of outcomesThis laboratory-based evaluation provides a comparative, standardized measure of RDT performance for distinguishing between well and poorly performing tests to serve as a basis for procurement decisions by malaria control programmes and to guide United Nations procurement policy.
In round 5, the proportion of tests that achieved a PDS ≥ 75% at 200 parasites/µL is comparable to those in rounds 3 and 4 for P. falciparum (78.6%); that for P. vivax, 42.4%, is similar to that in round 4.
Several RDTs in the five rounds of testing consistently detected malaria at a low parasite density (200 parasites/µL), had low false-positive rates, are stable at tropical temperatures, are relatively easy to use and can detect P. falciparum or P. vivax infections or both.
Although the performance of the products varied widely at low parasite density (200 parasites/µL), all products had a high rate of detection of P. falciparum at 2000 or 5000 parasites/µL, as did the majority of products for P. vivax at 2000 parasites/µL.
P. falciparum tests that target the HRP2 antigen had the highest detection rates, and two previously evaluated tests that target pan-pLDH for detection of Plasmodium spp. infec-tion also achieved a good PDS. In round 5, the two poorest performing tests for detection of P. falciparum were based on P. falciparum-specific pLDH detection. Thus, the choice of 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 testing lots after purchase and before use in the field. Furthermore, anomalies that interfered with test interpreta-tion were regularly recorded during round 5 (Annex S2). All products had issues with red background and with incomplete clearing, and cases of samples failing to flow or migrate on the RDT were reported for 62% of products.
Ninety-eight percent of the RDTs evaluated in round 5 were in cassette format.
With regard to products retested under the compulsory resubmission requirement, one showed improved (4.8%) detection of P. falciparum and one improved (4.3%) detection of P. vivax, while six and two had diminished performance (> 5% decrease) for detection of P. falciparum (mean, 13.9%; median, 8.4%) and P. vivax (mean, 8.5%), respectively. All products except one had the same or lower false-positive rates (mean improvement, 3.7%).
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54 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
1.5. How can product testing results inform rdt procurement and use?Accurate diagnosis is vital to good malaria case management, whether based on microscopy or RDTs. The results of this report should be used to identify a short list of RDTs for procurement for use in settings where good microscopy is not available or appropriate. Box 3 lists WHO’s minimum criteria for RDT selection, and Annex S3 provides a step-by-step approach to selecting an RDT, taking into consideration local malaria transmission and illness where the tests will be used (e.g. Plasmodium species, target antigen, parasite densities, climate) and other important considerations, including ease of use in the field (Annex S2), training or retraining require-ments and lot testing.1
The tabular results in TableS2 are colour-coded to reflect achievement of WHO performance requirements for RDT procurement, and a web-based tool that allows filtering of product testing results by various parameters to assist in selecting products with the performance characteristics most suitable for a country’s health programme is available and maintained by FIND (12). Comprehensive guidance on several aspects of procurement can be found in Good practices for selecting and procuring rapid diagnostic tests for malaria and guidance on implementation in Universal access to malaria diagnosis (13, 14).
1 The WHO-FIND malaria RDT evaluation programme provides lot-testing capacity in two regional laboratories free of charge; it can be accessed at [email protected] and [email protected].
1.6. product testing and WHo programme for prequalification of diagnostics and medical devicesThe WHO prequalification of diagnostics and medical devices programme uses the results of product testing as the labora-tory evaluation component of the prequalification process for malaria RDTs. These data are used to set priorities for dossier review and inspection. Although prequalification is not currently a requirement for WHO procurement, manu-facturers are encouraged to apply for it. A list of prequalified diagnostics, including malaria RDTs, is available at http://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/.
Box 3: WHO selection criteria for the procurement of RDTs
Products should be selected in line with the following set of criteria, based on the results of the assessment of the WHO Malaria RDT Product Testing Programme:
(A) For the detection of Plasmodium falciparum (Pf) in all transmission settings the panel detection score (PDS) against Pf samples should be at least 75% at 200 parasites/μL.
(B) For the detection of Plasmodium vivax (Pv) in all transmission settings the panel detection score (PDS) against Pv samples should be at least 75% at 200 parasites/μL.
(C) The false positive rate should be less than 10%.
(D) The invalid rate should be less than 5%.
Only products meeting performance criteria outlined in A,B,C and D are recommended for procurement
6 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Figure S1: Malaria RDT performance in phase 2 of rounds 2-5 against wild-type (clinical) samples containing P. falciparum at low (200) and high (2000-5000) parasite density (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 the 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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sUM
Ma
rY
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1-5
76 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Figure S1: Malaria RDT performance in phase 2 of rounds 2-5 against wild-type (clinical) samples containing P. falciparum at low (200) and high (2000-5000) parasite density (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 the 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
Cor
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024
BIO
CR
EDIT
Mal
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8 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Figure S2: Malaria RDT performance in phase 2 of rounds 2-5 against wild-type (clinical) samples containing P. vivax at low (200) and high (2000 or 5000) parasite density (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 the 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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mb
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asy
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aria
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id T
est
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ice
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f (H
RP
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(PA
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igen
Det
ectio
n T
est
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ice
MF
V-1
24R
AZ
OG
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aria
pf
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PII)
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H)/
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igen
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ectio
n D
evic
e M
FV
-124
FA
BO
N M
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an/P
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apid
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t D
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isca
n® M
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f/P
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hC
G M
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tion
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t D
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e M
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aria
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t M
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N-0
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f (H
RP
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pv
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ntig
en D
etec
tion
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t D
evic
e 1-
13-1
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aria
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) / p
v (p
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ectio
n T
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ice
MF
V-1
24V
Mal
aria
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Ad
vanc
ed Q
ualit
y™ O
ne S
tep
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aria
P.f
/P.v
Tri-
Line
Tes
t IT
P11
003
TC
40
sUM
Ma
rY
ro
Un
ds
1-5
98 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Figure S2: Malaria RDT performance in phase 2 of rounds 2-5 against wild-type (clinical) samples containing P. vivax at low (200) and high (2000 or 5000) parasite density (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 the minimum specified reading time, are positive. b Clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality.
100
90
80
70
60
50
40
30
20
10
0
100
80
60
40
20
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Fals
e-p
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ve Plasm
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sp
p.
rate
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mp
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and
inva
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rea
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200 parasites/µL2000 parasites/µLFalse-positive Plasmodium spp. rate (%)Invalid rate (%)
10 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Figure S3: Panel detection score of malaria combination and pan-only RDTs, meeting WHO procurement criteria for false-positive and invalid rates, in phase 2 of rounds 2-5 against wild-type (clinical) samples containing P. falciparum and P. vivax at low (200) parasite density (parasites/μL)
100
80
60
40
20
00 20 40 60 80 100
Panel detection score P. falciparuma
Pan
el d
etec
tion
sco
re P
. viv
axa 100
95
90
85
80
75
Panel detection score P. falciparuma
Pan
el d
etec
tion
sco
re P
. viv
axa
75 80 85 90 95 100
75 80 85 90 95 100
Panel detection score P. falciparuma
Pan
el d
etec
tion
sco
re P
. viv
axa
60
40
20
0
60
40
20
00 20 40 60
Panel detection score P. falciparuma
Pan
el d
etec
tion
sco
re P
. viv
axa
1 diagnosticks MALARIA (Pan/Pf) Cassette- MPNFWBC1007.42 Core™ Malaria Pv/Pf - MAL-1900223 FalciVax™ - Rapid test for Malaria Pv/Pf - 503000254 SD BIOLINE Malaria Ag Pf/ Pf/ Pv - 05FK1005 SD BIOLINE Malaria Ag Pf/Pv - 05FK80/05FK836 Malaria pf (HRP II) / (PAN-pLDH) Antigen Detection Test Device - MFV-124R7 IND ONE STEP MALARIA ANTIGEN P.f/Pan TEST - 535-108 SD BIOLINE Malaria Ag P.f/Pan - 05FK60/05FK639 BIONOTE MALARIA P.f.& Pan Ag Rapid Test Kit - RG19-0810 diagnosticks MALARIA (Pan/Pv/Pf) Cassette - MPNVFC1007.511 ICT Malaria Dual Test - ML0312 BIONOTE MALARIA P.f.& P.v. Ag Rapid Test Kit - RG19-1213 Core™ Malaria Pan/Pv/Pf - MAL-19002614 NanoSign Malaria pf/pan Ag 3.0 - RMAP1015 Humasis Malaria P.f/P.v Antigen Test - AMFV-702516 RAPID 1-2-3® HEMA CASSETTE MALARIA PF/PV TEST - MAL-PFV-CAS/25(100)17 Parascreen® - Rapid test for Malaria Pan/Pf - 5031002518 OnSight™ - ParaQuick-2 (Pv,Pf) Malaria Test - 537-25-DB19 diagnosticks- Malaria (Pv/Pf) Cassette - KMVFC600220 CareStart™ Malaria HRP2/pLDH (Pf/Pv) COMBO - G016121 Medisensor Malaria HRP2/pLDH (Pf/Pv) COMBO - M16122 SD BIOLINE Malaria Ag Pf/ Pan - 05FK6623 CareStart™ Malaria HRP2/pLDH (Pf/PAN) COMBO - G013124 DIAQUICK Malaria P.f/Pan Cassette - Z11200CE25 Humasis Malaria P.f/Pan Antigen Test - AMAL-702526 CareStart™ Malaria HRP2/pLDH (Pf/VOM) COMBO - G017127 HiSens Malaria Ag P.f/P.v Combo Card - HR312328 HiSens Malaria Ag P.f/VOM Combo Card - HR332329 Medisensor Malaria HRP2/pLDH (Pf/VOM) COMBO - M17130 Malaria Pf/Pan One Step Rapid Test - RT 2022231 CareStart™ Malaria pLDH 3 Line Test - G012132 Advanced Quality™ Rapid Malaria Test (Pf/Pan) - ITP1100533 FirstSign™ ParaView (Pan+Pf) - 2101CB-2534 Wondfo® One Step Malaria P.f/P.v Whole Blood Test - W056-C35 CareStart™ Malaria Screen - G023136 OnSite Pf/Pan Ag Rapid Test - R0113C37 Vikia® Malaria Ag Pf/Pan - 41249938 ABON™ Plus Malaria P.f/Pan Rapid Test Device (Whole Blood) - IMA-T40239 First Response® Malaria Ag. pLDH/HRP2 Combo Card Test - I16FRC
40 Malaria Pf (HRPII)/ PV (PLDH) Antigen Detection Test Device - GM00641 ParaHIT - Total Ver. 1.0 (Device) - 55IC204-1042 Advantage Malaria Pan + Pf Card - IR23102543 GenBody™Malaria Pf/Pan Ag - MALAG10044 HiSens Malaria Ag Pf/Pv (HRP2/pLDH) Card - HR292345 Maleriscan® Malaria Pf/PAN (Pv, Pm, Po) 3 Line Antigen Test - MAT-PF/PAN-5046 CareStart™ Malaria/Pregnancy Combo (pLDH/HRP2/HCG) - G022147 Surestep™ Easy Malaria Pf/Pan Rapid Test Device - IMA-T40248 EzDx™ Malaria Pan/Pf Rapid Test Detection kit - RK MAL 00149 Clearview® Malaria Combo - VB1150 Malascan™ Device - Rapid test for Malaria Pf/Pan - 5040202551 ASAN Easy Test® Malaria Pf/Pan Ag - AM4650-K52 Malaria pf (HRP II) / pv (pLDH) Antigen Detection Test Device - MFV-124V53 OnSite Pf/Pv Ag Rapid Test - R0112C54 Advantage Malaria Card - IR21102555 BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C30RHA2556 BioTracer™ Malaria Pf/PAN Rapid Card - 1701257 ICT MALARIA COMBO - ML0258 ParaHIT - Total Ver. 1.0 (Dipstick) - 55IC203-1059 IMMUNOQUICK CONTACT MALARIA +4 - 0525K2560 ABON Malaria Pan/P.f. Rapid Test Device - IMA-B40261 MeDiPro Malaria Ag HRP2/pLDH Combo - IR-0051K62 ACCUCARE ONE STEP MALARIA Pf/Pan Antigen Test - MAGC 2563 ParaHIT® total (dipstick) - 55IC201-1064 Malaria pf (HRP II)/PAN (pLDH) Antigen Detection Test Device - 1-13-101-165 ParaHIT®fV Rapid test for P. falciparum and P.vivax Malaria - Device - 55IC402-566 AZOG Malaria pf (HRPII)/pf (LDH)/ (PAN-LDH) Antigen Detection Device - MFV-124F67 Malaria Pf./Pan Antigen (MAL Pf/Pan) Test Kit - A03-18-32268 Malaria pf (HRP II) / pv (pLDH) Antigen Detection Test Device - MFV-124V69 Maleriscan® Malaria Pf/Pv - MAT-5070 OptiMAL-IT - 71002471 Malaria Pf/Pv - GM00272 Malaria Pf/ PAN - GM00473 One Step Malaria P.f/Pan Test - W56-C74 Advantage Mal Card - IR22102575 HiSens Malaria Ag P.f/P.v Card - HR282376 SD BIOLINE Malaria Ag - 05FK4077 NanoSign Malaria Pf/Pv Ag - RMAD10
a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.
sUM
Ma
rY
ro
Un
ds
1-5
1110 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Table S1: Product resubmissions: WHO malaria RDT product testing rounds 1—5
Manufacturer Product name Catalogue No.
Product re-submission
Round
Voluntary Compulsory
Access BIo, Inc.
CareStart™ Malaria HRP2/PLDH (Pf/Pv) COMBO G0161 2, 4CareStart™ Malaria HRP2/PLDH (Pf/VOM) COMBO G0171 2, 4CareStart™Malaria HRP2 (Pf) G0141 1 5CareStart™ Malaria HRP2/pLDH (Pf/PAN) Combo G0131 1 5CareStart™Malaria pLDH (PAN) G0111 1 5
Advy Chemical Pvt. Ltd. (Affiliate of Bharat Serums & Vaccines Ltd. ) EzDx™ Malaria Pan/Pf Rapid Test Detection Kit RK MAL 001 4, 5
Biosynex IMMUNOQUICK® MALARIA falciparum 0502_K25 1 5
AZOGMalaria pf (HRP II) / (PAN-LDH) Antigen Detection Test Devicea MFV-124R 1, 3Malaria pf (pLDH) / PAN-pLDH Test Device MFV-124 3, 5
Bhat Bio-Tech India (P) Ltd. Maleriscan® Malaria Pf/PAN (Pv, Pm, Po) 3 Line Antigen Test MAT-PF/PAN-50 4, 5Bioland NanoSign Malaria Pf/Pan Ag RMAP10 3, 4
Blue Cross Bio-Medical (Beijing) Co., Ltd.One Step Malaria Pf Test (cassette) 522352 2, 3, 4One Step Malaria P.F/P.V Test (Cassette) 523352 4, 5
CTK Biotech, Inc.Onsite Pf Ag Rapid Test R0114C 2, 3Onsite Malaria Pf/Pan Malaria Ag Rapid Test R0113C 2, 3, 4, 5Onsite Malaria Pf/Pv Ag Rapid Test R0112C 2, 3, 4
DiaMed - A Division of Bio-Rad OptiMAL-IT 710024 1, 3
Guangzhou Wondfo Biotech Co. Ltd.Wondfo One Step Malaria Pf/Pan Whole Blood Test W56-C 1, 3One Step Malaria P.f Testb W37-C 2, 3, 4
ICT INTERNATIONALICT Malaria Combo Cassette Test ML02 1, 3, 4ICT Malaria Pf Cassette Test ML01 1, 3ICT Malaria Dual Test ML03 3, 5
InTec Products, Inc. Advanced Quality™ One Step Malaria Pf Test ITP11002TC1/TC40 1, 3 5Humasis Co., Ltd. Humasis Malaria Pf/Pan Antigen Test AMAL-7025 4, 5
J.Mitra & Co. Pvt. Ltd.Advantage Pan Malaria Card IR013025 1 5Advantage Mal Card IR221025 1 5Advantage P.f Malaria Card IR016025 1 5
Orchid Biomedical SystemsParacheck® Pf Device - Rapid test for P. falciparum Malaria (Ver. 3)c 30301025 1, 3, 4Paracheck® Pf Dipstick - Rapid test for P. falciparum Malaria (Ver.3)c 30302025 1, 3, 4
Premier Medical Corporation Ltd. First Response® Malaria Ag Combo (pLDH/HRP2)d I16FRC 1, 2, 5First Response Malaria Ag P. falciparum (HRP2) Card Test I13FRC 1 5
SSA Diagnostics & Biotech Systems diagnosticks- Malaria (Pf)Cassette WB KMFC6001 2, 5
Standard Diagnostics Inc. SD BIOLINE Malaria Ag 05FK40 1, 3SD BIOLINE Malaria Ag Pf/Pan 05FK60/05FK63 1, 3, 5SD BIOLINE Malaria Antigen 05FK50/05FK53 1 5
Unimed International Inc. FirstSign™ - ParaView (Pan+Pf) Malaria Test 2101 CB-25 2, 4
Vision Biotech (Pty) Ltd / Orgenics (Alere Healthcare (Pty) Ltd subsidaries)
Malaria Rapid Combo/Clearview® Malaria Combo VB11e 1, 3Malaria Rapid Pf /Clearview ®Malaria Pf VB01 1, 3, 5Malaria Rapid Dual/Clearview® Malaria Dual Test Device VB20e 1, 3, 5
Zephyr Biomedical Systems
Malascan™ Device - Rapid test for Malaria Pf/Pan 50402025 1, 3Parabank™ Device - Rapid test for Malaria Pan 50301025 1, 3Parascreen™ Device -Rapid test for Malaria Pan/Pf 50310025 1, 3, 4, 5Falcivax Rapid Test for Malaria Pv/Pf (device) 50300025 2, 4
a Round 1 product name error: published - Malaria Pf (HRPII)/pv-LDH) Antigen Detection Test Device Code; corrected product name: Malaria Pf (HRPII/PAN-LDH) Antigen Detection Test Device Code. No change in product code.
b In round 2, product did not pass phase-1, therefore results do not feature in summary tables. c Ver.3 was introduced after round 1d Error in WHO malaria RDT product testing: round 1 report: product code (II6FRC30) should have been ( I16FRC ), as in round 2e New company acquisition (Alere™), therefore change in product branding and catalogue numbers; VB011 to VB11 and VB020 to VB20. Manufacturer confirmed
compliance with product definition.
12 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Tabl
e S2
: Mal
aria
RDT
pha
se-2
per
form
ance
in r
ound
s 2–
5 ag
ains
t w
ild-t
ype
(clin
ical
) sa
mpl
es c
onta
inin
g P.
falc
ipar
um (
Pf)
and
P. v
ivax
(Pv
) at
low
(200
)
and
high
(200
0-50
00)
para
site
den
sity
(pa
rasi
tes/
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 r
ate
(%)l
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
False
-po
sitiv
e
non-
Pf
infe
ctio
ne
False
-po
sitiv
e
Pf
infe
ctio
nf
False
-po
sitiv
e
non-
Pf
infe
ctio
ng
False
-po
sitiv
e
Pf
infe
ctio
nh
False
-pos
itive
Pl
asm
odiu
m sp
p.
Infe
ctio
ni
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
td32
.7N
A99
.0N
AN
A0.
0N
A0.
00.
40.
04
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia P
f Tes
tjIT
P110
02TC
1/TC
40In
Tec
Prod
ucts
, Inc
.53
.0N
A93
.0N
AN
A3.
6N
A5.
77.
7 (2
33)
0.4
5
Adva
ntag
e P.
f. M
alar
ia C
ardj
IR01
6025
J. M
itra
& C
o. P
vt. L
td.
89.0
NA
99.0
NA
NA
0.7
NA
0.0
0.0
0.0
5BI
OCRE
DIT
Mal
aria
pf(H
RP II
)H
R010
0Ra
piG
en In
c.99
.0N
A10
0.0
NA
NA
97.1
NA
95.5
999
.1 (2
31)
0.5
4BI
ONOT
E M
ALAR
IA P
.f. A
g Ra
pid
Test
Kit
RG19
-11
Bion
ote,
Inc.
85.9
NA
99.0
NA
NA
0.0
NA
1.4
2.0
0.1
3Ca
reSt
art™
Mal
aria
HRP
2 (P
f)jG
0141
Acce
ss B
io, I
nc.
91.0
NA
100.
0N
AN
A0.
0N
A0.
00.
90.
05
Care
Star
t™ M
alar
ia H
RP2/
pLDH
Pf t
est
G01
81Ac
cess
Bio
, Inc
.98
.0N
A10
0.0
NA
NA
0.6
NA
1.3
3.0
0.0
2Cl
earv
iew
® M
alar
ia P
.f.j
VB01
Visi
on B
iote
ch (P
ty) L
td83
.8N
A10
0.0
NA
NA
0.0
NA
0.0
0.0
0.0
3Co
re™
Mal
aria
Pf
MAL
-190
020
Core
Dia
gnos
tics
97.0
NA
100.
0N
AN
A0.
0N
A0.
01.
0 (1
98)
0.3
3di
agno
stic
ks-
Mal
aria
(Pf)
Cass
ette
WB
KMFC
6001
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
88.0
NA
100.
0N
AN
A2.
1N
A1.
40.
9 (2
35)
0.3
5di
agno
stic
ks-
Mal
aria
(Pf)
Dips
tick
WB
KMFD
6007
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
80.0
NA
99.0
NA
NA
2.5
NA
3.8
2.0
0.0
2Fi
rst R
espo
nse®
Mal
aria
Ag
P. fa
lcip
arum
(HRP
2) C
ard
Test
jI1
3FRC
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.95
.0N
A10
0.0
NA
NA
0.7
NA
0.0
0.4
0.0
5Fi
rstS
ign™
Mal
aria
Pf
2100
CB-2
5U
nim
ed In
tern
atio
nal I
nc.
94.9
NA
100.
0N
AN
A0.
7N
A1.
472.
2 (2
31)
0.2
4H
iSen
s M
alar
ia A
g Pf
HRP
2 Ca
rd
HR3
023
HBI
Co.
, Ltd
.87
.0N
A10
0.0
NA
NA
0.0
NA
0.0
1.0
0.1
2IC
T Di
agno
stic
s M
alar
ia P
.f.j
ML0
1IC
T IN
TERN
ATIO
NAL
86.9
NA
98.0
NA
NA
0.0
NA
0.0
0.0
0.0
3IM
MU
NOQ
UIC
K CO
NTA
CT fa
lcip
arum
05
19K2
5Bi
osyn
ex81
.8N
A10
0.0
NA
NA
3.6
(139
)N
A1.
44.
0 (1
99)
0.3
3IM
MU
NOQ
UIC
K® M
ALAR
IA fa
lcip
arum
j05
02_K
25Bi
osyn
ex72
.0N
A93
.0N
AN
A3.
6N
A4.
35.
1 (2
34)
0.2
5IN
D ON
E ST
EP M
ALAR
IA A
NTI
GEN
P.f
535-
11IN
D Di
agno
stic
s In
c.61
.2N
A99
.0N
AN
A2.
2N
A14
.71
6.0
0.1
4
KHB®
Mal
aria
Ag
P.f R
apid
Tes
tKH
-R-0
6-20
Sh
angh
ai K
ehua
Bio
-eng
inee
ring
Co.,L
td.
79.0
NA
91.8
(98)
NA
NA
11.4
NA
12.9
10.6
(235
)0.
75
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.83
.7N
A98
.0N
AN
A1.
5N
A0.
00.
40.
24
Nan
oSig
n M
alar
ia P
f Ag
RMAF
10Bi
olan
d, L
td84
.9N
A10
0.0
NA
NA
0.0
NA
0.0
0.0
0.3
3On
e St
ep M
alar
ia P
.F T
est (
Cass
ette
)j52
2352
Blue
Cro
ss B
io-M
edica
l (Be
ijing
) Co.
, Ltd
.94
.9N
A99
.0N
AN
A0.
0N
A1.
471.
30.
04
OnSi
ght™
- M
alar
ia P
f Tes
t51
1-25
-DB
Amge
nix
Inte
rnat
iona
l, In
c.74
.0N
A99
.0N
AN
A8.
1N
A2.
511
.00.
02
OnSi
te P
f Ag
Rapi
d Te
stj
R011
4CCT
K Bi
otec
h, In
c.85
.9N
A10
0.0
NA
NA
0.7
NA
0.0
3.5
0.0
3Pa
rach
eck®
Pf-
Rapi
d Te
st fo
r P. f
alci
paru
m M
alar
ia D
evic
e (V
er.3
)j30
2030
025
Orch
id B
iom
edic
al S
yste
ms
95.9
NA
98.0
NA
NA
0.0
NA
0.0
1.3
0.0
4Pa
rach
eck®
Pf-
Rapi
d Te
st fo
r P. f
alci
paru
m M
alar
ia D
ipst
ick (
Ver.3
)j30
2040
025
Orch
id B
iom
edic
al S
yste
ms
70.4
NA
99.0
NA
NA
0.0
NA
0.0
0.9
0.0
4Pa
raH
IT®
- f (
Devi
ce)
55IC
104-
50Sp
an D
iagn
ostic
s Lt
d.84
.9N
A10
0.0
NA
NA
0.0
NA
0.0
0.0
0.0
3Pa
raH
IT®
-f (D
ipst
ick)
55IC
103-
50Sp
an D
iagn
ostic
s Lt
d.80
.8N
A99
.0N
AN
A0.
0N
A1.
42.
50.
03
SD B
IOLI
NE
Mal
aria
Ag
P.f.
(HRP
2/pL
DH)k
05FK
90St
anda
rd D
iagn
ostic
s In
c.87
.9N
A10
0.0
NA
NA
0.0
NA
0.0
2.0
0.0
3SD
BIO
LIN
E M
alar
ia A
g Pf
j05
FK50
/05F
K53
Stan
dard
Dia
gnos
tics,
Inc.
95.0
NA
99.0
NA
NA
0.0
NA
2.9
0.0
0.0
5Tr
usty
™ M
alar
ia A
ntig
en P
.f. te
stA0
3-01
-322
Artr
on L
abor
ator
ies
Inc.
88.8
NA
100.
0N
AN
A4.
4 (1
35)
NA
2.94
5.2
(230
)0.
74
Visi
on M
alar
ia P
fjVB
01Vi
sion
Bio
tech
(Pty
) Ltd
84.0
NA
100.
0N
AN
A2.
1N
A1.
45.
1 (2
35)
0.1
5W
ondf
o On
e St
ep M
alar
ia P
.f Te
stj
W 3
7-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.89
.8N
A99
.0N
AN
A0.
0N
A0.
00.
4 (2
31)
0.2
4Pf
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.
69.7
0.0
99.0
62.9
0.0
0.0
0.0
0.0
0.0
0.0
3AB
ON™
Plu
s M
alar
ia P
.f/Pa
n Ra
pid
Test
Dev
ice
(Who
le B
lood
)IM
A-T4
02AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td85
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910
0.0
97.1
0.0
0.0
0.0
0.0
0.4
0.0
4AC
CUCA
RE O
NE
STEP
MAL
ARIA
Pf/
Pan
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en T
est
MAG
C 25
LAB-
CARE
Dia
gnos
tics (
Indi
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VT. L
TD.
66.0
37.1
92.0
97.1
0.3
0.0
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)0.
0 (1
99)
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7.3
(234
)0.
45
Adva
nced
Qua
lity™
Rap
id M
alar
ia T
est (
Pf/P
an)
ITP1
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c Pr
oduc
ts, I
nc.
88.0
60.0
100.
097
.10.
3 (3
89)
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0 (1
97)
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8.7
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15
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ntag
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al C
ardj
IR22
1025
J. M
itra
& C
o. P
vt. L
td.
30.0
94.3
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0.7
0.5
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5
sUM
Ma
rY
ro
Un
ds
1-5
1312 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
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
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itive
ra
tesb
(%)
Inva
lid r
ate
(%)l
Roun
d
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pa
rasit
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r 50
00
para
sites
/μL
200
pa
rasit
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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
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sam
ples
Pf s
ampl
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sam
ples
False
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sitiv
e
non-
Pf
infe
ctio
ne
False
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sitiv
e
Pf
infe
ctio
nf
False
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e
non-
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ng
False
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sitiv
e
Pf
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nh
False
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itive
Pl
asm
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p.
Infe
ctio
ni
Adva
ntag
e M
alar
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an +
Pf C
ard
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J. M
itra
& C
o. P
vt. L
td.
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0.0
100.
03.
50.
00.
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0 (6
9)0.
00.
25
AZOG
Mal
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pf (
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apid
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tech
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34
diag
nost
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MAL
ARIA
(Pan
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Cass
ette
M
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Tabl
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(con
tinue
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(con
tinue
d)
14 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Prod
uct
Cata
logu
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r M
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actu
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l det
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Pv samplesd
Pf samplesc
Pv samplesd
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ampl
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sam
ples
Pf s
ampl
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sam
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False
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sitiv
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non-
Pf
infe
ctio
ne
False
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Pf
infe
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nf
False
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False
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False
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m sp
p.
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Rapi
d Te
stj
R011
2CCT
K Bi
otec
h, In
c.79
.610
0.0
100.
010
0.0
1.5
0.0
2.0
0.0
1.3
0.0
4Pa
raHI
T®fV
Rap
id te
st fo
r P. f
alcip
arum
and
P. v
ivax
Mal
aria
- De
vice
55IC
402-
50Sp
an D
iagn
ostic
s Lt
d.63
.037
.191
.085
.72.
0 (3
99)
5.7
0.5
2.9
6.4
0.1
5
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
Tabl
e S2
: Mal
aria
RDT
pha
se-2
per
form
ance
in r
ound
s 2–
5 ag
ains
t w
ild-t
ype
(clin
ical
) sa
mpl
es c
onta
inin
g P.
falc
ipar
um (
Pf)
and
P. v
ivax
(Pv
) at
low
(200
)
and
high
(200
0-50
00)
para
site
den
sity
(pa
rasi
tes/
μL)
and
clea
n-ne
gati
ve s
ampl
es (c
ontin
ued)
sUM
Ma
rY
ro
Un
ds
1-5
1514 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
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 r
ate
(%)l
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
False
-po
sitiv
e
non-
Pf
infe
ctio
ne
False
-po
sitiv
e
Pf
infe
ctio
nf
False
-po
sitiv
e
non-
Pf
infe
ctio
ng
False
-po
sitiv
e
Pf
infe
ctio
nh
False
-pos
itive
Pl
asm
odiu
m sp
p.
Infe
ctio
ni
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
80/0
5FK8
3St
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
Won
dfo®
One
Ste
p M
alar
ia P
.f/P.
v W
hole
Blo
od T
est
W05
6-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.87
.028
.698
.097
.11.
5 (3
99)
2.9
1.5
2.9
2.1
0.1
5Pf
, Pv
and
pan
Core
™ M
alar
ia P
an/P
v/Pf
M
AL-1
9002
6Co
re D
iagn
ostic
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.
5SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s93
.911
.499
.094
.30.
0 (3
89)
0.0
(139
)0.
0 (1
96)
2.9
(69)
4.0
(199
)1.
13
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.
89.0
45.0
100.
010
0.0
0.0
(399
)2.
50.
00.
024
.50.
12
Para
max
-3 R
apid
Tes
t for
Mal
aria
Pan
/Pv/
Pf (d
evic
e)50
3200
25Ze
phyr
Bio
med
ical
s93
.045
.010
0.0
100.
00.
0 (3
96)
0.0
(159
)0.
0 (1
99)
0.0
37.0
(198
)0.
72
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ardj
IR01
3025
J. M
itra
& C
o. P
vt. L
td.
77.0
100.
098
.010
0.0
NA
NA
NA
NA
0.4
0.0
5AZ
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
)jG
0111
Acce
ss B
io, I
nc.
84.0
88.6
99.0
97.1
NA
NA
NA
NA
0.0
0.0
5
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
s Pv
om, P
lasm
odiu
m v
ivax
, ova
le a
nd m
alar
iae
a A
sam
ple
is c
onsi
dere
d de
tect
ed o
nly
if al
l RDT
s fro
m b
oth
lots
read
by
the
first
tech
nici
an,
at m
inim
um s
peci
fied
read
ing
time,
are
pos
itive
b Th
e tot
al n
umbe
r of t
imes
a po
sitiv
e res
ult f
or m
alar
ia w
as g
ener
ated
whe
n it
shou
ld n
ot h
ave b
een
c Ro
und
1, n
=79;
roun
d 2,
n=1
00; r
ound
3, n
=99;
roun
d 4,
n=9
8; ro
und
5, n
=100
d Ro
und
1, n
=20;
roun
d 2,
n=4
0; ro
und
3, n
=35;
roun
d 4,
n=3
4; ro
und
5, n
=35
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 (ro
und
1 n=
316;
roun
d 2,
n=4
00; r
ound
3, n
=396
; rou
nd 4
, n=3
92; r
ound
5, n
=400
)f
Pf li
ne p
ositi
ve in
dica
tes
a fa
lse-
posi
tive
P. fa
lcip
arum
infe
ctio
n (ro
und
1, n
=80;
roun
d 2,
n=
160;
roun
d 3,
n=1
40; r
ound
4, n
=136
; rou
nd 5
, n=1
40)
g
For
com
bina
tion
test
s, pa
n or
Pv
line,
onl
y, p
ositi
ve in
dica
tes
a fa
lse-
posi
tive
non-
P. fa
lcip
arum
infe
ctio
n (r
ound
1, n
=15
8; r
ound
2, n
=20
0; r
ound
3, n
=19
8;
roun
d 4,
n=1
96; r
ound
5, n
=200
)h
Pf li
ne p
ositi
ve in
dica
tes
a fa
lse-
posi
tive
P. fa
lcip
arum
infe
ctio
n (ro
und
1, n
=40
; ro
und
2, n
=80,
roun
d 3,
n=7
0; ro
und
4, n
=68;
roun
d 5,
n=7
0)i
Roun
d 1,
n=1
68; r
ound
2, n
=200
; rou
nd 3
, n=2
00; r
ound
4, n
=232
roun
d 5,
n=2
36j
Prod
uct
resu
bmis
sion
, res
ults
fro
m m
ost
rece
nt r
ound
of
test
ing
repl
ace
prev
ious
re
sults
. Ref
er to
Tab
le S
1.
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 p
f-pL
DH).
For t
est l
ine-
spec
ific
resu
lts re
fer t
o th
e ta
bles
and
ann
exes
in th
e fu
ll re
port
s.l
Rou
nd 1
, n=
954;
rou
nd 2
, n=
1240
; ro
und
3, n
=12
04;
roun
d 4,
n=
1192
; Ro
und
5, n
=121
4
Perf
orm
ance
mea
sure
Reco
mm
ende
d W
HO
pr
ocur
emen
t cr
iteria
Pa
nel d
etec
tion
scor
e fo
r Pf a
nd P
v 20
0/µL
sam
ples
≥ 75
%
Fals
e-po
sitiv
e ra
tes
agai
nst c
lean
-neg
ativ
es
< 10
%
Inva
lid ra
te<
5% o
f tes
ts c
ondu
cted
Tabl
e S2
(con
tinue
d)
16 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Tabl
e S3
: Mal
aria
RDT
rou
nds
2—5
heat
sta
bilit
y re
sult
s on
a c
ultu
red
P. fa
lcip
arum
sam
ple
at lo
w (2
00)
and
high
(200
0) p
aras
ite
dens
ity
(par
asit
es/μ
L).
Posi
tivi
ty r
ate
at b
asel
ine
and
afte
r 60
day
s’ in
cuba
tion
at 3
5 °C
and
45
°C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(p
an li
ne)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(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
4
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia P
f Tes
taIT
P110
02TC
1/TC
40In
Tec
Prod
ucts
, Inc
.93
.396
.790
.010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5
Adva
ntag
e P.
f. M
alar
ia C
arda
IR01
6025
J. M
itra
& C
o. P
vt. L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5BI
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)aG
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
5Ca
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
WBa
KMFC
6001
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
5di
agno
stic
ks-
Mal
aria
(Pf)
Dips
tick
WB
KM
FD60
07SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A2
Firs
t Res
pons
e® M
alar
ia A
g P.
falc
ipar
um (H
RP2)
Car
d Te
sta
I13F
RCPr
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
5Fi
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
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
Inte
rnat
iona
l10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
IMM
UN
OQU
ICK
CON
TACT
falc
ipar
um
0519
K25
Bios
ynex
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3IM
MU
NOQ
UIC
K® M
ALAR
IA fa
lcip
arum
a05
02_K
25Bi
osyn
ex10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A5
IND
ONE
STEP
MAL
ARIA
AN
TIG
EN P
.f 53
5-11
IND
Diag
nost
ics
Inc.
100.
010
0.0
86.7
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
KHB®
Mal
aria
Ag
P.f R
apid
Tes
tKH
-R-0
6-20
Sh
angh
ai K
ehua
Bio
-eng
inee
ring
Co.,L
td.
100.
010
0.0
100.
010
0.0
100.
010
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Step
Mal
aria
P.f/
Pan
Test
a W
56-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.46
.713
.326
.710
0.0
100.
010
0.0
0.0
36.7
73.3
70.0
80.0
100.
03
Tabl
e S3
(con
tinue
d)
(con
tinue
d)
18 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(p
an li
ne)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(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
OnSi
te P
f/Pa
n Ag
Rap
id T
esta
R011
3CCT
K Bi
otec
h, In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
03.
390
.010
0.0
100.
05
OptiM
AL-I
T 71
0024
Diam
ed -
A D
ivis
ion
of B
io-R
ad0.
00.
00.
010
0.0
90.0
0.0
0.0
0.0
0.0
100.
090
.00.
03
Para
HIT
- T
otal
Ver
. 1.0
(Dev
ice)
55IC
204-
10Sp
an D
iagn
ostic
s Lt
d.10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
010
0.0
100.
010
0.0
4Pa
raH
IT -
Tot
al V
er. 1
.0 (D
ipst
ick)
55IC
203-
10Sp
an D
iagn
ostic
s Lt
d.10
0.0
93.3
46.7
100.
010
0.0
60.0
50.0
0.0
0.0
100.
090
.00.
04
Para
HIT
® to
tal (
dips
tick)
55IC
201-
10Sp
an D
iagn
ostic
s Lt
d55
.085
.055
.010
0.0
100.
095
.010
.00.
00.
050
.045
.070
.02
Para
scre
en®
- Ra
pid
test
for M
alar
ia P
an/P
fa50
3100
25Ze
phyr
Bio
med
ical
s10
0.0
100.
010
0.0
100.
010
0.0
100.
010
.03.
313
.310
0.0
100.
010
0.0
5Ri
ghtS
ign™
Mal
aria
P.f.
/Pan
Rap
id T
est C
asse
tte
IMPN
-C52
Han
gzho
u Bi
otes
t Bio
tech
Co.
Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
020
.010
0.0
100.
060
.010
0.0
5SD
BIO
LIN
E M
alar
ia A
g P.
f/Pan
a 05
FK60
/05F
K63
Stan
dard
Dia
gnos
tics
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
100.
010
0.0
100.
05
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
Viki
a® M
alar
ia A
g Pf
/Pan
4124
99IM
ACCE
SS S
.A.S
100.
096
.796
.710
0.0
100.
010
0.0
0.0
0.0
0.0
60.0
60.0
0.0
5Pf
and
Pv/
Pvom
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia P
.f/P.
v Tr
i-Li
ne T
est
ITP1
1003
TC4
0In
Tec
Prod
ucts
, Inc
.96
.710
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3Ad
vant
age
Mal
aria
Car
d IR
2110
25J.
Mitr
a &
Co.
Pvt
. Ltd
.10
0.0
96.7
96.7
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
ASAN
Eas
y Te
st®
Mal
aria
Pf/
Pan
AgAM
4650
-KAS
AN P
harm
aceu
tical
Co.
, Ltd
10
0.0
96.7
63.3
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A5
BION
OTE
MAL
ARIA
P.f.
& P
.v. A
g Ra
pid
Test
Kit
RG19
-12
Bion
ote,
Inc.
100.
096
.710
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A3
Care
Star
t™ M
alar
ia H
RP2/
pLDH
(Pf/
Pv) C
OMBO
aG
0161
Acce
ss B
io, I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4Ca
reSt
art™
Mal
aria
HRP
2/pL
DH (P
f/VO
M) C
OMBO
aG
0171
Acce
ss B
io, I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4Co
re™
Mal
aria
Pv/
PfM
AL-1
9002
2Co
re D
iagn
ostic
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
ics
& B
iote
ch S
yste
ms
100.
095
.095
.010
0.0
100.
095
.0N
AN
AN
AN
AN
AN
A2
Falc
iVax
™ -
Rap
id te
st fo
r Mal
aria
Pv/
Pfa
5030
0025
Zeph
yr B
iom
edic
als
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/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/VOM
Com
bo C
ard
HR3
323
HBI
Co.
, Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Hum
asis
Mal
aria
P.f/
P.v
Antig
en T
est
AMFV
-702
5H
umas
is, C
o., L
td.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4M
alar
ia p
f (H
RP II
) / p
v (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e1-
13-1
01-3
Uni
ted
Biot
ech,
Inc.
10
0.0
100.
010
0.0
90.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4M
alar
ia p
f (H
RP II
) / p
v (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e M
FV-1
24V
AZOG
, Inc
.10
0.0
100.
096
.710
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
3M
alar
ia P
f (H
RPII)
/ PV
(PLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
GM
006
Geno
mix
Mol
ecul
ar D
iagn
ostic
s Pvt
. Ltd
.83
.390
.083
.310
0.0
90.0
70.0
NA
NA
NA
NA
NA
NA
5M
alar
ia P
f/Pv
GM
002
Geno
mix
Mol
ecul
ar D
iagn
ostic
s Pvt
.Ltd.
40.0
33.3
40.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A4
Mal
eris
can®
Mal
aria
Pf/
PAN
(Pv,
Pm, P
o) 3
Lin
e An
tigen
Tes
tM
AT-P
F/PA
N-5
0Bh
at B
io-T
ech
Indi
a (P
) Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
AN
AN
AN
AN
AN
A5
Mal
eris
can®
Mal
aria
Pf/
Pv
MAT
-50
Bhat
Bio
-Tec
h In
dia
(P) L
td10
0.0
60.0
30.0
100.
090
.095
.0N
AN
AN
AN
AN
AN
A2
Med
isen
sor M
alar
ia H
RP2/
pLDH
(Pf/
Pv) C
OMBO
M16
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
Med
isen
sor M
alar
ia H
RP2/
pLDH
(Pf/
VOM
) COM
BOM
171
Med
isen
sor,
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4On
e St
ep M
alar
ia P
.F/P
.V T
est (
Cass
ette
)a52
3352
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
5On
Sigh
t™ -
Par
aQui
ck-2
(Pv,P
f) M
alar
ia T
est
537-
25-D
BAm
geni
x In
tern
atio
nal,
Inc.
100.
010
0.0
100.
010
0.0
100.
085
.0N
AN
AN
AN
AN
AN
A2
OnSi
te P
f/Pv
Ag
Rapi
d Te
sta
R011
2CCT
K Bi
otec
h, In
c.10
0.0
100.
090
.010
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4Pa
raHI
T®fV
Rap
id te
st fo
r P. f
alcip
arum
and
P. v
ivax
Mal
aria
- De
vice
55IC
402-
50Sp
an D
iagn
ostic
s Lt
d.10
0.0
96.7
96.7
100.
010
0.0
90.0
NA
NA
NA
NA
NA
NA
5
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
/05F
K83
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
4W
ondf
o® O
ne S
tep
Mal
aria
P.f/
P.v
Who
le B
lood
Tes
tW
056-
CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
100.
096
.793
.310
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
5
Tabl
e S3
: Mal
aria
RDT
rou
nds
2—5
heat
sta
bilit
y re
sult
s on
a c
ultu
red
P. fa
lcip
arum
sam
ple
at lo
w (2
00)
and
high
(200
0) p
aras
ite
dens
ity
(par
asit
es/μ
L).
Posi
tivi
ty r
ate
at b
asel
ine
and
afte
r 60
day
s’ in
cuba
tion
at 3
5 °C
and
45
°C (c
ontin
ued)
sUM
Ma
rY
ro
Un
ds
1-5
1918 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(P
f lin
e)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(p
an li
ne)
Perc
enta
ge p
ositi
ve t
est
resu
lts f
or P
. fal
cipa
rum
(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
only
Adva
ntag
e Pa
n M
alar
ia C
arda
IR01
3025
J. M
itra
& C
o. P
vt. L
td.
NA
NA
NA
NA
NA
NA
36.7
66.7
60.0
100.
010
0.0
90.0
5AZ
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
)aG
0111
Acce
ss B
io, I
nc.
NA
NA
NA
NA
NA
NA
100.
010
0.0
100.
010
0.0
100.
010
0.0
5
Clea
rvie
w®
Mal
aria
pLD
Ha
7088
4025
Org
enic
s Lt
d. (
Inve
rnes
s M
edic
al
Inno
vatio
ns)
NA
NA
NA
NA
NA
NA
96.7
93.3
100.
010
0.0
100.
010
0.0
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
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
Pvo
m, P
lasm
odiu
m v
ivax
, ova
le a
nd m
alar
iae
Indi
cate
s re
sults
for t
hose
pro
duct
s th
at m
eet a
ll W
HO
reco
mm
ende
d pr
ocur
emen
t crit
eria
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
S1.
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
enta
ge p
ositi
ve t
est
resu
lts
for
P. f
alci
paru
m (P
f lin
e)Pe
rcen
tage
pos
itive
tes
t re
sults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
enta
ge p
ositi
ve t
est
resu
lts
for
P. f
alci
paru
m (p
an li
ne)
Perc
enta
ge p
ositi
ve t
est
resu
lts
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
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
AN
ASD
BIO
LIN
E M
alar
ia A
g P.
f. (H
RP2/
pLDH
)- (P
F(pL
DH) l
ine)
05
FK90
Stan
dard
Dia
gnos
tics
Inc.
0.0
0.0
0.0
33.3
33.3
33.3
NA
NA
NA
NA
NA
NA
NA
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
4SD
BIO
LIN
E M
alar
ia A
g Pf
/ Pf/
Pv
- (P
F(pL
DH) l
ine)
05FK
100
Stan
dard
Dia
gnos
tics
Inc.
26
.73.
33.
310
0.0
100.
010
0.0
NA
NA
NA
NA
NA
NA
4
Tabl
e S3
(con
tinue
d)
20 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
2. references
1. World Malaria Report 2013. Geneva: World Health Organization; 2013.
2. Guidelines for the treatment of malaria. 2nd Ed. Geneva: World Health Organization; 2010.
3. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 1 (2008). Geneva: World Health Organization; 2009.
4. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 2 (2009). Geneva: World Health Organization; 2010.
5. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 3 (2010–11). Geneva: World Health Organization; 2011.
6. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 4 (2012). Geneva: World Health Organization; 2012.
7. Informal consultation on laboratory methods for quality assurance of malaria rapid diagnostic tests. Manila: WHO Regional Office for the Western Pacific; 2004 (RS/2004/GE/26(PHL).
8. Prequalification of in vitro diagnostics. Geneva: World Health Organization (http://www.who.int/diagnostics_laboratory/evaluations/en/, accessed 16 May 2014).
9. Parasitological confirmation of malaria diagnosis. Report of a WHO technical consultation. Geneva, 6–8 October 2009. Geneva: World Health Organization; 2010.
10. Gamboa D, Ho MF, Bendezu J, 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.
11. Kumar N, Pande V, Bhatt RM, Shah NK, Mishra N, Srivastava B, Valecha N, Anvikar AR: Genetic deletion of HRP2 and HRP3 in Indian Plasmodium falciparum population and false negative malaria rapid diagnostic test. Acta Trop 2013, 125(1):119-121.
12. Malaria RDT interactive guide. http://www.finddiag-nostics.org/programs/malaria-afs/malaria/rdt_quality_control/product_testing/interactive-guide/index.jsp.
13. Good practices for selecting and procuring rapid diagnostic tests for malaria. Geneva: World Health Organization; 2011.
14. Universal access to malaria diagnostic testing: an opera-tional manual. Geneva: World Health Organization; 2011.
an
ne
xes
2120 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
annexes
22 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
annex s1: characteristics of evaluation panels used in rounds 1–5 of WHo malaria rdt product testing, 2008–2013Currently, the basis for diagnosing malaria with antigen-detecting RDTs is the detection in a patient’s blood of one or more target malaria antigens, including HRP2 (P. falciparum only), pLDH (Plasmodium spp.(pan-pLDH), P. falciparum (Pf-pLDH), non-falciparum (Pv-pLDH, Pvom-pLDH) and aldolase (all Plasmodium spp). The antigen concentration in samples with the same parasite density varies. Therefore, the concentrations of malaria antigens in the samples that comprise evaluation panels must be consistent in successive rounds of WHO malaria RDT product testing to ensure that the results of each round are highly comparable (statistically equivalent).
Therefore, antigen concentrations were quantified in triplicate in all panel samples, including dilution pairs of 200 and 2000 parasites/µL, by quantitative ELISA. Only results that were consistent in the triplicate runs and showed a value factor between the 200 and the 2000 parasites/µL dilutions close to 10 were considered acceptable and eligible for the performance evaluation panel. In some instances, the antigen concentration was below the detection limit of the ELISA, particularly for aldolase, which is present in malaria parasite samples at much lower concentrations than the other two antigens. Samples that gave inconsistent results for more than one of the three antigens were excluded from the panel.
Despite careful standardization of procedures, the tables and figures below show a wide variation in antigen concentra-tions for the same parasite density. There are a number of possible explanations, including differences in the level of antigen expression by isolates; different durations of infection (accumulating antigens); different parasite growth stages at the time of collection (expressing different levels of antigen); the presence of circulating HRP2 from previous growth cycles; and HRP2 produced by parasites sequestered in the host’s vascular tissues that cannot be accounted for in the estimate of parasite density on the blood slide.
Before each round of WHO malaria RDT product testing, the distribution of HRP2, pLDH and aldolase concentrations at 200 parasites/µL dilution of the wild-type P. falciparum and wild-type P. vivax samples selected for the phase-2 panels were systematically compared with those in the previous round to ensure there was no statistically significant differ-ence. The figures and tables below show the distribution of antigen concentrations in all five performance evaluation panels. No statistically significant differences were seen (Kruskal-Wallis test; p > 0.15), confirming that the results of each new round are additive (and comparable) to the previous ones. In the following box and whisker plots, the end of whiskers represent minimum and maximum values; the box represents middle 50% of data and the line through box represents median values; the crosses represent the mean values.
Figure AS1.1: Box-and-whisker plot of distribution of P. falciparum HRP2 concentration (ng/mL) in product testing phase 2 (wildtype) panels.
10.5 2 4 8 16 32 64 128
P. falciparum HRP2 concentration (ng/ml)
Round 5
Round 4
Round 3
Round 2
Round 1
Figure AS1.3: Box-and-whisker plot of distribution of P. vivax pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels.
1 2 4 8 16 32 64
P. vivax pLDH concentration (ng/ml)
Round 5
Round 4
Round 3
Round 2
Round 1
Figure AS1.2: Box-and-whisker plot of distribution of P. falciparum pLDH concentration (ng/mL) in product testing phase 2 (wildtype) panels.
0.5
0.25
0.12
5 1 2 4 8 16 32 64
P. falciparum pLDH concentration (ng/ml)
Round 5
Round 4
Round 3
Round 2
Round 1
Figure AS1.4: Box-and-whisker plot of distribution of P. falciparum aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels.
0.062
50.2
5
0.015
625 1 4 16
P. falciparum aldolase concentration (ng/ml)
Round 5
Round 4
Round 3
Round 2
Round 1
an
ne
xes
2322 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Figure AS1.5: Box-and-whisker plot of distribution of P. vivax aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels.
1 2 4 8 16P. vivax aldolase concentration (ng/ml)
Round 5
Round 4
Round 3
Round 2
Round 1
Table AS1.1: Statistics for P. falciparum HRP2 concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5
Number of valuesa 78 99 99 98 99
Minimum 0.80 0.62 0.62 0.62 0.62
25% percentile 2.90 1.90 2.10 2.97 3.00
Median 9.57 6.76 6.83 6.98 7.05
75% percentile 18.94 16.91 17.37 15.65 15.31
Maximum 73.70 73.70 66.70 62.48 62.48
Mean 15.28 12.70 12.77 12.72 11.74
Std. Deviation 16.98 15.75 15.19 14.72 13.20a The number of values is the number of samples for which consistent ELISA results were obtained.
Table AS1.2: Statistics for P. falciparum pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5
Number of valuesa 74 93 92 92 94
Minimum 0.71 0.19 0.19 0.19 0.19
25% percentile 6.68 6.27 6.23 6.20 6.90
Median 11.95 10.31 11.18 10.92 12.24
75% percentile 23.75 20.10 22.70 21.28 23.05
Maximum 47.15 47.15 47.15 53.53 43.02
Mean 15.31 13.71 15.08 14.97 15.53
Std. Deviation 11.47 10.90 11.72 11.98 11.43a The number of values is the number of samples for which consistent ELISA results were obtained.
Table AS1.3: Statistics for P. vivax pLDH concentration (ng/mL) in wildtype product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5
Number of valuesa 20 37 33 32 34
Minimum 5.10 1.64 1.64 1.64 1.64
25% percentile 8.10 8.40 7.30 6.96 6.26
Median 12.65 17.00 19.78 17.50 13.22
75% percentile 27.40 29.69 31.89 29.84 23.42
Maximum 44.40 47.90 47.90 47.90 47.90
Mean 17.38 20.24 20.99 20.00 16.84
Std. Deviation 11.57 13.27 13.55 13.00 12.59a The number of values is the number of samples for which consistent ELISA results were obtained.
24 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Table AS1.4: Statistics for P. falciparum aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5
Number of valuesa 77 98 99 98 99
Minimum 0.00 0.00 0.00 0.00 0.00
25% percentile 0.84 0.74 0.67 0.63 0.52
Median 1.61 1.49 1.40 1.25 1.17
75% percentile 2.25 2.25 2.23 2.25 2.07
Maximum 9.90 9.90 9.90 9.08 7.74
Mean 1.93 1.79 1.76 1.72 1.52
Std. Deviation 1.73 1.66 1.69 1.68 1.52a The number of values is the number of samples for which consistent ELISA results were obtained.
Table AS1.5: Statistics for P. vivax aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5
Number of valuesa 20 40 34 33 35
Minimum 3.21 1.70 1.70 1.70 3.21
25% Percentile 4.02 4.11 4.07 4.41 5.55
Median 6.33 6.15 6.10 6.16 6.86
75% Percentile 8.47 8.47 8.32 9.10 9.43
Maximum 13.15 13.40 13.30 15.00 15.00
Mean 6.73 6.81 6.45 6.86 7.78
Std. Deviation 2.89 3.15 2.90 3.23 3.30a The number of values is the number of samples for which consistent ELISA results were obtained.
an
ne
xes
2524 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
annex s2: Malaria rdt field assessment and anomaliesThe purpose of this assessment, on a limited number of RDTs, is to assess aspects of packaging, safety and ease-of-use and not to evaluate diagnostic accuracy.
Obtain samples of each malaria RDT under consideration (at least one box packaged as intended for delivery to end users).
Obtain malaria parasite-negative blood samples, and where readily accessible, parasite-positive blood samples for testing against RDTs.
Table AS2.1: Field assessment of RDT packaging, safety and ease-of-use to guide product selection
Date of assessment Commercial name Catalogue number Lot number(s)
Yes No NA Problems /CommentsPackaging and accessories
The RDT box is in good conditionRDTs are in individual sealed pouches
The correctly indicated number of RDTs are in the boxA desiccant is included in each individual RDT pouch
An expiry date is visible on each RDT pouchAll required accessories are included in the correct quantities
(RDT, buffer, blood transfer device, alcohol swab, lancet, gloves, test tubes (for dipsticks, only)
If no, what is not included:
InstructionsInstructions are included
Instructions are in the national language(s)The instructions are for the correct product The instructions include figures displaying
all possible interpretations of the RDT resultsThe text and figures are accurate and consistent
(specifically order of test lines and results interpretation)Preparation and procedure
The test pouch is easy to openIt is easy to write on the test device
The test lines on the device are clearly labelledIt is easy to use the device for blood collectionIt is easy to open the buffer bottle or ampoule
The buffer bottle or ampoules have sufficient volume for testing all RDTs in the box
The buffer bottle or ampoule dispenses even dropsIt is easy to fill the sample well correctly with the provided blood
transfer deviceIt is easy to fill the buffer well correctly (no overflow)
The buffer and sample flow well along the test strip Result interpretationControl and test lines
Control line is clearTest line(s) are clear
Good clearance of blood by time of reading If no, number of tests in the box affected:
Steps and reading time Reading time <30 min
Two or fewer timed steps Was one or more of the last 10 tests
you performed invalid (no control line)?If YES, how many?
SafetyAre there mixing wells (risk of blood splash)?
Retractable needle for finger prick?Is the RDT in a cassette format (unexposed strip)?
Have waste disposal safety concerns been addressed? (If no, please describe)
26 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Figure AS2.1 illustrates examples of RDT observations/anomalies encountered and routinely recorded during Round 5 of WHO Malaria RDT Product Testing at the CDC. In most cases, these anomalies do not invalidate the results, as reactivity in the control and test line areas are still visible, but they may pose challenges to health workers interpreting the results. Furthermore, they should be reported to manufacturers.
An expanded list of notable observations concerning RDT packaging, kit accessories (buffer vials, desiccants) and instruc-tions for use, is under development for use in both product testing and lot testing activities of the WHO-FIND Malaria RDT Evaluation Programme.
Figure AS2.1: Malaria RDT anomalies encountered in production lots
a) Observations on the test strip
Red background Background staining is relatively common. In this example, the result is positive as test lines are positive; however, a more intense red background may obscure weak positive test lines, giving false-negative results
Incomplete clearing Poor clearing of blood may obscure weak positive test lines, giving false-negative results. In this example, the result is positive as the test line is visible
b) Observations of flow problems
Failure to flow Blood and buffer did not run the length of the strip
Irregular migration that obscures test line(s)
One portion of the nitrocellulose near the test band was not absorptive and remained dry during wicking, creating irregular migra-tion of blood/buffer with red background that may obscure test line.
Irregular migration One portion of the nitrocellulose near the test band was not absorptive and remained dry during wicking, creating irregular migra-tion of blood/buffer with red background. In this example, the result is positive, as the test line is clearly visible.
C T1 T2
C T
C T1 T2
C T
C T1 T2
C T1
an
ne
xes
2726 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
c) Observations on test lines
Ghost test lines White lines on a stained background. In this example, the result is negative, as the test line is not dark and is thus not visible.
Patchy broken test line(s)
The test line is visible but interrupted (broken).
Diffuse test line(s) Test line wider than control, without clearly defined edge.
d) RDT structural problems
Strip misplaced in the cassette
Strip can be seen only partially in the results window.
Specimen pad not seen in sample window
Normally, the colour of the conjugated antibody can be seen in the sample window (commonly purple, pink or blue).
C T1 T2 T3
C T1 T2
C T
C T1 T2
28 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-5 (2008-2013)
Figure AS3.1: How to select of an appropriate RDT
Step 1.1Define setting of use
What? target parasite species and antigena
Pf-only or mixed Pf/non-Pf infections:- HRP2- pLDH-Pf; pLDH-pan
Pf and non-Pf infections (single species)b:- HRP2, aldolase; HRP2, pLDH-pan- HRP2, pLDH-Pv; HRP2, pLDH-Pvom- HRP2, pLDH-pan; pLDH-Pv- pLDH-Pf, pLDH-pan; pLDH-Pf, pLDH-Pv- pLDH-Pf, pLDH-Pvom
P. vivax, only:- aldolase- pLDH-pan- pLDH-Pv
**Pf without HRP2 – Do not use HRP2-based RDTsc
Where? Exposure to high temperature e.g. tropical environment ORtemperature-controlled environment, including during transport and storage
Who? Laboratory personnel ORhealth workers outside laboratories
Step 1.2Review RDT performance
WHO RDT product testing resultsd and apply WHO recommended RDT selection criteriae
- Panel detection score - False-positivity rate - Invalid rate - Ease-of-use- Thermal stability
Sensitivity and specificity based on high-quality field studies in relevant populations
Generate short-list of RDTs
Step 1.3Apply national guidelines and experience in use of RDTs
National malaria treatment guidelines
In-country experience, ease-of-use assessments (Annex 5), availability of training materials
Step 1.4Other considerations
- Price- Manufacturer: production capacity, lead times, heat stability data- Delivery schedules (e.g. staggered deliveries), box size, shelf life- Registration requirements of national regulatory authorities- Product lot testing results- Overall budget requirements (Annex 5)
a Pf-only or mixed Pf/non-Pf infections: Most areas of sub-Saharan Africa and lowland Papua New Guinea; Pf and non-Pf infections (single species): Most endemic areas of Asia and the Americas and isolated areas of the Horn of Africa; Mainly P. vivax-only: areas of East Asia, central Asia, South America, and some highland areas elsewhere
b Tests with a P. falciparum-specific line and pan-specific line will not distinguish P. falciparum-only infections from mixed P. falciparum infections. Distinguishing P. falciparum from mixed P. falciparum-vivax infections is important only if a full course of primaquine is routinely given for infections due to P. vivax. This must be weighed against the loss of ability to detect P. malariae and P. ovale if a test has only P. falciparum- and P. vivax-specific lines. Inclusion of further test lines (e.g. Pf-Pv-pan-pLDH) to detect these increases the complexity of test interpretation. A programme should prioritize these various advantages and disadvantages according to local conditions in the initial stage of making procurement decisions.
c P. falciparum parasites lacking HRP2 +/- HRP3 genes have been identified with high frequency in parts of South America (10). d See references (3–6).e WHO RDT procurement criteria : http://www.who.int/malaria/publications/atoz/rdt_selection_criteria/en/ (accessed 26 June 2014).
For a comprehensive guide to procurement of malaria RDTs extending beyond selection to quantification, budgeting, technical specifications, management of tenders, contracts, supply management and monitoring of supplier performance and managing product variations, see reference (13).
annex s3: selection of an appropriate rdt
28
Mala
ria R
apid
Diag
nost
ic Te
st Pe
rform
ance
Re
sults
of W
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rodu
ct te
sting
of m
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RDT
s: Ro
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Couv Rd5_VertTurq-st2.indd 1 17/07/14 15:37
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