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Malaria Rapid Diagnostic Test Performance
Results of WHO product testing of malaria RDTs: Round 1 (2008)
1
Malaria Rapid Diagnostic Test Performance
Results of WHO product testing of malaria RDTs: Round 1 (2008)
Conte
nts
WHO Library Cataloguing-in-Publication Data :
Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 1 (2008).
1.Malaria - diagnosis. 2.Antimalarials - therapeutic use. 3.Malaria - drug therapy. 4.Diagnostic tests, Routine. 5.Reagent kits, Diagnostic - utilization. 6.Sensitivity and specificity. I.UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases. II.Centers for Disease Control (U.S.). III.Foundation for Innovative New Diagnostics.
ISBN 978 92 4 159807 1 (NLM classification: WC 750)
Copyright © World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases 2009
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Conte
ntsAcknowledgements d VAbbreviations d VI
1. EXECUTIVE SUMMARY d 11.1. Introduction d 11.2. The WHO Product Testing Programme d 11.3. Results of the evaluation d 11.4. Summary of outcomes d 31.5. Use of these results d 3
2. BACKGROUND d 3
3. OBJECTIVES d 5
4. MATERIALS AND METHODS d 64.1. Test selection d 64.2. Outline of the Product Testing Protocol d 74.3. Evaluation panels d 74.4. RDT registration d 94.5. Specimen panel registration d 94.6. Test phases d 94.7. Performing rapid tests d 104.8. Interpretation of results d 10
5. DATA MANAGEMENT d 11
6. QUALITY ASSURANCE d 11
7. ETHICAL CONSIDERATIONS d 12
8. DATA ANALYSIS d 128.1. Defining sensitivit y and specificit y/
detection and false positive rates d 128.2. False-positives d 128.2.1. Incorrect species identification d 128.2.2. False-positives from Plasmodium-
negative samples d 128.3. Band intensit y d 138.4. Lot agreement d 138.5. Reader variabilit y d 138.6. Invalid tests d 138.7. Heat (thermal) stabilit y d 13
9. LABORATORY VERSUS FIELD-BASED MALARIA RDT EVALUATIONS d 13
10. RESULTS d 1410.1. Summary d 1410.2. Phase 1 - P. falciparum culture panel d 20
10.3. Phase 2 - Wild t ype P. falciparum and P. vivax and Plasmodium spp. negative samples d 21
10.3.1. P. falciparum detection rate d 2110.3.2. P. vivax detection rate d 2210.3.3. Combined Detection of
P. falciparum and P. vivax d 2210.3.4. P. falciparum and P. vivax positivit y rate d 2310.3.5. Band intensit y d 2510.3.6. False positive rates d 2510.3.7. Inter-reader variabilit y d 29
11. HEAT STABILITY d 3211.1. P. falciparum test lines d 3211.2. Pan test lines d 34
12. EASE OF USE DESCRIPTION d 35
13. DISCUSSION OF KEY FINDINGS d 3813.1. Parasite detection and its relationship
to sensitivit y d 3813.2. False-positive rate and specificit y d 3913.3. Heat (thermal) stabilit y d 3913.4. Ease of use description d 4013.5. Inter-lot variabilit y d 4013.6. Inter-reader variabilit y d 4013.7. Target antigens and species d 40
14. ADDITIONAL MEASURES TO ENSURE QUALITY AND UTILITY OF RDT TESTING d 41
14.1. Beyond procurement d 4114.2. Lot testing d 42
15. CONCLUSIONS d 42
16. REFERENCES d 43
ANNEXES d 45Annex 1: Characteristics of rapid malaria
tests in the evaluation d 46Annex 2: Malaria RDT guide to results
interpretation d 53Annex 3: Phase 1 results d 58Annex 4: Phase 2 results d 63Annex 5: Example algorithm for selecting
a malaria RDT d 90Annex 6: Introducing RDT-based malaria
diagnosis into national programmes d 92
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)I
FIGURES
Figure E1: Summary performance of malaria RDTs against blood samples containing wild type P. falciparum at low (200) and high (2000 or 5000) parasite densities (parasites/μl) and malaria-negative samples.
Figure 1: Mode of action of antigen-detecting malaria RDTs
Figure 2: Network of specimen collection, characterization and testing sites
Figure 3: Malaria RDT Product Testing Overview
Figure 4a: Origin of P. falciparum wild type samples
Figure 4b: Origin of P. vivax wild type samples
Figure 5: Testing procedure for Product A against a sample density of 2000 or 5000 parasites/μl
Figure 6: Testing procedure for Product A against a sample density of 200 parasites/μl
Figure 7: Phase 1 P. falciparum detection rate of malaria RDTs at low (200) and high (2000 or 5000) parasite densities (parasites/μl) according to target antigen type (HRP2 or pLDH)
Figure 8: Phase 2 P. falciparum detection rate of malaria RDTs at low (200) and high (2000 or 5000) parasite density (parasites/μl) according to target antigen type (HRP2 or pLDH)
Figure 9: Phase 2 P. vivax detection rate of malaria RDTs at low (200) and high (2000 or 5000) parasite densities (parasites/μl) according to target antigen type (aldolase, pLDH, aldolase + pLDH)
Figure 10: Phase 2 wild type P. falciparum detection rate and positivity rate at 200 parasites/μl
Figure 11: Phase 2 wild type P. vivax detection rate and positivity rate at 200 parasites/μl
Figure 12: P. falciparum (P. falciparum test line) false positive rate against clean negative samples
Figure 13: P. falciparum (P. falciparum test line) false positive rate against Plasmodium spp. negative samples containing potentially cross-reacting blood immunological abnormalities or infectious pathogens
Figure 14: Plasmodium spp. (pan or P. vivax test line) false positive rate against clean negatives
Figure 15: Plasmodium spp. (pan or P. vivax test line) false positive rate against Plasmodium spp. negative samples containing potentially cross-reacting blood immunological abnormalities or infectious pathogens
Figure 16: P. falciparum false positive rate versus P. falciparum detection rate at low (200) parasite density (parasites/μl)
Figure 17: P. vivax false positive rate versus P. vivax detection rate at low (200) parasite density (parasites/μl)
Figure 18: Wild type P. falciparum detection rate according to first and second readings at 200 parasites/μl
Figure 19: Wild type P. vivax detection rate according to first and second readings at 200 parasites/μl
Figure 20: Heat stability of P. falciparum specific (HRP2) test line of P. falciparum only tests against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
Figure 21: Heat stability of P. falciparum specific (HRP2) test line of P. falciparum tests against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
Figure 22: Heat stability of P. falciparum specific (HRP2) test line in combination tests against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
Figure 23: Heat stability of P. falciparum specific (HRP2) test line in combination tests against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)I I
Figure 24: Heat stability of pan-line of pan-specific tests against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
Figure 25: Heat stability of pan-line of pan-specific tests against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
Figure 26: Heat stability of pan-line of combination tests against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
Figure 27: Heat stability of pan-line of combination tests against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
Figure 28: Heat stability of pan-line of pan-specific tests only against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
Figure 29: Heat stability of pan-line of pan-specific tests only against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
Figure A6.1: Example malaria RDT implementation budget
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)I I I
TABLES
Table 1: Manufacturers and products accepted into Round 1 of WHO-FIND Malaria RDT Evaluation Programme
Table 2: Characteristics of Plasmodium spp. negative specimens
Table 3: Summary performance of malaria RDTs against 20 cultured P. falciparum lines at low (200) and high (2000 or 5000) parasite densities (parasites/μl)
Table 3a: Summary performance of malaria RDTs against 20 cultured P. falciparum lines at low (200) and high (2000 or 5000) parasite densities (parasites/μl) based on a delayed reading when specified by the manufacturer
Table 4: Summary performance of malaria RDTs against wild type P. falciparum and P. vivax samples at low (200) and high (2000 or 5000) parasite densities (parasites/μl) and Plasmodium spp. negative samples
Table 4a: Summary performance of malaria RDTs against wild type P. falciparum at low (200) and high (2000 or 5000) parasite densities (parasites/μl) based on a delayed reading when specified by the manufacturer
Table 5: Heat stability testing results for 41 malaria RDTs on a cultured P. falciparum sample at low (200) and high (2000 or 5000) parasite densities (parasites/μl) . Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C
Table 6: Ease of use description of 41 malaria RDTs
Table A3.1: Lot variability in positive results against P. falciparum culture samples at low (200) and high (2000 or 5000) parasite densities (parasites/μl)
Table A3.1a: Lot variability in positive results against P. falciparum culture samples at low (200) and high (2000 or 5000) parasite densities (parasites/μl) based on a delayed reading when specified by the manufacturer
Table A3.2: Detection rate of 20 P. falciparum culture lines at low and high parasite densities based on initial reading according to manufacturers instructions and a delayed second reading performed within 1 hour
Table A3.3: Distribution of test band intensity scores (0-4) against 20 P. falciparum cultured parasites at low (200) and high (2000 or 5000) parasite densities (parasites/μl)
Table A3.3a: Distribution of test band intensity scores (0-4) against 20 P. falciparum cultured parasites at low (200) and high (2000 or 5000) parasite densities (parasites/μl) based on a delayed reading when specified by the manufacturer
Table A4.1: Lot variability in positive results against P. falciparum and P. vivax samples at low (200) and high (2000 or 5000) parasite densities (parasites/μl)
Table A4.1a: Lot variability in positive results against P. falciparum and P. vivax samples at low (200) and high (2000 or 5000) parasite densities (parasites/μl) based on delayed readings when specified by the manufacturer
Table A4.2: Reader variability in detection rate of P. falciparum samples (n=79) based on an initial reading according to manufacturers instructions and a second reading within 1 hour
Table A4.3: Reader variability in detection rate for P. vivax samples (n=20) based on an initial reading according to manufacturers instructions and a second reading within 1 hour
Table A4.4: Distribution of test band intensity (0-4) scores against wild type P. falciparum samples (n=79) at low (200) and high (2000 or 5000) parasite densities (parasites/μl)
Table A4.4a: Distribution of test band intensity (0-4) scores against wild type P. falciparum samples (n=79) at low (200) and high (2000 or 5000) parasite densities (parasites/μl) based on delayed readings when specified by the manufacturer
Table A4.5: Distribution of Pan/Pv test band intensity (0-4) scores for P. vivax (n=20) samples at low (200) and high (2000 or 5000) parasite densities (parasites/μl)
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)I V
Table A4.5a: Distribution of Pan/Pv test band intensity (0-4) scores for P. vivax (n=20) samples at low (200) and high (2000 or 5000) parasite densities (parasites/μl) samples based on a delayed reading according to manufacturers recommendation
Table A4.6: Detection rate of P. falciparum in low (200) and high (2000 or 5000) parasite densities (parasites/μl) by continent
Table A4.6a: Detection rate of P. falciparum in low (200) and high (2000 or 5000) parasite densities (parasites/μl) by continent based on a delayed reading when specified by the manufacturer
Table A4.7: P. falciparum test line false positive results for P. vivax samples (n=20) at low (200) and high (2000 or 5000) parasite densities (parasites/μl)
Table A4.7a: P. falciparum test line false positive results for P. vivax samples (n=20) at low (200) and high (2000 or 5000) parasite densities (parasites/μl) based on a delayed reading when specified by the manufacturer
Table A4.8: Combination test pan line false positive non Pf infection on P. falciparum samples (n=79) at low (200) and high (2000 or 5000) parasite densities (parasites/μl)
Table A4.8a: Combination test pan line false positive non Pf infection on Pf samples (n=79) at low (200) and high (2000 or 5000) parasite densities (parasites/μl) based on a delayed reading when specified by the manufacturer
Table A4.9: False positive rate of P. falciparum (or pan) test line results on all malaria-negative samples
Table A4.9a: False positive rate of P. falciparum (or pan) test line results on all malaria-negative samples based on a delayed reading when specified by the manufacturer
Table A4.10: False positive rate of P. falciparum (or pan) test line results for samples containing specific non-malarial infectious pathogens
Table A4.10a: False positive rate of P. falciparum (or pan) test line results for samples containing specific non-malarial infectious pathogens based on a delayed second reading when specified by the manufacturer
Table A4.11: False positive rate of P. falciparum (or pan) test line results for samples containing potentially cross-reacting blood immunological factors
Table A4.11a: False positive rate of P. falciparum (or pan) test line results for samples containing potentially cross-reacting blood immunological factors based on a delayed reading when specified by the manufacturer
Table A4.12: False positive rate of pan/Pv test line results on all malaria-negative samples
Table A4.12a: False positive rate of pan test line results on all malaria-negative samples based on a delayed second reading when specified by the manufacturer
Table A4.13: Heat stability testing results for P. falciparum test line on P. falciparum samples at low parasite density (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C
Table A4.13a: Heat stability testing results for pan test line of combination RDTs on P. falciparum samples at low parasite density (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C
Table A4.14: Heat stability testing results for P. falciparum test line on P. falciparum samples at high parasite density (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C
Table A4.14a: Heat stability testing results for pan test line of combination RDTs on P. falciparum samples at high parasite density (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C
Table A4.15: Heat stability testing results for P. falciparum (or pan) test line on parasite negative samples. Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C
Table A4.15a: Heat stability testing results for pan test line of combination RDTs on negative samples. Positivity rate at baseline, and after 60 days incubation at 35°C and 45°C
Table A6.1: Example malaria RDT implementation budget
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)V
ACKNOWLEDGEMENTS
The evaluation described in this report was a joint project of the WHO Regional Office for the Western Pacific (WPRO), the Foundation for Innovative New Diagnostics (FIND), TDR, Special Programme for Research and Training in Tropical Diseases sponsored by UNICEF, UNDP, World Bank and WHO and the US Centers for Disease Control and Prevention (CDC), under the WHO-FIND Malaria RDT Evaluation Programme. The project was financed by FIND, the Australian Agency for International Development (AusAID), the United States Agency for International Development (USAID) and TDR. The project would not have been possible without the cooperation and support of the specimen collection sites, and the specimen characterization laboratories mentioned herein. The project acknowledges the technical advice from many malaria diagnostic manufacturers and developers in the development of the programme. The WHO-FIND Malaria RDT Evaluation Programme is grateful to all those who contributed to the conduct of the evaluation and preparation of this report.
Salim Abdullah Ifakara Health Research and Development Centre, Tanzania
Audrey Albertini FIND, Switzerland
Frederic Ariey Institut Pasteur, Cambodia
John Barnwell US Centers for Disease Control and Prevention / National Center for Infectious Diseases, USA
David Bell WHO – Regional Office for the Western Pacific, Philippines
Qin Cheng Army Malaria Institute, Australia
Peter Chiodini Hospital for Tropical Diseases, United Kingdom
Jane Cunningham TDR, Special Programme for Research and Training in Tropical Diseases, Switzerland
Linda Dantes WHO – Regional Office for the Western Pacific, Philippines
Djibrine Djalle Institut Pasteur Bangui, Central African Republic
Dionicia Gamboa Universidad Peruana Cayetano Heredia Instituto de Medicina Tropical, Peru
Michelle Gatton Queensland Institute of Medical Research, Australia
Iveth Gonzalez FIND, Switzerland
Beatrice Gordis FIND, Switzerland
Sandra Incardona Consultant, FIND, Switzerland
Jean Joly TDR, Special Programme for Research and Training in Tropical Diseases, Switzerland
Sophie Jones US Centers for Disease Control and Prevention / National Center for Infectious Diseases, USA
Derryck Klarkowski Médecins Sans Frontières, Netherlands
Myat Phone Kyaw Department of Medical Research, Myanamar
Jennifer Luchavez Research Institute of Tropical Medicine, Philippines
Lucian Marts US Centers for Disease Control and Prevention / National Center for Infectious Diseases, USA
James McCarthy Queensland Institute of Medical Research, University of Queensland, Australia
Didier Menard Institut Pasteur de Madagascar, Madagascar
Claribel Murillo Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Colombia
Bernhards Ogutu Kenya Medical Research Institute (KEMRI), Kenya
Wellington Oyibo University of Lagos, Nigeria
Rosanna Peeling TDR, Special Programme for Research and Training in Tropical Diseases, Switzerland
Anita Pelecanos Queensland Institute of Medical Research, Australia
Mark Perkins FIND, Switzerland
Charuni Senanayake WHO – Regional Office for the Western Pacific, Philippines
Michael Valentine US Centers for Disease Control and Prevention / National Center for Infectious Diseases , USA
Melissa Vega TDR, Special Programme for Research and Training in Tropical Diseases, Switzerland
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)V I
ABBREVIATIONS
ACT Artemisinin-based combination therapy
AMI Army Malaria Institute
AusAID Australian Agency for International Development
CDC US Centers for Disease Control and Prevention
CLIA Clinical Laboratory Improvement Amendments
FIND Foundation for Innovative New Diagnostics
HRP2 Histidine-rich protein 2
HTD Hospital for Tropical Diseases
pLDH Plasmodium lactate dehydrogenase
p/μL Parasites per microlitre
QA Quality Assurance
QC Quality Control
QMS Quality Management Systems
RDT Rapid Diagnostic Test (for the purposes of this report, this refers to immunochromatographic lateral flow devices for the detection of malaria parasite antigens)
SOP Standard Operating Procedure
TDR Special Programme for Research and Training in Tropical Diseases sponsored by UNICEF, UNDP, World Bank and WHO
USAID United States Agency for International Development
WPRO Western Pacific Regional Office
WHO World Health Organization
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)1
1. EXECUTIVE SUMMARY
1.1. INTRODUCTIONThe World Health Organization estimates that 3.3 billion persons were at risk of acquiring malaria in 2006, with 247 million of these developing clinical malaria (86% in Africa), and nearly 1 million (mostly African children) dying from the disease. Malaria remains endemic in 109 countries, and while parasite-based diagnosis is increasing, most suspected cases of malaria are still not properly identified, with accurate diagnosis and disease monitoring consequently remaining elusive (1).
WHO recommends that malaria case management be based on parasite-based diagnosis in all cases, with the exception of young children in areas of high transmission and where lack of resources or need for urgent response temporarily limits its application. The use of antigen-detecting rapid diagnostic tests (RDTs) forms a vital part of this strategy, providing the possibility of parasite-based diagnosis in areas where good quality microscopy can not be maintained. The number of RDTs available, and the scale of their use, has rapidly increased over the past few years. However, limitations of comparative field trials and the heterogeneous nature of malaria transmission has limited the availability of good quality performance data that national malaria programmes require to make informed decisions on procurement and implementation. To this end in 2006, WHO and FIND (Foundation for Innovative New Diagnostics) launched an evaluation program to assess the performance of commercially available malaria RDTs and allow direct product comparisons that would assist WHO, other UN agencies and national governments in making procurement decisions and would ultimately encourage improvement in the quality of manufacturing.
1.2. THE WHO PRODUCT TESTING PROGRAMME
This report, which presents the results of the first round of WHO product testing of malaria antigen-detecting RDTs, was completed in November 2008 in collaboration with FIND, the US Centers for Disease Control and Prevention (CDC) and other partners (Fig.2). All companies manufacturing under ISO-13485 Quality System Standard were invited to submit up to 3 tests for evaluation under the programme. In this first round of testing, 41 products from 21 manufacturers were evaluated against prepared blood panels of cultured Plasmodium falciparum parasites and 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 ease of use assessment was recorded. Of the 41 products, 16 detect P. falciparum alone, 22 detect and
1 One is P. vivax specific
differentiate P. falciparum from non-P. falciparum malaria1, and 3 detect P. falciparum and non-P. falciparum malaria without distinguishing between them. Manufacturers submitted 2 lots of each product for evaluation.
The evaluation is designed to provide comparative data on the performance of the submitted production lots of each product. Such data will be used to guide procurement decisions of WHO and other UN agencies and national governments. Product testing is part of a continuing programme of work to improve the quality of RDTs that are used, and to support broad implementation of reliable malaria diagnosis in areas where malaria is prevalent. A second round of product testing began in April 2009. It is anticipated that a further round will be undertaken in 2010, with a call for expressions of interest later in 2009.
1.3. RESULTS OF THE EVALUATIONThe results (summarized in Tables 3, 3a, 4, 4a and Figure E1) provide comparative data on 2 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 below the mean parasite density found in many populations with endemic malaria. For the purposes of this report, 'detection rate' of a product is the percentage of malaria samples in the panel giving a positive result by two RDTs per lot at the lower parasite density, and a single RDT per lot at the higher parasite density. Thus, it is not a measure of RDT clinical sensitivity, or positivity rate against the panel but rather a combined measure of positivity rate, along with inter-test and inter-lot consistency.
The clinical sensitivity of an RDT to detect malaria is highly dependent on the local conditions, including parasite density, in the target population, and so will vary highly between malaria-endemic populations. The results in this report show comparative performance between RDTs, and give an idea of which products are likely to provide higher sensitivity in the field, particularly in populations with low-density infections. As the detection rate at 2000 parasites/μL indicates, the sensitivity of many of these products will be similar in populations with higher parasite densities, although a subset of any population will include vulnerable individuals who may develop illness at low parasite densities (e.g. young children, pregnant women, those well protected by bed nets) and must always be taken into account when interpreting RDT results.
Heat stability (summarized in Table 5) is vital to maintaining sensitivity of the test in the field. As a result, for procurement, it is essential that careful consideration be given to stability results to ensure that products to be used in areas with high temperatures of transport and storage have demonstrated great stability in the product testing programme. Requirements will vary between countries: for example, if tests are to be deployed in areas where temperatures rarely rise above 30°C, less emphasis needs to be placed on stability at high temperatures.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)2
Figure E1: Summary performance of malaria RDTs against blood samples containing wild type P. falciparum at low (200) and high (2000 or 5000) parasite densities (parasites/μl) and malaria-negative samples.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)3
Ease of use requirements will also vary, depending on the extent of training and the work environment of the end-users. Particularly in primary health care settings, the simpler the tests, the easier it will be to avoid errors in preparation and interpretation.
1.4. SUMMARY OF OUTCOMES There is now a mechanism in place that allows •laboratory-based evaluation of RDT performance in a standardized way to distinguish between well and poorly performing tests to inform procurement and prioritization for entry into WHO prequalification and procurement schemes.
Several RDTs are available that demonstrated consistent •detection of malaria at low parasite densities (200 parasites/μl), have low false positive rates, are stable at tropical temperatures, are relatively easy to use, and can detect P. falciparum, P. vivax infections, or both.
Performance between products varied widely at low •parasite density (200 parasites/μl); however, most products showed a high level of detection at 2000 or 5000 parasites/μl.
• P. falciparum tests targeting HRP2 antigen demonstrated the highest detection rates, but some tests targeting pLDH also exhibited high detection rates.
Test performance varied between lots, and widely •between similar products, confirming the advisability of lot-testing post purchase and prior to use in the field.
The results underscore the need for manufacturers •to have adequate reference materials for product development and lot-release. The WHO-FIND malaria RDT evaluation programme, in collaboration with the CDC, will soon offer quality standard panels to manufacturers to assist in this process.
1.5. USE OF THESE RESULTSUltimately, it is imperative that procurement decisions based on these results take into consideration local conditions of malaria transmission and illness where the tests will be used (e.g. Plasmodium species, target antigen variation, parasite densities, climate). Procurement of RDTs must not occur without programmatic and infrastructure preparation for proper use, including supply chain management, training on test usage and disposal, and training on patient management in response to results. This report provides an algorithm to assist in this decision-making process (Annex 5).
2. BACKGROUND
In 2006, WHO estimated that 3.3 billion persons were at risk of acquiring malaria. Of these, 247 million were infected (86% in Africa) and nearly 1 million (mostly African children) died of the infection. In 2008, malaria was still endemic in 109 countries worldwide, 45 of them in Africa. WHO estimates that approximately 1.1 million persons were still dying of malaria that year (1).
In the past decade, major new opportunities for the control of malaria have emerged, including implementation of long-lasting insecticidal nets, indoor residual spraying of insecticides and artemisinin-based combination therapy (ACT). These tools, in combination with increased coverage of malaria control programs, are likely to reduce the burden of malaria infection in countries where they are adequately implemented. In turn, the proportion of febrile episodes attributable to malaria is likely to decrease substantially.
Despite WHO recommendations for laboratory-confirmed diagnosis of malaria infections2, diagnosis is often made
2 With the exception of children under 5 years of age in areas of high transmission in whom treatment may be provided on the basis of a clinical diagnosis
on clinical grounds (2). However, in most endemic areas malaria makes up a minority of 'malaria-like' febrile illness. Microscopy has been the cornerstone of diagnosis and remains the recommended method of malaria diagnosis at a central level, but the need for trained personnel, adequate reagents and equipment limit its availability and accessibility. Rapid, accurate and accessible diagnostic tools are becoming increasingly important, as programmes expand parasite-based diagnosis and the prevalence of malaria decreases. In recent years, rapid diagnostic tests (RDTs), which detect Plasmodium-specific antigens (proteins) in whole blood of infected people, have emerged as an attractive alternative to microscopy. Currently available RDTs come in various formats (dipstick, cassette or card) and contain bound antibodies to specific antigens such as histidine-rich protein-2 (HRP2) (specific to P. falciparum), pan-specific or species-specific plasmodium lactate dehydrogenase (pLDH) or aldolase (specific to all the major Plasmodium species: P. falciparum, P. vivax, P. malariae, P. ovale (Figure 1).
To be widely useful, a RDT must have high sensitivity to ensure all clinically-significant malaria infections are detected; high specificity to enable monitoring of low malaria prevalence and appropriate management of non-malarial fever; and high stability to allow transport and storage in ambient conditions in malaria-endemic areas. Published field trials of RDTs show high variability in performance, likely due to inadequate quality of manufacture, incorrect storage and handling, poor preparation and interpretation,
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)4
a
b
c
Bound Ab
Free labelledAb
Captured Ag–labelledAb complex
Capturedlabelled Ab
Parasite Agcaptured bylabelled Ab
Labelled Ab–Agcomplex capturedby bound Ab oftest band
Lysing agentand labelled Ab
Test line(bound Ab)*
Parasitized blood
Buffer/flushing agent
Control line(bound Ab)*
Nitrocellulose strip
Blood and labelled Ab flushed along strip
*Not normally visible
Labelled Abcaptured by bound Ab ofcontrol band
Figure 1: Mode of action of antigen-detecting malaria RDTs
Mode of action of common malaria RDT format: (a) Dye-labeled antibody (Ab), specific for target antigen, is present on the lower end of the nitrocellulose strip or in a well provided with the strip. Antibody, also specific for the target antigen, is bound to the strip in a thin (test) line, and either antibody specific for the labeled antibody, or antigen, is bound at the control line. (b) Blood and buffer, which have been placed on the strip or in the well, are mixed with the labeled antibody and are drawn up the strip across the lines of bound antibody. (c) If antigen is present, some labeled antibody will be trapped on the test line. Other labeled antibody is trapped on the control line.
and sometimes poor study methods, analysis and reporting ( 3-11).
The number of RDTs available on the market has grown rapidly since their introduction in the late 1990s. It is estimated that there are 60 brands and over 200 tests commercially available today, with an estimated 50-70 million tests used in 20083. However, regulatory oversight of diagnostics is often weak, and procurement agencies have faced considerable problems in selecting appropriate RDTs and ensuring quality. In view of the inconsistency in field study results and the inherent difficulties in
3 WHO. Unpublished data
assessing large numbers of products in a standardized way through field trials, WHO and various partners embarked on a Malaria Rapid Diagnostic Test Product Evaluation Programme in 2002 to develop and employ standardized assessment of malaria RDT performance, and to guide procurement decisions and regulatory mechanisms. The Programme has been overseen by WPRO and TDR in partnership with FIND, and has been guided by a Steering Committee4 and several consultations from 2003 to 2008. A network of specimen collection sites was established to contribute specimens to a global bank at the US CDC and to facilitate local quality control activities (Figure 2).
4 WHO/FIND/CDC, Methods manual for product testing of malaria rapid diagnostic tests (version 1). 2008
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)5
3. OBJECTIVES
Evaluate malaria RDTs to produce performance data •that can guide procurement of RDTs for use in the field.
Figure 2: Network of specimen collection, characterization and testing sites
Abbreviations: AMI Army Malaria Institute (Queensland, Australia); CDC Centers for Disease Control and Prevention (Atlanta, United States of America); CIDEIM Centro Internacional de Entrenamiento y Investigaciones Médicas (Cali, Colombia); DMR Experimental Medicine Research Division (Department of Medical Research, Yangon, Myanmar); HTD Hospital for Tropical Diseases (London, United Kingdom of Great Britain and Ireland); IHRDC Ifakara Health Research and Development Center (Bagamoyo, The United Republic of Tanzania); IMT Instituto de Medicina Tropical (Universidad Peruana Cayetano Heredia, Lima, Peru); IPB Institut Pasteur de Bangui (Bangui, Central African Republic); IPC Institut Pasteur du Cambodge (Phnom Penh, Cambodia); IPM Institut Pasteur de Madagascar (Antananarivo, Madagascar); RITM Research Institute of Tropical Medicine (Manila, Philippines); UL University of Lagos (Lagos, Nigeria).
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)6
4. MATERIALS AND METHODS
4.1. TEST SELECTION In August 2007, the WHO-FIND Malaria RDT Evaluation Programme issued a call for expression of interest to manufacturers of malaria RDTs along with information regarding the requirements for submission of a product and the conditions for participation in the Evaluation Programme5. Requirements included: ISO 13485:2003
5 http://www.wpro.who.int/sites/rdt/who_rdt_evaluation/ (accessed 08 April 2009)
certification, supply of sufficient quantities of products (1100 tests from each of 2 lots), and compliance with in-house real time stability testing protocol6.
After an initial call for expressions of interest, 21 manufacturers submitted a total of 41 products to be included in Round 1 (including 2 co-listed (identical) products).
In summary, of the 41 products: 16 detect P. falciparum alone, 22 detect and differentiate P. falciparum from non-P. falciparum malaria7, and 3 detect P. falciparum and non-P. falciparum malaria without distinguishing between them. Annexes 1 and 2 provide a comprehensive overview of product characteristics.
6 Methods Manual for Product Testing of Malaria RDT Version One 2008. SOP 2.2d; available at www.wpro.who.int/sites/rdt/documents.htm (accessed 08 April 2009)
7 One is P. vivax specific
Table 1: Manufacturers and products accepted into Round 1 of WHO-FIND Malaria RDT Evaluation Programme
Manufacturer Product name Catalogue No.* Target Antigen
Access Bio, Inc.CareStart Malaria HRP2 (Pf)CareStart Malaria HRP2/pLDH (Pf/PAN) COMBOCareStart Malaria pLDH (PAN)
G0141G0131G0111
HRP2HRP2/pLDHpLDH
ACON Laboratories, Inc. Malaria Plasmodium falciparum Rapid test Device (Whole blood) IMA-402 HRP2Amgenix International, Inc. OnSight – ParaQuick (Pan, Pf) Test 536-25DB HRP2/pLDHAZOG, Inc. AZOG Malaria pf (HRP-II) /pv (pLDH) Antigen Detection Test Device MFV-124R HRP2/pLDH
BiosynexImmunoquick Malaria FalciparumImmunoquick Malaria +4
0502_K250506_K25
HRP2HRP2/pLDH
Diagnostics Automation/ Cortez Diagnostics, Inc.
Malaria P.F/Vivax 17211OP-25 HRP2/aldolase
DiaMed AG OptiMAL-IT 710024 pLDH/pLDH
Human GmbHHexagon MalariaHexagon Malaria Combi
5805158024
HRP2HRP2/aldolase
IND Diagnostic Inc. One Step Malaria Antigen Strip 820-1 pLDH
Innovatek Medical Inc.Quickstick Malaria Antigen Test (Co- listing with IND Diagnostics Inc. One Step Malaria Antigen Strip)**
-- pLDH
InTec Products, Inc.ADVANCED QUALITYTM One Step Malaria (p.f.) Test (whole blood)ADVANCED QUALITYTM MALARIA (p.f) POCT
ITP11002TC40ITP11002TC1
HRP2HRP2
Inverness Medical Innovations, Inc. Binax Now Malaria IN660050 HRP2/aldolase
J. Mitra & Co. Pvt. Ltd.Advantage Pan Malaria CardAdvantage P.f. Malaria Card Advantage Mal Card
IR013025IR016025IR221025
pLDHHRP2pLDH/pLDH
Orchid Biomedical SystemsParacheck Pf Rapid test for P. falciparum Malaria (Device) Paracheck Pf Rapid test for P. falciparum Malaria (Dipstick)
3030102530302025
HRP2HRP2
Premier Medical Corporation Ltd.First Response Malaria Ag HRP2First Response Malaria Ag Combo (pLDH/HRP2)
II3FRC30II6FRC30
HRP2pLDH/HRP2
ICT DiagnosticsICT Malaria Pf Cassette Test (ML01)ICT Malaria Combo Cassette Test (ML02)
ML01 ML02
HRP2HRP2/aldolase
Span Diagnostics Ltd.
Parahit-f DIPSTICK FOR FALCIPARUM MALARIAParahit-f TEST DEVICE FOR FALCIPARUM MALARIAParahit-Total Device Rapid test for P. falciparum and Pan malarial species
259772597525989
HRP2HRP2HRP2/pLDH/aldolase
Standard Diagnostics, Inc.SD BIOLINE Malaria AgSD BIOLINE Malaria Ag Pf SD BIOLINE Malaria Ag Pf/Pan
05FK40-02-5 05FK50-02-4 05FK60-02-3
pLDH/pLDHHRP2HRP2/pLDH
Unimed International, Inc.FirstSign – Malaria Pf Card TestFirstSign – ParaView-2 (Pv + Pf) Card Test
--2102CB-25
HRP2HRP2/pLDH
Vision Biotech (Pty) Ltd.Malaria Rapid PfMalaria Rapid ComboMalaria Rapid Dual
VB01VB011VB020
HRP2HRP2/aldolaseHRP2/pLDH
Guangzhou Wondfo Biotech Co., Ltd Wondfo One Step Malaria Pf/Pan Whole Blood Test W56-C (4.0 mm) HRP2/pLDH
Zephyr BiomedicalsParascreen Rapid Test for Malaria Pan/Pf (Device)Malascan Rapid Test for Malaria Pf/Pan (Device)Parabank Rapid Test for Malaria Pan (Device)
503100255040202550301025
HRP2/pLDHHRP2/aldolasepLDH
* Some products may include different catalogue numbers for different box sizes, contact manufacturers for details.** Co-listing: One product is submitted for assessment. Manufacturers confirm that second product is identical with different label.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)7
Participating manufacturers received results of test performance and reproducibility prior to publication.
4.2. OUTLINE OF THE PRODUCT TESTING PROTOCOL
The testing process is outlined in Figure 3 and in the Methods Manual for Product Testing of Malaria Rapid Diagnostic Tests - Version One8. In brief, RDTs from each of two lots of each product were evaluated against a panel of parasite-positive and parasite-negative cryo-preserved blood samples, and a panel of parasite-negative samples. Both lots were also tested for heat (thermal) stability, evaluated before and after 2 months’ storage at 4°C, 35°C and 45°C. Finally, an ease-of-use description was developed using a standard assessment format (Figure 3). The testing process and all results were overseen by the specimen bank steering committee, and manufacturers were given an opportunity to comment on individual product results prior to publication.
8 Available at www.wpro.who.int/sites/rdt/documents.htm
4.3. EVALUATION PANELSRDTs were evaluated against three panels, specifically: i) P. falciparum culture lines (includes a subset,
'manufacturer's panel') at low (200 parasites/μl) and high parasite densities (2000 or 5000 parasites/μl).
ii) Wild-type Plasmodium species (P. falciparum, P. vivax) from naturally infected humans and parasite-negative samples at low (200 parasites/μl) and high parasite densities (2000 or 5000 parasites/μl).
iii) Parasite-negative panel ('clean' samples and disease-specific or blood factor-specific samples).
An overview of the sample collection and characterization process can be found in the "Outline of Product Testing and Associated Protocols"9 and detailed methods manuals prepared for laboratory quality control10 and product testing of malaria RDTs9-15. Characterization results can be found at www.wpro.who.int/sites/rdt .
9 Initiative for Quality Assurance of Malaria Rapid Diagnostic Tests: Outline of product testing and associated protocols; available at www.wpro.who.int/sites/rdt/documents.htm (accessed 08 April 2009)
10 Methods Manual for Laboratory Quality Control Testing of Malaria Rapid Diagnostic Test Version 5a available at
www.wpro.who.int/sites/rdt/documents.htm (accessed 08 April 2009)
Figure 3: Malaria RDT Product Testing Overview
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)8
Figure 4a: Origin of P. falciparum wild type samples Figure 4b: Origin of P. vivax wild type samples
In summary, each panel specimen was characterized for: i) Geographical originii) Species by duplicate microscopy11 (two microscopists)
and confirmation by nested PCR of mono-species infection12
iii) HRP2 sequence by PCR amplification13
iv) Antigen concentration, determined by quantitative ELISA for HRP2, pLDH, aldolase14
v) PCR for malaria and confirmatory testing for other pathology in the case of parasite-negative samples
Panel composition
P. falciparum-cultured parasites panel
Twenty culture-adapted strains of P. falciparum of varied geographical origin were selected, including 13 strains with type B HRP2 sequence, 5 with Type A, and 3 with Type C HRP2 sequence. All specimens were derived from the culture bank of US CDC, and diluted in O+ US donor blood15.
Wild type parasite panel
The parasite-positive wild type panel consisted of samples from 79 cases of P. falciparum and 20 cases of P. vivax, derived from 9 collection sites in Asia, Africa and South America (Figs 2, 4a and 4b).
11 Methods Manual for Product Testing of Malaria RDTs Version One 2008 Chapter 4 SOP 4.5, 4.6
12 Methods Manual for Product Testing of Malaria RDTs Version One 2008 Chapter 5 SOP 5.7, 5.8
13 Methods Manual for Product Testing of Malaria RDTs Version One 2008 Chapter 5 SOP 5.9
14 Methods Manual for Product Testing of Malaria RDTs Version One 2008 Chapter 5 SOP 5.1-5.6
15 Methods Manual for Product Testing of Malaria RDTs Version One 2008 Chapter 3 SOP 3.9
Samples were collected from febrile patients and processed according to standardized methods designed to preserve target antigen concentration16. After dilutions and cryo-preservation, samples were transferred to the global bank at CDC for further characterization. The distribution of concentration of HRP2, aldolase and pLDH were determined on a larger sample, and a test panel developed that excluded samples with extremes of high or low antigen concentration.
Negative blood samples
The negative panel consisted of 'clean' parasite-negative samples from donor-derived blood banks in non-endemic areas of the Philippines, Madagascar, USA, and Nigeria, and parasite-negative samples from donors with diseases that may potentially be differential diagnoses of malaria, or with specific blood factors known to be common in the community or known to have the potential to cause false positive reactions on immunochromatographic tests (Table 2). Further details of the parasite-negative panel are found at http://www.wpro.who.int/sites/rdt.
16 Methods Manual for Laboratory Quality Control Testing of Malaria Rapid Diagnostic Tests Version 5a Chapter 3; available at www.wpro.who.int/sites/rdt/documents.htm
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)9
4.4. RDT REGISTRATIONThe receipt of each shipment of RDTs at the evaluation centre was recorded in a dedicated RDT register. Temperature monitoring devices were offered to manufacturers free of charge, to accompany RDTs shipments to CDC. All RDTs were stored at ≤ 25°C immediately and temperature monitors were labeled with receipt date and forwarded for downloading, when applicable.
4.5. SPECIMEN PANEL REGISTRATIONAll panel specimens were assigned unique identification numbers at the collection sites and stored in aliquots of 50μl at -70°C until the time of testing. All data pertaining to specimen ID, storage location and characteristics was stored in a dedicated database.
4.6. TEST PHASESThe evaluation was divided into two testing phases:
Phase 1 - A first screening step to allow the selection of RDTs meeting minimal quality requirements. Products from two lots were evaluated against a panel of 20 culture-derived P. falciparum samples at high (2000 or 5000 parasites/μl) and low (200 parasites/μl) parasite densities.
Phase 2 - Products from two lots were evaluated against a panel of blood samples containing wild type parasites and a parasite-negative panel, evaluated for heat (thermal) stability, and assessed for ease of use:
a. The parasite-positive and parasite-negative panel was comprised of 79 P. falciparum, 20 P. vivax at two parasite densities (200 parasites/μl and 2000 or 5000 parasites/μl), and 90 parasite-negative controls.
b. Heat stability evaluation: Baseline testing of 10 RDTs from each of two lots against a single culture-derived isolate (Nigeria XII strain, Pf HRP2 sequence type B with a typical antigen concentration) at 200 parasites/μl and 2000 parasites/μl and 4 RDTs from each lot against a negative sample. This procedure was repeated after RDTs were maintained for 60 days at 4°C, 35°C and 45°C at 75% humidity.
Figure 5: Testing procedure for Product A against a sample density of 2000 or 5000 parasites/μl
The first reading was at the minimum time specified by the manufacturer; the second reading was up to one hour later and contributed to the determination of the final result only if the manufacturer specified that reading should be repeated if the initial reading was negative for malaria.
Based on positive results of the first test reading in each lot, the mean band intensity score =a+b/2
Total number of tests =2
Total number of tests x readings =4
product a
a b
Reading 1 Reading 2
Lot 1
Test 1
Reading 3 Reading 4
Lot 2
Test 2
Table 2: Characteristics of Plasmodium spp. negative specimens
Nature of negative sample1 No
‘Clean’ negative2 42
Anti-nuclear antibody positive (sera) 13
Anti-mouse antibody positive (plasma) 1
Rheumatoid factor positive (whole blood and sera) 4
Rapid plasma reagin positive (sera) 9
Chagas’ disease antibody positive (plasma) 2
Dengue antibody positive (whole blood and sera) 4
Leishmaniasis antibody positive (sera) 5
Schistosomiasis antibody positive (whole blood and sera) 10
1 Whole blood unless indicated. Sera and plasma samples were reconstituted packed cells
2 Healthy volunteers with no known current illness or blood abnormality
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)10
c. Ease of use assessment: After becoming familiar with the test device, technicians jointly described the test for blood safety characteristics, quality of instructions, number of timed steps and total time to result, using a standard reference guide17.
d. A stability assessment was also required to be conducted by manufacturers at the manufacturing site. Manufac-turers were requested to assess real-time heat stability at three month intervals against high and low parasite densities supplied by WHO at the upper limit of their recommended storage temperature throughout shelf-life and at the end of shelf-life. Results are submitted to WHO at regular intervals, for internal use, only.
4.7. PERFORMING RAPID TESTSAll RDTs were brought to room temperature prior to first use. Desiccant was inspected for colour changes and products were discarded if present. RDTs were labeled with patient ID, dilution, and the date when test was performed. Performance of rapid tests was in accordance with manufacturer’s instructions, with the exception that blood transfer was carried out by micro-pipette from the sample tube. The result was recorded by a technician at the
17 Methods Manual for Product Testing of Malaria RDTs Version One 2008. Chapter 7, available at www.wpro.who.int/sites/rdt/documents.htm
minimum specified reading time and by a second technician within 1 hour. Technicians were rotated, and blinded to sample type and to each other's results during Phase II. Annexes 1 and 2 contain a descriptive and illustrated summary of the test characteristics, steps and guide to interpretation of results.
4.8. INTERPRETATION OF RESULTSResults of control and test lines were recorded as negative or positive by each technician. Each test was read against a standard colour chart and the band intensity graded as 0 (no band), 1, 2, 3 or 4. If the control line is recorded as absent by either technician, the test is recorded as invalid.
Figures 5 and 6 illustrate the testing sequence at low and high parasite densities.
Figure 6: Testing procedure 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 one hour later and contributed to the determination of the final result only if the manufacturer specified that reading should be repeated if the initial reading was negative for malaria.
Based on the positive results of first test reading (2 tests per lot), the mean band intensity score =a+b+c+d/4 (excluding negative results).
product a
ba dcTest 1 Test 2
Lot 1
Reading 1 Reading 2
Test 3 Test 4
Lot 2
Reading 3 Reading 4
Total number of tests =4
Total number of tests x readings =8
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)11
5. DATA MANAGEMENT
The receipt of products was hand recorded in an RDT register at the CDC as per Standard Operating Procedures (SOPs). Data associated with specimen collection and characterization was recorded first on hard copy report forms as per the SOPs at the collection sites (Figure 2), HTD (ELISA reporting) and CDC (PCR) and then entered directly into formatted excel spreadsheets that were subsequently imported into a specially developed database.
The results of the product panel testing and heat stability testing conducted at the CDC were recorded on report forms by each technician individually, as per the SOP.
These results were transferred to a Master Results Sheet and subsequently registered in the database via one of two mechanisms: i) direct database entry or ii) into an excel spreadsheet formatted for subsequent importation into the database.
In order to control for data entry errors, all data discrepancies between Reader 1 and Reader 2 were resolved through inspection of the original hard copy report forms.
All source documents and electronic records of study data have been kept in secure areas until the conclusion of the evaluation, data analysis and report publication.
Individual product testing reports and accompanying raw data were assembled for manufacturers’ review 60 days prior to release of the published report.
6. QUALITY ASSURANCE
Product testing followed SOPs developed through prior testing experience and based on recommendations of expert consultations6,8. A pilot phase using a limited number of tests and an abbreviated panel was conducted to refine these procedures. The quality of critical steps was controlled, as follows:
Quality of the malaria RDTs and their use:•All RDTs were stored in a controlled environment at ≤ 25°C; the pouch was opened and desiccant checked immediately before use; manufacturer instructions were followed with the exception of use of the blood transfer device provided by the manufacturer (a micropipette was used to ensure correct blood volume).A temperature-monitoring device was offered to be included with the RDTs for shipment to the testing site.
Quality and objectivity of the RDT reading results:• Results were read in good lighting by trained technicians tested for visual acuity. Technicians were rotated. Readings of a second technician were reported for discrepant rates; it should be noted that these may have been affected by changes in presence or intensity of test lines with time. All wild parasite samples at low parasite density were first randomized with a similar number of negative control samples and re-labeled for blinded reading of the RDT results.
Quality of the specimen bank samples:• SOPs were established for the preparation of all specimen bank samples8. Culture lines of parasites and wild-type samples were selected taking into account previous evidence and data from specifically conducted studies. All diluted parasite samples were stored and transported at -70°C, and were used only once within 8 hours of thawing.
Quality of the product testing site: •The Malaria Epidemiology Branch of the Division of Parasitic Diseases at CDC is one of the major operating components of the Department of Health and Human Services (HHS) of the USA. The laboratory holds Clinical Laboratory Improvement Amendments (CLIA) accreditation and is monitored by internal Quality Management Systems (QMS) programmes.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)12
7. ETHICAL CONSIDERATIONS
Each specimen collection site obtained approval from a WHO Research Ethics Review Committee and local institutional review board for specimen collection, transport and archiving of blood samples for the purpose of product testing, lot testing and quality assurance procedures.
8. DATA ANALYSIS
8.1. DEFINING SENSITIVITY AND SPECIFICITY/DETECTION AND FALSE POSITIVE RATES
Malaria RDTs detect parasite-derived antigen. The relationship of the concentration of antigen available from the blood sample (after lysis of red cells and parasites) to the peripheral parasite density varies highly due to a series of host and parasite factors. The population frequency of specific factors that may result in false positive results may also vary. Therefore, field sensitivity and specificity of an RDT may change in different epidemiological situations. The evaluation reported here does not predict sensitivity or specificity in a given field situation. It reports comparative detection of target antigens and false positive rates of RDTs against a standardized panel, in a controlled, repeatable manner. As the panel is developed to be a close approximation of field samples, the comparative detection rates between products are expected to be reflected by similar comparative detection rates in the field. As the panel is designed to include a large number of samples close to the limits of detection of RDTs, the panel is likely to discriminate more clearly than a field trial. It follows that in some settings, such as where parasite density is very high, differences in detection rates between tests observed against the WHO evaluation panel may not be observed in patient populations. Furthermore, where parasite densities are very low, detection rates may be lower than those reported here.
Referring to Figure 6, to be classified as detecting a sample, a product must return 4 positive tests at the manufacturers’ recommended minimum reading time (2 from Lot 1, 2 from Lot 2 at initial reading time) when tested using a parasite density of 200 parasites/μl. When tested against 2000 or 5000 parasites/μl (Figure 5) the product must return 2 positive tests at the manufacturers’ recommended minimum reading time (1 from each lot). Thus, a “positive” result is a
measure of consistency of result, as well as ability to detect antigen.
The detection rate was defined as the percentage of P. falciparum wild type samples detected by the product. The non-P. falciparum detection rate is the percentage of Plasmodium positive/P. falciparum negative samples identified by the product.
8.2. FALSE POSITIVESFalse positive results are analysed and reported as two separate groups; those that had incorrect species identification, and those that returned a positive result for samples containing no Plasmodium spp. parasites. Specifically, the false positive rate is the percentage of all tests that returned a positive test when it shouldn't have, based on reader 1 results.
8.2.1. Incorrect species identificationA test is considered as returning an incorrect species result if a positive P. falciparum test line appears with a sample containing non-P. falciparum parasites. P. vivax samples resulting in a visible line on a P. falciparum-specific test line are also considered to be false positives.
8.2.2. False positives from Plasmodium-negative samples
Any test that produces a positive reading to samples with no Plasmodium parasites is considered a false-positive. In Phase 2, parasite-negative samples consist of clean negative samples and also samples containing other infectious agents (e.g. Dengue, Leishmania, Chagas) and immunological factors (rheumatoid factor, anti-nuclear antibodies, heterophile antibodies).
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)13
8.3. BAND INTENSITYAll positive tests results were recorded according to the band intensity against a standard reference chart, matched closely to line colour. Based on Reader 1 results, the distribution of band intensity results is presented as the mean band intensity of positive results. In addition, the intensity was expressed for each possible result (0, 1, 2, 3 or 4)18 as the percentage recorded at that level.
8.4. LOT AGREEMENT Disagreement between test lots is calculated from the number of samples that returned a positive result on both RDTs tested in that lot against parasite-positive samples at 200 parasites/μl, and on the single RDT from each lot tested against samples at 2000 or 5000 parasites/μl. Thus, high inter-lot agreement indicates consistency in detecting malaria parasites.
18 A standard intensity comparison chart is used, allowing matching to the closest of 4 common colour variants of labelled antibodies used on RDTs, each at 4 levels of intensity.
8.5. READER VARIABILITYTwo readings of each test are conducted, although only the first is certain to comply with the manufacturer’s guidelines for reading test results. A second reading is performed within one hour. Detection rates for both readers are calculated to assess how sensitive the results are to the time of reading.
8.6. INVALID TESTSThe total number of tests that were deemed invalid during testing of both lots, using samples at 200 parasites/μl and 2000 or 5000 parasites/μl.
8.7. HEAT (THERMAL) STABILITY The results of heat stability testing are reported as the number of positive tests (maximum 10) and mean band intensity (for positive tests only) per lot at baseline and after lots were stored at 4°C, 35°C and 45°C for 2 months against one P. falciparum parasite sample at 200 and 2000 parasites/μl.
9. LABORATORY VERSUS FIELD-BASED MALARIA RDT EVALUATIONS
Despite the strengths of the product testing programme, the evaluation is not completely analogous to field testing of malaria RDTs. In order to compose a panel that could be reproducibly used to evaluate RDTs, blood samples were diluted, frozen and stored below −70°C. Blood that has undergone a freeze thaw process may not have exactly the same characteristics as fresh blood, but as red cell lysis occurs as a first step on RDTs, the effect of this is limited. A further variation from field equivalence is the use of a micro-pipette to supply blood to the RDT device rather than the blood transfer device provided by the manufacturer. This was necessary because blood is collected from a cryo-tube rather than a finger-prick. This technique also ensured consistency of testing by reducing the likelihood of operator error.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)14
10. RESULTS
10.1. SUMMARY
In Round 1 of the WHO-FIND Malaria RDT Evaluation Programme, 41 products were evaluated against P. falciparum culture samples, blood samples collected from parasitaemic patients from three continents and a large panel of parasite negative samples. Heat stability was assessed at temperatures commonly encountered in malaria endemic countries. Twelve research institutes were engaged in either sample collection or sample characterization to establish the evaluation panels. Between May and November 2008, in total, over 41 000 tests were performed at the US Centers for Disease Control and Prevention.
The results of the evaluation reveal the following key outcomes:
1. Several RDTs are available that demonstrated consistent detection of malaria at low parasite densities (200 parasites/μl), have low false-positive rates, are stable at tropical temperatures, are relatively easy to use, and can detect P. falciparum, P. vivax infections, or both.
2. Performance between products varied widely at low parasite density (200 parasites/μl); however, most products showed a high level of detection at 2000 to 5000 parasites/μl.
3. P. falciparum tests targeting HRP2 antigen demonstrated the highest detection rates, but some tests targeting pLDH also exhibited high detection rates.
4. Test performance varied between lots, and widely between similar products.
Tables 3 and 4 summarize the performance of 41 malaria RDTs against P. falciparum cultured parasites (Table 3) and blood containing wild type P. falciparum and P. vivax parasites and Plasmodium spp. negative samples (Table 4). Tables 3a and 4a present summary results for 7 products based on a delayed reading when specified in the manufacturers' instructions. Detailed information pertaining to all product testing results is included in Annex 3 (Phase 1) and Annex 4 (Phase 2). A graphical representation of this data follows below.
In summary tables, data is colour coded according to arbitrary categories, to ease the interpretation of results, and these do not imply limits of acceptable or unacceptable performance.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)15
Tabl
e 3:
Sum
mar
y pe
rfor
man
ce o
f m
alar
ia R
DTs
agai
nst
20 c
ultu
red
P. f
alci
paru
m li
nes
at lo
w (
200)
and
hig
h (2
000
or 5
000)
par
asit
e de
nsit
ies
(par
asit
es/μ
l)
Prod
uct
Man
ufac
ture
r
Dete
ctio
n ra
te‡
(n=2
0)Fa
lse
posi
tive
non
-Pf
infe
ctio
n †
(%)
Inva
lid r
ate
(%)
200
para
site
s/μl
2,00
0 or
5,0
00
para
site
s/μl
200
para
site
s/μl
2,00
0 or
5,0
00
para
site
s/μl
Pf o
nly
ADVA
NCE
D QU
ALIT
Y TM
MAL
ARIA
(p.f)
POC
T In
Tec
Prod
ucts
, Inc
.15
.090
.0N
/AN
/A0.
0
ADVA
NCE
D QU
ALIT
Y TM
One
Ste
p M
alar
ia (p
.f.) T
est (
who
le b
lood
)In
Tec
Prod
ucts
, Inc
.10
.090
.0N
/AN
/A0.
0Ad
vant
age
P.f.
Mal
aria
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.85
.010
0.0
N/A
N/A
0.0
Care
Star
t Mal
aria
HRP
2 (P
f)Ac
cess
Bio
, Inc
.10
0.0
100.
0N
/AN
/A0.
0Fi
rst R
espo
nse
Mal
aria
Ag
HRP
2Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
100.
010
0.0
N/A
N/A
0.0
Firs
tSig
n –
Mal
aria
Pf C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.0.
080
.0N
/AN
/A0.
0H
exag
on M
alar
iaH
uman
Gm
bH5.
095
.0N
/AN
/A0.
0IC
T M
alar
ia P
f Cas
sett
e Te
st (M
L01)
ICT
Diag
nost
ics
55.0
100.
0N
/AN
/A0.
0Im
mun
oqui
ck M
alar
ia F
alci
paru
mBi
osyn
ex55
.010
0.0
N/A
N/A
0.0
Mal
aria
Pla
smod
ium
falc
ipar
um R
apid
test
Dev
ice
(Who
le b
lood
)AC
ON L
abor
ator
ies,
Inc.
85.0
95.0
N/A
N/A
0.0
Mal
aria
Rap
id P
fVi
sion
Bio
tech
(Pty
) Ltd
.70
.010
0.0
N/A
N/A
0.0
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
evic
e)
Orch
id B
iom
edic
al S
yste
ms
15.0
95.0
N/A
N/A
2.5
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
ipst
ick)
Or
chid
Bio
med
ical
Sys
tem
s55
.010
0.0
N/A
N/A
0.0
Para
hit-
f DIP
STIC
K FO
R FA
LCIP
ARU
M M
ALAR
IASp
an D
iagn
ostic
s Lt
d.45
.010
0.0
N/A
N/A
0.0
Para
hit-
f TES
T DE
VICE
FOR
FAL
CIPA
RUM
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
10.0
90.0
N/A
N/A
0.0
SD B
IOLI
NE
Mal
aria
Ag
Pf
Stan
dard
Dia
gnos
tics,
Inc.
90.0
100.
0N
/AN
/A0.
0Pf
& P
an/P
f &
Pv
Adva
ntag
e M
al C
ard
J. M
itra
& C
o. P
vt. L
td.
0.0
100.
01.
250.
000.
0AZ
OG M
alar
ia p
f (H
RP-I
I) /p
v (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
eAZ
OG, I
nc.
85.0
100.
00.
000.
000.
0Bi
nax
Now
Mal
aria
In
vern
ess
Med
ical
Inno
vatio
ns, I
nc.
80.0
100.
00.
000.
000.
0Ca
reSt
art M
alar
ia H
RP2/
pLDH
(Pf/
PAN
) COM
BOAc
cess
Bio
, Inc
.95
.010
0.0
1.25
0.00
0.0
Firs
t Res
pons
e M
alar
ia A
g Co
mbo
(PLD
H/H
RP2)
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.95
.010
0.0
0.00
0.00
0.0
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.15
.095
.02.
470.
000.
0H
exag
on M
alar
ia C
ombi
Hum
an G
mbH
10.0
95.0
0.00
0.00
0.0
ICT
Mal
aria
Com
bo C
asse
tte
Test
(ML0
2)IC
T Di
agno
stic
s75
.010
0.0
1.25
0.00
0.0
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
85.0
100.
00.
000.
000.
0M
alar
ia P
.F/V
ivax
Diag
nost
ic A
utom
atio
n / C
orte
z Di
agno
stic
s, In
c.0
(19)
6.67
(15)
82.6
991
.67
36.7
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
50.0
95.0
0.00
0.00
0.0
Mal
aria
Rap
id D
ual
Visi
on B
iote
ch (P
ty) L
td.
75.0
100.
00.
000.
000.
0M
alas
can
Rapi
d Te
st fo
r Mal
aria
Pf/
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
15.0
100.
00.
000.
000.
0On
e St
ep M
alar
ia A
ntig
en S
trip
IND
Diag
nost
ic In
c.0.
070
.00.
000.
000.
0On
Sigh
t – P
araQ
uick
(Pan
, Pf)
Test
Amge
nix
Inte
rnat
iona
l, In
c.65
.010
0.0
0.00
0.00
0.0
OptiM
AL-I
TDi
aMed
AG
0.0
100.
01.
250.
000.
0Pa
rahi
t-To
tal D
evic
e Ra
pid
test
for P
. fal
cipa
rum
and
Pan
mal
aria
l spe
cies
.Sp
an D
iagn
ostic
s Lt
d.5.
090
.00.
000.
000.
0Pa
rasc
reen
Rap
id T
est f
or M
alar
ia P
an/P
f (De
vice
)Ze
phyr
Bio
med
ical
s30
.010
0.0
0.00
0.00
0.0
Quic
kstic
k M
alar
ia A
ntig
en T
est
Inno
vate
k M
edic
al In
c.0.
070
.00.
000.
000.
0SD
BIO
LIN
E M
alar
ia A
gSt
anda
rd D
iagn
ostic
s, In
c.0.
085
.00.
000.
000.
0SD
BIO
LIN
E M
alar
ia A
g Pf
/Pan
St
anda
rd D
iagn
ostic
s, In
c.85
.010
0.0
0.00
0.00
0.0
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
30.0
90.0
0.00
0.00
0.0
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
0.0
95.0
N/A
N/A
0.0
Care
Star
t Mal
aria
pLD
H (P
AN)
Acce
ss B
io, I
nc.
60.0
100.
0N
/AN
/A0.
0Pa
raba
nk R
apid
Tes
t for
Mal
aria
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
0.0
65.0
N/A
N/A
0.0
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spe
cies
† -
Pan
or P
v lin
e on
ly p
ositi
ve in
dica
tes
a fa
lse
posi
tive
non
P. fa
lcip
arum
infe
ctio
n ‡ -
a s
ampl
e is
con
side
red
dete
cted
onl
y if
all R
DTs
from
bot
h lo
ts re
ad b
y th
e fir
st te
chni
cian
, at
min
imum
spe
cifie
d re
adin
g tim
e, a
re p
ositi
ve
Dete
ctio
n ra
te (%
)≥9
585
-94
50-8
4<
50
Fals
e po
sitiv
e ra
te (%
)<2
2-5
6 -1
0>1
0
Inva
lid ra
te (%
)<1
% o
f tes
ts
cond
ucte
d1-
2% o
f tes
ts
cond
ucte
d2-
5% o
f tes
ts
cond
ucte
d>5
% o
f tes
ts
cond
ucte
d
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)16
Tabl
e 3a
: Sum
mar
y pe
rfor
man
ce o
f m
alar
ia R
DTs
agai
nst
20 c
ultu
red
P.fal
cipa
rum
line
s at
low
(20
0) a
nd h
igh
(200
0 or
500
0) p
aras
ite
dens
itie
s (p
aras
ites
/μl)
base
d on
a
dela
yed
read
ing
whe
n sp
ecifi
ed b
y th
e m
anuf
actu
rer
Prod
uct
Man
ufac
ture
r
Dete
ctio
n ra
te‡
(n=2
0)Fa
lse
posi
tive
non
-Pf
infe
ctio
n †
(%)
Inva
lid r
ate
(%)
200
para
site
s/μl
2,00
0 or
5,0
00
para
site
s/μl
200
para
site
s/μl
2,00
0 or
5,0
00
para
site
s/μl
Pf &
Pan
/Pf
& P
vFi
rstS
ign
– Pa
raVi
ew-2
(Pv
+ Pf
) Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
5095
00
0Im
mun
oqui
ck M
alar
ia +
4Bi
osyn
ex85
100
00
0M
alar
ia P
.F/V
ivax
Diag
nost
ics
Auto
mat
ion/
Cort
ez D
iagn
ostic
s, In
c.0
(19)
0 (1
7)75
.47
96.1
534
.17
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s25
100
00
0Pa
rasc
reen
Rap
id T
est f
or M
alar
ia P
an/P
f (De
vice
)Ze
phyr
Bio
med
ical
s70
100
00
0W
ondf
o On
e St
ep M
alar
ia P
f/Pa
n W
hole
Blo
od T
est
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
., Lt
d40
900
2.5
0Pf
onl
yPa
raba
nk R
apid
Tes
t for
Mal
aria
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
095
N/A
N/A
0Pf
- P
lasm
odiu
m fa
lcip
arum
Pv
- P
lasm
odiu
m v
ivax
pan
- Pl
asm
odiu
m s
peci
es
† - P
an o
r Pv
line
only
pos
itive
indi
cate
s a
fals
e po
sitiv
e no
n P.
falc
ipar
um in
fect
ion
‡ - a
sam
ple
is c
onsi
dere
d de
tect
ed o
nly
if al
l RDT
s fr
om b
oth
lots
read
by
the
first
tech
nici
an, a
t min
imum
spe
cifie
d re
adin
g tim
e, a
re p
ositi
ve
Tabl
e 4:
Sum
mar
y pe
rfor
man
ce o
f m
alar
ia R
DTs
agai
nst
wild
typ
e P.
fal
cipa
rum
and
P. v
ivax
sam
ples
at
low
(20
0) a
nd h
igh
(200
0 or
500
0) p
aras
ite
dens
itie
s (p
aras
ites
/μl
) an
d Pl
asm
odiu
m s
pp. n
egat
ive
sam
ples
Prod
uct
Man
ufac
ture
r
Dete
ctio
n ra
te‡
(%)
Fals
e po
siti
ve r
ates
(%
) Fa
lse
posi
tive
rat
es (
%)
Tota
l fal
se
posi
tive
rat
es*
(%)
Inva
lid
rate
(%
)
200
para
site
s/μl
2000
or
5000
pa
rasi
tes/
μl20
0 pa
rasi
tes/
μl20
00 o
r 50
00 p
aras
ites
/μl
Clea
n N
egat
ive
sam
ples
Pf s
ampl
es
(n=7
9)Pv
sam
ples
(n
=20)
Pf
sam
ples
(n
=79)
Pv s
ampl
es
(n=2
0)
Pf s
ampl
es
Pv s
ampl
es
Pf s
ampl
es
Pv s
ampl
es
Fals
e po
siti
ve
non
Pf
infe
ctio
n† (n
=316
)
Fals
e po
siti
ve
Pf in
fect
ion◊
(n
=80)
Fal
se p
osit
ive
non
Pf
infe
ctio
n† (n
=158
)
Fals
e po
siti
ve
Pf in
fect
ion◊
(n
=40)
Fals
e po
siti
ve
Plas
mod
ium
sp
p. in
fect
ion
(n=1
68)
Pf o
nly
ADVA
NCE
D QU
ALIT
Y TM
MAL
ARIA
(p.f)
POC
T In
Tec
Prod
ucts
, Inc
.56
.96
N/A
100
N/A
N/A
12.5
N/A
17.5
16.0
70
ADVA
NCE
D QU
ALIT
Y TM
One
Ste
p M
alar
ia (p
.f.) T
est (
who
le
bloo
d)In
Tec
Prod
ucts
, Inc
.67
.09
N/A
100
N/A
N/A
48.7
5N
/A45
27.9
80
Adva
ntag
e P.
f. M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
97.4
7N
/A10
0N
/AN
/A1.
25N
/A2.
50
0Ca
reSt
art M
alar
ia H
RP2
(Pf)
Acce
ss B
io, I
nc.
98.7
3N
/A98
.73
N/A
N/A
5N
/A7.
52.
380
Firs
t Res
pons
e M
alar
ia A
g H
RP2
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.10
0N
/A10
0N
/AN
/A0
N/A
02.
980
Firs
tSig
n –
Mal
aria
Pf C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.31
.65
N/A
86.0
8N
/AN
/A12
.5N
/A15
2.41
(166
)0
Hex
agon
Mal
aria
Hum
an G
mbH
39.2
4N
/A94
.94
N/A
N/A
7.89
(76)
N/A
2.5
4.19
(167
)1.
18IC
T M
alar
ia P
f Cas
sett
e Te
st (M
L01)
ICT
Diag
nost
ics
82.2
8N
/A97
.47
N/A
N/A
1.27
N/A
2.5
0.6
0Im
mun
oqui
ck M
alar
ia F
alci
paru
mBi
osyn
ex91
.14
N/A
100
N/A
N/A
0N
/A0
0.6
0M
alar
ia P
lasm
odiu
m fa
lcip
arum
Rap
id te
st D
evic
e (W
hole
bl
ood)
ACON
Lab
orat
orie
s, In
c.92
.41
N/A
100
N/A
N/A
0N
/A0
00
Mal
aria
Rap
id P
fVi
sion
Bio
tech
(Pty
) Ltd
.68
.35
N/A
97.4
7N
/AN
/A0
N/A
00.
60
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
evic
e)
Orch
id B
iom
edic
al S
yste
ms
54.4
3N
/A97
.47
N/A
N/A
3.95
(76)
N/A
51.
25 (1
60)
2.69
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
ipst
ick)
Or
chid
Bio
med
ical
Sys
tem
s74
.68
N/A
100
N/A
N/A
16.4
6N
/A10
7.19
(167
)0.
51Pa
rahi
t-f D
IPST
ICK
FOR
FALC
IPAR
UM
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
78.4
8N
/A10
0N
/AN
/A0
N/A
00.
60
Para
hit-
f TES
T DE
VICE
FOR
FAL
CIPA
RUM
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
39.2
4N
/A97
.47
N/A
N/A
0N
/A0
00
SD B
IOLI
NE
Mal
aria
Ag
Pf
Stan
dard
Dia
gnos
tics,
Inc.
97.4
7N
/A98
.73
N/A
N/A
0N
/A0
2.38
0
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)17
Dete
ctio
n ra
te (%
)≥9
585
-94
50-8
4<
50
Fals
e po
sitiv
e ra
te (%
)<2
2-5
6-10
>10
Inva
lid ra
te (%
)<1
% o
f tes
ts
cond
ucte
d1-
2% o
f tes
ts
cond
ucte
d2-
5% o
f tes
ts
cond
ucte
d>5
% o
f tes
ts
cond
ucte
d
Prod
uct
Man
ufac
ture
r
Dete
ctio
n ra
te‡
(%)
Fals
e po
siti
ve r
ates
(%
) Fa
lse
posi
tive
rat
es (
%)
Tota
l fal
se
posi
tive
rat
es*
(%)
Inva
lid
rate
(%
)
200
para
site
s/μl
2000
or
5000
pa
rasi
tes/
μl20
0 pa
rasi
tes/
μl20
00 o
r 50
00 p
aras
ites
/μl
Clea
n N
egat
ive
sam
ples
Pf s
ampl
es
(n=7
9)Pv
sam
ples
(n
=20)
Pf
sam
ples
(n
=79)
Pv s
ampl
es
(n=2
0)
Pf s
ampl
es
Pv s
ampl
es
Pf s
ampl
es
Pv s
ampl
es
Fals
e po
siti
ve
non
Pf
infe
ctio
n† (n
=316
)
Fals
e po
siti
ve
Pf in
fect
ion◊
(n
=80)
Fal
se p
osit
ive
non
Pf
infe
ctio
n† (n
=158
)
Fals
e po
siti
ve
Pf in
fect
ion◊
(n
=40)
Fals
e po
siti
ve
Plas
mod
ium
sp
p. in
fect
ion
(n=1
68)
Pf &
Pan
/Pf
& P
vAd
vant
age
Mal
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.62
.03
100
100
100
2.53
00
04.
170
AZOG
Mal
aria
pf (
HRP
-II)
/pv
(pLD
H) A
ntig
en D
etec
tion
Test
De
vice
AZOG
, Inc
.77
.22
3010
095
1.9
00
2.5
9.52
0
Bina
x N
ow M
alar
ia
Inve
rnes
s M
edic
al In
nova
tions
, Inc
.91
.14
1010
085
0.32
3.8
0 (1
57)
50.
000.
34Ca
reSt
art M
alar
ia H
RP2/
pLDH
(Pf/
PAN
) COM
BOAc
cess
Bio
, Inc
.97
.47
9010
095
0.32
1.25
02.
52.
980
Firs
t Res
pons
e M
alar
ia A
g Co
mbo
(PLD
H/H
RP2)
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.10
075
100
650
3.75
020
3.57
0Fi
rstS
ign
– Pa
raVi
ew-2
(Pv
+ Pf
) Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
48.1
098
.73
850.
953.
750
50.
000
Hex
agon
Mal
aria
Com
biH
uman
Gm
bH46
.84
097
.47
500
00
(157
)2.
63 (3
8)2.
990.
67IC
T M
alar
ia C
ombo
Cas
sett
e Te
st (M
L02)
ICT
Diag
nost
ics
86.0
80
100
950.
323.
750
50.
60
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
93.6
730
98.7
310
00
(314
)0
0 (1
57)
00.
600
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nost
ics,
Inc.
73.5
8 (5
3)0
(15)
94.8
7 (3
9)30
.77
(13)
1.03
(97)
0 (3
0)2.
08 (4
8)0
(18)
1.56
67.5
1
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
87.3
410
100
900.
327.
50
7.5
7.74
0M
alar
ia R
apid
Dua
l Vi
sion
Bio
tech
(Pty
) Ltd
.75
.95
598
.73
901.
270
00
10.1
20
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s63
.29
097
.47
750.
636.
250
17.5
5.36
0On
e St
ep M
alar
ia A
ntig
en S
trip
IND
Diag
nost
ic In
c.1.
270
67.0
960
2.22
3.75
1.9
01.
800
OnSi
ght –
Par
aQui
ck (P
an, P
f) Te
stAm
geni
x In
tern
atio
nal,
Inc.
59.4
950
100
100
01.
250
00.
000
OptiM
AL-I
TDi
aMed
AG
36.7
195
96.2
100
3.8
00.
630
0.00
0Pa
rahi
t-To
tal D
evic
e Ra
pid
test
for P
. fal
cipa
rum
and
Pan
m
alar
ial s
peci
es.
Span
Dia
gnos
tics
Ltd.
35.4
40
93.6
750
0 (3
15)
00
2.5
0.00
0.17
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
50.6
325
100
950.
633.
80
01.
190.
17Qu
icks
tick
Mal
aria
Ant
igen
Tes
tIn
nova
tek
Med
ical
Inc.
1.27
067
.09
602.
223.
751.
91.
80SD
BIO
LIN
E M
alar
ia A
gSt
anda
rd D
iagn
ostic
s, In
c.29
.1150
96.2
100
01.
250
01.
790
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
an
Stan
dard
Dia
gnos
tics,
Inc.
96.2
3510
095
0 (3
10)
00
2.56
(39)
1.19
1.35
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
60.7
630
98.7
395
3.52
(312
)1.
3 (7
7)0
(155
)2.
56 (3
9)6.
591.
85Pa
n on
lyAd
vant
age
Pan
Mal
aria
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.72
.15
100
100
100
N/A
N/A
N/A
N/A
1.79
0Ca
reSt
art M
alar
ia p
LDH
(PAN
)Ac
cess
Bio
, Inc
.92
.41
100
100
100
N/A
N/A
N/A
N/A
6.55
0Pa
raba
nk R
apid
Tes
t for
Mal
aria
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
1.27
3087
.34
100
N/A
N/A
N/A
N/A
2.99
(167
)0
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n - P
lasm
odiu
m sp
ecie
s † -
For
com
bina
tion
test
s, Pa
n or
Pv
line,
onl
y, po
sitiv
e in
dica
tes
a fa
lse
posi
tive
non
P. fa
lcip
arum
infe
ctio
n ‡ -
A s
ampl
e is
con
side
red
dete
cted
onl
y if
all R
DTs
from
bot
h lo
ts re
ad b
y th
e fir
st te
chni
cian
, at m
inim
um s
peci
fied
read
ing
time,
are
pos
itive
◊ - P
f lin
e po
sitiv
e in
dica
tes
a fa
lse
posi
tive
P. fa
lcip
arum
infe
ctio
n * -
The
tota
l num
ber o
f tim
es a
pos
itive
resu
lt fo
r mal
aria
was
gen
erat
ed w
hen
it sh
ould
not
hav
e be
en (P
f+; P
f +/P
an o
r Pv
-; P
f+/P
an o
r Pv+
; Pf-
/Pan
or P
v+)
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)18
Tabl
e 4a
: Sum
mar
y pe
rfor
man
ce o
f m
alar
ia R
DTs
agai
nst
P. f
alci
paru
m li
nes
at lo
w (
200)
and
hig
h (2
000
or 5
000)
par
asit
e de
nsit
ies
(par
asit
es/μ
l) ba
sed
on a
del
ayed
re
adin
g w
hen
spec
ified
by
the
man
ufac
ture
r
Prod
uct
Man
ufac
ture
r
Dete
ctio
n ra
te‡
(%)
Fals
e po
siti
ve r
ates
(%
) Fa
lse
posi
tive
rat
es (
%)
Tota
l fal
se
posi
tive
ra
tes*
(%
)
Inva
lid r
ate
(%)
200
para
site
s/μl
2000
or
5000
par
asit
es/μ
l20
0 pa
rasi
tes/
μl20
00 o
r 50
00 p
aras
ites
/μl
Pf s
ampl
es
(n=7
9)Pv
sam
ples
(n
=20)
Pf
sam
ples
(n
=79)
Pv s
ampl
es
(n=2
0)
Pf s
ampl
es
Pv s
ampl
es
Pf s
ampl
es
Pv s
ampl
es
Clea
n N
egat
ive
sam
ples
Fals
e po
siti
ve
non
Pf
infe
ctio
n† (n
=316
)
Fals
e po
siti
ve P
f in
fect
ion◊
(n
=80)
Fal
se
posi
tive
no
n Pf
in
fect
ion†
(n=1
58)
Fals
e po
siti
ve P
f in
fect
ion◊
(n
=40)
Fals
e po
siti
ve
Plas
mod
ium
sp
. Inf
ecti
on
(n=1
68)
Pf &
Pan
/Pf
& P
vFi
rstS
ign
– Pa
raVi
ew-2
(Pv
+ Pf
) Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
64,5
60
100
100
02.
5 (8
0)0
2,5
00
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
93,6
745
100
950
1.25
(80)
02,
57,
140,
17M
alar
ia P
.F/V
ivax
Diag
nost
ic A
utom
atio
n / C
orte
z Di
agno
stic
s, In
c.71
.43
(56)
0 (1
5)92
.5 (4
0)45
.45
(11)
00
(30)
4,17
0 (1
5)3,
2367
,17
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s68
,35
098
,73
851,
587.
5 (8
0)0
12,5
6,55
0Pa
rasc
reen
Rap
id T
est f
or M
alar
ia P
an/P
f (De
vice
)Ze
phyr
Bio
med
ical
s65
,82
5598
,73
100
0,63
00,
630
2,38
0,09
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
68,3
535
98,7
390
1,92
3.9
(77)
05.
13 (3
9)7,
381,
85Pa
n on
lyPa
raba
nk R
apid
Tes
t for
Mal
aria
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
13,9
275
97,4
710
0N
/AN
/AN
/AN
/AN
/A0
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spec
ies
† - F
or c
ombi
natio
n te
sts,
Pan
or P
v lin
e, o
nly,
posi
tive
indi
cate
s a
fals
e po
sitiv
e no
n P.
falc
ipar
um in
fect
ion
‡ - A
sam
ple
is c
onsi
dere
d de
tect
ed o
nly
if al
l RDT
s fr
om b
oth
lots
read
by
the
first
tech
nici
an, a
t min
imum
spe
cifie
d re
adin
g tim
e, a
re p
ositi
ve◊ -
Pf l
ine
posi
tive
indi
cate
s a
fals
e po
sitiv
e P.
falc
ipar
um in
fect
ion
Dete
ctio
n ra
te (%
)≥9
585
-94
50-8
4<
50
Fals
e po
sitiv
e ra
te (%
)<2
2-5
6-10
>10
Inva
lid ra
te (%
)<1
% o
f tes
ts
cond
ucte
d1-
2% o
f tes
ts
cond
ucte
d2-
5% o
f tes
ts
cond
ucte
d>5
% o
f tes
ts
cond
ucte
d
Tabl
e 5:
Hea
t st
abili
ty t
esti
ng r
esul
ts f
or m
alar
ia R
DTs
on a
cul
ture
d P.
fal
cipa
rum
sam
ple
at lo
w (2
00) a
nd h
igh
(200
0 or
500
0) p
aras
ite
dens
ity
(par
asit
es/μ
l). P
osit
ivit
y ra
te a
t ba
selin
e, a
nd a
fter
60
days
incu
bati
on a
t 35
°C a
nd 4
5°C
Prod
uct
Man
ufac
ture
r
Posi
tive
tes
ts r
esul
ts f
or P
. fa
lcip
arum
(Pf
line
)20
0 pa
rasi
tes/
μl
Posi
tive
tes
ts r
esul
ts f
or P
. fa
lcip
arum
(Pf
line
)20
00 p
aras
ites
/μl
Posi
tive
tes
ts r
esul
ts f
or P
. fa
lcip
arum
(Pa
n lin
e)20
0 pa
rasi
tes/
μl
Posi
tive
tes
ts r
esul
ts f
or P
. fa
lcip
arum
(Pa
n lin
e)20
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
itiv
e (m
ax. 2
0)N
umbe
r of
tes
ts p
osit
ive
(max
. 20)
Num
ber
of t
ests
pos
itiv
e (m
ax. 2
0)N
umbe
r of
tes
ts p
osit
ive
(max
. 20)
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
Lots
1 a
nd 2
com
bine
dLo
ts 1
and
2 c
ombi
ned
Pf o
nly
ADVA
NCE
D QU
ALIT
Y TM
MAL
ARIA
(p.f)
POC
T In
Tec
Prod
ucts
, Inc
.16
1918
2020
20N
/AN
/AN
/AN
/AN
/AN
/AAD
VAN
CED
QUAL
ITY
TM O
ne S
tep
Mal
aria
(p.f.
) Tes
t (w
hole
blo
od)
InTe
c Pr
oduc
ts, I
nc.
1617
920
1920
N/A
N/A
N/A
N/A
N/A
N/A
Adva
ntag
e P.
f. M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
1920
2020
2020
N/A
N/A
N/A
N/A
N/A
N/A
Care
Star
t Mal
aria
HRP
2 (P
f)Ac
cess
Bio
, Inc
.20
2020
2020
20N
/AN
/AN
/AN
/AN
/AN
/AFi
rst R
espo
nse
Mal
aria
Ag
HRP
2Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
2020
2020
2020
N/A
N/A
N/A
N/A
N/A
N/A
Firs
tSig
n –
Mal
aria
Pf C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.4
30
2018
19N
/AN
/AN
/AN
/AN
/AN
/AH
exag
on M
alar
iaH
uman
Gm
bH10
712
1920
20N
/AN
/AN
/AN
/AN
/AN
/A
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)19
Prod
uct
Man
ufac
ture
r
Posi
tive
tes
ts r
esul
ts f
or P
. fa
lcip
arum
(Pf
line
)20
0 pa
rasi
tes/
μl
Posi
tive
tes
ts r
esul
ts f
or P
. fa
lcip
arum
(Pf
line
)20
00 p
aras
ites
/μl
Posi
tive
tes
ts r
esul
ts f
or P
. fa
lcip
arum
(Pa
n lin
e)20
0 pa
rasi
tes/
μl
Posi
tive
tes
ts r
esul
ts f
or P
. fa
lcip
arum
(Pa
n lin
e)20
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
itiv
e (m
ax. 2
0)N
umbe
r of
tes
ts p
osit
ive
(max
. 20)
Num
ber
of t
ests
pos
itiv
e (m
ax. 2
0)N
umbe
r of
tes
ts p
osit
ive
(max
. 20)
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
ICT
Mal
aria
Pf C
asse
tte
Test
(ML0
1)IC
T Di
agno
stic
s20
2019
2020
20N
/AN
/AN
/AN
/AN
/AN
/AIm
mun
oqui
ck M
alar
ia F
alci
paru
mBi
osyn
ex20
2020
2020
20N
/AN
/AN
/AN
/AN
/AN
/AM
alar
ia P
lasm
odiu
m fa
lcip
arum
Rap
id te
st D
evic
e (W
hole
blo
od)
ACON
Lab
orat
orie
s, In
c.20
2020
2020
20N
/AN
/AN
/AN
/AN
/AN
/A
Mal
aria
Rap
id P
fVi
sion
Bio
tech
(Pty
) Ltd
.20
2017
2020
20N
/AN
/AN
/AN
/AN
/AN
/APa
rach
eck
Pf R
apid
test
for P
. fal
cipa
rum
Mal
aria
(D
evic
e)
Orch
id B
iom
edic
al S
yste
ms
1814
1020
1720
N/A
N/A
N/A
N/A
N/A
N/A
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia
(Dip
stic
k)
Orch
id B
iom
edic
al S
yste
ms
1920
1720
2020
N/A
N/A
N/A
N/A
N/A
N/A
Para
hit-
f DIP
STIC
K FO
R FA
LCIP
ARU
M M
ALAR
IASp
an D
iagn
ostic
s Lt
d.20
2020
2020
20N
/AN
/AN
/AN
/AN
/AN
/APa
rahi
t-f T
EST
DEVI
CE F
OR F
ALCI
PARU
M M
ALAR
IASp
an D
iagn
ostic
s Lt
d.14
108
2019
19N
/AN
/AN
/AN
/AN
/AN
/ASD
BIO
LIN
E M
alar
ia A
g Pf
St
anda
rd D
iagn
ostic
s, In
c.20
2020
2020
20N
/AN
/AN
/AN
/AN
/AN
/APf
& P
an/P
f &
Pv
Adva
ntag
e M
al C
ard
J. M
itra
& C
o. P
vt. L
td.
2020
1119
2019
119
820
2020
AZOG
Mal
aria
pf (
HRP
-II)
/pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
AZOG
, Inc
.12
137
2020
208
75
1814
4
Bina
x N
ow M
alar
ia
Inve
rnes
s M
edic
al In
nova
tions
, Inc
.20
2020
2020
191
00
1919
15Ca
reSt
art M
alar
ia H
RP2/
pLDH
(Pf/
PAN
) COM
BOAc
cess
Bio
, Inc
.20
1920
2020
2020
1920
2020
20Fi
rst R
espo
nse
Mal
aria
Ag
Com
bo (P
LDH
/HRP
2)Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
2020
2020
2020
1914
2020
2020
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.19
140
2019
150
00
00
0H
exag
on M
alar
ia C
ombi
Hum
an G
mbH
1311
1020
1719
00
00
00
ICT
Mal
aria
Com
bo C
asse
tte
Test
(ML0
2)IC
T Di
agno
stic
s20
2020
2020
201
10
1815
15Im
mun
oqui
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MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)2 0
10.2. PHASE 1 - P. FALCIPARUM CULTURE PANEL
The majority (73%) of tests consistently detected ≥ 95% of P. falciparum cultured parasites at high parasite densities; however, detection rate was highly variable at low parasite densities (0-100%). At low parasite densities, the top ten products all targeted HRP2 (Figure 7).
Table 3a illustrates detection rates at low and high parasite densities based on a delayed second reading if it was specifically indicated in the package insert following initial negative results at the specified reading time. For 3 products, results were unchanged and for 4 products detection rates increased.
Figure 7: Phase 1 P. falciparum detection rate of malaria RDTs at low (200) and high (2000 or 5000) parasite densities (parasites/μl) according to target antigen type (HRP2 or pLDH)†
† - Phase 1 Evaluation Panel : 20 P. falciparum culture samples. RDTs - 2 tests x 2 lots at 200 parasites/μl ; 1 test x 2 lots at 2000 parasites/μl
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)21
10.3. PHASE 2 - WILD TYPE P. FALCIPARUM AND P. VIVAX AND PLASMODIUM SPP. NEGATIVE SAMPLES
10.3.1. P. falciparum detection rateCompared to the P. falciparum cultured parasite panel, P. falciparum detection rates of wild type samples were generally higher, reflecting the increased antigen content of wild type samples. As in Phase 1, the majority of tests (35; 85%) detected ≥ 95% of P. falciparum samples at high
parasite densities but only 6 tests (15%) had this high level of detection at low parasite density (200 parasites/μl). All of these 6 products targeted HRP2; however 3 products targeting pLDH detected > 60% of P. falciparum samples. (Figure 8).
Table 4a illustrates detection rates at low and high parasite densities based on a delayed second reading if it was specifically indicated in the package insert following initial negative results at the specified reading time. At the low parasite density (200 parasites/μl), the P. falciparum detection rate increased for 5 of the 7 products, based on the delayed reading.
Figure 8: Phase 2 P. falciparum detection rate of malaria RDTs at low (200) and high (2000 or 5000) parasite density (parasites/μl) according to target antigen type (HRP2 or pLDH)†
†- Phase 2 Evaluation Panel included 79 blood samples containing wild type P. falciparum. RDTs - 2 tests x 2 lots at 200 parasites/μl and 1 test x 2 lots at 2000 parasites/μl
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)22
10.3.2. P. vivax detection rate P. vivax was generally less well detected than P. falciparum in clinical samples. As Figure 9 illustrates, even at high parasite densities (2000 or 5000 parasites/μl) several products failed to consistently detect clinical samples infected with P. vivax samples and detection rates dropped at low parasite density, with only 5 products (25%) detecting > 90% of samples. Products targeting pLDH performed better than those targeting aldolase. One product had a higher detection rate at 200 parasites/μl compared to 2000 parasites/μl because false positive P. falciparum specific test lines at 2000 parasites/μl were counted as incorrect or negative results.
10.3.3. Combined detection of P. falciparum and P. vivax
Considering combination tests, 3 products had detection rates > 60% for both P. falciparum and P. vivax at the low parasite density (200 parasites/μl) (Tables 4. 4a). However, several performed well at high parasite densities. Two pan-specific tests showed high detection rates of both P. falciparum and P. vivax.
†- Phase 2 Evaluation Panel included 20 blood samples containing wild type P. vivax. RDTs - 2 tests x 2 lots at 200 parasites/μl and 1 test x 2 lots at 2000 parasites/μl
Figure 9: Phase 2 P. vivax detection rate of malaria RDTs at low (200) and high (2000 or 5000) parasite densities (parasites/μl) according to target antigen type (aldolase, pLDH, aldolase + pLDH)†
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)23
10.3.4. P. falciparum and P. vivax positivity rate In addition to detection rate, positivity rate was also measured. This puts aside test and lot differences captured in detection rate and simply measures the total number of times a test returned a positive result. As expected,
positivity rate was higher but mirrored detection rate of wild type P. falciparum and P. vivax samples (Figs 10, 11) with one exception. In this exceptional case, the product had a very high invalid rate against P. falciparum samples (Table 4) and invalid test results were included in the calculation of positivity rate but excluded from detection rate.
†- Phase 2 Evaluation Panel included 79 blood samples containing wild type P. falciparum. RDTs - 2 tests x 2 lots at 200 parasites/μl and 1 test x 2 lots at 2000 parasites/μl
Figure 10: Phase 2† wild type P. falciparum detection rate and positivity rate at 200 parasites/μl
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)24
†- Phase 2 Evaluation Panel included 20 blood samples containing wild type P. vivax . RDTs - 2 tests x 2 lots at 200 parasites/μl and 1 test x 2 lots at 2000 parasites/μl
Figure 11: Phase 2† wild type P. vivax detection rate and positivity rate at 200 parasites/μl
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)25
10.3.5. Band intensity Although RDTs are not quantitative, technicians did grade positive results according to a standard chart and mean band intensity (for positive results) was calculated (Annex 4 - Tables A4.4, A4.5). There was a positive correlation between detection rate and band intensity and reader agreement; suggesting that, as expected, strong test bands are interpreted more reliably.
10.3.6. False positive rates Overall false positive rates were modest, rarely > 10% on parasite-free blood bank specimens or Plasmodium spp. negative samples containing potentially cross-reacting factors (Figs 12-15). False positive results were seen on both P. falciparum and pan/P. vivax test lines. No consistently higher rate of false positive was seen with blood abnormalities compared to infectious pathogens; however, sample sizes were small. For detailed information regarding the blood abnormality or pathogen that generated false positive results for a specific product refer to Annex 4 (Tables A4.10-A4.12).
Figure 12: P. falciparum (P. falciparum test line*) false positive rate against clean negative samples†
†- Phase 2 Evaluation Panel included 90 Plasmodium spp. negative samples of which 42 were "clean" negatives. RDTs - 2 tests x 2 lots at 200 parasites/μl and 1 test x 2 lots at 2000 parasites/μl*- includes Pf specific lines on combination tests and pan-specific lines on pan-specific only products.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)26
†- Phase 2 Evaluation Panel included 90 Plasmodium spp. negative samples - 42 clean negatives; 27 samples with blood immunological abnormalities and 21 with non Plasmodium spp. infectious pathogens. RDTs - 2 tests x 2 lots at 200 parasites/μl and 1 test x 2 lots at 2000 parasites/μl*- includes Pf specific lines on combination tests and pan-specific lines on pan-specific only products
Figure 13: P. falciparum (P. falciparum test line*) false positive rate against Plasmodium spp. negative samples containing potentially cross-reacting blood immunological abnormalities or infectious pathogens†
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)27
†- Phase 2 Evaluation Panel included 90 Plasmodium spp. negative samples - 42 clean negatives; 27 samples with blood immunological abnormalities and 21 with non Plasmodium spp. infectious pathogens. RDTs - 2 tests x 2 lots at 200 parasites/μl and 1 test x 2 lots at 2000 parasites/μl*- includes pan of pv line on combination tests and pan-specific line on pan-specific only products
Figure 14: Plasmodium spp. (pan or P. vivax test line*) false positive rate against clean negatives†
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)28
†- Phase 2 Evaluation Panel included 90 Plasmodium spp. negative samples - 42 clean negatives; 27 samples with blood immunological abnormalities and 21 with non Plasmodium spp. infectious pathogens. RDTs - 2 tests x 2 lots at 200 parasites/μl and 1 test x 2 lots at 2000 parasites/μl*- includes pan of pv line on combination tests and pan-specific line on pan-specific only products
Figure 15: Plasmodium spp. (pan or P. vivax test line*) false positive rate against Plasmodium spp. negative samples containing potentially cross-reacting blood immunological abnormalities or infectious pathogens†
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)29
Figure 16 and 17 illustrates that high rates of detection of P. falciparum or of P. vivax were not associated with a significant overall increase in false positive rates.
Figure 16: P. falciparum false positive rate19 versus P. falciparum detection rate at low (200) parasite density (parasites/μl)
Figure 17: P. vivax false positive rate versus P. vivax detection rate at low (200) parasite density (parasites/μl)
10.3.7. Inter-reader variability Each RDT result was read twice, the first, according to the manufacturers minimum reading time and a second reading was performed by a different technician within one hour. The mean time between readings for each product can be found in Tables A4.2, A4.3 (Annex 4). Figures 18 and 19 illustrate that for many products, the second reading yielded more positive results. However, for two products Reader 2 results returned fewer positive results secondary
to the fading of weak test band signals. In the case of 7 products20 manufacturers specifically indicated that a second reading should be performed if the initial results were negative. Results are therefore reported on the basis of the delayed reading in Tables 3a, 4a and in Annex 4 (Tables A4.1a, A4.4a-A4.12a)
20 Parascreen Rapid Test for Malaria (Pan/Pf) Device, Parabank Rapid Test for Malaria Pan (Device), Malascan Rapid Test for Malaria Pf/Pan (Device), ImmunoQuick Malaria + 4, Malaria Pf/vivax, Wondfo One Step Malaria Pf/Pan Whole Blood Test, FirstSign – ParaView-2 (Pv + Pf) Card Test.
19
19 On the clean negative panel, only.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)3 0
Figure 18: Wild type P. falciparum detection rate according to first and second readings at 200 parasites/μl
*- Manufacturers recommend a delayed reading if initial test results are negative.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)31
Figure 19: Wild type P. vivax detection rate according to first and second readings at 200 parasites/μl
*- Manufacturers recommend a delayed reading if initial test results are negative.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)32
11. HEAT STABILITY
A single P. falciparum culture sample was used as the reference sample for heat stability testing. Variations in baseline performance reflect inter-test variation as the sample at 200 parasites/μl was at the limit of detection of some products.
Several products were stable, meaning that they detected a P. falciparum cultured sample the same number of times at baseline and following incubation for 2 months (75% humidity) at 4°C, 35°C and 45°C. Detailed results are presented in Tables A4.13-A4.15 (Annex 4); in Table 5 and Figs 20-29, the results of both lots are combined (maximum score 20; 10 tests per lot).
Overall products (including HRP2 and pan test lines) were significantly more stable against samples with high (2000 or 5000) compared to low parasite densities, Figures 21, 23, 25 and Figures 20, 22, 24, respectively. For several, P. falciparum and combination tests, HRP2 test lines showed a high degree of stability at 35°C but several dropped off at 45°C. Some products showed an improved performance with incubation (Figs 22, 26). Baseline detection based on pan test lines was lower than baseline HRP2 test line results and the pan test lines of many products had poorer stability than HRP2 test lines.
Ultimately, there are products in each test category (Pf only, combination, pan only) that show good consistent baseline detection and heat stability up to 45°C for 2 months.
The summary results of heat/thermal stability testing are presented in Table 5.
11.1. P. FALCIPARUM TEST LINES Figure 20: Heat stability of P. falciparum specific (HRP2) test line of P. falciparum only tests against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
0
5
10
15
20
Parahit-f TEST DEVICE FOR FALCIPARUM MALARIAParacheck Pf Rapid Test for P. falciparum Malaria (Dipstick)Paracheck Pf Rapid Test for P. falciparum Malaria (Device)Malaria Rapid PfICT Malaria Pf Rapid Test (ML01)Hexagon MalariaFirstSign – Malaria Pf Card Test
CareStart Malaria HRP2 (Pf)First Response Malaria Ag HRP2Immunoquick Malaria FalciparumMalaria Plasmodium falciparum Rapid test Device (Whole blood)Parahit-f DIPSTICK FOR FALCIPARUM MALARIASD BIOLINE Malaria Ag Pf
Advantage P.f. Malaria CardADVANCED QUALITY TM One Step Malaria (p.f.) Test (whole blood)ADVANCED QUALITY TM MALARIA (p.f) POCT 45°C35°CBaseline
No. of positive results from two lots
Figure 21: Heat stability of P. falciparum specific (HRP2) test line of P. falciparum tests against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
15
20
Parahit-f TEST DEVICE FOR FALCIPARUM MALARIAParacheck Pf Rapid Test for P. falciparum Malaria (Device)Hexagon MalariaFirstSign – Malaria Pf Card TestADVANCED QUALITY TM One Step Malaria (p.f.) Test (whole blood)
ADVANCED QUALITY TM MALARIA (p.f) POCTAdvantage P.f. Malaria CardCareStart Malaria HRP2 (Pf)First Response Malaria Ag HRP2ICT Malaria Pf Rapid Test (ML01)Immunoquick Malaria FalciparumMalaria Plasmodium falciparum Rapid test Device (Whole blood)Malaria Rapid PfParacheck Pf Rapid Test for P. falciparum Malaria (Dipstick)Parahit-f DIPSTICK FOR FALCIPARUM MALARIASD BIOLINE Malaria Ag Pf
45°C35°CBaseline
No. of positive results from two lots
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)33
Figure 22: Heat stability of P. falciparum specific (HRP2) test line in combination tests against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
0
5
10
15
20
Wondfo One Step Malaria Pf/Pan Whole Blood TestCareStart Malaria HRP2/pLDH (Pf/PAN) COMBO
SD BIOLINE Malaria Ag Pf/PanBinax Now MalariaFirst Response Malaria Ag Combo (PLDH/HRP2)ICT Malaria Combo Cassette Test (ML02)Immunoquick Malaria +4Malaria Rapid ComboMalaria Rapid Dual
SD BIOLINE Malaria AgQuickstick Malaria Antigen TestOne Step Malaria Antigen StripParascreen Rapid Test for Malaria Pan/Pf (Device)ParahitTotal Device Rapid Test for P. falciparum and Pan Malarial SpeciesOptiMAL- ITOnSight – ParaQuick (Pan, Pf)Malascan Rapid Test for Malaria Pf/Pan (Device)
Malaria P.F/VIVAXHexagon Malaria CombiFirstSign – ParaView-2 (Pv + Pf) Card TestAdvantage Mal CardAZOG Malaria pf (HRP-II)/pv (pLDH) Antigen Detection Test Device
45°C35°CBaseline
No. of positive results from two lots
Figure 23: Heat stability of P. falciparum specific (HRP2) test line in combination tests against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
0
5
10
15
20
Quickstick Malaria Antigen TestOne Step Malaria Antigen Strip
Parascreen Rapid Test for Malaria Pan/Pf (Device)SD BIOLINE Malaria Ag Pf/PanBinax Now Malaria
ParahitTotal Device Rapid Test for P. falciparum and Pan Malarial SpeciesWondfo One Step Malaria Pf/Pan Whole Blood Test
OptiMAL- IT
Malaria P.F/VIVAXHexagon Malaria CombiFirstSign – ParaView-2 (Pv + Pf) Card Test
Advantage Mal CardCareStart Malaria HRP2/pLDH (Pf/PAN) COMBOFirst Response Malaria Ag Combo (PLDH/HRP2)ICT Malaria Combo Cassette Test (ML02)Immunoquick Malaria +4Malaria Rapid ComboMalaria Rapid DualMalascan Rapid Test for Malaria Pf/Pan (Device)OnSight – ParaQuick (Pan, Pf)SD BIOLINE Malaria Ag
AZOG Malaria pf (HRP-II)/pv (pLDH) Antigen Detection Test Device
45°C35°CBaseline
No. of positive results from two lots
Figure 24: Heat stability of pan-line of pan-specific tests against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
0
5
10
15
20Parabank Rapid Test for Malaria Pan (Device)
CareStart Malaria pLDH (PAN)
Advantage Pan Malaria Card
45°C35°CBaseline
No. of positive results from two lots
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)3 4
Figure 25: Heat stability of pan-line of pan-specific tests against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
10
15
20Parabank Rapid Test for Malaria Pan (Device)
CareStart Malaria pLDH (PAN)Advantage Pan Malaria Card
45°C35°CBaseline
No. of positive results from two lots
11.2. PAN TEST LINESFigure 26: Heat stability of pan-line of combination tests against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
0
5
10
15
20Wondfo One Step Malaria Pf/Pan Whole Blood TestSD BIOLINE Malaria Ag Pf/PanSD BIOLINE Malaria Ag
OptiMAL- ITOne Step Malaria Antigen StripQuickstick Malaria Antigen TestMalascan Rapid Test for Malaria Pf/Pan (Device)
Malaria Rapid DualMalaria Rapid ComboICT Malaria Combo Cassette Test (ML02)First Response Malaria Ag Combo (PLDH/HRP2)CareStart Malaria HRP2/pLDH (Pf/PAN) COMBO
Binax Now MalariaParascreen Rapid Test for Malaria Pan/Pf (Device)ParahitTotal Device Rapid Test for P. falciparum and Pan Malarial Species
Advantage Mal CardAZOG Malaria pf (HRP-II)/pv (pLDH) Antigen Detection Test Device
Hexagon Malaria CombiImmunoquick Malaria +4Malaria P.F/VIVAXOnSight – ParaQuick (Pan, Pf)
45°C35°CBaseline
No. of positive results from two lots
Figure 27: Heat stability of pan-line of combination tests against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
0
5
10
15
20 Wondfo One Step Malaria Pf/Pan Whole Blood TestSD BIOLINE Malaria Ag Pf/PanSD BIOLINE Malaria AgQuickstick Malaria Antigen TestOne Step Malaria Antigen StripParascreen Rapid Test for Malaria Pan/Pf (Device)ParahitTotal Device Rapid Test for P. falciparum and Pan Malarial SpeciesMalaria P.F/VIVAXHexagon Malaria Combi
OptiMAL- ITOnSight – ParaQuick (Pan, Pf)Malascan Rapid Test for Malaria Pf/Pan (Device)Malaria Rapid DualMalaria Rapid ComboImmunoquick Malaria +4ICT Malaria Combo Cassette Test (ML02)Binax Now MalariaAZOG Malaria pf (HRP-II)/pv (pLDH) Antigen Detection Test Device
Advantage Mal CardCareStart Malaria HRP2/pLDH (Pf/PAN) COMBOFirst Response Malaria Ag Combo (PLDH/HRP2)
45°C35°CBaseline
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)35
Figure 28: Heat stability of pan-line of pan-specific tests only against a low density P. falciparum sample (200 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
0
5
10
15
20Parabank Rapid Test for Malaria Pan (Device)CareStart Malaria pLDH (PAN)Advantage Pan Malaria Card
45°C35°CBaseline
Figure 29: Heat stability of pan-line of pan-specific tests only against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation.
10
15
20Parabank Rapid Test for Malaria Pan (Device)
Advantage Pan Malaria CardCareStart Malaria pLDH (PAN)
45°C35°CBaseline
12. EASE OF USE DESCRIPTION
After becoming proficient at using a product, two technicians jointly produced an agreed assessment of product usability. The results are presented in Table 6.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)3 6
Tabl
e 6:
Eas
e of
use
des
crip
tion
of
41 m
alar
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dia
gnos
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test
s
Prod
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Man
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d sa
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†In
stru
ctio
n qu
alit
y‡ Co
mbi
ned
scor
e (m
ax. 5
)
Num
ber
of t
imed
st
eps
Tota
l ti
me
to
resu
lt
Bloo
d tr
ansf
er
devi
ce
Form
at
Lang
uage
of
inst
ruct
ion
Item
s in
clud
ed in
pa
ckag
e*M
ixin
g w
ells
in
volv
ed
Retr
acta
ble
need
le
Strip
ex
pose
d Sc
ore
(m
ax. 3
) N
o di
agra
mDi
agra
m o
f re
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Diag
ram
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&
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ax.2
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nly
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ALIT
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MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)37
Prod
uct
Man
ufac
ture
r
Bloo
d sa
fety
†In
stru
ctio
n qu
alit
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mbi
ned
scor
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Num
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of t
imed
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l ti
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to
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lt
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at
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mal
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24
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:00
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ish
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itra
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24
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:00
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ish
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ish
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apid
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alar
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ixin
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invo
lved
Yes
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trac
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edle
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rip E
xpos
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d m
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hese
are
not
nec
essa
rily
stan
dard
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tent
s. Pr
ocur
ers
shou
ld v
erify
wha
t mat
eria
ls a
ccom
pany
test
kits
with
the
man
ufac
ture
r and
ens
ure
they
pro
cure
all
the
requ
ired
acce
ssor
ies
at th
e sa
me
time.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)3 8
13. DISCUSSION OF KEY FINDINGS
This report describes the performance of many of the available malaria antigen-detecting RDTs manufactured under the ISO-13485 quality standard. Malaria RDTs have the potential to provide a huge step forward in the management of febrile illness in malaria-endemic areas. To be useful in this context, malaria RDTs must have adequate:
1. sensitivity, to detect nearly all clinically-significant cases of malaria;
2. specificity, to accurately discriminate non-malarial febrile illness from malaria, to ensure appropriate management and accurate disease monitoring;
3. stability, for accuracy to be maintained after transport and storage in ambient conditions;
4. ease of use and safety, to allow safe and correct preparation, and correct interpretation of results.
In order to assist national malaria control programmes, and other procurement agencies to select products appropriate to their needs, malaria RDTs were evaluated in terms of these four major requirements. The blood panel used successfully discriminated between the RDTs evaluated, showing a considerable range of performance. Importantly, a number of products demonstrated a high rate of antigen detection combined with a low false-positive rate and good heat (thermal) stability, attributes essential if they are to be relied on as a basis for malaria treatment decisions in most endemic populations.
The principal results in this report are presented in Tables 3, 3a, 4, 4a. The table groups the RDTs by type, depending on what they aim to detect, e.g. P. falciparum only, P. falciparum and non-falciparum species, or all malaria species without discrimination. Detection rates at both high and low concentrations are presented, as are false-positive rates, and the percentage of invalid test results. Tests in each category are listed alphabetically, but the results are colour-coded to assist the reader in quick interpretation of the data. These colour codes are intended to be used to quickly compare performance in the different categories and not as performance cut-offs to guide test selection or procurement. When choosing an appropriate product, it is important to also review the stability results (Table 5) in the context of the expected conditions of transport and storage of the RDTs in the field.
This evaluation is performed against a standardized panel of frozen blood samples by experienced technicians in a research laboratory and is not a field evaluation of RDT accuracy in a specific epidemiological context in the hands of intended users. The panel is designed to mimic fresh blood samples from real cases as closely as possible, while allowing direct comparison of a large number of products
simultaneously in a manner that controls for confounding factors and is calibrated to a level likely to discriminate performance differences of various products. In interpreting the results, it is therefore important that the following notes are taken into account.
13.1. PARASITE DETECTION AND ITS RELATIONSHIP TO SENSITIVITY
Evaluation of the RDTs against the parasite-positive panel with parasite densities of 200 parasites/μL (Figs 8, 9) revealed a wide range of detection rates between products. Testing at higher parasite densities (2000 or 5000 parasites/μL) was less able to demonstrate small differences in performance. As two tests each from two different lots were tested, and as all four results had to be positive for a sample to be considered detected by an RDT, a positive result indicated both the ability of a product to detect the target antigen in the sample, and to do this consistently (both tests from both lots).
The rate of detection against the panel used in this evaluation is expected to differ from the sensitivity for detection of malaria in a specific clinical setting. There are five main reasons for this:
i. Performance may vary between lots or batches of the same product. Variability in lot performance is an issue with all diagnostics, and it can not be guaranteed that the results found here will predict results from different RDT lots that are purchased. It is important to test lots prior to distribution to the field, to ensure that expected performance is maintained (Section 14.2).
ii. In clinical settings, patients show a wide variety of parasite densities, the range of which will depend on the local epidemiology of the disease. The magnitude of the parasite density in the population tested affects the clinical sensitivity of the test. Detection rates in the test panel of blood samples diluted to 200 parasites/μL are likely to underestimate the clinical sensitivity of an RDT in many situations, especially in high-transmission areas where symptomatic patients often have much higher parasite densities in their blood. Many tests that showed only moderate sensitivity against the 200 parasite/μL panel may perform very well in such settings, as shown by the high performance of most products against the panel set at 2000 parasites/μL.
Importantly, when interpreting Figs E1, 7, 8 and 9 and the colour coding in Tables 3, 3a, 4, 4a the small differences in detection rates found among the better-performing RDTs in this evaluation are unlikely to result in noticeable differences in clinical sensitivity, and other issues such as stability, cost, or ease of use and manufacturing capacity may be more important factors in test selection.
When considering the parasite density of the target populations and the likely field sensitivity of RDTs, it is important to note that, even in areas with high transmission and strong malaria immunity, populations may include individuals with low parasite densities but
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)39
clinically significant infections (e.g. young children, pregnant women, others with low immunity). The ability to detect low parasite density infections reliably therefore remains important in these cases.
iii. Performance of tests against the challenge panel may not directly relate to sensitivity in clinical testing as there is variability in the amino acid sequence of the HRP2 antigen of P. falciparum that may affect the ability of RDTs to detect it. In certain P. falciparum parasites the HRP2 antigen may not be detectable at all. Specifically, there is evidence that P. falciparum strains in some areas of South America may express HRP2 antigens very poorly or not at all.21 If a significant proportion of parasites in a given area do not express HRP2, it is necessary to use tests detecting other target antigens (pLDH or aldolase). The distribution of such strains is currently being mapped.
iv. The methods used to transport and store tests can affect their field sensitivity. All the tests used in this evaluation were shipped and stored under conditions intended to safeguard against degradation caused by high temperature or other extreme conditions. If similar precautions are not taken with purchased RDTs, loss of performance could result. Ambient temperatures of storage conditions vary widely in settings where these tests are commonly used, as do temperatures during transport, and requirements for heat stability of a product will therefore differ.
v. Diagnostic sensitivity and specificity are dependent on the quality of preparation and interpretation of the tests. Highly trained individuals performed all the testing in this product evaluation. In clinical settings, malaria RDTs will often be used by health workers with limited training and supervision. Simplicity of design and clearly-interpretable results will have an influence on ensuring that the technical proficiency of a product translates into accurate diagnosis in the field.
13.2. FALSE POSITIVE RATE AND SPECIFICITY False positive rates are reported here against a panel of 'clean' negative samples taken from blood donated in low-transmission settings by people without malaria symptoms. Also calculated were false positive rates against a smaller number of samples with specific characteristics that affect the likelihood of a false-positive result from an immuno-diagnostic test (e.g. rheumatoid factor, anti-nuclear antibody), or that may be of significance in a specific population (e.g. leishmaniasis, dengue). The importance of these results will vary with the intended area of use. High false positive rates against samples of blood from dengue patients, for example, may not be a significant factor to consider in regions where dengue does not occur. In view of the small number of samples in each category in this evaluation, the results should be considered primarily as a guide, to highlight potential cross-reactions that will require
21 WHO 2009, unpublished data. Clarification of these findings will be made in following publications of the WHO-FIND malaria RDT evaluation programme.
close monitoring if relevant to the target population.
In general, it is preferable to procure a product with a low rate of false-positive reactions. In the case of many diagnostic tests, a trade-off must be made between a preference for a high rate of antigen detection (sensitivity) and a low false positive rate (specificity). The context in which the test will be used will guide the relative importance of these two factors in choosing one product over another. In this evaluation there was no correlation of loss of sensitivity associated with high specificity, with a number of products attaining both a high detection rate (predicting a high sensitivity) and a low false-positive rate (predicting a high specificity).
13.3. HEAT (THERMAL) STABILITY RDTs in this evaluation were held for two months at 35°C and 45°C and then retested to evaluate stability at these temperatures. The importance of thermal stability will vary according to the ambient conditions under which a product is expected to be transported and stored. Thus, stability at high temperatures will be vital if an RDT is to be stored at clinic level in a country where ambient temperatures can reach 45°C in the hot season, but less critical in a high-altitude or cooler tropical environment where temperatures rarely rise above 35°C. Most of the commercial RDTs list 30°C as the maximal storage temperature. Higher temperatures were used for this evaluation because it is unusual for malaria–endemic countries to have maximum ambient temperatures less than 35°C, though the use of cool storage methods will also allow the use of less heat-stable products. Where transport and storage of RDTs is likely to occur at high ambient temperatures, heat (thermal) stability should be seen as a significant factor in ensuring maintenance of sensitivity.
High humidity will accelerate the degradation of malaria RDTs and other lateral flow tests. All the products in this evaluation were packaged in individual envelopes that contain a desiccant and are designed to be moisture-proof. This allows the user to open the envelope of a specific test at the time of use, limiting exposure to high humidity. During the stability testing phase of this evaluation, RDTs were stored at 75% humidity. The packaging should, if in good condition, protect the contents from exposure to high humidity during storage. As such, the stability testing results presented here provide an assessment of both the stability of the RDT and the quality of its packaging.
Several products showed high stability at the temperatures and time periods used in this evaluation. In general, pan-specific lines (pLDH and aldolase) were less stable than HRP2 test lines, but there was overlap between the antibodies against these targets with some pLDH tests maintaining high positivity rates after 2 months at 45°C. A small number of products showed a consistent improvement in positivity rate after incubation, for reasons which are not clear.
Though temperature and humidity were held constant in this evaluation, in the field temperatures fluctuate with time of day and season. While two months’ storage at a set temperature can not accurately predict long-term stability
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)4 0
under field conditions, loss of parasite detection over this period indicates a likelihood that significant sensitivity will be lost when similar or higher storage temperatures comprise a significant amount of the storage time, and indicates likelihood of a higher susceptibility to degradation during short periods of exposure to much higher temperatures, such as during transport (12, 13).
13.4. EASE OF USE DESCRIPTIONThe sensitivity and specificity of RDT results will depend to some extent on the quality of preparation and interpretation of the test. In general, a simpler format with fewer steps or fewer extraneous materials is likely to be prepared and interpreted more reliably. Thus, cassette-format RDTs are generally more reliably prepared and interpreted than products in dip-stick format (14). The extra cost involved in such a format may be offset by the advantages of increased accuracy and, in some cases, less additional equipment required to perform them.
The method of blood transfer from the patient to the test is important for the safety of the user, and for the accuracy of volume of blood transferred. Devices for blood transfer are supplied with RDTs, and vary widely in design. The performance of blood transfer devices was not formally assessed in this evaluation, as blood was transferred from a tube by a micro-pipette to ensure the manufacturer-specified volume was used. Programmes procuring RDTs should consider the adequacy of the blood transfer device supplied, including previous experience of health workers and the costs and time required for re-training. It may often be appropriate to discuss with manufacturers changing the blood transfer device from that normally supplied.
Clarity of results is important to test interpretation. A clearly visible (intense) test line is less likely to be overlooked than a line that is barely visible. While reading proficiency and adequate work places should always be ensured, health workers may sometimes have sub-optimal vision or work in conditions of inadequate lighting. The intensity of the line of the test band is closely associated with error rate and with the detection rate found in this report (Tables A4.4, A4.4a, A4.5, A4.5a).
The importance of format and simplicity of test design will depend on the intended end-users. Trained laboratory technicians may handle a complicated procedure more reliably than village-level volunteers with limited supervision. In all cases, specific proficiency-based training and adequate supervision should be included in any RDT-based diagnostic programme, and clear instructions should be provided in a language and format appropriate for the end-user22(14-16).
13.5. INTER-LOT VARIABILITY This testing programme evaluated only two production lots of each product. Malaria RDTs are complex biological
22 See www.wpro.who.int/sites/rdt for generic examples
products made of components commonly supplied from multiple sources, and subject to various conditions during manufacture that may affect the quality of the final product. All manufacturers entered in this evaluation have current ISO 13485:2003 certification, a standard designed to give assurance of consistency of quality of final product if correctly implemented. The results presented here indicate that inter-lot variability does occur, and WHO strongly recommends that a sample of RDTs from each production lot be tested prior to dissemination to the field to ensure it meets an appropriate standard. This can be facilitated by WHO (see section 14.2).
Since inter-test variability also occurs, this will be detected to some extent by routine lot testing. Ensuring manufacturers have good manufacturing standards should minimize the likelihood of inconsistencies due to poor practice in the manufacturing process.
13.6. INTER-READER VARIABILITYAll RDTs in this evaluation were interpreted by two technicians, blinded to the other technicians' results. The first reading was performed at the minimum time specified by the manufacturer to obtain a result, and this reading is used as the primary determinant of RDT performance. The second reading was obtained later, usually within 45 minutes, always within 90 minutes. Where a manufacturer specifically instructed in the product insert that interpretation be deferred if a result was not visible at the time of the initial reading, the result of the second reader was also reported.
The difference between the two readings reported here was therefore subject to the stability of the result: if a test became positive after the minimum time specified by a manufacturer to obtain a result, this appeared as a discrepancy between the two readers. The intensity of the test lines of antigen-detecting RDTs was also dependent on the amount of available antigen. Therefore, at the low parasite-densities used in this evaluation where a test line intensity was close to the limit of human visual perception (i.e. close to the operational limits of the product), inter-reader discrepancies were more likely to occur.
Early, accurate and stable RDT results are important in the context of busy clinical work. Specifying a single reading time at which the result can be determined to be negative or positive is also an advantage in terms of training and consistency of use. It is recommended that low inter-reader variability and early availability of result be considered in making decisions on procurement, but that the stability of the result (an adequate time period during which the result may be read) is also ensured.
13.7. TARGET ANTIGENS AND SPECIESMalaria RDTs included in this evaluation detect one or more of three parasite antigens (HRP2, pLDH, and aldolase) in various combinations. HRP2 is present only in P. falciparum, whereas aldolase and pLDH are present in all four species
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)41
and may be used as pan or all-species targets. Some tests use differences in pLDH sequences between species as a means to differentiate P. falciparum from P. vivax and other species. There is considerable overlap in the detection rates of products targeting the different antigens in this evaluation. While the products with the highest detection rates for P. falciparum targeted HRP2, a number of pLDH-detecting products demonstrated high detection rates against P. falciparum and P. vivax. The stability of tests targeting these different antigens also overlapped.
The choice of RDT should take target antigen into account: HRP2-detecting RDTs should not be used in areas where high rates of HRP2 non-expression occur. Tests detecting only HRP2 (without pLDH or aldolase lines) will have limited utility where non-falciparum malaria is common. pLDH (and possibly aldolase) RDTs may have further advantages where antigen persistence (common with HRP2) may result in a high false-positive rate in areas where early re-testing in the weeks soon after treatment is common.
The required sensitivity of a test may also vary with species; a less sensitive test may be acceptable for detection of P. vivax compared to detection of P. falciparum, as severe outcomes due to missed diagnoses are less likely. Use of a sufficiently sensitive pan-specific test may be appropriate in areas where both P. falciparum and P. vivax occur, if all infections were to be managed initially as a P. falciparum infection with artemisinin-based combination therapy (ACT).
It should be noted that pan-species tests were not evaluated for detection of P. ovale or P. malariae due to lack of sources of suitable mono-species infections of these parasites.
14. ADDITIONAL MEASURES TO ENSURE QUALITY AND UTILITY OF RDT TESTING
This report provides data to guide programmes in selecting products likely to perform to a high standard in the particular contexts in which the programme operates. The final decision on product selection requires that this data be considered in a systematic way, often with other data obtained from the manufacturer and other sources. An algorithm to guide this process, adapted from the quality assurance guide of the WHO Global Malaria Programme (found at www.wpro.who.int/sites/rdt) is given in Annex 5.
While malaria RDTs have application in a number of settings, the area in which they have the greatest impact on public health is in extension of access to accurate, parasite-based diagnosis of malaria to regions and populations where good quality microscopy-based analysis is impractical to maintain. This currently applies to most people at risk of malaria in endemic countries (1). In many settings where RDTs have been introduced, the true rate of parasitaemia has been found to be dramatically lower than expected, allowing health systems to save on wasted RDTs and to focus
appropriately on the management of non-malarial causes of fever, including pneumonia and sepsis. A successful RDT programme must therefore address not just malaria but also the management of other common and severe febrile illness that occur locally as differential diagnoses of malaria, if the potential full public health impact of an RDT programme is to be achieved.
14.1. BEYOND PROCUREMENTRDTs are often added to a procurement list that includes mainly chemical agents such as pharmaceuticals, bednets, and insecticides. Unlike these products, however, diagnostic tests are relatively more complex to implement, not least because they represent the starting point, not the end point, in a health system intervention, and their use presumes that appropriate patient management, based on testing, will follow. Thus, successful introduction of RDTs requires careful planning going beyond rational procurement to ensure consistent supplies of all necessary materials (including gloves, sharps disposal containers, and supplies required for further case management), training of users, and community sensitization. This extends beyond malaria management to management of other febrile diseases and health service delivery systems.
This report provides information to guide procurement of RDTs within this framework. A number of factors beyond performance characteristics reported here must influence procurement decisions. An example algorithm to guide these decisions is given in Annex 5. Details of implementation will vary widely between programmes according to local capacity and needs. Further recommendations on budgeting, planning and implementation can be found in Annex 6.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)42
14.2. LOT TESTING Complementary to the product testing programme, WHO and FIND currently support three laboratories that perform continual quality assurance of RDTs in the form of lot testing. These lot testing facilities respond to formal requests from national malaria programmes, manufacturers, and procurement bodies and assess the quality of RDT lots when they arrive in country, before distribution. Testing is performed with carefully prepared blood panels such as those used for this evaluation. A number of other national institutions have also developed this capacity. Lot-testing reassures countries that the product they have purchased is performing to a high standard and helps to ensure that manufacturers produce consistently good lots and improve their products.
Countries and/or manufacturers ship between 125-175 RDTs to the regional lot testing centre where they are evaluated against a small panel of parasites at high and low parasite
densities and negative samples. They are subsequently incubated at a temperature close to the manufacturer's specified storage temperature and retested every three months until their expiry date. Initial results are available after five days and then sent at regular intervals. Details of the protocol can be found in a published methods manual for lot testing.23
All countries and procuring agencies are encouraged to participate in the lot testing programme and in the near future it is intended to publish overall performance of products submitted for lot testing.
23 WHO, Rapid Diagnostic Tests for Malaria: Methods Manual for Laboratory Quality Control Testing. Version 5a. 2008, WHO - Regional Office for the Western Pacific. Available at:
www.wpro.who.int/sites/rdt/documents/list.htm
15. CONCLUSIONS
This study is a landmark in the field of malaria RDT evaluations because of the number of products evaluated and its comprehensiveness including, samples with low and high parasite densities, detailed parasite characterization (antigen quantification, HRP 2,3 characterization) multiple test lots and heat stability assessment. New laboratory methods were developed and validated to support parasite characterization and this work generated new findings regarding the variation in antigen content at similar parasite densities and the variation in the structure and expression of HRP proteins. The latter will critically inform RDT selection in several endemic countries.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)43
16. REFERENCES
1. WHO, World Malaria Report 2008. 2008, WHO - Global Malaria Programme: Geneva.
2. WHO, WHO Technical Consultation to review the role of parasitological diagnosis to support malaria disease management: focus on the use of RDTs in areas of high transmission deploying ACT treatments. 2005, World Health Organization: Geneva.
3. Kolaczinski, J., et al., Comparison of the OptiMAL rapid antigen test with field microscopy for the detection of Plasmodium vivax and P. falciparum: considerations for the application of the rapid test in Afghanistan. Ann Trop Med Parasitol, 2004. 98(1): p. 15-20.
4. Richter, J., et al., Co-reactivity of plasmodial histidine-rich protein 2 and aldolase on a combined immuno-chromographic-malaria dipstick (ICT) as a potential semi-quantitative marker of high Plasmodium falciparum parasitaemia. Parasitol Res, 2004. 94(5): p. 384-5.
5. Huong, N.M., et al., Comparison of three antigen detection methods for diagnosis and therapeutic monitoring of malaria: a field study from southern Vietnam. Trop Med Int Health, 2002. 7(4): p. 304-8.
6. Mason, D.P., et al., A comparison of two rapid field immunochromatographic tests to expert microscopy in the diagnosis of malaria. Acta Trop, 2002. 82(1): p. 51-9.
7. Van den Broek, I., et al., Evaluation of three rapid tests for diagnosis of P. falciparum and P. vivax malaria in Colombia. Am J Trop Med Hyg, 2006. 75(6): p. 1209-15.
8. McMorrow, M.L., et al., Challenges in routine implementation and quality control of rapid diagnostic tests for malaria--Rufiji District, Tanzania. Am J Trop Med Hyg, 2008. 79(3): p. 385-90.
9. Wanji, S., et al., Performance and usefulness of the Hexagon rapid diagnostic test in children with asymptomatic malaria living in the Mount Cameroon region. Malar J, 2008. 7: p. 89.
10. Willcox, M.L., et al., Rapid diagnostic tests for the home-based management of malaria, in a high-transmission area. Ann Trop Med Parasitol, 2009. 103(1): p. 3-16.
11. Belizario, V.Y., et al., Field evaluation of malaria rapid diagnostic tests for the diagnosis of P. falciparum and non-P. falciparum infections. Southeast Asian J Trop Med Public Health, 2005. 36(3): p. 552-61.
12. Jorgensen, P., et al., Malaria rapid diagnostic tests in tropical climates: The need for a cool chain. American Journal of Tropical Medicine and Hygiene, 2006. 74(5).
13. Chiodini, P.L., et al., The heat stability of Plasmodium lactate dehydrogenase-based and histidine-rich protein 2-based malaria rapid diagnostic tests. Trans R Soc Trop Med Hyg, 2007. 101(4): p. 331-7.
14. Rennie, W., et al., Minimising human error in malaria rapid diagnosis: clarity of written instructions and health worker performance. Trans R Soc Trop Med Hyg, 2007. 101(1): p. 9-18.
15. Harvey, S.A., et al., Improving community health worker use of malaria rapid diagnostic tests in Zambia: package instructions, job aid and job aid-plus-training. Malar J, 2008. 7(1): p. 160.
16. Tavrow, P., E Knebel, L Cogswell, Using quality design to improve malaria rapid diagnostic tests in Malawi, in Operations Research Results 1(4). 2000, Published for the United States Agency for International Development (USAID) by the Quality Assurance Project (QAP): Bethesda, Maryland.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)4 4
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)45
ANNEXES
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)4 6
ANNE
X 1:
CHAR
ACTE
RISTIC
S OF
RAP
ID M
ALAR
IA TE
STS
IN TH
E EV
ALUA
TION
Man
ufac
ture
rPr
oduc
t na
me
Plas
mod
ium
sp
ecie
s ta
rget
ed(F
=P.
fa
lcip
arum
V
=P.
viv
ax
O =
P. o
vale
M =
P. m
alar
iae
P =
PAN
; maj
or
Plas
mod
ium
sp
ecie
s)
Targ
et
Ant
igen
1Fo
rmat
Sequ
ence
and
typ
e of
bou
nd a
ntib
ody2
Requ
ired
vo
lum
e (μ
l) of
w
hole
bl
ood
Buff
er
volu
me
(dro
ps)
Inte
rmed
iate
St
ep
Tim
e to
re
sult
s3 (m
ins)
Max
imum
re
adin
g ti
me3
Resu
lts
Inte
rpre
-ta
tion
(T
ype
A-E
)4
Resu
lts
Inte
rpre
tati
on (
Type
A-E
)4
CT1
T2
Acce
ss B
io, I
nc.
Care
Star
t M
alar
ia p
LDH
(P
AN)
PpL
DH
Cass
ette
√pL
DH
52
drop
s -
20
-
B
CT
SA
Care
Star
t M
alar
ia H
RP2/
pLD
H (P
f/PA
N) C
OM
BO
F, P
pLD
H/H
RP2
Cass
ette
√pL
DH
HRP
25
2 dr
ops
-
20 -
C
CT1
T2S
A
Care
Star
t M
alar
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RP2
(Pf)
FH
RP2
Cass
ette
√H
RP2
52
drop
s -
20
-
A
CT
SA
ACO
N
Labo
rato
ries,
In
c.
Mal
aria
Pl
asm
odiu
m
falc
ipar
um
Rapi
d Te
st
Dev
ice
(Who
le
Bloo
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FH
RP2
Cass
ette
√H
RP2
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drop
sM
ixin
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e 1
min
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eeze
tu
be 5
tim
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1020
A
CT
S
Amge
nix
Inte
rnat
iona
l, In
c.
OnS
ight
-
Para
Qui
ck
(Pan
, Pf)
Tes
tP,
FpL
DH
,HRP
2Ca
sset
te√
pLD
HH
RP2
56
drop
s -
15
15C
CT1
T2A
B
AZO
G, I
nc.
AZO
G M
alar
ia
pf (H
RP-I
I) /
pv (p
LDH
) An
tigen
D
etec
tion
Test
D
evic
e
F,P"H
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pL
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Cass
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-
20 -
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CT1
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unoq
uick
M
alar
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Falc
ipar
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HRP
2D
ipst
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RP2
20
adul
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ch
ildre
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drop
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10
15A
CT
Imm
unoq
uick
M
alar
ia +
4F,
PH
RP2/
pLD
HD
ipst
ick
√pL
DH
HRP
220
ad
ults
/5
child
ren
6 dr
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er in
tube
, Bl
ood
on s
tick,
st
ick
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be15
30C
CT2
T1
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)47
Man
ufac
ture
rPr
oduc
t na
me
Plas
mod
ium
sp
ecie
s ta
rget
ed(F
=P.
fa
lcip
arum
V
=P.
viv
ax
O =
P. o
vale
M =
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alar
iae
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; maj
or
Plas
mod
ium
sp
ecie
s)
Targ
et
Ant
igen
1Fo
rmat
Sequ
ence
and
typ
e of
bou
nd a
ntib
ody2
Requ
ired
vo
lum
e (μ
l) of
w
hole
bl
ood
Buff
er
volu
me
(dro
ps)
Inte
rmed
iate
St
ep
Tim
e to
re
sult
s3 (m
ins)
Max
imum
re
adin
g ti
me3
Resu
lts
Inte
rpre
-ta
tion
(T
ype
A-E
)4
Resu
lts
Inte
rpre
tati
on (
Type
A-E
)4
CT1
T2
Dia
gnos
tics
Auto
mat
ion/
Cor
tez
Dia
gnos
tics,
Inc.
Mal
aria
Pf /
Vi
vax
(Mal
aria
Co
mbo
Tes
t)
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2/Al
dola
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sset
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2Al
dola
se5
1 dr
ops
1 dr
op in
bl
ood
wel
l, 5
drop
s in
bu
ffer
wel
l
1560
min
(30
min
)D
CT1
T2
Dia
Med
AG
Opt
iMal
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PpL
DH
Dip
stic
k-Ca
sset
te√
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LD
H10
1 dr
op-
wel
l 14
drop
- w
ell 2
Wai
t 1
min
af
ter
buff
er
Bloo
d in
wel
l 1
stir,
Wai
t 1 m
in,
Stic
k in
wel
l 1
wai
t 10
min
,Tr
ansf
er s
tick
to w
ell 2
, aft
er
10 m
inut
es
rem
ove
from
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CP
Pf
Hum
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Hex
agon
M
alar
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15
A
Hex
agon
M
alar
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dola
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aldo
lase
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25
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15
C
IND
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gnos
tic
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Ste
p M
alar
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Antig
en S
trip
P,F
pLD
H (p
an,
pf)
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stic
k√
LDH
(pf
spec
ifi c)
pLD
H20
1 dr
op
con-
juga
te
wel
l,3
drop
s w
ashi
ng
wel
l
Bloo
d in
co
njug
ate
wel
l, m
ix a
nd
wai
t 1 m
in,
stic
k in
wel
l, w
ait 5
min
,St
ick
in
was
hing
wel
l, w
ait 1
0 m
in"
15 -
C
CT2
T1
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)4 8
Man
ufac
ture
rPr
oduc
t na
me
Plas
mod
ium
sp
ecie
s ta
rget
ed(F
=P.
fa
lcip
arum
V
=P.
viv
ax
O =
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vale
M =
P. m
alar
iae
P =
PAN
; maj
or
Plas
mod
ium
sp
ecie
s)
Targ
et
Ant
igen
1Fo
rmat
Sequ
ence
and
typ
e of
bou
nd a
ntib
ody2
Requ
ired
vo
lum
e (μ
l) of
w
hole
bl
ood
Buff
er
volu
me
(dro
ps)
Inte
rmed
iate
St
ep
Tim
e to
re
sult
s3 (m
ins)
Max
imum
re
adin
g ti
me3
Resu
lts
Inte
rpre
-ta
tion
(T
ype
A-E
)4
Resu
lts
Inte
rpre
tati
on (
Type
A-E
)4
CT1
T2
Inno
vate
k M
edic
al In
c.
Qui
ckst
ick
Mal
aria
An
tigen
Tes
tP,
FpL
DH
(pan
, pf
)D
ipst
ick
√pL
DH
(pf
spec
ifi c)
pLD
H
20
1 dr
op
con-
juga
te
wel
l,3
drop
s w
ashi
ng
wel
l
Bloo
d in
co
njug
ate
wel
l, m
ix a
nd
wai
t 1 m
in,
stic
k in
wel
l, w
ait 5
min
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ick
in
was
hing
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l, w
ait 1
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c Pr
oduc
ts,
Inc.
ADVA
NCE
D Q
UAL
ITY
TM
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p M
alar
ia (p
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FH
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ip
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e a
cass
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!
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103
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ops)
-
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TC
SD
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D Q
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ITY
TM
MAL
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PO
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FH
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Card
no
sepa
rate
pr
oduc
t in
sert
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103
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Inve
rnes
s M
edic
al
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nc.
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ow
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aria
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an
tigen
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mal
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ops
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MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)49
Man
ufac
ture
rPr
oduc
t na
me
Plas
mod
ium
sp
ecie
s ta
rget
ed(F
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fa
lcip
arum
V
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viv
ax
O =
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vale
M =
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alar
iae
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; maj
or
Plas
mod
ium
sp
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s)
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et
Ant
igen
1Fo
rmat
Sequ
ence
and
typ
e of
bou
nd a
ntib
ody2
Requ
ired
vo
lum
e (μ
l) of
w
hole
bl
ood
Buff
er
volu
me
(dro
ps)
Inte
rmed
iate
St
ep
Tim
e to
re
sult
s3 (m
ins)
Max
imum
re
adin
g ti
me3
Resu
lts
Inte
rpre
-ta
tion
(T
ype
A-E
)4
Resu
lts
Inte
rpre
tati
on (
Type
A-E
)4
CT1
T2
J. M
itra
& C
o.
Pvt.
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ntag
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f. M
alar
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ard
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+
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n M
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ia
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5 dr
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-
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B
CT1
T2A
B
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ntag
e M
al C
ard
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-
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CT
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Syst
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pid
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ette
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s -
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alci
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m
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aria
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ick)
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ick,
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Prem
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T1T2
C
Firs
t Res
pons
e M
alar
ia A
g H
RP2
FH
RP2
Cass
ette
√H
RP2
52
drop
s -
20
-
A
TC
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)50
Man
ufac
ture
rPr
oduc
t na
me
Plas
mod
ium
sp
ecie
s ta
rget
ed(F
=P.
fa
lcip
arum
V
=P.
viv
ax
O =
P. o
vale
M =
P. m
alar
iae
P =
PAN
; maj
or
Plas
mod
ium
sp
ecie
s)
Targ
et
Ant
igen
1Fo
rmat
Sequ
ence
and
typ
e of
bou
nd a
ntib
ody2
Requ
ired
vo
lum
e (μ
l) of
w
hole
bl
ood
Buff
er
volu
me
(dro
ps)
Inte
rmed
iate
St
ep
Tim
e to
re
sult
s3 (m
ins)
Max
imum
re
adin
g ti
me3
Resu
lts
Inte
rpre
-ta
tion
(T
ype
A-E
)4
Resu
lts
Inte
rpre
tati
on (
Type
A-E
)4
CT1
T2
ICT
Dia
gnos
tics
ICT
Mal
aria
Pf
Cass
ette
Tes
t (M
L01)
FH
RP2
Cass
ette
√H
RP2
55
drop
s -
15
15A
TC
ICT
Mal
aria
Co
mbo
Ca
sset
te T
est
(ML0
2)
F, P
HRP
2/pa
n m
alar
ia
Antig
enCa
sset
te√
HRP
2pa
n m
alar
ia
antig
en5
5 dr
ops
-
1515
D
CT1
T1
Span
Dia
gnot
ics
Ltd.
Para
hit-
f D
IPST
ICK
FOR
FALC
IPAR
UM
M
ALAR
IA
FH
RP2
Dip
stic
k√
HRP
28
4 dr
ops
Buff
er in
tu
be, b
lood
on
stic
k,St
ick
in tu
be
1530
A
CT
Para
hit-
f TES
T D
EVIC
E FO
R FA
LCIP
ARU
M
MAL
ARIA
FH
RP2
Cass
ette
√H
RP2
84
drop
s15
30A
CT
Para
hit-
Tota
l D
evic
e Ra
pid
test
for P
. fa
lcip
arum
an
d Pa
n m
alar
ial
spec
ies
F, P
HRP
2/pL
DH
/al
dola
seCa
sset
te√
HRP
2pL
DH
/ad
olas
e 8
4 dr
ops
1530
D
CT1
T2
Stan
dard
D
iagn
ostic
s In
c.
SD B
IOLI
NE
Mal
aria
Ag
F, P
pLD
H"C
asse
tte
√pL
DH
(p
an)
pLD
H
(Pf)
54
drop
s -
15
30C
CT1
T2A
B
Dip
stic
k"√
pLD
H (p
an)
pLD
H (P
f)5
HRP
25
4 dr
ops
-
1530
A
CT1
AB
SD B
IOLI
NE
Mal
aria
Ag
Pf/
Pan
FH
RP2
Cass
ette
√H
RP2
54
drop
s -
15
30C
CT1
T2A
B
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)51
Man
ufac
ture
rPr
oduc
t na
me
Plas
mod
ium
sp
ecie
s ta
rget
ed(F
=P.
fa
lcip
arum
V
=P.
viv
ax
O =
P. o
vale
M =
P. m
alar
iae
P =
PAN
; maj
or
Plas
mod
ium
sp
ecie
s)
Targ
et
Ant
igen
1Fo
rmat
Sequ
ence
and
typ
e of
bou
nd a
ntib
ody2
Requ
ired
vo
lum
e (μ
l) of
w
hole
bl
ood
Buff
er
volu
me
(dro
ps)
Inte
rmed
iate
St
ep
Tim
e to
re
sult
s3 (m
ins)
Max
imum
re
adin
g ti
me3
Resu
lts
Inte
rpre
-ta
tion
(T
ype
A-E
)4
Resu
lts
Inte
rpre
tati
on (
Type
A-E
)4
CT1
T2
Uni
med
In
tern
atio
nal,
Inc.
Firs
tSig
n –
Mal
aria
Pf
Card
Tes
tF
HRP
2Ca
sset
te√
HRP
25
6 dr
ops
-
1515
A
CT
SR
Firs
tSig
n –
Para
View
-2
(Pv
+ Pf
) Car
d Te
st
F, V
pLD
H/H
RP2
Cass
ette
√pL
DH
(s
peci
fi c
Pv)
HRP
25
4 dr
ops
-
1515
E
CT1
T2S
R
Visi
on B
iote
ch
(Pty
) Ltd
.
Mal
aria
Rap
id
PfF
HRP
2Ca
sset
te√
HRP
25
5 dr
ops
-
15 -
A
CT
Mal
aria
Rap
id
Com
boP,
FH
RP2/
Aldo
lase
Cass
ette
√H
RP2
Aldo
lase
55
drop
s -
15
-
D
CT1
T2
Mal
aria
Rap
id
Dua
l P,
FH
RP2/
pLD
HCa
sset
te√
HRP
2pL
DH
55
drop
s -
15
-
D
CT1
T2
Gua
ngzh
ou
Won
dfo
Biot
ech
Co. L
td.
Won
dfo
One
St
ep M
alar
ia
Pf/P
an W
hole
Bl
ood
Test
F, P
pLD
H/
HRP
2Ca
sset
te√
pLD
HH
RP2
53
drop
s -
15
30C
CT1
T2A
B
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)52
Man
ufac
ture
rPr
oduc
t na
me
Plas
mod
ium
sp
ecie
s ta
rget
ed(F
=P.
fa
lcip
arum
V
=P.
viv
ax
O =
P. o
vale
M =
P. m
alar
iae
P =
PAN
; maj
or
Plas
mod
ium
sp
ecie
s)
Targ
et
Ant
igen
1Fo
rmat
Sequ
ence
and
typ
e of
bou
nd a
ntib
ody2
Requ
ired
vo
lum
e (μ
l) of
w
hole
bl
ood
Buff
er
volu
me
(dro
ps)
Inte
rmed
iate
St
ep
Tim
e to
re
sult
s3 (m
ins)
Max
imum
re
adin
g ti
me3
Resu
lts
Inte
rpre
-ta
tion
(T
ype
A-E
)4
Resu
lts
Inte
rpre
tati
on (
Type
A-E
)4
CT1
T2
Zeph
yr
Biom
edic
als
Para
scre
en
Rapi
d Te
st fo
r M
alar
ia P
an/
Pf (D
evic
e)
P, F
pLD
H, H
RP2
Cass
ette
√pL
DH
HRP
25
4 dr
ops
-
15-3
0 -
C
CT1
T2A
B
Para
bank
Ra
pid
Test
for
Mal
aria
Pan
(D
evic
e)
PpL
DH
Cass
ette
√pL
DH
54
drop
s *
15-3
0 -
B
CT
AB
Mal
asca
n Ra
pid
Test
for
Mal
aria
Pf/
Pan
(Dev
ice)
F, P
HRP
2, P
an
spec
ifi c
aldo
lase
Cass
ette
√Al
dola
seH
RP2
54
drop
s -
15
-30
-
C
CT1
T2A
B
1 -
pLD
H =
plas
mod
ium
lact
ate
dehy
drog
enas
e ; H
RP =
hist
idin
e ric
h pr
otei
n 2
- Se
quen
ce w
hen
test
hel
d In
a h
oriz
onta
l pos
ition
and
the
sam
ple
wel
l at f
ar ri
ght a
nd c
ontr
ol li
ne f
ar le
ft3
- Fr
om p
lace
men
t of b
uffe
r, or
fro
m 'i
nter
med
iate
ste
p' if
this
is p
rese
nt4
- Se
e An
nex
2Ea
ch p
rodu
ct s
houl
d id
eally
be
acco
mpa
nied
by
all r
equi
red
mat
eria
ls (l
ance
t, pi
pett
e et
c.) P
artic
ular
ly w
hen
used
at t
he v
illag
e he
alth
wor
ker l
evel
; how
ever
, thi
s is
oft
en n
ot th
e ca
se a
nd th
e co
nten
ts d
epen
d on
the
requ
est o
f pro
curin
g ag
ent.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)53
ANNEX 2: MALARIA RDT GUIDE TO RESULTS INTERPRETATION
Type A: Malaria Generic Pf RDT Results Guide
Results Window: C=control line; T=test line with bound HRP-2 antibody.
C T
Negative Results: One line 'C' appears in the results window.
C T
positive Results: P. falciparum infection. Two lines 'C' and 'T' appear in the results window. Test is positive even if the test line is faint.
C T
C T
Invalid Results: No 'C' line appears in the results window. Repeat the test using a new RDT if no control line appears.
C T
C T
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)54
Type B: Malaria Generic Major Plasmodium species (PAN) RDT Results Guide
Results Window: C=control line; T=test line with bound HRP2 antibody.
C T
Negative Results: One line 'C' appears in the results window.
C T
positive Results: Plasmodium species (P. falciparum, P. vivax, P.malariae, P.ovale) infection. Two lines 'C' and 'T' appear in the results window. Test is positive even is the test line is faint.
C T
C T
Invalid Results: No 'C' line appears in the results window. Repeat the test using a new RDT if no control line appears.
C T
C T
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)55
Type C: Malaria Generic Pan-Pf RDT Results Guide
Results Window: C=control line; T1=test line with bound pLDH or aldolase antibody; T2=test line with bound HRP2 or Pf specifi c pLDH antibody.
C T2T1
Negative Results: Only one line 'C' appears in the results window.
C T1 T2
positive Results:
P. falciparum: Two lines 'C' and 'T2" appear in the results window.
C T1 T2
C T1 T2
Non-falciparum infection (P. vivax, P.ovale, P.malariae) or mixed infection of these: Two lines 'C' and 'T1" appear in the results window.
C T1 T2
P. falciparum or mixed infection. Three lines 'C', 'T1' and 'T2' appear in the results window.
C T1 T2
Invalid Results: No 'C' line appears in the results window. Repeat the test using a new RDT if no control line appears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)56
Type D: Malaria Generic Pf-Pan RDT Results Guide
Results Window: C=control line; T1=test line with bound HRP2 or Pf specifi c LDH antibody; T2=test line with bound pLDH or aldolase antibody.
C T2T1
Negative Results: Only one line 'C' appears in the results window.
C T
positive Results:
P. falciparum infection. Two lines 'C' and 'T1" appear in the results window.
C T1 T2
Non-falciparum infection (P. vivax, P.ovale, P.malariae) or mixed infection of these. Two lines 'C' and 'T2" appear in the results window.
C T1 T2
P. falciparum or mixed infection. Three lines 'C', 'T1' and 'T2' appear in the results window.
C T1 T2
Invalid Results: No 'C' line appears in the results window. Repeat the test using a new RDT if no control line appears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)57
Type E: Malaria Generic Pv-Pf RDT Results Guide
Results Window: C=control line; T1=test line with bound P. vivax specifi c pLDH; T2=test line with bound HRP-2 antibody.
C T2T1
Negative Results: Only one line 'C' appears in the results window.
C T
positive Results:
P. falciparum infection. Two lines 'C' and 'T2" appear in the results window.
C T1 T2
C T1 T2
P. vivax infection. Two lines 'C' and 'T1" appear in the results window.
C T1 T2
P. falciparum and P. vivax mixed infection. Three lines 'C', 'T1' and 'T2' appear in the results window.
C T1 T2
Invalid Results: No 'C' line appears in the results window. Repeat the test using a new RDT if no control line appears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)58
ANN
EX 3:
PHAS
E 1
RESU
LTS
Tabl
e A
3.1:
Lot
var
iabi
lity
in p
osit
ive
resu
lts†
agai
nst
P. f
alci
paru
m c
ultu
re s
ampl
es a
t lo
w (
200)
and
hig
h (2
000
or 5
000)
par
asit
e de
nsit
ies
(par
asit
es/μ
l)
Prod
uct
Man
ufac
ture
r
P. f
alci
paru
m s
ampl
es (
n=20
)
Tot
al p
osit
ive
resu
lts
retu
rned
200
para
site
s/μl
2,00
0 or
5,0
00 p
aras
ites
/μl
Lot
1 Lo
t 2
Lot
1 Lo
t 2
Test
1
Test
2N
o. p
osit
ive
agre
emen
ts
(max
=20)
*Te
st 1
Te
st 2
No.
pos
itiv
e ag
reem
ents
(m
ax=2
0)*
Test
1Te
st 1
Pf o
nly
ADVA
NCE
D QU
ALIT
Y TM
MAL
ARIA
(p.f)
POC
T In
Tec
Prod
ucts
, Inc
.7
74
69
419
19AD
VAN
CED
QUAL
ITY
TM O
ne S
tep
Mal
aria
(p.f.
) Tes
t (w
hole
bl
ood)
InTe
c Pr
oduc
ts, I
nc.
912
77
74
2018
Adva
ntag
e P.
f. M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
1919
1818
1817
2020
Care
Star
t Mal
aria
HRP
2 (P
f)Ac
cess
Bio
, Inc
.20
2020
2020
2020
20Fi
rst R
espo
nse
Mal
aria
Ag
HRP
2Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
2020
2020
2020
2020
Firs
tSig
n –
Mal
aria
Pf C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.7
20
12
116
18H
exag
on M
alar
iaH
uman
Gm
bH6
11
47
419
20IC
T M
alar
ia P
f Cas
sett
e Te
st (M
L01)
ICT
Diag
nost
ics
1918
1814
1511
2020
Imm
unoq
uick
Mal
aria
Fal
cipa
rum
Bios
ynex
1515
1414
1212
2020
Mal
aria
Pla
smod
ium
falc
ipar
um R
apid
test
Dev
ice
(Who
le
bloo
d)AC
ON L
abor
ator
ies,
Inc.
1919
1917
1917
2019
Mal
aria
Rap
id P
fVi
sion
Bio
tech
(Pty
) Ltd
.17
1715
1817
1720
20Pa
rach
eck
Pf R
apid
test
for P
. fal
cipa
rum
Mal
aria
(Dev
ice)
Or
chid
Bio
med
ical
Sys
tem
s7
7 (1
9)3
1412
1019
18 (1
8)Pa
rach
eck
Pf R
apid
test
for P
. fal
cipa
rum
Mal
aria
(Dip
stic
k)
Orch
id B
iom
edic
al S
yste
ms
1215
1216
1413
2020
Para
hit-
f DIP
STIC
K FO
R FA
LCIP
ARU
M M
ALAR
IASp
an D
iagn
ostic
s Lt
d.16
1515
149
920
20Pa
rahi
t-f T
EST
DEVI
CE F
OR F
ALCI
PARU
M M
ALAR
IASp
an D
iagn
ostic
s Lt
d.2
42
66
320
18SD
BIO
LIN
E M
alar
ia A
g Pf
St
anda
rd D
iagn
ostic
s, In
c.19
1818
1919
1920
20Pf
& P
an/P
f &
Pv
Adva
ntag
e M
al C
ard
J. M
itra
& C
o. P
vt. L
td.
45
10
10
2020
AZOG
Mal
aria
pf (
HRP
-II)/
pv (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
eAZ
OG, I
nc.
1818
1718
1918
2020
Bina
x N
ow M
alar
ia
Inve
rnes
s M
edic
al In
nova
tions
, Inc
.17
1717
1716
1620
20Ca
reSt
art M
alar
ia H
RP2/
pLDH
(Pf/
PAN
) COM
BOAc
cess
Bio
, Inc
.20
1919
2020
2020
20Fi
rst R
espo
nse
Mal
aria
Ag
Com
bo (P
LDH
/HRP
2)Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
2020
2019
2019
2020
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.9
64
99
720
19H
exag
on M
alar
ia C
ombi
Hum
an G
mbH
43
29
127
1920
ICT
Mal
aria
Com
bo C
asse
tte
Test
(ML0
2)IC
T Di
agno
stic
s18
1716
1918
1720
20Im
mun
oqui
ck M
alar
ia +
4Bi
osyn
ex17
1717
1920
1920
20
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nost
ics,
Inc.
0 (1
5)0
(11)
0 (1
8)0
(15)
0 (1
1)0
(16)
2(10
)0
(14)
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
1413
1116
1513
2019
Mal
aria
Rap
id D
ual
Visi
on B
iote
ch (P
ty) L
td.
1817
1617
1816
2020
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s10
87
55
320
20On
e St
ep M
alar
ia A
ntig
en S
trip
IND
Diag
nost
ic In
c.0
00
00
015
17On
Sigh
t – P
araQ
uick
(Pan
, Pf)
Test
Amge
nix
Inte
rnat
iona
l, In
c.15
1513
1617
1620
20Op
tiMAL
-IT
DiaM
ed A
G0
00
00
020
20Pa
rahi
t-To
tal D
evic
e Ra
pid
test
for P
. fal
cipa
rum
and
Pan
m
alar
ial s
peci
es.
Span
Dia
gnos
tics
Ltd.
55
35
41
1819
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
810
614
1212
2020
Quic
kstic
k M
alar
ia A
ntig
en T
est
Inno
vate
k M
edic
al In
c.0
00
00
015
17SD
BIO
LIN
E M
alar
ia A
gSt
anda
rd D
iagn
ostic
s, In
c.0
00
02
018
19SD
BIO
LIN
E M
alar
ia A
g Pf
/Pan
St
anda
rd D
iagn
ostic
s, In
c.17
1817
1718
1720
20W
ondf
o On
e St
ep M
alar
ia P
f/Pa
n W
hole
Blo
od T
est
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
., Lt
d13
129
119
818
19
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)59
Tabl
e A
3.1a
: Lot
var
iabi
lity
in p
osit
ive
resu
lts
agai
nst
P. f
alci
paru
m c
ultu
re s
ampl
es a
t lo
w (
200)
and
hig
h (2
000
or 5
000)
par
asit
e de
nsit
ies
(par
asit
es/μ
l) ba
sed
on a
de
laye
d re
adin
g w
hen
spec
ified
by
the
man
ufac
ture
r
Prod
uct
Man
ufac
ture
r
P. f
alci
paru
m s
ampl
es (
n=20
)
Tot
al p
osit
ive
resu
lts
retu
rned
200
para
site
s/μl
2,00
0 or
5,0
00 p
aras
ites
/μl
Lot
1 Lo
t 2
Lot
1 Lo
t 2
Test
1
Test
2N
o. p
osi-
tive
agr
eem
ents
(m
ax=2
0)*
Test
1
Test
2N
o. p
osi-
tive
agr
eem
ents
(m
ax=2
0)*
Test
1Te
st 1
Pf &
Pan
/Pf
& P
vFi
rstS
ign
– Pa
raVi
ew-2
(Pv
+ Pf
) Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
1315
1115
1313
2019
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
1919
1819
1918
2020
Mal
aria
P.F
/Viv
axDi
agno
stic
s Au
tom
atio
n/Co
rtez
Dia
-gn
ostic
s, In
c.1
(16)
0 (1
1)1
(18)
1(15
)2
(11)
1 (1
6)1
(12)
0 (1
4)
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s10
107
915
820
20Pa
rasc
reen
Rap
id T
est f
or M
alar
ia P
an/P
f (De
vice
)Ze
phyr
Bio
med
ical
s18
1414
1717
1720
20W
ondf
o On
e St
ep M
alar
ia P
f/Pa
n W
hole
Blo
od T
est
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
., Lt
d11
128
1616
1518
19Pa
n on
lyPa
raba
nk R
apid
Tes
t for
Mal
aria
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
41
01
31
2019
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spe
cies
* N
umbe
r of s
ampl
es th
at re
turn
ed a
pos
itive
resu
lt fo
r bot
h te
sts.
Whe
re o
ne te
st w
as in
valid
and
the
othe
r pos
itive
, pos
itive
agr
eem
ent w
as re
cord
ed.
Prod
uct
Man
ufac
ture
r
P. f
alci
paru
m s
ampl
es (
n=20
)
Tot
al p
osit
ive
resu
lts
retu
rned
200
para
site
s/μl
2,00
0 or
5,0
00 p
aras
ites
/μl
Lot
1 Lo
t 2
Lot
1 Lo
t 2
Test
1
Test
2N
o. p
osit
ive
agre
emen
ts
(max
=20)
*Te
st 1
Te
st 2
No.
pos
itiv
e ag
reem
ents
(m
ax=2
0)*
Test
1Te
st 1
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
138
62
21
2019
Care
Star
t Mal
aria
pLD
H (P
AN)
Acce
ss B
io, I
nc.
1818
1717
1513
2020
Para
bank
Rap
id T
est f
or M
alar
ia P
an (D
evic
e)Ze
phyr
Bio
med
ical
s0
00
00
018
14Pf
- P
lasm
odiu
m fa
lcip
arum
Pv
- P
lasm
odiu
m v
ivax
pan
- Pl
asm
odiu
m s
peci
es
† res
ults
are
bas
ed o
n th
e fir
st re
ader
s in
terp
reta
tion
acco
rdin
g to
man
ufac
ture
rs in
stru
ctio
ns.
* Num
ber o
f sam
ples
that
retu
rned
a p
ositi
ve re
sult
for b
oth
test
s. W
here
one
test
was
inva
lid a
nd th
e ot
her p
ositi
ve, p
ositi
ve a
gree
men
t was
reco
rded
.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)6 0
Tabl
e A
3.2:
Det
ecti
on ra
te o
f 20
P. fa
lcip
arum
cul
ture
line
s at l
ow a
nd h
igh
para
site
den
siti
es b
ased
on
init
ial r
eadi
ng a
ccor
ding
to m
anuf
actu
rers
inst
ruct
ions
and
a d
elay
ed
seco
nd r
eadi
ng p
erfo
rmed
wit
hin
1 ho
ur
Prod
uct
Man
ufac
ture
r
Dete
ctio
n ra
te‡
200
para
site
s/μl
2,00
0 -
5,00
0 pa
rasi
tes/
μl
Read
er
1† (n=
80)
Read
er 2
(n
=80)
Perc
ent
agre
emen
t be
twee
n re
a-de
rs (
n=80
)
Mea
n ti
me
betw
een
read
ings
Read
er 1
† (n
=40)
Read
er
2(n=
40)
Mea
n ti
me
betw
een
read
ings
Pf o
nly
Adva
nced
Qua
lity
One
Step
Mal
aria
(pf)
Test
(Who
le B
lood
) ITP
1100
2TC1
Inte
c Pr
oduc
ts In
c.43
.75
62.5
68.7
50:
19:5
295
97.5
0:19
:33
Adva
nced
Qua
lity
One
Step
Mal
aria
(Pf)
Test
(Who
le B
lood
) ITP
1100
2TC4
0In
tec
Prod
ucts
Inc.
36.2
557
.568
.75
0:22
:18
9597
.50:
21:3
9Ad
vant
age
P.f.
Mal
aria
Car
dJ.
Mitr
a Co
mpa
ny P
vt L
td92
.595
950:
16:2
810
010
00:
19:0
0Ca
reSt
art M
alar
ia H
RP2
(Pf)
Acce
ss B
io, I
nc.
100
100
100
0:13
:44
100
100
0:13
:13
Firs
t Res
pons
e M
alar
ia A
g H
RP2
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.10
010
010
00:
20:1
610
010
00:
22:3
4Fi
rstS
ign
– M
alar
ia P
f Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
158.
7583
.75
0:20
:10
8582
.50:
19:0
3H
exag
on M
alar
iaH
uman
Gm
bH22
.538
.75
78.7
50:
20:5
897
.595
0:20
:13
ICT
Mal
aria
Pf C
asse
tte
Test
(ML0
1)IC
T Di
agno
stic
s82
.586
.25
86.2
50:
17:3
210
010
00:
17:1
2Im
mun
oqui
ck M
alar
ia F
alci
paru
mBi
osyn
ex70
9080
0:13
:06
100
100
0:15
:36
Mal
aria
Pla
smod
ium
falc
ipar
um R
apid
test
Dev
ice
(Who
le b
lood
)AC
ON L
abor
ator
ies,
Inc.
92.5
87.5
92.5
0:20
:16
97.5
100
0:24
:18
Mal
aria
Rap
id P
fVi
sion
Bio
tech
86.2
598
.75
87.5
0:11
:18
100
100
0:10
:37
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
evic
e)
Orch
id B
iom
edic
al S
yste
ms
50.6
3 (7
9)72
.15
(79)
65.3
8 (7
8)0:
15:0
497
.37
(38)
100
0:13
:26
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
ipst
ick)
Or
chid
Bio
med
ical
Sys
tem
s71
.25
51.2
580
0:15
:47
100
100
0:17
:32
Para
hit-
f DIP
STIC
K FO
R FA
LCIP
ARU
M M
ALAR
IASp
an D
iagn
ostic
s67
.562
.582
.50:
20:1
310
010
00:
21:5
7Pa
rahi
t-f T
EST
DEVI
CE F
OR F
ALCI
PARU
M M
ALAR
IASp
an D
iagn
ostic
s22
.538
.75
81.2
50:
22:4
795
100
0:20
:36
SD B
IOLI
NE
Mal
aria
Ag
Pf
Stan
dard
Dia
gnos
tics,
Inc.
93.7
590
96.2
50:
28:4
910
010
00:
32:1
8Pf
& P
an/P
f &
Pv
Adva
ntag
e M
al C
ard
J. M
itra
Com
pany
Pvt
Ltd
12.5
36.2
568
.75
0:18
:13
100
100
0:20
:12
AZOG
Mal
aria
pf (
HRP
-II)
/pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
AZOG
, Inc
.91
.25
97.5
93.7
50:
12:2
610
010
00:
13:0
0Bi
nax
Now
Mal
aria
In
vern
ess
Med
ical
Inno
vatio
ns83
.75
77.5
86.2
50:
20:5
810
010
00:
25:0
7Ca
reSt
art M
alar
ia H
RP2/
pLDH
(Pf/
PAN
) COM
BOAc
cess
Bio
, Inc
.98
.75
98.7
597
.50:
09:5
010
010
00:
09:2
0Fi
rst R
espo
nse
Mal
aria
Ag
Com
bo (P
LDH
/HRP
2)Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
98.7
598
.75
100
0:29
:34
100
100
0:29
:54
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.41
.25
7071
.25
0:16
:33
97.5
97.5
0:15
:28
Hex
agon
Mal
aria
Com
biH
uman
Gm
bH35
33.7
566
.25
0:23
:23
97.5
97.5
0:22
:40
ICT
Mal
aria
Com
bo C
asse
tte
Test
(ML0
2)IC
T Di
agno
stic
s90
91.2
596
.25
0:19
:00
100
100
0:19
:17
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
91.2
595
91.2
50:
23:2
510
010
00:
22:3
6M
alar
ia P
.F/V
ivax
Diag
nost
ic A
utom
atio
n/Co
rtez
Dia
gnos
tics,
Inc.
0
(52)
7.55
(53)
92.3
1 (5
2)0:
24:2
98.
33 (2
4)3.
85 (2
6)0:
23:5
1M
alar
ia R
apid
Com
boVi
sion
Bio
tech
72.5
87.5
850:
16:2
897
.510
00:
15:4
5M
alar
ia R
apid
Dua
l Vi
sion
Bio
tech
87.5
96.2
591
.25
0:19
:24
100
100
0:18
:40
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s35
5575
0:33
:02
100
100
0:33
:00
One
Step
Mal
aria
Ant
igen
Str
ipIN
D Di
agno
stic
Inc.
00
100
0:06
:21
8067
.50:
06:1
9On
Sigh
t – P
araQ
uick
(Pan
, Pf)
Test
Amge
nix
Inte
rnat
iona
l, In
c.78
.75
8593
.75
0:19
:04
100
100
0:18
:51
OptiM
AL-I
TDi
aMed
021
.25
78.7
50:
23:0
410
010
00:
24:1
3Pa
rahi
t-To
tal D
evic
e Ra
pid
test
for P
. fal
cipa
rum
and
Pan
mal
aria
l spe
cies
.Sp
an D
iagn
ostic
s23
.75
32.5
86.2
50:
23:4
892
.595
0:22
:22
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
5582
.572
.5N
/A10
010
0N
/AQu
icks
tick
Mal
aria
Ant
igen
Tes
tIn
nova
tek
Med
ical
Inc.
00
100
0:06
:21
8067
.50:
06:1
9SD
BIO
LIN
E M
alar
ia A
gSt
anda
rd D
iagn
ostic
s, In
c.2.
53.
7596
.25
0:23
:37
92.5
97.5
0:25
:51
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
an
Stan
dard
Dia
gnos
tics,
Inc.
87.5
87.5
100
N/A
100
100
N/A
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
56.2
568
.75
77.5
0:13
:31
92.5
92.5
0:10
:14
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
J. M
itra
Com
pany
Pvt
Ltd
31.2
561
.25
47.5
0:18
:25
97.5
100
0:19
:52
Care
Star
t Mal
aria
pLD
H (P
AN)
Acce
ss B
io, I
nc.
8586
.25
76.2
50:
13:4
010
097
.50:
12:3
6Pa
raba
nk R
apid
Tes
t for
Mal
aria
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
011
.25
88.7
50:
32:5
280
97.5
0:32
:29
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spe
cies
† -
Rea
d ac
cord
ing
to m
anuf
actu
rers
inst
ruct
ions
‡ - A
sam
ple
is c
onsi
dere
d de
tect
ed o
nly
if al
l RDT
s fr
om b
oth
lots
read
by
the
first
tech
nici
an, a
t min
imum
spe
cifie
d re
adin
g tim
e, a
re p
ositi
veTh
ose
test
s in
whi
ch a
man
ufac
ture
rs re
com
men
ded
a de
laye
d re
adin
g if
initi
al re
sults
wer
e ne
gativ
e.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)61
Tabl
e A
3.3:
Dis
trib
utio
n of
tes
t ba
nd in
tens
ity
scor
es (
0-4)
aga
inst
20
P. f
alci
paru
m c
ultu
red
para
site
s at
low
(20
0) a
nd h
igh
(200
0 or
500
0) p
aras
ite
dens
itie
s (p
aras
ites
/μl)
Prod
uct
Man
ufac
ture
r
200
para
site
s/μl
sam
ples
(n=
20)
2,00
0 or
5,0
00 p
aras
ites
/μl s
ampl
es (
n=20
) 2
00 p
aras
ites
/μl s
ampl
es (
n=20
)2,
000
or 5
,000
par
asit
es/μ
l sam
ples
(n
=20)
Perc
enta
ge d
istr
ibut
ion
of t
est
Pf b
and
inte
nsit
y† (n
=80)
Perc
enta
ge d
istr
ibut
ion
of t
est
Pf b
and
inte
nsit
y† (n
=40)
Perc
enta
ge d
istr
ibut
ion
of P
an t
est
band
inte
nsit
y (n
=80)
Perc
enta
ge d
istr
ibut
ion
of P
an t
est
band
inte
nsit
y (n
=40)
0*1
23
40
12
34
01
23
40
12
34
Pf o
nly
ADVA
NCE
D QU
ALIT
Y TM
MAL
ARIA
(p.f)
POC
T In
Tec
Prod
ucts
, Inc
.63
.75
32.5
2.5
1.25
05
17.5
2015
42.5
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
ADVA
NCE
D QU
ALIT
Y TM
One
Ste
p M
alar
ia (p
.f.)
Test
(who
le b
lood
)In
Tec
Prod
ucts
, Inc
.56
.25
37.5
6.25
00
515
22.5
22.5
35N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Adva
ntag
e P.
f. M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
7.5
46.2
535
8.75
2.5
02.
55
1577
.5N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Care
Star
t Mal
aria
HRP
2 (P
f)Ac
cess
Bio
, Inc
.0
2532
.536
.25
6.25
00
2.5
12.5
85N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Firs
t Res
pons
e M
alar
ia A
g H
RP2
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.0
36.2
535
208.
750
02.
510
87.5
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Firs
tSig
n –
Mal
aria
Pf C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.85
12.5
1.25
1.25
015
3515
2510
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Hex
agon
Mal
aria
Hum
an G
mbH
77.5
17.5
3.75
1.25
02.
537
.525
1520
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
ICT
Mal
aria
Pf C
asse
tte
Test
(ML0
1)IC
T Di
agno
stic
s17
.550
28.7
53.
750
05
12.5
27.5
55N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Imm
unoq
uick
Mal
aria
Fal
cipa
rum
Bios
ynex
3063
.75
6.25
00
015
27.5
2532
.5N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Mal
aria
Pla
smod
ium
falc
ipar
um R
apid
test
Dev
ice
(Who
le b
lood
)AC
ON L
abor
ator
ies,
Inc.
7.5
5530
6.25
1.25
2.5
010
4047
.5N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Mal
aria
Rap
id P
fVi
sion
Bio
tech
(Pty
) Ltd
.13
.75
76.2
510
00
012
.510
37.5
40N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia
(Dev
ice)
Or
chid
Bio
med
ical
Sys
tem
s50
37.5
11.2
51.
250
7.5
1020
4517
.5N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia
(Dip
stic
k)
Orch
id B
iom
edic
al S
yste
ms
28.7
555
13.7
52.
50
010
3042
.517
.5N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Para
hit-
f DIP
STIC
K FO
R FA
LCIP
ARU
M M
ALAR
IASp
an D
iagn
ostic
s Lt
d.32
.550
12.5
3.75
1.25
02.
527
.525
45N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Para
hit-
f TES
T DE
VICE
FOR
FAL
CIPA
RUM
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
77.5
201.
250
1.25
527
.520
27.5
20N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
SD B
IOLI
NE
Mal
aria
Ag
Pf
Stan
dard
Dia
gnos
tics,
Inc.
6.25
23.7
542
.525
2.5
00
7.5
7.5
85N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Pf &
Pan
/Pf
& P
vAd
vant
age
Mal
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.87
.512
.50
00
027
.547
.525
091
.25
8.75
00
00
42.5
507.
50
AZOG
Mal
aria
pf (
HRP
-II)
/pv
(pLD
H) A
ntig
en
Dete
ctio
n Te
st D
evic
eAZ
OG, I
nc.
8.75
66.2
517
.57.
50
05
1032
.552
.561
.25
38.7
50
00
2.5
82.5
150
0
Bina
x N
ow M
alar
ia
Inve
rnes
s M
edic
al In
nova
tions
, Inc
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.25
67.5
13.7
52.
50
010
1545
3010
00
00
012
.587
.50
00
Care
Star
t Mal
aria
HRP
2/pL
DH (P
f/PA
N) C
OMBO
Acce
ss B
io, I
nc.
1.25
21.2
547
.525
50
05
1085
2.5
96.2
51.
250
00
035
4520
Firs
t Res
pons
e M
alar
ia A
g Co
mbo
(PLD
H/H
RP2)
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.1.
2516
.25
4032
.510
00
2.5
17.5
8037
.562
.50
00
2.5
050
407.
5
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.58
.75
22.5
12.5
6.25
02.
57.
55
3055
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Hex
agon
Mal
aria
Com
biH
uman
Gm
bH65
33.7
51.
250
02.
527
.522
.522
.525
100
00
00
100
00
00
ICT
Mal
aria
Com
bo C
asse
tte
Test
(ML0
2)IC
T Di
agno
stic
s10
3540
13.7
51.
250
07.
515
77.5
97.5
2.5
00
022
.567
.510
00
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
8.75
36.2
543
.75
7.5
3.75
00
7.5
2072
.510
00
00
020
707.
52.
50
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nost
ics,
Inc.
100
00
00
955
00
045
11.2
525
153.
7532
.55
12.5
7.5
42.5
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
27.5
61.2
58.
752.
50
2.5
7.5
1040
4098
.75
1.25
00
020
800
00
Mal
aria
Rap
id D
ual
Visi
on B
iote
ch (P
ty) L
td.
12.5
52.5
26.2
57.
51.
250
512
.510
72.5
88.7
511
.25
00
027
.572
.50
00
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s65
31.2
53.
750
00
2035
27.5
17.5
100
00
00
52.5
3512
.50
0
One
Step
Mal
aria
Ant
igen
Str
ipIN
D Di
agno
stic
Inc.
100
00
00
2072
.57.
50
010
00
00
022
.570
7.5
00
OnSi
ght –
Par
aQui
ck (P
an, P
f) Te
stAm
geni
x In
tern
atio
nal,
Inc.
21.2
547
.522
.55
3.75
02.
510
2067
.598
.75
1.25
00
02.
547
.535
12.5
2.5
OptiM
AL-I
TDi
aMed
AG
100
00
00
067
.525
7.5
098
.75
1.25
00
00
6527
.57.
50
Para
hit-
Tota
l Dev
ice
Rapi
d te
st fo
r P. f
alci
paru
m
and
Pan
mal
aria
l spe
cies
.Sp
an D
iagn
ostic
s Lt
d.76
.25
21.2
51.
250
1.25
7.5
2027
.522
.522
.510
00
00
010
00
00
0
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
4528
.75
22.5
1.25
2.5
010
2530
3510
00
00
035
4515
50
Quic
kstic
k M
alar
ia A
ntig
en T
est
Inno
vate
k M
edic
al In
c.10
00
00
020
72.5
7.5
00
100
00
00
22.5
707.
50
0
SD B
IOLI
NE
Mal
aria
Ag
Stan
dard
Dia
gnos
tics,
Inc.
97.5
2.5
00
07.
555
32.5
50
100
00
00
7525
00
0
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
an
Stan
dard
Dia
gnos
tics,
Inc.
12.5
57.5
252.
52.
50
55
1080
100
00
00
5545
00
0
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Te
stG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
43.7
551
.25
50
07.
512
.527
.532
.520
9010
00
010
4530
12.5
2.5
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
68.7
530
1.25
00
2.5
2055
202.
568
.75
301.
250
02.
520
5520
2.5
Care
Star
t Mal
aria
pLD
H (P
AN)
Acce
ss B
io, I
nc.
1583
.75
1.25
00
02.
545
37.5
1515
83.7
51.
250
00
2.5
4537
.515
Para
bank
Rap
id T
est f
or M
alar
ia P
an (D
evic
e)Ze
phyr
Bio
med
ical
s10
00
00
020
47.5
27.5
50
100
00
00
2047
.527
.55
0
* den
otes
no
band
Pf
- P
lasm
odiu
m fa
lcip
arum
Pv
- P
lasm
odiu
m v
ivax
pan
- Pl
asm
odiu
m s
peci
es
† thi
s in
clud
es P
an li
ne in
tens
ity o
nly
for P
an-o
nly
test
s
Tabl
e A
3.2:
Det
ecti
on ra
te o
f 20
P. fa
lcip
arum
cul
ture
line
s at l
ow a
nd h
igh
para
site
den
siti
es b
ased
on
init
ial r
eadi
ng a
ccor
ding
to m
anuf
actu
rers
inst
ruct
ions
and
a d
elay
ed
seco
nd r
eadi
ng p
erfo
rmed
wit
hin
1 ho
ur
Prod
uct
Man
ufac
ture
r
Dete
ctio
n ra
te‡
200
para
site
s/μl
2,00
0 -
5,00
0 pa
rasi
tes/
μl
Read
er
1† (n=
80)
Read
er 2
(n
=80)
Perc
ent
agre
emen
t be
twee
n re
a-de
rs (
n=80
)
Mea
n ti
me
betw
een
read
ings
Read
er 1
† (n
=40)
Read
er
2(n=
40)
Mea
n ti
me
betw
een
read
ings
Pf o
nly
Adva
nced
Qua
lity
One
Step
Mal
aria
(pf)
Test
(Who
le B
lood
) ITP
1100
2TC1
Inte
c Pr
oduc
ts In
c.43
.75
62.5
68.7
50:
19:5
295
97.5
0:19
:33
Adva
nced
Qua
lity
One
Step
Mal
aria
(Pf)
Test
(Who
le B
lood
) ITP
1100
2TC4
0In
tec
Prod
ucts
Inc.
36.2
557
.568
.75
0:22
:18
9597
.50:
21:3
9Ad
vant
age
P.f.
Mal
aria
Car
dJ.
Mitr
a Co
mpa
ny P
vt L
td92
.595
950:
16:2
810
010
00:
19:0
0Ca
reSt
art M
alar
ia H
RP2
(Pf)
Acce
ss B
io, I
nc.
100
100
100
0:13
:44
100
100
0:13
:13
Firs
t Res
pons
e M
alar
ia A
g H
RP2
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.10
010
010
00:
20:1
610
010
00:
22:3
4Fi
rstS
ign
– M
alar
ia P
f Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
158.
7583
.75
0:20
:10
8582
.50:
19:0
3H
exag
on M
alar
iaH
uman
Gm
bH22
.538
.75
78.7
50:
20:5
897
.595
0:20
:13
ICT
Mal
aria
Pf C
asse
tte
Test
(ML0
1)IC
T Di
agno
stic
s82
.586
.25
86.2
50:
17:3
210
010
00:
17:1
2Im
mun
oqui
ck M
alar
ia F
alci
paru
mBi
osyn
ex70
9080
0:13
:06
100
100
0:15
:36
Mal
aria
Pla
smod
ium
falc
ipar
um R
apid
test
Dev
ice
(Who
le b
lood
)AC
ON L
abor
ator
ies,
Inc.
92.5
87.5
92.5
0:20
:16
97.5
100
0:24
:18
Mal
aria
Rap
id P
fVi
sion
Bio
tech
86.2
598
.75
87.5
0:11
:18
100
100
0:10
:37
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
evic
e)
Orch
id B
iom
edic
al S
yste
ms
50.6
3 (7
9)72
.15
(79)
65.3
8 (7
8)0:
15:0
497
.37
(38)
100
0:13
:26
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
ipst
ick)
Or
chid
Bio
med
ical
Sys
tem
s71
.25
51.2
580
0:15
:47
100
100
0:17
:32
Para
hit-
f DIP
STIC
K FO
R FA
LCIP
ARU
M M
ALAR
IASp
an D
iagn
ostic
s67
.562
.582
.50:
20:1
310
010
00:
21:5
7Pa
rahi
t-f T
EST
DEVI
CE F
OR F
ALCI
PARU
M M
ALAR
IASp
an D
iagn
ostic
s22
.538
.75
81.2
50:
22:4
795
100
0:20
:36
SD B
IOLI
NE
Mal
aria
Ag
Pf
Stan
dard
Dia
gnos
tics,
Inc.
93.7
590
96.2
50:
28:4
910
010
00:
32:1
8Pf
& P
an/P
f &
Pv
Adva
ntag
e M
al C
ard
J. M
itra
Com
pany
Pvt
Ltd
12.5
36.2
568
.75
0:18
:13
100
100
0:20
:12
AZOG
Mal
aria
pf (
HRP
-II)
/pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
AZOG
, Inc
.91
.25
97.5
93.7
50:
12:2
610
010
00:
13:0
0Bi
nax
Now
Mal
aria
In
vern
ess
Med
ical
Inno
vatio
ns83
.75
77.5
86.2
50:
20:5
810
010
00:
25:0
7Ca
reSt
art M
alar
ia H
RP2/
pLDH
(Pf/
PAN
) COM
BOAc
cess
Bio
, Inc
.98
.75
98.7
597
.50:
09:5
010
010
00:
09:2
0Fi
rst R
espo
nse
Mal
aria
Ag
Com
bo (P
LDH
/HRP
2)Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
98.7
598
.75
100
0:29
:34
100
100
0:29
:54
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.41
.25
7071
.25
0:16
:33
97.5
97.5
0:15
:28
Hex
agon
Mal
aria
Com
biH
uman
Gm
bH35
33.7
566
.25
0:23
:23
97.5
97.5
0:22
:40
ICT
Mal
aria
Com
bo C
asse
tte
Test
(ML0
2)IC
T Di
agno
stic
s90
91.2
596
.25
0:19
:00
100
100
0:19
:17
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
91.2
595
91.2
50:
23:2
510
010
00:
22:3
6M
alar
ia P
.F/V
ivax
Diag
nost
ic A
utom
atio
n/Co
rtez
Dia
gnos
tics,
Inc.
0
(52)
7.55
(53)
92.3
1 (5
2)0:
24:2
98.
33 (2
4)3.
85 (2
6)0:
23:5
1M
alar
ia R
apid
Com
boVi
sion
Bio
tech
72.5
87.5
850:
16:2
897
.510
00:
15:4
5M
alar
ia R
apid
Dua
l Vi
sion
Bio
tech
87.5
96.2
591
.25
0:19
:24
100
100
0:18
:40
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s35
5575
0:33
:02
100
100
0:33
:00
One
Step
Mal
aria
Ant
igen
Str
ipIN
D Di
agno
stic
Inc.
00
100
0:06
:21
8067
.50:
06:1
9On
Sigh
t – P
araQ
uick
(Pan
, Pf)
Test
Amge
nix
Inte
rnat
iona
l, In
c.78
.75
8593
.75
0:19
:04
100
100
0:18
:51
OptiM
AL-I
TDi
aMed
021
.25
78.7
50:
23:0
410
010
00:
24:1
3Pa
rahi
t-To
tal D
evic
e Ra
pid
test
for P
. fal
cipa
rum
and
Pan
mal
aria
l spe
cies
.Sp
an D
iagn
ostic
s23
.75
32.5
86.2
50:
23:4
892
.595
0:22
:22
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
5582
.572
.5N
/A10
010
0N
/AQu
icks
tick
Mal
aria
Ant
igen
Tes
tIn
nova
tek
Med
ical
Inc.
00
100
0:06
:21
8067
.50:
06:1
9SD
BIO
LIN
E M
alar
ia A
gSt
anda
rd D
iagn
ostic
s, In
c.2.
53.
7596
.25
0:23
:37
92.5
97.5
0:25
:51
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
an
Stan
dard
Dia
gnos
tics,
Inc.
87.5
87.5
100
N/A
100
100
N/A
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
56.2
568
.75
77.5
0:13
:31
92.5
92.5
0:10
:14
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
J. M
itra
Com
pany
Pvt
Ltd
31.2
561
.25
47.5
0:18
:25
97.5
100
0:19
:52
Care
Star
t Mal
aria
pLD
H (P
AN)
Acce
ss B
io, I
nc.
8586
.25
76.2
50:
13:4
010
097
.50:
12:3
6Pa
raba
nk R
apid
Tes
t for
Mal
aria
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
011
.25
88.7
50:
32:5
280
97.5
0:32
:29
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spe
cies
† -
Rea
d ac
cord
ing
to m
anuf
actu
rers
inst
ruct
ions
‡ - A
sam
ple
is c
onsi
dere
d de
tect
ed o
nly
if al
l RDT
s fr
om b
oth
lots
read
by
the
first
tech
nici
an, a
t min
imum
spe
cifie
d re
adin
g tim
e, a
re p
ositi
veTh
ose
test
s in
whi
ch a
man
ufac
ture
rs re
com
men
ded
a de
laye
d re
adin
g if
initi
al re
sults
wer
e ne
gativ
e.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)62
Tabl
e A
3.3a
: Dis
trib
utio
n of
test
ban
d in
tens
ity
(0-4
) sco
res a
gain
st 2
0 P.
falc
ipar
um c
ultu
red
para
site
s at l
ow (2
00) a
nd h
igh
(200
0 or
500
0) p
aras
ite
dens
itie
s (pa
rasi
tes/
μl)
base
d on
a d
elay
ed r
eadi
ng w
hen
spec
ified
by
the
man
ufac
ture
r
Prod
uct
Man
ufac
ture
r
200
para
site
s/μl
sam
ples
(n=
20)
2,00
0 or
5,0
00 p
aras
ites
/μl
sam
ples
(n=
20)
200
par
asit
es/μ
l sam
ples
(n=
20)
2,00
0 or
5,0
00 p
aras
ites
/μl s
ampl
es
(n=2
0)
Perc
enta
ge d
istr
ibut
ion
of t
est
Pf
band
inte
nsit
y† (n
=80)
Perc
enta
ge d
istr
ibut
ion
of t
est
Pf
band
inte
nsit
y† (n
=40)
Perc
enta
ge d
istr
ibut
ion
of P
an t
est
band
inte
nsit
y (n
=80)
Perc
enta
ge d
istr
ibut
ion
of P
an t
est
band
in
tens
ity
(n=4
0)
0*1
23
40
12
34
No
band
12
34
No
band
12
34
Pf &
Pan
/Pf
& P
v
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.30
56.2
510
2.5
1.25
2.5
7.5
7.5
2557
.5N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
536
.25
3520
3.75
02.
55
12.5
8098
.75
1.25
00
02.
570
252.
50
Mal
aria
P.F
/Viv
axDi
agno
stic
s Au
tom
atio
n/Co
rtez
Dia
gnos
tics,
Inc.
955
00
097
.50
2.5
00
43.7
513
.75
17.5
17.5
7.5
32.5
57.
512
.542
.5
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s45
46.2
57.
50
1.25
020
3035
1596
.25
3.75
00
025
62.5
12.5
00
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
17.5
41.2
533
.75
6.25
1.25
02.
515
2557
.591
.25
8.75
00
015
4032
.512
.50
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Te
stG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
31.2
560
6.25
2.5
07.
57.
530
2035
53.7
543
.75
2.5
00
7.5
3032
.512
.517
.5
Pan
only
Para
bank
Rap
id T
est f
or M
alar
ia P
an (D
evic
e)Ze
phyr
Bio
med
ical
s88
.75
11.2
50
00
2.5
42.5
4510
088
.75
11.2
50
00
2.5
42.5
4510
0† =
this
incl
udes
Pan
line
inte
nsity
onl
y fo
r Pan
-onl
y te
sts
* den
otes
no
band
Pf
- P
lasm
odiu
m fa
lcip
arum
Pv
- P
lasm
odiu
m v
ivax
pan
- Pl
asm
odiu
m s
peci
es
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)63
ANNE
X 4:
PHAS
E 2
RESU
LTS
Tabl
e A4
.1: L
ot v
aria
bilit
y in
pos
itiv
e re
sult
s† ag
ains
t P.
fal
cipa
rum
and
P. v
ivax
sam
ples
at
low
(20
0) a
nd h
igh
(200
0 or
500
0) p
aras
ite
dens
itie
s (p
aras
ites
/μl)
Prod
uct
Man
ufac
ture
r
P. f
alci
paru
m s
ampl
es (
n=79
)P.
viv
ax s
ampl
es (
n=20
)
Tot
al p
osit
ive
resu
lts
retu
rned
Tot
al p
osit
ive
resu
lts
retu
rned
200
para
site
s/μl
2,00
0 or
5,
000
para
site
s/μl
200
para
site
s/μl
2,00
0 or
5,
000
para
site
s/μl
Lot
1 Lo
t 2
Lot
1 Lo
t 2
Lot
1 Lo
t 2
Lot
1 Lo
t 2
Test
1
Test
2N
o. p
osit
ive
agre
emen
ts
(max
=79)
*Te
st 1
Te
st 2
No.
pos
itiv
e ag
reem
ents
(m
ax=7
9)*
Test
1Te
st 1
Test
1
Test
2N
o. p
osit
ive
agre
emen
ts
(max
=20)
*Te
st 1
Te
st 2
No.
pos
itiv
e ag
reem
ents
(m
ax=2
0)*
Test
1
Test
1
Pf o
nly
ADVA
NCE
D QU
ALIT
Y TM
MAL
ARIA
(p.f)
PO
CT
InTe
c Pr
oduc
ts, I
nc.
5961
5163
6054
7979
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
ADVA
NCE
D QU
ALIT
Y TM
One
Ste
p M
alar
ia
(p.f.
) Tes
t (w
hole
blo
od)
InTe
c Pr
oduc
ts, I
nc.
6770
6272
6962
7979
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Adva
ntag
e P.
f. M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
7877
7778
7978
7979
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Care
Star
t Mal
aria
HRP
2 (P
f)Ac
cess
Bio
, Inc
.79
7979
7879
7878
79N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Firs
t Res
pons
e M
alar
ia A
g H
RP2
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.79
7979
7979
7979
79N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Firs
tSig
n –
Mal
aria
Pf C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.38
4431
3936
3175
71N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Hex
agon
Mal
aria
Hum
an G
mbH
46
(78)
44
(78)
3447
(7
8)46
(7
8)40
76
(78)
76
(78)
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
ICT
Mal
aria
Pf C
asse
tte
Test
(ML0
1)IC
T Di
agno
stic
s73
7369
7376
7279
77N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AIm
mun
oqui
ck M
alar
ia F
alci
paru
mBi
osyn
ex75
7673
7776
7579
79N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AM
alar
ia P
lasm
odiu
m fa
lcip
arum
Rap
id
test
Dev
ice
(Who
le b
lood
)AC
ON L
abor
ator
ies,
Inc.
7477
7376
7876
7979
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Mal
aria
Rap
id P
fVi
sion
Bio
tech
(Pty
) Ltd
.61
6255
7677
7477
79N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/APa
rach
eck
Pf R
apid
test
for
P. fa
lcip
arum
M
alar
ia (D
evic
e)
Orch
id B
iom
edic
al S
yste
ms
53
(75)
48
(77)
4555
(7
6)54
(7
8)51
72
(74)
78
(78)
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m
Mal
aria
(Dip
stic
k)
Orch
id B
iom
edic
al S
yste
ms
6866
(7
8)62
7067
6578
(7
8)78
(7
8)N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Para
hit-
f DIP
STIC
K FO
R FA
LCIP
ARU
M
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
6972
6772
6967
7979
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Para
hit-
f TES
T DE
VICE
FOR
FAL
CIPA
RUM
M
ALAR
IASp
an D
iagn
ostic
s Lt
d.54
4543
4543
3879
77N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
SD B
IOLI
NE
Mal
aria
Ag
Pf
Stan
dard
Dia
gnos
tics,
Inc.
7979
7978
7877
7978
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Pf &
Pan
/Pf
& P
vAd
vant
age
Mal
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.60
6358
5962
5579
7920
2020
2020
2020
20AZ
OG M
alar
ia p
f (H
RP-I
I) /p
v (p
LDH
) An
tigen
Det
ectio
n Te
st D
evic
eAZ
OG, I
nc.
7070
6470
7369
7979
1110
713
1511
2019
Bina
x N
ow M
alar
ia
Inve
rnes
s M
edic
al In
nova
tions
, In
c.78
7776
7675
7278
(7
8)79
5 2
(19)
26
64
2017
Care
Star
t Mal
aria
HRP
2/pL
DH (P
f/PA
N)
COM
BOAc
cess
Bio
, Inc
.79
7878
7779
7779
7920
1818
2020
2020
19
Firs
t Res
pons
e M
alar
ia A
g Co
mbo
(PLD
H/
HRP
2)Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
7979
7979
7979
7979
1919
1818
1817
1517
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.54
5147
5648
4378
790
00
33
110
19
Hex
agon
Mal
aria
Com
biH
uman
Gm
bH50
5043
5149
4578
(7
8)77
00
00
1 (1
9)0
10
(19)
13
(19)
ICT
Mal
aria
Com
bo C
asse
tte
Test
(ML0
2)IC
T Di
agno
stic
s74
7571
7577
7479
795
73
40
019
19Im
mun
oqui
ck M
alar
ia +
4Bi
osyn
ex77
7777
7677
7678
7912
1412
1210
820
20
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Co
rtez
Dia
gnos
tics,
Inc.
22
(29)
19
(27)
28 (3
9)14
(2
1)17
(2
0)26
(36)
30
(31)
16
(17)
0 (7
)0
(7)
0 (9
)0
(9)
0 (7
)0
(14)
3 (1
0)3
(8)
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
7273
7078
7776
7979
59
38
85
1918
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)6 4
Prod
uct
Man
ufac
ture
r
P. f
alci
paru
m s
ampl
es (
n=79
)P.
viv
ax s
ampl
es (
n=20
)
Tot
al p
osit
ive
resu
lts
retu
rned
Tot
al p
osit
ive
resu
lts
retu
rned
200
para
site
s/μl
2,00
0 or
5,
000
para
site
s/μl
200
para
site
s/μl
2,00
0 or
5,
000
para
site
s/μl
Lot
1 Lo
t 2
Lot
1 Lo
t 2
Lot
1 Lo
t 2
Lot
1 Lo
t 2
Test
1
Test
2N
o. p
osit
ive
agre
emen
ts
(max
=79)
*Te
st 1
Te
st 2
No.
pos
itiv
e ag
reem
ents
(m
ax=7
9)*
Test
1Te
st 1
Test
1
Test
2N
o. p
osit
ive
agre
emen
ts
(max
=20)
*Te
st 1
Te
st 2
No.
pos
itiv
e ag
reem
ents
(m
ax=2
0)*
Test
1
Test
1
Mal
aria
Rap
id D
ual
Visi
on B
iote
ch (P
ty) L
td.
7169
6575
7471
7879
12
110
33
1820
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s64
6156
6363
5878
781
20
11
017
16
One
Step
Mal
aria
Ant
igen
Str
ipIN
D Di
agno
stic
Inc.
109
413
199
5766
23
14
10
1316
OnSi
ght –
Par
aQui
ck (P
an, P
f) Te
stAm
geni
x In
tern
atio
nal,
Inc.
6066
5755
5951
7979
1415
1312
1210
2020
OptiM
AL-I
TDi
aMed
AG
4747
3639
3733
7777
1920
1920
2020
2020
Para
hit-
Tota
l Dev
ice
Rapi
d te
st fo
r P.
falc
ipar
um a
nd P
an m
alar
ial s
peci
es.
Span
Dia
gnos
tics
Ltd.
4247
3748
(7
8)39
3775
780
10
01
013
14
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf
(Dev
ice)
Zeph
yr B
iom
edic
als
5453
4650
5448
7979
1313
109
10
(19)
620
19
Quic
kstic
k M
alar
ia A
ntig
en T
est
Inno
vate
k M
edic
al In
c.10
94
1319
957
662
31
41
013
16SD
BIO
LIN
E M
alar
ia A
gSt
anda
rd D
iagn
ostic
s, In
c.46
4432
3839
3077
7716
1412
1214
1120
20
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
an
Stan
dard
Dia
gnos
tics,
Inc.
74
(76)
7877
76
(77)
78
(78)
7879
7911
(1
9)10
910
99
18
(19)
20
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le
Bloo
d Te
stG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
62
(77)
5954
68
(78)
67
(78)
6478
(7
8)76
(7
7)13
12 (1
9)10
14
(18)
13 /
1210
2018
(1
9)Pa
n on
lyAd
vant
age
Pan
Mal
aria
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.65
6862
7268
6679
7920
2020
2020
2020
20Ca
reSt
art M
alar
ia p
LDH
(PAN
)Ac
cess
Bio
, Inc
.77
7775
7777
7679
7920
2020
2020
2020
20Pa
raba
nk R
apid
Tes
t for
Mal
aria
Pan
(D
evic
e)Ze
phyr
Bio
med
ical
s8
165
1011
473
7211
108
89
720
20
Pf -
Pla
smod
ium
falc
ipar
umPv
- P
lasm
odiu
m v
ivax
† Res
ults
are
bas
ed o
n th
e fir
st re
ader
s in
terp
reta
tion
acco
rdin
g to
man
ufac
ture
rs in
stru
ctio
ns.
* Num
ber o
f sam
ples
that
retu
rned
a p
ositi
ve re
sult
for b
oth
test
s. W
here
one
test
was
inva
lid a
nd th
e ot
her p
ositi
ve, p
ositi
ve a
gree
men
t was
reco
rded
.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)65
Tabl
e A4
.1a:
Lot
var
iabi
lity
in p
osit
ive
resu
lts
agai
nst
P. f
alci
paru
m a
nd P
. viv
ax s
ampl
es a
t lo
w (
200)
and
hig
h (2
000
or 5
000)
par
asit
e de
nsit
ies
(par
asit
es/μ
l) ba
sed
on
dela
yed
read
ings
whe
n sp
ecifi
ed b
y th
e m
anuf
actu
rer
Prod
uct
Man
ufac
ture
r
P. f
alci
paru
m s
ampl
es (
n=79
)P.
viv
ax s
ampl
es (
n=20
)
Tot
al p
osit
ive
resu
lts
retu
rned
Tot
al p
osit
ive
resu
lts
retu
rned
200
para
site
s/μl
2,00
0 or
5,
000
para
site
s/μl
200
para
site
s/μl
2,00
0 or
5,0
00
para
site
s/μl
Lot
1 Lo
t 2
Lot
1 Lo
t 2
Lot
1 Lo
t 2
Lot
1 Lo
t 2
Test
1
Test
2N
o. p
osit
ive
agre
emen
ts
(max
=79)
*Te
st 1
Te
st 2
No.
pos
itiv
e ag
reem
ents
(m
ax=7
9)*
Test
1Te
st
1Te
st 1
Te
st 2
No.
pos
itiv
e ag
reem
ents
(m
ax=2
0)*
Test
1
Test
2N
o. p
osit
ive
agre
emen
ts
(max
=20)
*Te
st 1
Te
st 1
Pf &
Pan
/Pf
& P
vFi
rstS
ign
– Pa
raVi
ew-2
(Pv
+ Pf
) Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
6663
6064
5855
7979
23
10
40
2020
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
7677
7479
7979
78 (7
8)79
1315
1314
1512
2019
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Co
rtez
Dia
gnos
tics,
Inc.
24
(29)
20
(29)
30 (4
0)15
(2
5)17
(1
9)27
(39)
96.7
7 (3
1)88
.24
(17)
0 (8
)0
(8)
0 (1
0)0
(9)
0 (5
)0
(12)
6 (1
0)2
(5)
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s64
6458
6568
6178
791
10
42
117
18
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf
(Dev
ice)
Zeph
yr B
iom
edic
als
6464
5965
6559
7879
1615
1317
14 (1
9)12
2020
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le
Bloo
d Te
stG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
64
(77)
6359
68
(78)
65
(78)
6178
(78)
76
(77)
1213
(19)
11 1
2 (1
8)12
918
19
(19)
Pan
only
Para
bank
Rap
id T
est f
or M
alar
ia P
an
(Dev
ice)
Zeph
yr B
iom
edic
als
2419
1527
2720
7777
1716
1618
1818
2020
Pf -
Pla
smod
ium
falc
ipar
umPv
- P
lasm
odiu
m v
ivax
* Num
ber o
f sam
ples
that
retu
rned
a p
ositi
ve re
sult
for b
oth
test
s. W
here
one
test
was
inva
lid a
nd th
e ot
her p
ositi
ve, p
ositi
ve a
gree
men
t was
reco
rded
.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)6 6
Tabl
e A4
.2: R
eade
r va
riabi
lity
in d
etec
tion
rat
e‡ of
P. f
alci
paru
m s
ampl
es (
n=79
) ba
sed
on in
itia
l rea
ding
acc
ordi
ng t
o m
anuf
actu
rers
inst
ruct
ions
and
sec
ond
read
ing
wit
hin
1 ho
ur
Prod
uct
Man
ufac
ture
r
Dete
ctio
n ra
te o
f P.
fal
cipa
rum
sam
ples
200
para
site
s/μl
2,00
0 or
5,0
00 p
aras
ites
/μl
Read
er 1
(n
=316
)Re
ader
2
(n=3
16)
No.
inva
lid
test
s Re
ader
1
No.
inva
lid
test
s Re
ader
2
Mea
n ti
me
betw
een
read
ings
(h
:m:s
)
Read
er 1
(n
=158
) Re
ader
2
(n=1
58)
No.
inva
lid
test
s Re
ader
1
No.
inva
lid
test
s Re
ader
2
Mea
n ti
me
betw
een
read
ings
(h
:m:s
)
Pf o
nly
ADVA
NCE
D QU
ALIT
Y TM
MAL
ARIA
(p.f)
POC
T In
Tec
Prod
ucts
, Inc
.76
.985
.13
00
0:24
:40
100
100
00
0:22
:10
ADVA
NCE
D QU
ALIT
Y TM
One
Ste
p M
alar
ia (p
.f.) T
est (
who
le b
lood
)In
Tec
Prod
ucts
, Inc
.87
.97
89.8
70
00:
16:2
310
099
.37
00
0:16
:24
Adva
ntag
e P.
f. M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
98.7
399
.37
00
0:13
:47
100
100
00
0:14
:58
Care
Star
t Mal
aria
HRP
2 (P
f)Ac
cess
Bio
, Inc
.99
.68
99.0
50
00:
18:1
499
.37
100
00
0:18
:55
Firs
t Res
pons
e M
alar
ia A
g H
RP2
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.10
010
00
00:
13:5
810
010
00
00:
13:0
8Fi
rstS
ign
– M
alar
ia P
f Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
49.6
862
.66
00
0:19
:56
92.4
199
.37
00
0:19
:46
Hex
agon
Mal
aria
Hum
an G
mbH
58.8
4 (3
11)
67.2
(311
)5
50:
27:0
897
.44
(156
)97
.44
(156
)2
20:
28:2
2IC
T M
alar
ia P
f Cas
sett
e Te
st (M
L01)
ICT
Diag
nost
ics
93.3
596
.84
00
0:17
:42
98.7
310
00
00:
17:2
1Im
mun
oqui
ck M
alar
ia F
alci
paru
mBi
osyn
ex96
.298
.10
00:
17:3
610
010
00
00:
17:3
8M
alar
ia P
lasm
odiu
m fa
lcip
arum
Rap
id te
st D
evic
e (W
hole
blo
od)
ACON
Lab
orat
orie
s, In
c.96
.52
97.7
80
00:
21:4
010
010
00
00:
21:3
6M
alar
ia R
apid
Pf
Visi
on B
iote
ch (P
ty) L
td.
87.3
492
.09
00
0:19
:04
98.7
399
.37
00
0:18
:12
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
evic
e)
Orch
id B
iom
edic
al S
yste
ms
68.6
3 (3
06)
89.7
4 (3
12)
104
0:18
:05
98.6
8 (1
52)
99.3
6 (1
56)
62
0:17
:33
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
ipst
ick)
Or
chid
Bio
med
ical
Sys
tem
s86
.03
(315
)90
.48
(315
)1
10:
15:4
310
0 (1
56)
100
(157
)2
10:
16:0
2Pa
rahi
t-f D
IPST
ICK
FOR
FALC
IPAR
UM
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
89.2
490
.82
00
0:17
:46
100
100
00
0:16
:15
Para
hit-
f TES
T DE
VICE
FOR
FAL
CIPA
RUM
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
59.1
862
.66
00
0:17
:16
98.7
310
00
00:
25:4
4SD
BIO
LIN
E M
alar
ia A
g Pf
St
anda
rd D
iagn
ostic
s, In
c.99
.37
99.6
80
00:
15:1
399
.37
100
00
0:14
:46
Pf &
Pan
/Pf
& P
vAd
vant
age
Mal
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.77
.22
82.2
80
00:
13:2
210
099
.37
00
0:13
:36
AZOG
Mal
aria
pf (
HRP
-II)
/pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
AZOG
, Inc
.89
.56
94.9
40
00:
15:2
910
010
00
00:
15:3
2Bi
nax
Now
Mal
aria
In
vern
ess
Med
ical
Inno
vatio
ns, I
nc.
96.8
494
.62
00
0:17
:32
100
(157
)10
0 (1
57)
11
0:17
:19
Care
Star
t Mal
aria
HRP
2/pL
DH (P
f/PA
N) C
OMBO
Acce
ss B
io, I
nc.
99.0
597
.47
00
0:16
:01
100
98.7
30
00:
15:1
6Fi
rst R
espo
nse
Mal
aria
Ag
Com
bo (P
LDH
/HRP
2)Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
100
99.6
80
00:
17:4
510
099
.37
00
0:17
:49
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.66
.14
79.4
30
00:
24:3
699
.37
100
00
0:21
:49
Hex
agon
Mal
aria
Com
biH
uman
Gm
bH63
.29
67.7
20
00:
20:3
998
.73
(157
)98
.73
10
0:19
:36
ICT
Mal
aria
Com
bo C
asse
tte
Test
(ML0
2)IC
T Di
agno
stic
s95
.25
98.7
30
00:
16:3
110
010
00
00:
17:3
2Im
mun
oqui
ck M
alar
ia +
4Bi
osyn
ex97
.15
98.4
20
00:
20:3
999
.37
100
(157
)0
10:
21:2
3M
alar
ia P
.F/V
ivax
Diag
nost
ic A
utom
atio
n / C
orte
z Di
agno
stic
s, In
c.74
.23
(97)
74.5
1 (1
02)
219
214
0:16
:43
95.8
3 (4
8)93
.75
(48)
110
110
0:17
:14
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
94.9
493
.99
00
0:15
:49
100
99.3
70
00:
15:3
8M
alar
ia R
apid
Dua
l Vi
sion
Bio
tech
(Pty
) Ltd
.91
.46
97.1
50
00:
13:0
899
.37
98.7
30
00:
13:2
3M
alas
can
Rapi
d Te
st fo
r Mal
aria
Pf/
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
79.4
382
.59
00
0:18
:13
98.7
399
.37
00
0:17
:50
One
Step
Mal
aria
Ant
igen
Str
ipIN
D Di
agno
stic
Inc.
16.1
422
.47
00
0:17
:32
77.8
579
.75
00
0:17
:19
OnSi
ght –
Par
aQui
ck (P
an, P
f) Te
stAm
geni
x In
tern
atio
nal,
Inc.
75.9
588
.61
00
0:19
:59
100
100
00
0:19
:17
OptiM
AL-I
TDi
aMed
AG
53.8
46.8
40
00:
18:5
297
.47
97.4
70
00:
19:4
0Pa
rahi
t-To
tal D
evic
e Ra
pid
test
for P
. fal
cipa
rum
and
Pan
mal
aria
l sp
ecie
s.Sp
an D
iagn
ostic
s Lt
d.55
.87
(315
)55
.06
10
0:16
:44
96.8
497
.47
00
0:29
:58
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
66.7
781
.65
00
0:16
:05
100
99.3
70
00:
16:1
4Qu
icks
tick
Mal
aria
Ant
igen
Tes
tIn
nova
tek
Med
ical
Inc.
16.1
422
.47
00
0:17
:32
77.8
579
.75
00
0:17
:19
SD B
IOLI
NE
Mal
aria
Ag
Stan
dard
Dia
gnos
tics,
Inc.
52.8
561
.71
00
0:18
:14
97.4
798
.10
00:
17:3
6SD
BIO
LIN
E M
alar
ia A
g Pf
/Pan
St
anda
rd D
iagn
ostic
s, In
c.98
.71
(310
)98
.71
(311
)6
50:
16:4
210
010
00
00:
16:1
6W
ondf
o On
e St
ep M
alar
ia P
f/Pa
n W
hole
Blo
od T
est
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
., Lt
d82
.05
(312
)83
.33
(312
)4
40:
15:0
299
.35
(155
)99
.35
(155
)3
30:
19:5
1Pa
n on
lyAd
vant
age
Pan
Mal
aria
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.86
.39
93.3
50
00:
13:2
510
010
00
00:
14:0
1Ca
reSt
art M
alar
ia p
LDH
(PAN
)Ac
cess
Bio
, Inc
.97
.47
95.8
90
00:
15:2
410
010
00
00:
15:3
5Pa
raba
nk R
apid
Tes
t for
Mal
aria
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
14.2
430
.70
00:
15:5
291
.77
97.4
70
00:
15:2
9Pf
- P
lasm
odiu
m fa
lcip
arum
Pv
- P
lasm
odiu
m v
ivax
pan
- Pl
asm
odiu
m s
peci
es
‡ - A
sam
ple
is c
onsi
dere
d de
tect
ed o
nly
if al
l RDT
s fr
om b
oth
lots
read
by
the
first
tech
nici
an, a
t min
imum
spe
cifie
d re
adin
g tim
e, a
re p
ositi
ve
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)67
Tabl
e A4
.3: R
eade
r va
riabi
lity
in d
etec
tion
rat
e‡ fo
r P.
viv
ax s
ampl
es (
n=20
) ba
sed
on in
itia
l rea
ding
acc
ordi
ng t
o m
anuf
actu
rers
inst
ruct
ions
and
sec
ond
read
ing
wit
hin
1 ho
ur
Prod
uct
Man
ufac
ture
r
Dete
ctio
n ra
te f
or P
. viv
ax s
ampl
es
200
para
site
s/μl
2,00
0 or
5,0
00 p
aras
ites
/μl
Read
er 1
(n
=80)
Read
er 2
(n
=80)
No.
inva
lid
test
s Re
ader
1
No.
inva
lid
test
s Re
ader
2
Mea
n ti
me
betw
een
read
ings
(h
:m:s
)
Read
er 1
(n
=40)
Read
er 2
(n
=40)
No.
inva
lid
test
s Re
ader
1
No.
inva
lid
test
s Re
ader
2
Mea
n ti
me
betw
een
read
ings
(h
:m:s
)
Pf &
Pan
/Pf
& P
vAd
vant
age
Mal
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.10
098
.75
00
0:12
:38
100
950
00:
11:0
6AZ
OG M
alar
ia p
f (H
RP-I
I) /p
v (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
eAZ
OG, I
nc.
61.2
567
.50
00:
11:3
097
.592
.50
00:
12:0
9
Bina
x N
ow M
alar
ia
Inve
rnes
s M
edic
al In
nova
tions
, Inc
.24
.05
(79)
51
00:
13:3
592
.595
00
0:12
:37
Care
Star
t Mal
aria
HRP
2/pL
DH (P
f/PA
N) C
OMBO
Acce
ss B
io, I
nc.
97.5
950
00:
12:3
297
.597
.50
00:
11:3
5Fi
rst R
espo
nse
Mal
aria
Ag
Com
bo (P
LDH
/HRP
2)Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
92.5
93.7
50
00:
14:5
480
82.5
00
0:13
:48
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.7.
511
.25
00
0:15
:46
9010
00
00:
15:2
7H
exag
on M
alar
ia C
ombi
Hum
an G
mbH
1.27
(79)
1.27
(79)
11
0:20
:46
60.5
3 (3
8)57
.89
(38)
22
0:22
:15
ICT
Mal
aria
Com
bo C
asse
tte
Test
(ML0
2)IC
T Di
agno
stic
s20
43.7
50
00:
14:2
595
92.5
00
0:16
:56
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
6071
.25
00
0:15
:22
100
97.5
00
0:15
:54
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nost
ics,
Inc.
0 (3
0)0
(30)
5050
0:19
:26
33.3
3 (1
8)53
.33
(15)
2225
0:18
:14
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
37.5
350
00:
13:4
692
.595
00
0:15
:16
Mal
aria
Rap
id D
ual
Visi
on B
iote
ch (P
ty) L
td.
2038
.75
00
0:14
:07
9597
.50
00:
13:2
3M
alas
can
Rapi
d Te
st fo
r Mal
aria
Pf/
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
6.25
100
00:
17:0
282
.587
.50
00:
16:0
2On
e St
ep M
alar
ia A
ntig
en S
trip
IND
Diag
nost
ic In
c.12
.510
00
0:11
:07
72.5
650
00:
10:1
8On
Sigh
t – P
araQ
uick
(Pan
, Pf)
Test
Amge
nix
Inte
rnat
iona
l, In
c.66
.25
91.2
50
00:
16:5
110
010
00
00:
16:5
1Op
tiMAL
-IT
DiaM
ed A
G98
.75
88.7
50
00:
21:3
810
095
00
0:17
:36
Para
hit-
Tota
l Dev
ice
Rapi
d te
st fo
r P. f
alci
paru
m a
nd P
an
mal
aria
l spe
cies
.Sp
an D
iagn
ostic
s Lt
d.2.
52.
50
00:
16:1
467
.555
00
0:17
:09
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
56.9
6 (7
9)78
.48
(79)
11
0:16
:47
97.5
100
00
0:17
:00
Quic
kstic
k M
alar
ia A
ntig
en T
est
Inno
vate
k M
edic
al In
c.12
.510
00
0:11
:07
72.5
650
00:
10:1
8SD
BIO
LIN
E M
alar
ia A
gSt
anda
rd D
iagn
ostic
s, In
c.70
83.7
50
00:
16:0
810
097
.50
00:
17:0
3SD
BIO
LIN
E M
alar
ia A
g Pf
/Pan
St
anda
rd D
iagn
ostic
s, In
c.50
.63
(79)
69.6
2 (7
9)1
10:
15:4
997
.44
(39)
97.4
4 (3
9)1
10:
16:3
3
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
66.2
3 (7
7)62
.34
(77)
33
0:14
:36
97.4
4 (3
9)94
.87
(39)
11
0:17
:57
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
100
100
00
0:12
:53
100
100
00
0:11
:18
Care
Star
t Mal
aria
pLD
H (P
AN)
Acce
ss B
io, I
nc.
100
100
00
0:12
:04
100
97.5
00
0:11
:42
Para
bank
Rap
id T
est f
or M
alar
ia P
an (D
evic
e)Ze
phyr
Bio
med
ical
s47
.586
.25
00
0:16
:23
100
100
00
0:16
:59
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spe
cies
‡ -
A s
ampl
e is
con
side
red
dete
cted
onl
y if
all R
DTs
from
bot
h lo
ts re
ad b
y th
e fir
st te
chni
cian
, at m
inim
um s
peci
fied
read
ing
time,
are
pos
itive
Tabl
e A4
.2: R
eade
r va
riabi
lity
in d
etec
tion
rat
e‡ of
P. f
alci
paru
m s
ampl
es (
n=79
) ba
sed
on in
itia
l rea
ding
acc
ordi
ng t
o m
anuf
actu
rers
inst
ruct
ions
and
sec
ond
read
ing
wit
hin
1 ho
ur
Prod
uct
Man
ufac
ture
r
Dete
ctio
n ra
te o
f P.
fal
cipa
rum
sam
ples
200
para
site
s/μl
2,00
0 or
5,0
00 p
aras
ites
/μl
Read
er 1
(n
=316
)Re
ader
2
(n=3
16)
No.
inva
lid
test
s Re
ader
1
No.
inva
lid
test
s Re
ader
2
Mea
n ti
me
betw
een
read
ings
(h
:m:s
)
Read
er 1
(n
=158
) Re
ader
2
(n=1
58)
No.
inva
lid
test
s Re
ader
1
No.
inva
lid
test
s Re
ader
2
Mea
n ti
me
betw
een
read
ings
(h
:m:s
)
Pf o
nly
ADVA
NCE
D QU
ALIT
Y TM
MAL
ARIA
(p.f)
POC
T In
Tec
Prod
ucts
, Inc
.76
.985
.13
00
0:24
:40
100
100
00
0:22
:10
ADVA
NCE
D QU
ALIT
Y TM
One
Ste
p M
alar
ia (p
.f.) T
est (
who
le b
lood
)In
Tec
Prod
ucts
, Inc
.87
.97
89.8
70
00:
16:2
310
099
.37
00
0:16
:24
Adva
ntag
e P.
f. M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
98.7
399
.37
00
0:13
:47
100
100
00
0:14
:58
Care
Star
t Mal
aria
HRP
2 (P
f)Ac
cess
Bio
, Inc
.99
.68
99.0
50
00:
18:1
499
.37
100
00
0:18
:55
Firs
t Res
pons
e M
alar
ia A
g H
RP2
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.10
010
00
00:
13:5
810
010
00
00:
13:0
8Fi
rstS
ign
– M
alar
ia P
f Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
49.6
862
.66
00
0:19
:56
92.4
199
.37
00
0:19
:46
Hex
agon
Mal
aria
Hum
an G
mbH
58.8
4 (3
11)
67.2
(311
)5
50:
27:0
897
.44
(156
)97
.44
(156
)2
20:
28:2
2IC
T M
alar
ia P
f Cas
sett
e Te
st (M
L01)
ICT
Diag
nost
ics
93.3
596
.84
00
0:17
:42
98.7
310
00
00:
17:2
1Im
mun
oqui
ck M
alar
ia F
alci
paru
mBi
osyn
ex96
.298
.10
00:
17:3
610
010
00
00:
17:3
8M
alar
ia P
lasm
odiu
m fa
lcip
arum
Rap
id te
st D
evic
e (W
hole
blo
od)
ACON
Lab
orat
orie
s, In
c.96
.52
97.7
80
00:
21:4
010
010
00
00:
21:3
6M
alar
ia R
apid
Pf
Visi
on B
iote
ch (P
ty) L
td.
87.3
492
.09
00
0:19
:04
98.7
399
.37
00
0:18
:12
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
evic
e)
Orch
id B
iom
edic
al S
yste
ms
68.6
3 (3
06)
89.7
4 (3
12)
104
0:18
:05
98.6
8 (1
52)
99.3
6 (1
56)
62
0:17
:33
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
ipst
ick)
Or
chid
Bio
med
ical
Sys
tem
s86
.03
(315
)90
.48
(315
)1
10:
15:4
310
0 (1
56)
100
(157
)2
10:
16:0
2Pa
rahi
t-f D
IPST
ICK
FOR
FALC
IPAR
UM
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
89.2
490
.82
00
0:17
:46
100
100
00
0:16
:15
Para
hit-
f TES
T DE
VICE
FOR
FAL
CIPA
RUM
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
59.1
862
.66
00
0:17
:16
98.7
310
00
00:
25:4
4SD
BIO
LIN
E M
alar
ia A
g Pf
St
anda
rd D
iagn
ostic
s, In
c.99
.37
99.6
80
00:
15:1
399
.37
100
00
0:14
:46
Pf &
Pan
/Pf
& P
vAd
vant
age
Mal
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.77
.22
82.2
80
00:
13:2
210
099
.37
00
0:13
:36
AZOG
Mal
aria
pf (
HRP
-II)
/pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
AZOG
, Inc
.89
.56
94.9
40
00:
15:2
910
010
00
00:
15:3
2Bi
nax
Now
Mal
aria
In
vern
ess
Med
ical
Inno
vatio
ns, I
nc.
96.8
494
.62
00
0:17
:32
100
(157
)10
0 (1
57)
11
0:17
:19
Care
Star
t Mal
aria
HRP
2/pL
DH (P
f/PA
N) C
OMBO
Acce
ss B
io, I
nc.
99.0
597
.47
00
0:16
:01
100
98.7
30
00:
15:1
6Fi
rst R
espo
nse
Mal
aria
Ag
Com
bo (P
LDH
/HRP
2)Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
100
99.6
80
00:
17:4
510
099
.37
00
0:17
:49
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.66
.14
79.4
30
00:
24:3
699
.37
100
00
0:21
:49
Hex
agon
Mal
aria
Com
biH
uman
Gm
bH63
.29
67.7
20
00:
20:3
998
.73
(157
)98
.73
10
0:19
:36
ICT
Mal
aria
Com
bo C
asse
tte
Test
(ML0
2)IC
T Di
agno
stic
s95
.25
98.7
30
00:
16:3
110
010
00
00:
17:3
2Im
mun
oqui
ck M
alar
ia +
4Bi
osyn
ex97
.15
98.4
20
00:
20:3
999
.37
100
(157
)0
10:
21:2
3M
alar
ia P
.F/V
ivax
Diag
nost
ic A
utom
atio
n / C
orte
z Di
agno
stic
s, In
c.74
.23
(97)
74.5
1 (1
02)
219
214
0:16
:43
95.8
3 (4
8)93
.75
(48)
110
110
0:17
:14
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
94.9
493
.99
00
0:15
:49
100
99.3
70
00:
15:3
8M
alar
ia R
apid
Dua
l Vi
sion
Bio
tech
(Pty
) Ltd
.91
.46
97.1
50
00:
13:0
899
.37
98.7
30
00:
13:2
3M
alas
can
Rapi
d Te
st fo
r Mal
aria
Pf/
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
79.4
382
.59
00
0:18
:13
98.7
399
.37
00
0:17
:50
One
Step
Mal
aria
Ant
igen
Str
ipIN
D Di
agno
stic
Inc.
16.1
422
.47
00
0:17
:32
77.8
579
.75
00
0:17
:19
OnSi
ght –
Par
aQui
ck (P
an, P
f) Te
stAm
geni
x In
tern
atio
nal,
Inc.
75.9
588
.61
00
0:19
:59
100
100
00
0:19
:17
OptiM
AL-I
TDi
aMed
AG
53.8
46.8
40
00:
18:5
297
.47
97.4
70
00:
19:4
0Pa
rahi
t-To
tal D
evic
e Ra
pid
test
for P
. fal
cipa
rum
and
Pan
mal
aria
l sp
ecie
s.Sp
an D
iagn
ostic
s Lt
d.55
.87
(315
)55
.06
10
0:16
:44
96.8
497
.47
00
0:29
:58
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
66.7
781
.65
00
0:16
:05
100
99.3
70
00:
16:1
4Qu
icks
tick
Mal
aria
Ant
igen
Tes
tIn
nova
tek
Med
ical
Inc.
16.1
422
.47
00
0:17
:32
77.8
579
.75
00
0:17
:19
SD B
IOLI
NE
Mal
aria
Ag
Stan
dard
Dia
gnos
tics,
Inc.
52.8
561
.71
00
0:18
:14
97.4
798
.10
00:
17:3
6SD
BIO
LIN
E M
alar
ia A
g Pf
/Pan
St
anda
rd D
iagn
ostic
s, In
c.98
.71
(310
)98
.71
(311
)6
50:
16:4
210
010
00
00:
16:1
6W
ondf
o On
e St
ep M
alar
ia P
f/Pa
n W
hole
Blo
od T
est
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
., Lt
d82
.05
(312
)83
.33
(312
)4
40:
15:0
299
.35
(155
)99
.35
(155
)3
30:
19:5
1Pa
n on
lyAd
vant
age
Pan
Mal
aria
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.86
.39
93.3
50
00:
13:2
510
010
00
00:
14:0
1Ca
reSt
art M
alar
ia p
LDH
(PAN
)Ac
cess
Bio
, Inc
.97
.47
95.8
90
00:
15:2
410
010
00
00:
15:3
5Pa
raba
nk R
apid
Tes
t for
Mal
aria
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
14.2
430
.70
00:
15:5
291
.77
97.4
70
00:
15:2
9Pf
- P
lasm
odiu
m fa
lcip
arum
Pv
- P
lasm
odiu
m v
ivax
pan
- Pl
asm
odiu
m s
peci
es
‡ - A
sam
ple
is c
onsi
dere
d de
tect
ed o
nly
if al
l RDT
s fr
om b
oth
lots
read
by
the
first
tech
nici
an, a
t min
imum
spe
cifie
d re
adin
g tim
e, a
re p
ositi
ve
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)6 8
Tabl
e A4
.4: D
istr
ibut
ion
of t
est
band
int
ensi
ty (
0-4)
sco
res
agai
nst
wild
typ
e P.
fal
cipa
rum
sam
ples
(n=
79)
at l
ow (
200)
and
hig
h (2
000
or 5
000)
par
asit
e de
nsit
ies
(par
asit
es/μ
l)
Prod
uct
Man
ufac
ture
r
200
par
asit
es/μ
l 2
,000
or
5,00
0 pa
rasi
tes/
μl 2
00 p
aras
ites
/μl
2,00
0 or
5,0
00 p
aras
ites
/μl
Perc
enta
ge d
istr
ibut
ion
of P
f te
st b
and
inte
nsit
y† (n
=316
)Pe
rcen
tage
dis
trib
utio
n of
Pf
test
ban
d in
tens
ity†
(n=1
58)
Perc
enta
ge d
istr
ibut
ion
of P
an t
est
band
in
tens
ity
(n=3
16)
Perc
enta
ge d
istr
ibut
ion
of P
an t
est
band
in
tens
ity
(n=1
58)
0*1
23
40*
12
34
No
band
12
34
No
band
12
34
Pf o
nly
ADVA
NCE
D QU
ALIT
Y TM
MAL
ARIA
(p
.f) P
OCT
InTe
c Pr
oduc
ts. I
nc.
23.1
32.9
134
.49
7.59
1.9
01.
2729
.1129
.1140
.51
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
ADVA
NCE
D QU
ALIT
Y TM
One
Ste
p M
alar
ia (p
.f.) T
est (
who
le b
lood
)In
Tec
Prod
ucts
. Inc
.12
.03
36.0
834
.18
14.5
63.
160
2.53
22.7
824
.05
50.6
3N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Adva
ntag
e P.
f. M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
1.27
12.0
342
.09
30.3
814
.24
00
1.9
22.1
575
.95
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Care
Star
t Mal
aria
HRP
2 (P
f)Ac
cess
Bio
. Inc
.0.
326.
0130
.729
.1133
.86
0.63
03.
1612
.66
83.5
4N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Firs
t Res
pons
e M
alar
ia A
g H
RP2
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.0
6.33
32.9
127
.53
33.2
30
0.63
1.27
10.1
387
.97
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Firs
tSig
n –
Mal
aria
Pf C
ard
Test
Uni
med
Inte
rnat
iona
l. In
c.50
.32
25.9
516
.14
6.01
1.58
7.59
10.1
327
.22
31.6
523
.42
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Hex
agon
Mal
aria
Hum
an G
mbH
42.0
929
.1123
.14.
111.
583.
86.
9632
.28
37.3
419
.62
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
ICT
Mal
aria
Pf C
asse
tte
Test
(ML0
1)IC
T Di
agno
stic
s6.
6527
.53
34.8
124
.37
6.65
1.27
013
.29
29.11
56.3
3N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AIm
mun
oqui
ck M
alar
ia F
alci
paru
mBi
osyn
ex3.
818
.04
33.8
634
.49
9.81
00
11.3
925
.32
63.2
9N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AM
alar
ia P
lasm
odiu
m fa
lcip
arum
Rap
id
test
Dev
ice
(Who
le b
lood
)AC
ON L
abor
ator
ies.
Inc.
3.48
19.3
37.6
632
.91
6.65
00.
636.
9632
.91
59.4
9N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Mal
aria
Rap
id P
fVi
sion
Bio
tech
(Pty
) Ltd
.12
.66
22.1
539
.56
20.8
94.
751.
271.
917
.09
29.11
50.6
3N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/APa
rach
eck
Pf R
apid
test
for P
. fal
cipa
-ru
m M
alar
ia (D
evic
e)
Orch
id B
iom
edic
al S
yste
ms
33.2
315
.51
22.4
720
.89
7.91
3.16
4.43
10.1
325
.95
56.3
3N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Para
chec
k Pf
Rap
id te
st fo
r P.
falc
ipar
um M
alar
ia (D
ipst
ick)
Or
chid
Bio
med
ical
Sys
tem
s14
.24
24.0
543
.67
12.9
75.
061.
270.
6315
.82
53.8
28.4
8N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Para
hit-
f DIP
STIC
K FO
R FA
LCIP
ARU
M
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
10.7
622
.47
37.9
720
.57
8.23
00
6.33
26.5
867
.09
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Para
hit-
f TES
T DE
VICE
FOR
FAL
CIPA
-RU
M M
ALAR
IASp
an D
iagn
ostic
s Lt
d.40
.82
21.8
431
.01
5.38
0.95
1.27
4.43
34.8
129
.1130
.38
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
SD B
IOLI
NE
Mal
aria
Ag
Pf
Stan
dard
Dia
gnos
tics.
Inc.
0.63
2.53
36.7
137
.34
22.7
80.
630
012
.66
86.7
1N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/APf
& P
an/P
f &
Pv
Adva
ntag
e M
al C
ard
J. M
itra
& C
o. P
vt. L
td.
22.7
851
.58
22.4
72.
850.
320
1.9
24.0
556
.96
17.0
931
.01
52.8
514
.56
1.58
00
4.43
53.1
631
.65
10.7
6AZ
OG M
alar
ia p
f (H
RP-I
I) /p
v (p
LDH
) An
tigen
Det
ectio
n Te
st D
evic
eAZ
OG. I
nc.
10.4
420
.57
36.3
922
.78
9.81
00.
634.
4331
.65
63.2
957
.91
37.0
35.
060
03.
832
.91
46.8
412
.03
4.43
Bina
x N
ow M
alar
ia
Inve
rnes
s M
edic
al In
nova
-tio
ns. I
nc.
3.16
17.0
945
.89
25.6
38.
230
08.
2327
.22
64.5
673
.42
18.0
48.
230.
320
6.33
15.8
258
.86
17.7
21.
27
Care
Star
t Mal
aria
HRP
2/pL
DH (P
f/PA
N) C
OMBO
Acce
ss B
io. I
nc.
0.95
7.59
30.7
37.9
722
.78
00
2.53
15.1
982
.28
0.95
30.0
657
.28
10.1
31.
580
0.63
7.59
41.1
450
.63
Firs
t Res
pons
e M
alar
ia A
g Co
mbo
(P
LDH
/HRP
2)Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
04.
4320
.25
29.11
46.2
00
0.63
8.23
91.1
45.
736
.08
44.6
212
.03
1.58
01.
2715
.82
32.2
850
.63
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l. In
c.33
.86
17.4
125
.63
14.2
48.
860.
632.
5312
.66
24.6
859
.49
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Hex
agon
Mal
aria
Com
biH
uman
Gm
bH36
.71
28.1
624
.05
9.81
1.27
1.9
4.43
27.8
536
.71
29.11
99.6
80.
320
00
80.3
817
.72
1.9
00
ICT
Mal
aria
Com
bo C
asse
tte
Test
(M
L02)
ICT
Diag
nost
ics
4.75
14.5
635
.76
25.6
319
.30
02.
5316
.46
81.0
174
.68
21.5
23.
480.
320
8.23
30.3
839
.87
18.9
92.
53
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
2.85
7.28
28.8
35.4
425
.63
0.63
00
13.2
986
.08
74.5
221
.34
3.5
0.64
04.
4614
.65
42.0
437
.58
1.27
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Co
rtez
Dia
gnos
tics.
Inc.
56.9
610
.76
14.5
612
.97
4.75
31.6
57.
5914
.56
18.3
527
.85
98.1
1.58
0.32
00
88.6
14.
435.
71.
270
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
5.06
22.7
841
.46
20.2
510
.44
00.
638.
2322
.15
68.9
961
.71
29.11
8.86
0.32
03.
827
.85
44.3
20.2
53.
8M
alar
ia R
apid
Dua
l Vi
sion
Bio
tech
(Pty
) Ltd
.8.
5423
.42
44.9
415
.51
7.59
0.63
2.53
11.3
923
.42
62.0
371
.84
26.5
81.
580
019
.62
27.8
543
.67
7.59
1.27
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s20
.57
28.1
639
.56
10.7
60.
951.
271.
919
.62
43.0
434
.18
91.7
76.
961.
270
018
.99
32.2
831
.01
16.4
61.
27
One
Step
Mal
aria
Ant
igen
Str
ipIN
D Di
agno
stic
Inc.
83.8
615
.19
0.63
0.32
022
.15
27.2
234
.81
15.8
20
83.2
315
.82
0.95
00
23.4
230
.38
34.1
812
.03
0On
Sigh
t – P
araQ
uick
(Pan
. Pf)
Test
Amge
nix
Inte
rnat
iona
l. In
c.24
.05
13.6
125
.32
21.8
415
.19
00.
633.
822
.78
72.7
877
.53
14.2
46.
961.
270
8.86
6.33
32.2
826
.58
25.9
5
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)69
Prod
uct
Man
ufac
ture
r
200
par
asit
es/μ
l 2
,000
or
5,00
0 pa
rasi
tes/
μl 2
00 p
aras
ites
/μl
2,00
0 or
5,0
00 p
aras
ites
/μl
Perc
enta
ge d
istr
ibut
ion
of P
f te
st b
and
inte
nsit
y† (n
=316
)Pe
rcen
tage
dis
trib
utio
n of
Pf
test
ban
d in
tens
ity†
(n=1
58)
Perc
enta
ge d
istr
ibut
ion
of P
an t
est
band
in
tens
ity
(n=3
16)
Perc
enta
ge d
istr
ibut
ion
of P
an t
est
band
in
tens
ity
(n=1
58)
0*1
23
40*
12
34
No
band
12
34
No
band
12
34
OptiM
AL-I
TDi
aMed
AG
46.2
41.7
711
.08
0.95
02.
5310
.13
39.2
432
.91
15.1
949
.05
40.1
99.
810.
950
2.53
13.2
940
.51
31.6
512
.03
Para
hit-
Tota
l Dev
ice
Rapi
d te
st fo
r P.
falc
ipar
um a
nd P
an m
alar
ial s
peci
es.
Span
Dia
gnos
tics
Ltd.
44.3
20.5
725
.63
7.59
1.9
3.16
6.33
28.4
827
.22
34.8
199
.68
0.32
00
072
.78
17.7
29.
490
0
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf
(Dev
ice)
Zeph
yr B
iom
edic
als
33.2
314
.56
26.9
16.1
49.
180
0.63
15.8
220
.89
62.6
686
.08
7.59
5.7
0.63
010
.13
13.2
942
.41
21.5
212
.66
Quic
kstic
k M
alar
ia A
ntig
en T
est
Inno
vate
k M
edic
al In
c.83
.86
15.1
90.
630.
320
22.1
527
.22
34.8
115
.82
083
.23
15.8
20.
950
023
.42
30.3
834
.18
12.0
30
SD B
IOLI
NE
Mal
aria
Ag
Stan
dard
Dia
gnos
tics,
Inc.
47.1
540
.82
11.7
10.
320
2.53
3.8
57.5
931
.65
4.43
96.2
3.8
00
026
.58
44.3
29.11
00
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
an
Stan
dard
Dia
gnos
tics,
Inc.
3.16
14.2
438
.92
26.2
717
.41
00
3.8
14.5
681
.65
91.1
47.
910.
950
012
.03
37.3
446
.84
3.8
0W
ondf
o On
e St
ep M
alar
ia P
f/Pa
n W
hole
Blo
od T
est
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
., Lt
d18
.99
37.3
429
.1110
.13
4.43
2.53
3.8
18.9
935
.44
39.2
434
.81
45.5
714
.56
4.75
0.32
3.16
6.33
36.0
834
.18
20.2
5
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
13.6
147
.15
34.4
94.
750
00
17.7
256
.33
25.9
513
.61
47.1
534
.49
4.75
00
017
.72
56.3
325
.95
Care
Star
t Mal
aria
pLD
H (P
AN)
Acce
ss B
io, I
nc.
2.53
34.8
155
.76.
010.
950
0.63
12.0
341
.77
45.5
72.
5334
.81
55.7
6.01
0.95
00.
6312
.03
41.7
745
.57
Para
bank
Rap
id T
est f
or M
alar
ia P
an
(Dev
ice)
Zeph
yr B
iom
edic
als
85.7
611
.39
1.58
0.95
0.32
8.23
15.1
928
.48
32.2
815
.82
85.7
611
.39
1.58
0.95
0.32
8.23
15.1
928
.48
32.2
815
.82
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spe
cies
Tabl
e A4
.4a:
Dis
trib
utio
n of
tes
t ba
nd i
nten
sity
(0-
4) s
core
s ag
ains
t w
ild t
ype
P. f
alci
paru
m s
ampl
es (
n=79
) at
low
(20
0) a
nd h
igh
(200
0 or
500
0) p
aras
ite
dens
itie
s (p
aras
ites
/μl)
base
d on
a d
elay
ed r
eadi
ng w
hen
spec
ified
by
the
man
ufac
ture
r
Prod
uct
Man
ufac
ture
r
200
par
asit
es/μ
l 2
,000
or
5,00
0 pa
rasi
tes/
μl 2
00 p
aras
ites
/μl
2,00
0 or
5,0
00 p
aras
ites
/μl
Perc
enta
ge d
istr
ibut
ion
of P
f te
st b
and
inte
nsit
y† (n
=316
)Pe
rcen
tage
dis
trib
utio
n of
Pf
test
ban
d in
tens
ity†
(n=1
58)
Perc
enta
ge d
istr
ibut
ion
of P
an t
est
band
in
tens
ity
(n=3
16)
Perc
enta
ge d
istr
ibut
ion
of P
an t
est
band
in
tens
ity
(n=1
58)
0*1
23
40*
12
34
No
band
12
34
No
band
12
34
Pf &
Pan
/Pf
& P
vFi
rstS
ign
– Pa
raVi
ew-2
(Pv
+ Pf
) Ca
rd T
est
Uni
med
Inte
rnat
iona
l, In
c.20
.57
14.2
425
25.6
314
.56
01.
273.
1622
.78
72.7
8N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
1.58
4.75
27.2
239
.87
26.5
80.
630
0.63
15.1
983
.54
55.7
335
.03
7.96
0.96
0.32
1.27
8.92
33.1
250
.96
5.73
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Co
rtez
Dia
gnos
tics,
Inc.
59.8
16.
0113
.61
13.9
26.
6535
.44
2.53
10.7
624
.05
27.2
299
.68
0.32
00
084
.81
5.06
8.23
1.9
0
Mal
asca
n Ra
pid
Test
for M
alar
ia
Pf/P
an (D
evic
e)Ze
phyr
Bio
med
ical
s17
.41
21.2
46.2
13.2
91.
90.
630.
6319
.62
30.3
848
.73
78.8
17.4
13.
80
010
.13
17.7
244
.94
24.0
53.
16
Para
scre
en R
apid
Tes
t for
Mal
aria
Pa
n/Pf
(Dev
ice)
Zeph
yr B
iom
edic
als
18.3
511
.71
34.8
120
.89
14.2
40.
630
7.59
16.4
675
.32
69.3
20.8
98.
231.
580
4.43
12.0
331
.65
31.0
120
.89
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
17.7
233
.54
30.7
11.0
86.
962.
532.
5318
.35
27.2
249
.37
28.4
841
.46
253.
161.
92.
533.
1625
.95
36.7
131
.65
Pan
only
Para
bank
Rap
id T
est f
or M
alar
ia
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
69.3
20.8
98.
540
1.27
2.53
6.96
29.11
32.9
128
.48
69.3
20.8
98.
540
1.27
2.53
6.96
29.11
32.9
128
.48
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spe
cies
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)70
Tabl
e A4
.5: D
istr
ibut
ion
of p
an/P
v te
st b
and
inte
nsit
y (0
-4)
scor
es f
or P
. viv
ax (
n=20
) sa
mpl
es a
t lo
w (
200)
and
hig
h (2
000
or 5
000)
par
asit
e de
nsit
ies
(par
asit
es/μ
l)
Prod
uct
Man
ufac
ture
r
200
para
site
s/μl
2,00
0 or
5,0
00 p
aras
ites
/μl
Perc
enta
ge d
istr
ibut
ion
of P
an t
est
band
inte
nsit
y (n
=80)
Perc
enta
ge d
istr
ibut
ion
of P
an t
est
band
inte
nsit
y (n
=80)
01
23
40
12
34
Pf &
Pan
/Pf
& P
vAd
vant
age
Mal
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.0
1.25
46.2
551
.25
1.25
00
05
95AZ
OG M
alar
ia p
f (H
RP-I
I) /p
v (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
eAZ
OG, I
nc.
38.7
548
.75
11.2
51.
250
02.
512
.560
25Bi
nax
Now
Mal
aria
In
vern
ess
Med
ical
Inno
vatio
ns, I
nc.
7523
.75
1.25
00
55
42.5
452.
5Ca
reSt
art M
alar
ia H
RP2/
pLDH
(Pf/
PAN
) COM
BOAc
cess
Bio
, Inc
.1.
2513
.75
71.2
513
.75
00
05
22.5
72.5
Firs
t Res
pons
e M
alar
ia A
g Co
mbo
(PLD
H/H
RP2)
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.3.
7518
.75
66.2
510
1.25
00
022
.577
.5Fi
rstS
ign
– Pa
raVi
ew-2
(Pv
+ Pf
) Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
92.5
6.25
1.25
00
105
52.5
32.5
0H
exag
on M
alar
ia C
ombi
Hum
an G
mbH
98.7
51.
250
00
4037
.522
.50
0IC
T M
alar
ia C
ombo
Cas
sett
e Te
st (M
L02)
ICT
Diag
nost
ics
77.5
22.5
00
00
2.5
52.5
37.5
7.5
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
4043
.75
16.2
50
00
010
7515
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nost
ics,
Inc.
100
00
00
850
150
0M
alar
ia R
apid
Com
boVi
sion
Bio
tech
(Pty
) Ltd
.55
37.5
7.5
00
02.
555
402.
5M
alar
ia R
apid
Dua
l Vi
sion
Bio
tech
(Pty
) Ltd
.80
200
00
542
.545
7.5
0M
alas
can
Rapi
d Te
st fo
r Mal
aria
Pf/
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
93.7
55
1.25
00
2.5
550
402.
5On
e St
ep M
alar
ia A
ntig
en S
trip
IND
Diag
nost
ic In
c.86
.25
13.7
50
00
27.5
1532
.520
5On
Sigh
t – P
araQ
uick
(Pan
, Pf)
Test
Amge
nix
Inte
rnat
iona
l, In
c.32
.520
38.7
58.
750
00
520
75Op
tiMAL
-IT
DiaM
ed A
G1.
2531
.25
53.7
513
.75
00
00
22.5
77.5
Para
hit-
Tota
l Dev
ice
Rapi
d te
st fo
r P. f
alci
paru
m a
nd P
an m
alar
ial s
peci
es.
Span
Dia
gnos
tics
Ltd.
97.5
2.5
00
032
.537
.527
.52.
50
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
4017
.538
.75
2.5
1.25
2.5
2.5
7.5
2562
.5Qu
icks
tick
Mal
aria
Ant
igen
Tes
tIn
nova
tek
Med
ical
Inc.
86.2
513
.75
00
027
.515
32.5
205
SD B
IOLI
NE
Mal
aria
Ag
Stan
dard
Dia
gnos
tics,
Inc.
28.7
536
.25
350
00
022
.557
.520
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
an
Stan
dard
Dia
gnos
tics,
Inc.
5035
150
02.
50
3550
12.5
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
3545
200
02.
52.
515
4535
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
010
73.7
516
.25
00
00
1090
Care
Star
t Mal
aria
pLD
H (P
AN)
Acce
ss B
io, I
nc.
05
61.2
533
.75
00
00
595
Para
bank
Rap
id T
est f
or M
alar
ia P
an (D
evic
e)Ze
phyr
Bio
med
ical
s52
.516
.25
26.2
55
00
02.
512
.585
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spe
cies
Tabl
e A4
.5a:
Dis
trib
utio
n of
pan
/Pv
test
ban
d in
tens
ity
(0-4
) sc
ores
for
P. v
ivax
(n=
20)
sam
ples
at
low
(20
0) a
nd h
igh
(200
0 or
500
0) p
aras
ite
dens
itie
s (p
aras
ites
/μl)
sam
ples
bas
ed o
n a
dela
yed
read
ing
whe
n sp
ecifi
ed b
y th
e m
anuf
actu
rer
Prod
uct
Man
ufac
ture
r
200
para
site
s/μl
2,00
0 or
5,0
00 p
aras
ites
/μl
Perc
enta
ge d
istr
ibut
ion
of P
an t
est
band
inte
nsit
y (n
=80)
Perc
enta
ge d
istr
ibut
ion
of P
an t
est
band
inte
nsit
y (n
=80)
01
23
40
12
34
Pf &
Pan
/Pf
& P
vFi
rstS
ign
– Pa
raVi
ew-2
(Pv
+ Pf
) Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
27.5
37.5
350
00
07.
552
.540
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nost
ics,
Inc.
100
00
00
8010
100
0M
alas
can
Rapi
d Te
st fo
r Mal
aria
Pf/
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
86.2
511
.25
2.5
00
02.
552
.535
10Pa
rasc
reen
Rap
id T
est f
or M
alar
ia P
an/P
f (De
vice
)Ze
phyr
Bio
med
ical
s22
.522
.535
200
02.
52.
522
.572
.5W
ondf
o On
e St
ep M
alar
ia P
f/Pa
n W
hole
Blo
od T
est
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
., Lt
d36
.25
4022
.51.
250
2.5
57.
537
.547
.5Pa
n on
lyPa
raba
nk R
apid
Tes
t for
Mal
aria
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
13.7
528
.75
43.7
513
.75
00
02.
512
.585
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spe
cies
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)71
Tabl
e A4
.6 D
etec
tion
rat
e‡ of
P. f
alci
paru
m in
low
(20
0) a
nd h
igh
(200
0 or
500
0) p
aras
ite
dens
itie
s (p
aras
ites
/μl)
by c
onti
nent
Prod
uct
Man
ufac
ture
r
200
para
site
s/μl
2000
or
5000
par
asit
es/μ
l
Dete
ctio
n ra
te b
y co
ntin
ent
of s
ampl
e or
igin
De
tect
ion
rate
by
cont
inen
t of
sam
ple
orig
in
Afric
a (n
=49)
Asia
(n=
22)
Sout
h Am
eric
a (n
=8)
Afric
a (n
=49)
Asia
(n=
22)
Sout
h Am
eric
a (n
=8)
Pf o
nly
ADVA
NCE
D QU
ALIT
Y TM
MAL
ARIA
(p.f)
POC
T In
Tec
Prod
ucts
, Inc
.57
.14
63.6
437
.510
010
010
0
ADVA
NCE
D QU
ALIT
Y TM
One
Ste
p M
alar
ia (p
.f.) T
est (
who
le b
lood
)In
Tec
Prod
ucts
, Inc
.71
.43
59.0
962
.510
010
010
0
Adva
ntag
e P.
f. M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
97.9
610
087
.510
010
010
0
Care
Star
t Mal
aria
HRP
2 (P
f)Ac
cess
Bio
, Inc
.97
.96
100
100
97.9
610
010
0
Firs
t Res
pons
e M
alar
ia A
g H
RP2
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.10
010
010
010
010
010
0
Firs
tSig
n –
Mal
aria
Pf C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.34
.69
31.8
212
.585
.71
90.9
175
Hex
agon
Mal
aria
Hum
an G
mbH
36.7
345
.45
37.5
93.8
895
.45
100
ICT
Mal
aria
Pf C
asse
tte
Test
(ML0
1)IC
T Di
agno
stic
s79
.59
86.3
687
.510
090
.91
100
Imm
unoq
uick
Mal
aria
Fal
cipa
rum
Bios
ynex
85.7
110
010
010
010
010
0
Mal
aria
Pla
smod
ium
falc
ipar
um R
apid
test
Dev
ice
(Who
le b
lood
)AC
ON L
abor
ator
ies,
Inc.
89.8
95.4
510
010
010
010
0
Mal
aria
Rap
id P
fVi
sion
Bio
tech
(Pty
) Ltd
.65
.31
77.2
762
.597
.96
100
87.5
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
evic
e)
Orch
id B
iom
edic
al S
yste
ms
55.1
59.0
937
.595
.92
100
100
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
ipst
ick)
Or
chid
Bio
med
ical
Sys
tem
s73
.47
77.2
775
100
100
100
Para
hit-
f DIP
STIC
K FO
R FA
LCIP
ARU
M M
ALAR
IASp
an D
iagn
ostic
s Lt
d.79
.59
81.8
262
.510
010
010
0
Para
hit-
f TES
T DE
VICE
FOR
FAL
CIPA
RUM
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
42.8
636
.36
2510
095
.45
87.5
SD B
IOLI
NE
Mal
aria
Ag
Pf
Stan
dard
Dia
gnos
tics,
Inc.
100
90.9
110
097
.96
100
100
Pf &
Pan
/Pf
& P
v
Adva
ntag
e M
al C
ard
J. M
itra
& C
o. P
vt. L
td.
69.3
959
.09
2510
010
010
0
AZOG
Mal
aria
pf (
HRP
-II)
/pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
AZOG
, Inc
.71
.43
86.3
687
.510
010
010
0
Bina
x N
ow M
alar
ia
Inve
rnes
s M
edic
al In
nova
tions
, Inc
.89
.895
.45
87.5
100
100
100
Care
Star
t Mal
aria
HRP
2/pL
DH (P
f/PA
N) C
OMBO
Acce
ss B
io, I
nc.
95.9
210
010
010
010
010
0
Firs
t Res
pons
e M
alar
ia A
g Co
mbo
(PLD
H/H
RP2)
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.10
010
010
010
010
010
0
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.46
.94
63.6
412
.597
.96
100
100
Hex
agon
Mal
aria
Com
biH
uman
Gm
bH46
.94
54.5
525
97.9
610
087
.5
ICT
Mal
aria
Com
bo C
asse
tte
Test
(ML0
2)IC
T Di
agno
stic
s85
.71
86.3
687
.510
010
010
0
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
91.8
495
.45
100
97.9
610
010
0
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nost
ics,
Inc.
68.7
5 (3
2)71
.43
(14)
100
(7)
92.5
9 (2
7)10
0 (8
)10
0 (4
)
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
87.7
690
.91
7510
010
010
0
Mal
aria
Rap
id D
ual
Visi
on B
iote
ch (P
ty) L
td.
77.5
572
.73
7597
.96
100
100
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s59
.18
72.7
362
.595
.92
100
100
One
Step
Mal
aria
Ant
igen
Str
ipIN
D Di
agno
stic
Inc.
2.04
00
79.5
950
37.5
OnSi
ght –
Par
aQui
ck (P
an, P
f) Te
stAm
geni
x In
tern
atio
nal,
Inc.
61.2
259
.09
5010
010
010
0
OptiM
AL-I
TDi
aMed
AG
48.9
822
.73
095
.92
100
87.5
Para
hit-
Tota
l Dev
ice
Rapi
d te
st fo
r P. f
alci
paru
m a
nd P
an m
alar
ial s
peci
es.
Span
Dia
gnos
tics
Ltd.
34.6
940
.91
2595
.92
95.4
575
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
51.0
250
5010
010
010
0
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)72
Prod
uct
Man
ufac
ture
r
200
para
site
s/μl
2000
or
5000
par
asit
es/μ
l
Dete
ctio
n ra
te b
y co
ntin
ent
of s
ampl
e or
igin
De
tect
ion
rate
by
cont
inen
t of
sam
ple
orig
in
Afric
a (n
=49)
Asia
(n=
22)
Sout
h Am
eric
a (n
=8)
Afric
a (n
=49)
Asia
(n=
22)
Sout
h Am
eric
a (n
=8)
Quic
kstic
k M
alar
ia A
ntig
en T
est
Inno
vate
k M
edic
al In
c.2.
040
079
.59
5037
.5
SD B
IOLI
NE
Mal
aria
Ag
Stan
dard
Dia
gnos
tics,
Inc.
40.8
213
.64
097
.96
95.4
587
.5
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
an
Stan
dard
Dia
gnos
tics,
Inc.
97.9
695
.45
87.5
100
100
100
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
63.2
763
.64
37.5
97.9
610
010
0
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
75.5
168
.18
62.5
100
100
100
Care
Star
t Mal
aria
pLD
H (P
AN)
Acce
ss B
io, I
nc.
91.8
495
.45
87.5
100
100
100
Para
bank
Rap
id T
est f
or M
alar
ia P
an (D
evic
e)Ze
phyr
Bio
med
ical
s2.
040
089
.895
.45
50
Afric
a -
Tanz
ania
, Cen
tral
Afr
ican
Rep
ublic
, Mad
agas
car,
Nig
eria
Asia
- M
yanm
ar, P
hilip
pine
s, Ca
mbo
dia
Sout
h Am
eric
a -
Peru
, Col
ombi
a
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spe
cies
‡ -
A s
ampl
e is
con
side
red
dete
cted
onl
y if
all R
DTs
from
bot
h lo
ts re
ad b
y th
e fir
st te
chni
cian
, at m
inim
um s
peci
fied
read
ing
time,
are
pos
itive
Tabl
e A4
.6a:
Det
ecti
on r
ate
of P
. fal
cipa
rum
in lo
w (
200)
and
hig
h (2
000
or 5
000)
par
asit
e de
nsit
ies
(par
asit
es/μ
l) by
con
tine
nt b
ased
on
a de
laye
d re
adin
g as
spe
cifie
d by
the
man
ufac
ture
r
Prod
uct
Man
ufac
ture
r
200
para
site
s/μl
2000
or
5000
par
asit
es/μ
l
Dete
ctio
n ra
te b
y co
ntin
ent
of s
ampl
e or
igin
De
tect
ion
rate
by
cont
inen
t of
sam
ple
orig
in
Afric
a (n
=49)
Asia
(n=
22)
Sout
h Am
eric
a (n
=8)
Afric
a (n
=49)
Asia
(n=
22)
Sout
h Am
eric
a (n
=8)
Pf &
Pan
/Pf
& P
v
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.63
.27
72.7
350
100
100
100
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
95.9
286
.36
100
100
100
100
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nost
ics,
Inc.
64.7
1 (3
4)73
.33
(15)
100
(7)
89.2
9 (2
8)10
0 (8
)10
0 (4
)
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s61
.22
81.8
275
97.9
610
010
0
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
69.3
959
.09
62.5
97.9
610
010
0
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
69.3
968
.18
62.5
97.9
610
010
0
Pan
only
Para
bank
Rap
id T
est f
or M
alar
ia P
an (D
evic
e)Ze
phyr
Bio
med
ical
s22
.45
00
97.9
610
087
.5
Afric
a -
Tanz
ania
, Cen
tral
Afr
ican
Rep
ublic
, Mad
agas
car,
Nig
eria
Asia
- M
yanm
ar, P
hilip
pine
s, Ca
mbo
dia
Sout
h Am
eric
a -
Peru
, Col
ombi
a
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spe
cies
‡ -
a s
ampl
e is
con
side
red
dete
cted
onl
y if
all R
DTs
from
bot
h lo
ts re
ad b
y th
e fir
st te
chni
cian
, at m
inim
um s
peci
fied
read
ing
time,
are
pos
itive
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)73
Tabl
e A4
.7 P
. fal
cipa
rum
tes
t lin
e fa
lse
posi
tive
res
ults
for
P. v
ivax
sam
ples
(n=
20)
at lo
w (
200)
and
hig
h (2
000
or 5
000)
par
asit
e de
nsit
ies
(par
asit
es/μ
l)
Prod
uct
Man
ufac
ture
r
P. v
ivax
sam
ples
(n=
20)
200
para
site
s/μl
2000
or
5000
par
asit
es/μ
l
Fals
e po
siti
ve P
f in
fect
ion◊
Fals
e po
siti
ve P
f in
fect
ion◊
Lot
1 (n
=40)
Lot
2 (n
=40)
Ove
rall
(n=8
0)Lo
t 1
(n=2
0)Lo
t 2
(n=2
0)O
vera
ll (n
=40)
Pf o
nly
ADVA
NCE
D QU
ALIT
Y TM
MAL
ARIA
(p.f)
POC
T In
Tec
Prod
ucts
, Inc
.7.
517
.512
.520
1517
.5AD
VAN
CED
QUAL
ITY
TM O
ne S
tep
Mal
aria
(p.f.
) Tes
t (w
hole
blo
od)
InTe
c Pr
oduc
ts, I
nc.
52.5
4548
.75
5040
45Ad
vant
age
P.f.
Mal
aria
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.2.
50
1.25
50
2.5
Care
Star
t Mal
aria
HRP
2 (P
f)Ac
cess
Bio
, Inc
.10
05
105
7.5
Firs
t Res
pons
e M
alar
ia A
g H
RP2
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.0
00
00
0Fi
rstS
ign
– M
alar
ia P
f Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
520
12.5
1515
15H
exag
on M
alar
iaH
uman
Gm
bH5.
41 (3
7)10
.26
(39)
7.89
(76)
05
2.5
ICT
Mal
aria
Pf C
asse
tte
Test
(ML0
1)IC
T Di
agno
stic
s0
(39)
2.5
1.27
(79)
50
2.5
Imm
unoq
uick
Mal
aria
Fal
cipa
rum
Bios
ynex
00
00
00
Mal
aria
Pla
smod
ium
falc
ipar
um R
apid
test
Dev
ice
(Who
le b
lood
)AC
ON L
abor
ator
ies,
Inc.
00
00
00
Mal
aria
Rap
id P
fVi
sion
Bio
tech
(Pty
) Ltd
.0
00
00
0Pa
rach
eck
Pf R
apid
test
for P
. fal
cipa
rum
Mal
aria
(Dev
ice)
Or
chid
Bio
med
ical
Sys
tem
s2.
63 (3
8)5.
26 (3
8)3.
95 (7
6)5
55
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
ipst
ick)
Or
chid
Bio
med
ical
Sys
tem
s7.
525
.64
(39)
16.4
6 (7
9)10
1010
Para
hit-
f DIP
STIC
K FO
R FA
LCIP
ARU
M M
ALAR
IASp
an D
iagn
ostic
s Lt
d.0
00
00
0Pa
rahi
t-f T
EST
DEVI
CE F
OR F
ALCI
PARU
M M
ALAR
IASp
an D
iagn
ostic
s Lt
d.0
00
00
0SD
BIO
LIN
E M
alar
ia A
g Pf
St
anda
rd D
iagn
ostic
s, In
c.0
00
00
0Pf
& P
an/P
f &
Pv
Adva
ntag
e M
al C
ard
J. M
itra
& C
o. P
vt. L
td.
00
00
00
AZOG
Mal
aria
pf (
HRP
-II)
/pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
AZOG
, Inc
.0
00
05
2.5
Bina
x N
ow M
alar
ia
Inve
rnes
s M
edic
al In
nova
tions
, Inc
.2.
56 (3
9)5
3.8
(79)
010
5Ca
reSt
art M
alar
ia H
RP2/
pLDH
(Pf/
PAN
) COM
BOAc
cess
Bio
, Inc
.2.
50
1.25
05
2.5
Firs
t Res
pons
e M
alar
ia A
g Co
mbo
(PLD
H/H
RP2)
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.2.
55
3.75
2515
20Fi
rstS
ign
– Pa
raVi
ew-2
(Pv
+ Pf
) Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
07.
53.
750
105
Hex
agon
Mal
aria
Com
biH
uman
Gm
bH0
0 (3
9)0
(79)
5.26
(19)
0 (1
9)2.
63 (3
8)IC
T M
alar
ia C
ombo
Cas
sett
e Te
st (M
L02)
ICT
Diag
nost
ics
52.
53.
755
55
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
00
00
00
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nost
ics,
Inc.
0 (1
4)0
(16)
0 (3
0)0
(10)
0 (8
)0
(18)
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
7.5
7.5
7.5
510
7.5
Mal
aria
Rap
id D
ual
Visi
on B
iote
ch (P
ty) L
td.
00
00
00
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s5
7.5
6.25
1520
17.5
One
Step
Mal
aria
Ant
igen
Str
ipIN
D Di
agno
stic
Inc.
07.
53.
750
00
OnSi
ght –
Par
aQui
ck (P
an, P
f) Te
stAm
geni
x In
tern
atio
nal,
Inc.
02.
51.
250
00
OptiM
AL-I
TDi
aMed
AG
00
00
00
Para
hit-
Tota
l Dev
ice
Rapi
d te
st fo
r P. f
alci
paru
m a
nd P
an m
alar
ial s
peci
es.
Span
Dia
gnos
tics
Ltd.
00
05
02.
5Pa
rasc
reen
Rap
id T
est f
or M
alar
ia P
an/P
f (De
vice
)Ze
phyr
Bio
med
ical
s5
2.56
(39)
3.8
(79)
00
0Qu
icks
tick
Mal
aria
Ant
igen
Tes
tIn
nova
tek
Med
ical
Inc.
07.
53.
750
00
SD B
IOLI
NE
Mal
aria
Ag
Stan
dard
Dia
gnos
tics,
Inc.
2.5
01.
250
00
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
an
Stan
dard
Dia
gnos
tics,
Inc.
0 (3
9)0
0 (7
9)5.
26 (1
9)0
2.56
(39)
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
0 (3
9)2.
63 (3
8)1.
3 (7
7)0
5.26
(19)
2.56
(39)
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
N/A
N/A
N/A
N/A
N/A
N/A
Care
Star
t Mal
aria
pLD
H (P
AN)
Acce
ss B
io, I
nc.
N/A
N/A
N/A
N/A
N/A
N/A
Para
bank
Rap
id T
est f
or M
alar
ia P
an (D
evic
e)Ze
phyr
Bio
med
ical
sN
/AN
/AN
/AN
/AN
/AN
/APf
- P
lasm
odiu
m fa
lcip
arum
Pv
- P
lasm
odiu
m v
ivax
pan
- Pl
asm
odiu
m s
peci
es
◊ - P
f lin
e po
sitiv
e in
dica
tes
a fa
lse
posi
tive
P. fa
lcip
arum
infe
ctio
n
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)74
Tabl
e A4
.7a:
P. f
alci
paru
m t
est
line
fals
e po
siti
ve r
esul
ts f
or P
. viv
ax s
ampl
es (
n=20
) at
low
(20
0) a
nd h
igh
(200
0 or
500
0) p
aras
ite
dens
itie
s (p
aras
ites
/μl)
base
d on
a
dela
yed
read
ing
whe
n sp
ecifi
ed b
y th
e m
anuf
actu
rer
Prod
uct
Man
ufac
ture
r
P. v
ivax
sam
ples
(n=
20)
200
para
site
s/μl
2000
or
5000
par
asit
es/μ
l
Fals
e po
siti
ve P
f in
fect
ion◊
Fals
e po
siti
ve P
f in
fect
ion◊
Lot
1 (n
=40)
Lot
2 (n
=40)
Ove
rall
(n=8
0)
Lot
1 (n
=20)
Lot
2 (n
=20)
Ove
rall
(n=4
0)
Pf &
Pan
/Pf
& P
v
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.2.
52.
52.
50
52.
5
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
02.
51.
250
52.
5
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nost
ics,
Inc.
0 (1
6)0
(14)
0 (3
0)0
(10)
0 (5
)0
(15)
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s5
107.
515
1012
.5
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
00
(39)
0 (7
9)0
00
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
2.56
(39)
5.26
(38)
3.9
(77)
100
(19)
5.13
(39)
Pan
only
Para
bank
Rap
id T
est f
or M
alar
ia P
an (D
evic
e)Ze
phyr
Bio
med
ical
sN
/AN
/AN
/AN
/AN
/AN
/A
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spe
cies
◊ -
Pf l
ine
posi
tive
indi
cate
s a
fals
e po
sitiv
e P.
falc
ipar
um in
fect
ion
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)75
Tabl
e A4
.8: C
ombi
nati
on t
est
pan
line
fals
e po
siti
ve n
on P
f in
fect
ion
on P
f sa
mpl
es (
n=79
) at
low
and
hig
h pa
rasi
te d
ensi
ties
(pa
rasi
tes/
μl)
Prod
uct
Man
ufac
ture
r
P. f
alci
paru
m s
ampl
es (
n=79
)
200
para
site
s/μl
2000
or
5000
par
asit
es/μ
l
Fals
e po
siti
ve n
on P
f in
fect
ion†
Fals
e po
siti
ve n
on P
f in
fect
ion†
Lot
1 (n
=158
)Lo
t 2
(n=1
58)
Ove
rall
(n=3
16)
Lot
1 (n
=79)
Lot
2 (n
=79)
Ove
rall
(n=1
58)
Pf &
Pan
/Pf
& P
vAd
vant
age
Mal
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.2.
532.
532.
530
00
AZOG
Mal
aria
pf (
HRP
-II)
/pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
AZOG
, Inc
.1.
91.
91.
90
00
Bina
x N
ow M
alar
ia
Inve
rnes
s M
edic
al In
nova
tions
, Inc
.0.
630
0.32
0 (7
8)0
0 (1
57)
Care
Star
t Mal
aria
HRP
2/pL
DH (P
f/PA
N) C
OMBO
Acce
ss B
io, I
nc.
00.
630.
320
00
Firs
t Res
pons
e M
alar
ia A
g Co
mbo
(PLD
H/H
RP2)
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.0
00
00
0Fi
rstS
ign
– Pa
raVi
ew-2
(Pv
+ Pf
) Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
01.
90.
950
00
Hex
agon
Mal
aria
Com
biH
uman
Gm
bH0
00
0 (7
8)0
0 (1
57)
ICT
Mal
aria
Com
bo C
asse
tte
Test
(ML0
2)IC
T Di
agno
stic
s0
0.63
0.32
00
0Im
mun
oqui
ck M
alar
ia +
4Bi
osyn
ex0
0 (1
56)
0 (3
14)
00
(78)
0 (1
57)
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nost
ics,
Inc.
1.79
(56)
0 (4
1)1.
03 (9
7)0
(31)
5.88
(17)
2.08
(48)
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
0.63
00.
320
00
Mal
aria
Rap
id D
ual
Visi
on B
iote
ch (P
ty) L
td.
0.63
1.9
1.27
00
0M
alas
can
Rapi
d Te
st fo
r Mal
aria
Pf/
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
0.63
0.63
0.63
00
0On
e St
ep M
alar
ia A
ntig
en S
trip
IND
Diag
nost
ic In
c.1.
92.
532.
221.
272.
531.
9On
Sigh
t – P
araQ
uick
(Pan
, Pf)
Test
Amge
nix
Inte
rnat
iona
l, In
c.0
00
00
0Op
tiMAL
-IT
DiaM
ed A
G4.
433.
163.
80
1.27
0.63
Para
hit-
Tota
l Dev
ice
Rapi
d te
st fo
r P. f
alci
paru
m a
nd P
an m
alar
ial s
peci
es.
Span
Dia
gnos
tics
Ltd.
00
(315
)0
(315
)0
00
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
0.63
0.63
0.63
00
0Qu
icks
tick
Mal
aria
Ant
igen
Tes
tIn
nova
tek
Med
ical
Inc.
1.9
2.53
2.22
1.27
2.53
1.9
SD B
IOLI
NE
Mal
aria
Ag
Stan
dard
Dia
gnos
tics,
Inc.
00
00
00
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
an
Stan
dard
Dia
gnos
tics,
Inc.
00
(155
)0
(310
)0
00
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
3.21
(156
)3.
85 (1
56)
3.52
(312
)0
(78)
0 (7
7)0
(155
)Pf
- P
lasm
odiu
m fa
lcip
arum
Pv
- P
lasm
odiu
m v
ivax
pan
- Pl
asm
odiu
m s
peci
es
† - F
or c
ombi
natio
n te
sts,
Pan
or P
v lin
e, o
nly,
posi
tive
indi
cate
s a
fals
e po
sitiv
e no
n P.
falc
ipar
um in
fect
ion
Tabl
e A4
.8a:
Com
bina
tion
tes
t pa
n lin
e fa
lse
posi
tive
non
Pf
infe
ctio
n on
Pf
sam
ples
(n=
79)
at lo
w (
200)
and
hig
h (2
000
or 5
000)
par
asit
e de
nsit
ies
(par
asit
es/μ
l) ba
sed
on a
del
ayed
rea
ding
whe
n sp
ecifi
ed b
y th
e m
anuf
actu
rer
Prod
uct
Man
ufac
ture
r
P. f
alci
paru
m s
ampl
es (
n=79
)
200
para
site
s/μl
2000
or
5000
par
asit
es/μ
l
Fals
e po
siti
ve n
on P
f in
fect
ion†
Fals
e po
siti
ve n
on P
f in
fect
ion†
Lot
1 (n
=158
)Lo
t 2
(n=1
58)
Ove
rall
(n=3
16)
Lot
1 (n
=79)
Lot
2 (n
=79)
Ove
rall
(n=1
58)
Pf &
Pan
/Pf
& P
v
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.0
00
00
0
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
00
(156
)0
(314
)0
(78)
0 (7
8)0
(156
)
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nost
ics,
Inc.
0 (5
8)0
(44)
0 (1
02)
3.23
(31)
5.88
(17)
4.17
(48)
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s1.
91.
271.
580
00
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
0.63
0.63
0.63
1.27
00.
63
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
2.56
(156
)1.
28 (1
56)
1.92
(312
)0
(78)
0 (7
7)0
(155
)
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spe
cies
† -
For
com
bina
tion
test
s, Pa
n or
Pv
line,
onl
y, po
sitiv
e in
dica
tes
a fa
lse
posi
tive
non
P. fa
lcip
arum
infe
ctio
n
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)76
Tabl
e A4
.9: F
alse
pos
itiv
e ra
te o
f P.
fal
cipa
rum
(or
pan
† ) t
est
line
resu
lts
on a
ll m
alar
ia-n
egat
ive
sam
ples
Prod
uct
Man
ufac
ture
r
Perc
enta
ge o
f fa
lse
posi
tive
Pf
(or
Pan† )
tes
t lin
es o
n”cl
ean”
neg
ativ
e sa
mpl
es
Perc
enta
ge o
f fa
lse
posi
tive
Pf
(or
Pan† )
tes
t lin
es o
n sa
mpl
es c
onta
inin
g no
n-Pl
asm
odiu
m
spp.
infe
ctio
us a
gent
s
Perc
enta
ge o
f fa
lse
posi
tive
Pf
(or
Pan† )
tes
t lin
es o
n sa
mpl
es c
onta
i-ni
ng im
mun
olog
ical
fac
tors
Lot
1 (n
=84)
Lot
2 (n
=84)
Ove
rall
(n=1
68)
Lot
1 (n
=42)
Lot
2 (n
=42)
Ove
rall
(n=8
4)Lo
t 1
(n=5
4)Lo
t 2
(n=5
4)O
vera
ll (n
=108
)
Pf o
nly
ADVA
NCE
D QU
ALIT
Y TM
MAL
ARIA
(p.f)
POC
T In
Tec
Prod
ucts
, Inc
.20
.24
11.9
16.0
711
.919
.05
15.4
835
.19
7.41
21.3
ADVA
NCE
D QU
ALIT
Y TM
One
Ste
p M
alar
ia (p
.f.) T
est (
who
le b
lood
)In
Tec
Prod
ucts
, Inc
.33
.33
22.6
227
.98
42.8
621
.95
(41)
32.5
3 (8
3)53
.729
.63
41.6
7Ad
vant
age
P.f.
Mal
aria
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.0
00
00
03.
71.
852.
78Ca
reSt
art M
alar
ia H
RP2
(Pf)
Acce
ss B
io, I
nc.
2.38
2.38
2.38
2.38
01.
191.
850
0.93
Firs
t Res
pons
e M
alar
ia A
g H
RP2
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.1.
194.
762.
980
4.76
2.38
00
0Fi
rstS
ign
– M
alar
ia P
f Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
1.2
(83)
3.61
(83)
2.41
(166
)0
14.2
97.
141.
850
(53)
0.93
(107
)H
exag
on M
alar
iaH
uman
Gm
bH3.
574.
82 (8
3)4.
19 (1
67)
2.44
(41)
0 (3
9)1.
25 (8
0)3.
71.
852.
78IC
T M
alar
ia P
f Cas
sett
e Te
st (M
L01)
ICT
Diag
nost
ics
01.
190.
60
2.38
1.19
03.
71.
85Im
mun
oqui
ck M
alar
ia F
alci
paru
mBi
osyn
ex1.
190
0.6
00
01.
851.
851.
85M
alar
ia P
lasm
odiu
m fa
lcip
arum
Rap
id te
st D
evic
e (W
hole
blo
od)
ACON
Lab
orat
orie
s, In
c.0
00
00
05.
561.
853.
7M
alar
ia R
apid
Pf
Visi
on B
iote
ch (P
ty) L
td.
1.19
00.
60
00
00
0Pa
rach
eck
Pf R
apid
test
for P
. fal
cipa
rum
Mal
aria
(Dev
ice)
Or
chid
Bio
med
ical
Sys
tem
s0
(81)
2.53
(79)
1.25
(160
)0
(39)
5 (4
0)2.
53 (7
9)1.
89 (5
3)1.
89 (5
3)1.
89 (1
06)
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
ipst
ick)
Or
chid
Bio
med
ical
Sys
tem
s7.
147.
23 (8
3)7.
19 (1
67)
7.14
9.52
8.33
1.85
15.0
9 (5
3)8.
41 (1
07)
Para
hit-
f DIP
STIC
K FO
R FA
LCIP
ARU
M M
ALAR
IASp
an D
iagn
ostic
s Lt
d.0
1.19
0.6
2.38
01.
190
1.85
0.93
Para
hit-
f TES
T DE
VICE
FOR
FAL
CIPA
RUM
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
00
00
00
00
0SD
BIO
LIN
E M
alar
ia A
g Pf
St
anda
rd D
iagn
ostic
s, In
c.2.
382.
382.
384.
767.
145.
950
00
Pf &
Pan
/Pf
& P
vAd
vant
age
Mal
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.2.
383.
572.
982.
380
1.19
1.85
1.85
1.85
AZOG
Mal
aria
pf (
HRP
-II)
/pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
AZOG
, Inc
.2.
381.
191.
792.
382.
382.
380
00
Bina
x N
ow M
alar
ia
Inve
rnes
s M
edic
al In
nova
tions
, Inc
.0
00
07.
143.
570
00
Care
Star
t Mal
aria
HRP
2/pL
DH (P
f/PA
N) C
OMBO
Acce
ss B
io, I
nc.
1.19
00.
62.
380
1.19
00
0Fi
rst R
espo
nse
Mal
aria
Ag
Com
bo (P
LDH
/HRP
2)Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
3.57
3.57
3.57
4.76
02.
380
3.7
1.85
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.7.
142.
41 (8
3)4.
79 (1
67)
7.14
4.76
5.95
5.56
7.41
6.48
Hex
agon
Mal
aria
Com
biH
uman
Gm
bH2.
382.
41 (8
3)2.
4 (1
67)
00
00
00
ICT
Mal
aria
Com
bo C
asse
tte
Test
(ML0
2)IC
T Di
agno
stic
s1.
190
0.6
2.38
2.38
2.38
7.41
3.7
5.56
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
00
00
2.38
1.19
00
0M
alar
ia P
.F/V
ivax
Diag
nost
ic A
utom
atio
n / C
orte
z Di
agno
stic
s, In
c.0
(35)
0 (2
9)0
(64)
9.09
(11)
0 (1
5)3.
85 (2
6)11
.54
(26)
5.26
(19)
8.89
(45)
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
4.76
5.95
5.36
9.76
(41)
7.14
8.43
(83)
5.56
5.56
5.56
Mal
aria
Rap
id D
ual
Visi
on B
iote
ch (P
ty) L
td.
03.
571.
790
4.76
2.38
01.
850.
93M
alas
can
Rapi
d Te
st fo
r Mal
aria
Pf/
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
5.95
4.76
5.36
4.76
02.
3811
.119.
2610
.19
One
Step
Mal
aria
Ant
igen
Str
ipIN
D Di
agno
stic
Inc.
1.19
2.41
(83)
1.8
(167
)0
(41)
2.38
1.2
(83)
3.7
1.85
2.78
OnSi
ght –
Par
aQui
ck (P
an, P
f) Te
stAm
geni
x In
tern
atio
nal,
Inc.
00
00
(41)
00
(83)
0 (5
3)0
(53)
0 (1
06)
OptiM
AL-I
TDi
aMed
AG
0 (8
3)0
0 (1
67)
0 (4
1)0
0 (8
3)3.
85 (5
2)1.
852.
83 (1
06)
Para
hit-
Tota
l Dev
ice
Rapi
d te
st fo
r P. f
alci
paru
m a
nd P
an m
alar
ial s
peci
es.
Span
Dia
gnos
tics
Ltd.
00
02.
380
1.19
01.
850.
93Pa
rasc
reen
Rap
id T
est f
or M
alar
ia P
an/P
f (De
vice
)Ze
phyr
Bio
med
ical
s0
2.38
1.19
02.
381.
191.
853.
77 (5
3)2.
8 (1
07)
Quic
kstic
k M
alar
ia A
ntig
en T
est
Inno
vate
k M
edic
al In
c.1.
192.
41 (8
3)1.
8 (1
67)
0 (4
1)2.
381.
2 (8
3)3.
71.
852.
78SD
BIO
LIN
E M
alar
ia A
gSt
anda
rd D
iagn
ostic
s, In
c.2.
381.
191.
790
00
3.7
3.7
3.7
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
an
Stan
dard
Dia
gnos
tics,
Inc.
01.
190.
62.
56 (3
9)4.
763.
7 (8
1)0
(53)
00
(107
)W
ondf
o On
e St
ep M
alar
ia P
f/Pa
n W
hole
Blo
od T
est
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
., Lt
d2.
41 (8
3)4.
763.
59 (1
67)
7.32
(41)
11.9
9.64
(83)
3.85
(52)
7.41
5.66
(106
)Pa
n on
lyAd
vant
age
Pan
Mal
aria
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.1.
192.
381.
790
00
00
0Ca
reSt
art M
alar
ia p
LDH
(PAN
)Ac
cess
Bio
, Inc
.4.
768.
336.
552.
3811
.97.
143.
71.
852.
78Pa
raba
nk R
apid
Tes
t for
Mal
aria
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
3.61
(83)
2.38
2.99
(167
)2.
380
1.19
7.55
(53)
3.7
5.61
(107
)Pf
- P
lasm
odiu
m fa
lcip
arum
Pv
- P
lasm
odiu
m v
ivax
pan
- Pl
asm
odiu
m s
peci
es
† - F
or P
an-o
nly
test
s
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)77
Tabl
e A4
.9a:
Fal
se p
osit
ive
rate
of
P. f
alci
paru
m (
or p
an† )
tes
t lin
e re
sult
s on
all
mal
aria
-neg
ativ
e sa
mpl
es b
ased
on
a de
laye
d re
adin
g w
here
spe
cifie
d by
the
m
anuf
actu
rer
Prod
uct
Man
ufac
ture
r
Perc
enta
ge o
f fa
lse
posi
tive
Pf
or P
an t
est
lines
on”
clea
n” n
egat
ive
sam
ples
Perc
enta
ge o
f fa
lse
posi
tive
Pf
or P
an t
est
lines
on
sam
ples
con
tain
ing
non-
Plas
mo-
dium
infe
ctio
us a
gent
s
Perc
enta
ge o
f fa
lse
posi
tive
Pf
or P
an t
est
lines
on
sam
ples
con
tain
ing
imm
unol
ogic
al
fact
ors
Lot
1 (n
=84)
Lot
2 (n
=84)
Ove
rall
(n=1
68)
Lot
1 (n
=42)
Lot
2 (n
=42)
Ove
rall
(n=8
4)Lo
t 1
(n=5
4)Lo
t 2
(n=5
4)O
vera
ll (n
=108
)
Pf &
Pan
/Pf
& P
vFi
rstS
ign
– Pa
raVi
ew-2
(Pv
+ Pf
) Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
5.95
0 (8
3)2.
99 (1
67)
00
01.
850
0.93
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
1.19
13.1
7.14
011
.95.
951.
8524
.07
12.9
6M
alar
ia P
.F/V
ivax
Diag
nost
ic A
utom
atio
n / C
orte
z Di
agno
stic
s, In
c.6.
45 (3
1)0
(31)
3.23
(62)
0 (9
)0
(14)
0 (2
3)10
.71
(28)
5.26
(19)
8.51
(47)
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s8.
334.
766.
557.
140
3.57
14.8
13.
79.
26Pa
rasc
reen
Rap
id T
est f
or M
alar
ia P
an/P
f (De
vice
)Ze
phyr
Bio
med
ical
s0
2.38
1.19
00
00
1.85
0.93
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
3.66
(82)
5.95
4.82
(166
)9.
76 (4
1)4.
767.
23 (8
3)4
(50)
9.26
6.73
(104
)Pa
n on
lyPa
raba
nk R
apid
Tes
t for
Mal
aria
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
1.22
(82)
1.19
1.2
(166
)2.
380
1.19
7.41
03.
7Pf
- P
lasm
odiu
m fa
lcip
arum
Pv
- P
lasm
odiu
m v
ivax
pan
- Pl
asm
odiu
m s
peci
es
† - fo
r Pan
-onl
y te
sts
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)78
Tabl
e A4
.10
Fals
e po
siti
ve r
ate
of P
. fal
cipa
rum
(or
pan
† ) t
est
line
resu
lts
for
sam
ples
con
tain
ing
spec
ific
non-
mal
aria
l inf
ecti
ous
path
ogen
s
Prod
uct
Man
ufac
ture
r
Perc
enta
ge o
f fa
lse
posi
tive
Pf
(or
Pan)
tes
t lin
es b
y in
fect
ious
pat
hoge
n
Deng
ueSc
hist
osom
iasi
s Le
ishm
ania
Chag
as
Lot
1 (n
=8)
Lot
2 (
n=8)
Lot
1 (n
=20)
Lot
2 (
n=20
)Lo
t 1
(n=1
0)Lo
t 2
(n=1
0)Lo
t 1
(n=4
)Lo
t 2
(n=4
)
Pf o
nly
ADVA
NCE
D QU
ALIT
Y TM
MAL
ARIA
(p.f)
POC
T In
Tec
Prod
ucts
, Inc
.0
010
1030
300
75AD
VAN
CED
QUAL
ITY
TM O
ne S
tep
Mal
aria
(p.f.
) Tes
t (w
hole
blo
od)
InTe
c Pr
oduc
ts, I
nc.
500
405.
26 (
19)
3050
7575
Adva
ntag
e P.
f. M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
00
00
00
00
Care
Star
t Mal
aria
HRP
2 (P
f)Ac
cess
Bio
, Inc
.0
00
010
00
0Fi
rst R
espo
nse
Mal
aria
Ag
HRP
2Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
00
00
010
025
Firs
tSig
n –
Mal
aria
Pf C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.0
12.5
05
010
075
Hex
agon
Mal
aria
Hum
an G
mbH
12.5
00
(19)
0 (1
9)0
0 (9
)0
0IC
T M
alar
ia P
f Cas
sett
e Te
st (M
L01)
ICT
Diag
nost
ics
00
00
010
00
Imm
unoq
uick
Mal
aria
Fal
cipa
rum
Bios
ynex
00
00
00
00
Mal
aria
Pla
smod
ium
falc
ipar
um R
apid
test
Dev
ice
(Who
le b
lood
)AC
ON L
abor
ator
ies,
Inc.
00
00
00
00
Mal
aria
Rap
id P
fVi
sion
Bio
tech
(Pty
) Ltd
.0
00
00
00
0Pa
rach
eck
Pf R
apid
test
for P
. fal
cipa
rum
Mal
aria
(Dev
ice)
Or
chid
Bio
med
ical
Sys
tem
s0
00
(18)
0 (1
8)0
(9)
100
25Pa
rach
eck
Pf R
apid
test
for P
. fal
cipa
rum
Mal
aria
(Dip
stic
k)
Orch
id B
iom
edic
al S
yste
ms
012
.55
520
200
0Pa
rahi
t-f D
IPST
ICK
FOR
FALC
IPAR
UM
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
00
00
100
00
Para
hit-
f TES
T DE
VICE
FOR
FAL
CIPA
RUM
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
00
00
00
00
SD B
IOLI
NE
Mal
aria
Ag
Pf
Stan
dard
Dia
gnos
tics,
Inc.
00
00
2030
00
Pf &
Pan
/Pf
& P
vAd
vant
age
Mal
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.0
00
010
00
0AZ
OG M
alar
ia p
f (H
RP-I
I) /p
v (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
eAZ
OG, I
nc.
00
50
010
00
Bina
x N
ow M
alar
ia
Inve
rnes
s M
edic
al In
nova
tions
, Inc
.0
00
00
300
0Ca
reSt
art M
alar
ia H
RP2/
pLDH
(Pf/
PAN
) COM
BOAc
cess
Bio
, Inc
.0
05
00
00
0Fi
rst R
espo
nse
Mal
aria
Ag
Com
bo (P
LDH
/HRP
2)Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
12.5
05
00
00
0Fi
rstS
ign
– Pa
raVi
ew-2
(Pv
+ Pf
) Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
12.5
010
00
100
25H
exag
on M
alar
ia C
ombi
Hum
an G
mbH
00
00
00
00
ICT
Mal
aria
Com
bo C
asse
tte
Test
(ML0
2)IC
T Di
agno
stic
s12
.512
.50
00
00
0Im
mun
oqui
ck M
alar
ia +
4Bi
osyn
ex0
00
50
00
0M
alar
ia P
.F/V
ivax
Diag
nost
ic A
utom
atio
n / C
orte
z Di
agno
stic
s, In
c.0
(2)
0 (3
)25
(4)
0 (9
)0
(4)
0 (3
)0
(1)
N/A
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
012
.55.
26 (
19)
020
2025
0M
alar
ia R
apid
Dua
l Vi
sion
Bio
tech
(Pty
) Ltd
.0
00
00
100
25M
alas
can
Rapi
d Te
st fo
r Mal
aria
Pf/
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
250
00
00
00
One
Step
Mal
aria
Ant
igen
Str
ipIN
D Di
agno
stic
Inc.
0 (7
)0
00
010
00
OnSi
ght –
Par
aQui
ck (P
an, P
f) Te
stAm
geni
x In
tern
atio
nal,
Inc.
00
0 (1
9)0
00
00
OptiM
AL-I
TDi
aMed
AG
00
0 (1
9)0
00
00
Para
hit-
Tota
l Dev
ice
Rapi
d te
st fo
r P. f
alci
paru
m a
nd P
an m
alar
ial s
peci
es.
Span
Dia
gnos
tics
Ltd.
00
50
00
00
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
00
00
010
00
Quic
kstic
k M
alar
ia A
ntig
en T
est
Inno
vate
k M
edic
al In
c.0
(7)
00
00
100
0SD
BIO
LIN
E M
alar
ia A
gSt
anda
rd D
iagn
ostic
s, In
c.0
00
00
00
0SD
BIO
LIN
E M
alar
ia A
g Pf
/Pan
St
anda
rd D
iagn
ostic
s, In
c.0
00
(19)
012
.520
00
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
00
5.26
(19
)10
2020
025
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
00
00
00
00
Care
Star
t Mal
aria
pLD
H (P
AN)
Acce
ss B
io, I
nc.
00
05
1030
025
Para
bank
Rap
id T
est f
or M
alar
ia P
an (D
evic
e)Ze
phyr
Bio
med
ical
s0
00
010
00
0Pf
- P
lasm
odiu
m fa
lcip
arum
Pv
- P
lasm
odiu
m v
ivax
pan
- Pl
asm
odiu
m s
peci
es
† -fo
r Pan
-onl
y te
sts
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)79
Tabl
e A4
.10a
: Fal
se p
osit
ive
rate
of
P. f
alci
paru
m (
or p
an† )
tes
t lin
e re
sult
s fo
r sa
mpl
es c
onta
inin
g sp
ecifi
c no
n-m
alar
ial i
nfec
tiou
s pa
thog
ens
base
d on
a d
elay
ed s
econ
d re
adin
g w
hen
spec
ified
by
the
man
ufac
ture
r
Prod
uct
Man
ufac
ture
r
Perc
enta
ge o
f fa
lse
posi
tive
Pf
(or
Pan)
tes
t lin
es b
y in
fect
ious
pat
hoge
n
Deng
ueSc
hist
osom
iasi
s Le
ishm
ania
Chag
as
Lot
1 (n
=8)
Lot
2 (n
=8)
Lot
1 (n
=20)
Lot
2 (n
=20)
Lot
1 (n
=10)
Lot
2 (n
=10)
Lot
1 (n
=4)
Lot
2 (n
=4)
Pf &
Pan
/Pf
& P
vFi
rstS
ign
– Pa
raVi
ew-2
(Pv
+ Pf
) Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
00
00
00
00
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
012
.50
150
100
0M
alar
ia P
.F/V
ivax
Diag
nost
ic A
utom
atio
n / C
orte
z Di
agno
stic
s, In
c.0
(2)
0 (3
)0
(2)
00
(4)
0 (3
)0
(1)
N/A
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s37
.50
00
00
00
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
00
00
00
00
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
00
15.7
9 (1
9)0
1010
025
Pan
only
Para
bank
Rap
id T
est f
or M
alar
ia P
an (D
evic
e)Ze
phyr
Bio
med
ical
s0
00
010
00
0Pf
- P
lasm
odiu
m fa
lcip
arum
Pv
- P
lasm
odiu
m v
ivax
pan
- Pl
asm
odiu
m s
peci
es
† -fo
r Pan
-onl
y te
sts
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)8 0
Tabl
e A4
.11: F
alse
pos
itiv
e ra
te o
f P.
fal
cipa
rum
(or
pan
† ) t
est
line
resu
lts
for
sam
ples
con
tain
ing
pote
ntia
lly c
ross
-rea
ctin
g bl
ood
imm
unol
ogic
al f
acto
rs
Prod
uct
Man
ufac
ture
r
Perc
enta
ge o
f fa
lse
posi
tive
Pf
(or
Pan)
tes
t lin
es b
y bl
ood
imm
unol
ogic
al f
acto
r
Rheu
mat
oid
fact
orAn
ti-n
ucle
ar a
ntib
odie
sAn
ti-m
ouse
ant
ibod
ies
Rapi
d pl
asm
a re
agin
(RP
R)
posi
tive
Lot
1 (n
=8)
Lot
2 (n
=8)
Lot
1 (n
=26)
Lot
2 (n
=26)
Lot
1 (n
=2)
Lot
2 (n
=2)
Lot
1 (n
=18)
Lot
2 (n
=18)
Pf o
nly
ADVA
NCE
D QU
ALIT
Y TM
MAL
ARIA
(p.f)
POC
T In
Tec
Prod
ucts
, Inc
.25
2530
.77
00
050
11.11
ADVA
NCE
D QU
ALIT
Y TM
One
Ste
p M
alar
ia (p
.f.) T
est (
who
le b
lood
)In
Tec
Prod
ucts
, Inc
.62
.562
.546
.15
19.2
350
5061
.1127
.78
Adva
ntag
e P.
f. M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
00
00
100
500
0Ca
reSt
art M
alar
ia H
RP2
(Pf)
Acce
ss B
io, I
nc.
12.5
00
00
00
0Fi
rst R
espo
nse
Mal
aria
Ag
HRP
2Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
00
00
00
00
Firs
tSig
n –
Mal
aria
Pf C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.0
03.
850
(25)
00
00
Hex
agon
Mal
aria
Hum
an G
mbH
2512
.50
00
00
0IC
T M
alar
ia P
f Cas
sett
e Te
st (M
L01)
ICT
Diag
nost
ics
00
00
050
05.
56Im
mun
oqui
ck M
alar
ia F
alci
paru
mBi
osyn
ex12
.50
03.
850
00
0M
alar
ia P
lasm
odiu
m fa
lcip
arum
Rap
id te
st D
evic
e (W
hole
blo
od)
ACON
Lab
orat
orie
s, In
c.12
.50
00
100
500
0M
alar
ia R
apid
Pf
Visi
on B
iote
ch (P
ty) L
td.
00
00
00
00
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
evic
e)
Orch
id B
iom
edic
al S
yste
ms
12.5
12.5
00
(25)
00
0 (1
7)0
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
ipst
ick)
Or
chid
Bio
med
ical
Sys
tem
s0
12.5
3.85
8 (2
5)0
500
22.2
2Pa
rahi
t-f D
IPST
ICK
FOR
FALC
IPAR
UM
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
00
00
050
00
Para
hit-
f TES
T DE
VICE
FOR
FAL
CIPA
RUM
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
00
00
00
00
SD B
IOLI
NE
Mal
aria
Ag
Pf
Stan
dard
Dia
gnos
tics,
Inc.
00
00
00
00
Pf &
Pan
/Pf
& P
vAd
vant
age
Mal
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.12
.50
03.
850
00
0AZ
OG M
alar
ia p
f (H
RP-I
I) /p
v (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
eAZ
OG, I
nc.
00
00
00
00
Bina
x N
ow M
alar
ia
Inve
rnes
s M
edic
al In
nova
tions
, Inc
.0
00
00
00
0Ca
reSt
art M
alar
ia H
RP2/
pLDH
(Pf/
PAN
) COM
BOAc
cess
Bio
, Inc
.0
00
00
00
0Fi
rst R
espo
nse
Mal
aria
Ag
Com
bo (P
LDH
/HRP
2)Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
00
03.
850
00
5.56
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.0
07.
6915
.38
00
5.56
0H
exag
on M
alar
ia C
ombi
Hum
an G
mbH
00
00
00
00
ICT
Mal
aria
Com
bo C
asse
tte
Test
(ML0
2)IC
T Di
agno
stic
s12
.50
7.69
3.85
050
5.56
0Im
mun
oqui
ck M
alar
ia +
4Bi
osyn
ex0
00
00
00
0
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nost
ics,
Inc.
0 (7
)0
(4)
25 (1
2)0
(9)
0N
/A0
(5)
16.6
7 (6
)
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
00
3.85
11.5
410
00
00
Mal
aria
Rap
id D
ual
Visi
on B
iote
ch (P
ty) L
td.
00
03.
850
00
0M
alas
can
Rapi
d Te
st fo
r Mal
aria
Pf/
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
00
23.0
815
.38
00
05.
56On
e St
ep M
alar
ia A
ntig
en S
trip
IND
Diag
nost
ic In
c.25
00
00
500
0On
Sigh
t – P
araQ
uick
(Pan
, Pf)
Test
Amge
nix
Inte
rnat
iona
l, In
c.0
00
(25)
0 (2
5)0
00
0Op
tiMAL
-IT
DiaM
ed A
G0
12.5
0 (2
4)0
100
00
0Pa
rahi
t-To
tal D
evic
e Ra
pid
test
for P
. fal
cipa
rum
and
Pan
mal
aria
l spe
cies
.Sp
an D
iagn
ostic
s Lt
d.0
00
00
00
5.56
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
012
.50
3.85
00
5.56
0 (1
7)Qu
icks
tick
Mal
aria
Ant
igen
Tes
tIn
nova
tek
Med
ical
Inc.
250
00
050
00
SD B
IOLI
NE
Mal
aria
Ag
Stan
dard
Dia
gnos
tics,
Inc.
2525
00
00
00
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
an
Stan
dard
Dia
gnos
tics,
Inc.
00
0 (2
5)0
00
00
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
00
0 (2
5)11
.54
500
5.88
(17)
5.56
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
00
00
00
00
Care
Star
t Mal
aria
pLD
H (P
AN)
Acce
ss B
io, I
nc.
12.5
00
00
05.
565.
56Pa
raba
nk R
apid
Tes
t for
Mal
aria
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
12.5
12.5
7.69
00
(1)
05.
565.
56Pf
- P
lasm
odiu
m fa
lcip
arum
Pv
- P
lasm
odiu
m v
ivax
pan
- Pl
asm
odiu
m s
peci
es
† - F
or P
an-o
nly
test
s
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)81
Tabl
e A4
.11a:
Fal
se p
osit
ive
rate
of P
. fal
cipa
rum
(or p
an† )
tes
t lin
e re
sult
s for
sam
ples
con
tain
ing
pote
ntia
lly c
ross
-rea
ctin
g bl
ood
imm
unol
ogic
al fa
ctor
s bas
ed o
n a
dela
yed
read
ing
whe
n sp
ecifi
ed b
y th
e m
anuf
actu
rer
Prod
uct
Man
ufac
ture
r
Perc
enta
ge o
f fa
lse
posi
tive
Pf
(or
Pan)
tes
t lin
es b
y bl
ood
imm
unol
ogic
al f
acto
r
Rheu
mat
oid
fact
orAn
ti-n
ucle
ar a
ntib
odie
sAn
ti-m
ouse
ant
ibod
ies
Rapi
d pl
asm
a re
agin
(RP
R)
posi
tive
Lot
1 (n
=8)
Lot
2 (n
=8)
Lot
1 (n
=26)
Lot
2 (n
=26)
Lot
1 (n
=2)
Lot
2 (n
=2)
Lot
1 (n
=18)
Lot
2 (n
=18)
Pf &
Pan
/Pf
& P
vFi
rstS
ign
– Pa
raVi
ew-2
(Pv
+ Pf
) Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
00
3.85
00
00
0Im
mun
oqui
ck M
alar
ia +
4Bi
osyn
ex0
00
19.2
350
500
38.8
9M
alar
ia P
.F/V
ivax
Diag
nost
ic A
utom
atio
n / C
orte
z Di
agno
stic
s, In
c.0
(7)
0 (4
)23
.08
(13)
0 (9
)0
N/A
0 (6
)16
.67
(6)
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s0
030
.77
7.69
00
00
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
00
03.
850
00
0W
ondf
o On
e St
ep M
alar
ia P
f/Pa
n W
hole
Blo
od T
est
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
., Lt
d0
04.
35 (2
3)11
.54
00
5.88
(17)
11.11
Pan
only
Para
bank
Rap
id T
est f
or M
alar
ia P
an (D
evic
e)Ze
phyr
Bio
med
ical
s0
011
.54
050
00
0Pf
- P
lasm
odiu
m fa
lcip
arum
Pv
- P
lasm
odiu
m v
ivax
pan
- Pl
asm
odiu
m s
peci
es
† - F
or P
an-o
nly
test
s
Tabl
e A4
.11: F
alse
pos
itiv
e ra
te o
f P.
fal
cipa
rum
(or
pan
† ) t
est
line
resu
lts
for
sam
ples
con
tain
ing
pote
ntia
lly c
ross
-rea
ctin
g bl
ood
imm
unol
ogic
al f
acto
rs
Prod
uct
Man
ufac
ture
r
Perc
enta
ge o
f fa
lse
posi
tive
Pf
(or
Pan)
tes
t lin
es b
y bl
ood
imm
unol
ogic
al f
acto
r
Rheu
mat
oid
fact
orAn
ti-n
ucle
ar a
ntib
odie
sAn
ti-m
ouse
ant
ibod
ies
Rapi
d pl
asm
a re
agin
(RP
R)
posi
tive
Lot
1 (n
=8)
Lot
2 (n
=8)
Lot
1 (n
=26)
Lot
2 (n
=26)
Lot
1 (n
=2)
Lot
2 (n
=2)
Lot
1 (n
=18)
Lot
2 (n
=18)
Pf o
nly
ADVA
NCE
D QU
ALIT
Y TM
MAL
ARIA
(p.f)
POC
T In
Tec
Prod
ucts
, Inc
.25
2530
.77
00
050
11.11
ADVA
NCE
D QU
ALIT
Y TM
One
Ste
p M
alar
ia (p
.f.) T
est (
who
le b
lood
)In
Tec
Prod
ucts
, Inc
.62
.562
.546
.15
19.2
350
5061
.1127
.78
Adva
ntag
e P.
f. M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
00
00
100
500
0Ca
reSt
art M
alar
ia H
RP2
(Pf)
Acce
ss B
io, I
nc.
12.5
00
00
00
0Fi
rst R
espo
nse
Mal
aria
Ag
HRP
2Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
00
00
00
00
Firs
tSig
n –
Mal
aria
Pf C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.0
03.
850
(25)
00
00
Hex
agon
Mal
aria
Hum
an G
mbH
2512
.50
00
00
0IC
T M
alar
ia P
f Cas
sett
e Te
st (M
L01)
ICT
Diag
nost
ics
00
00
050
05.
56Im
mun
oqui
ck M
alar
ia F
alci
paru
mBi
osyn
ex12
.50
03.
850
00
0M
alar
ia P
lasm
odiu
m fa
lcip
arum
Rap
id te
st D
evic
e (W
hole
blo
od)
ACON
Lab
orat
orie
s, In
c.12
.50
00
100
500
0M
alar
ia R
apid
Pf
Visi
on B
iote
ch (P
ty) L
td.
00
00
00
00
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
evic
e)
Orch
id B
iom
edic
al S
yste
ms
12.5
12.5
00
(25)
00
0 (1
7)0
Para
chec
k Pf
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia (D
ipst
ick)
Or
chid
Bio
med
ical
Sys
tem
s0
12.5
3.85
8 (2
5)0
500
22.2
2Pa
rahi
t-f D
IPST
ICK
FOR
FALC
IPAR
UM
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
00
00
050
00
Para
hit-
f TES
T DE
VICE
FOR
FAL
CIPA
RUM
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
00
00
00
00
SD B
IOLI
NE
Mal
aria
Ag
Pf
Stan
dard
Dia
gnos
tics,
Inc.
00
00
00
00
Pf &
Pan
/Pf
& P
vAd
vant
age
Mal
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.12
.50
03.
850
00
0AZ
OG M
alar
ia p
f (H
RP-I
I) /p
v (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
eAZ
OG, I
nc.
00
00
00
00
Bina
x N
ow M
alar
ia
Inve
rnes
s M
edic
al In
nova
tions
, Inc
.0
00
00
00
0Ca
reSt
art M
alar
ia H
RP2/
pLDH
(Pf/
PAN
) COM
BOAc
cess
Bio
, Inc
.0
00
00
00
0Fi
rst R
espo
nse
Mal
aria
Ag
Com
bo (P
LDH
/HRP
2)Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
00
03.
850
00
5.56
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.0
07.
6915
.38
00
5.56
0H
exag
on M
alar
ia C
ombi
Hum
an G
mbH
00
00
00
00
ICT
Mal
aria
Com
bo C
asse
tte
Test
(ML0
2)IC
T Di
agno
stic
s12
.50
7.69
3.85
050
5.56
0Im
mun
oqui
ck M
alar
ia +
4Bi
osyn
ex0
00
00
00
0
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nost
ics,
Inc.
0 (7
)0
(4)
25 (1
2)0
(9)
0N
/A0
(5)
16.6
7 (6
)
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
00
3.85
11.5
410
00
00
Mal
aria
Rap
id D
ual
Visi
on B
iote
ch (P
ty) L
td.
00
03.
850
00
0M
alas
can
Rapi
d Te
st fo
r Mal
aria
Pf/
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
00
23.0
815
.38
00
05.
56On
e St
ep M
alar
ia A
ntig
en S
trip
IND
Diag
nost
ic In
c.25
00
00
500
0On
Sigh
t – P
araQ
uick
(Pan
, Pf)
Test
Amge
nix
Inte
rnat
iona
l, In
c.0
00
(25)
0 (2
5)0
00
0Op
tiMAL
-IT
DiaM
ed A
G0
12.5
0 (2
4)0
100
00
0Pa
rahi
t-To
tal D
evic
e Ra
pid
test
for P
. fal
cipa
rum
and
Pan
mal
aria
l spe
cies
.Sp
an D
iagn
ostic
s Lt
d.0
00
00
00
5.56
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
012
.50
3.85
00
5.56
0 (1
7)Qu
icks
tick
Mal
aria
Ant
igen
Tes
tIn
nova
tek
Med
ical
Inc.
250
00
050
00
SD B
IOLI
NE
Mal
aria
Ag
Stan
dard
Dia
gnos
tics,
Inc.
2525
00
00
00
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
an
Stan
dard
Dia
gnos
tics,
Inc.
00
0 (2
5)0
00
00
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
00
0 (2
5)11
.54
500
5.88
(17)
5.56
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
00
00
00
00
Care
Star
t Mal
aria
pLD
H (P
AN)
Acce
ss B
io, I
nc.
12.5
00
00
05.
565.
56Pa
raba
nk R
apid
Tes
t for
Mal
aria
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
12.5
12.5
7.69
00
(1)
05.
565.
56Pf
- P
lasm
odiu
m fa
lcip
arum
Pv
- P
lasm
odiu
m v
ivax
pan
- Pl
asm
odiu
m s
peci
es
† - F
or P
an-o
nly
test
s
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)82
Tabl
e A4
.12:
Fal
se p
osit
ive
rate
of
pan/
P. v
ivax
tes
t lin
e re
sult
s on
all
mal
aria
-neg
ativ
e sa
mpl
es
Prod
uct
Man
ufac
ture
r
Perc
enta
ge o
f fa
lse
posi
tive
pan
tes
t lin
es o
n ”c
lean
” ne
gati
ve s
ampl
es
Perc
enta
ge o
f fa
lse
posi
tive
pan
tes
t lin
es o
n sa
mpl
es c
onta
inin
g no
n-Pl
asm
odiu
m in
fect
ious
age
nts
Perc
enta
ge o
f fa
lse
posi
tive
pan
te
st li
nes
on s
ampl
es c
onta
inin
g im
mun
olog
ical
fac
tors
Lot
1 (n
=84)
Lot
2 (n
=84)
Ove
rall
(n=1
68)
Lot
1 (n
=42)
Lot
2 (n
=42)
Ove
rall
(n=8
4)Lo
t 1
(n=5
4)Lo
t 2
(n=5
4)O
vera
ll (n
=108
)
Pf &
Pan
/Pf
& P
v
Adva
ntag
e M
al C
ard
J. M
itra
& C
o. P
vt. L
td.
3.57
3.57
3.57
2.38
(42)
4.76
(42)
3.57
1.85
3.7
2.78
AZOG
Mal
aria
pf (
HRP
-II)
/pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
AZOG
, Inc
.2.
3814
.29
8.33
4.76
(42)
11.9
(42)
8.33
3.7
12.9
68.
33
Bina
x N
ow M
alar
ia
Inve
rnes
s M
edic
al In
nova
tions
, Inc
.0
00
0 (4
2)0
(42)
00
00
Care
Star
t Mal
aria
HRP
2/pL
DH (P
f/PA
N) C
OMBO
Acce
ss B
io, I
nc.
2.38
2.38
2.38
2.38
(42)
2.38
(42)
2.38
1.85
00.
93
Firs
t Res
pons
e M
alar
ia A
g Co
mbo
(PLD
H/H
RP2)
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.0
2.38
1.19
0 (4
2)0
(42)
00
00
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.5.
95 (8
4)3.
61 (8
3)4.
79 (1
67)
7.14
(42)
0 (4
2)3.
57 (8
4)3.
7 (5
4)7.
41 (5
4)5.
56 (1
08)
Hex
agon
Mal
aria
Com
biH
uman
Gm
bH0
1.2
(83)
0.6
(167
)0
(42)
0 (4
2)0
03.
71.
85
ICT
Mal
aria
Com
bo C
asse
tte
Test
(ML0
2)IC
T Di
agno
stic
s0
00
0 (4
2)0
(42)
05.
565.
565.
56
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
01.
190.
60
(42)
0 (4
2)0
5.56
3.7
4.63
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nost
ics,
Inc.
0 (3
5)3.
45 (2
9)1.
56 (6
4)0
(11)
0 (1
5)0
(26)
7.69
(26)
5.26
(19)
6.67
(45)
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
5.95
7.14
6.55
9.76
(41)
7.14
(42)
8.43
(83)
7.41
7.41
7.41
Mal
aria
Rap
id D
ual
Visi
on B
iote
ch (P
ty) L
td.
020
.24
10.1
20
(42)
11.9
(42)
5.95
5.56
20.3
712
.96
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s0
00
2.38
(42)
0 (4
2)1.
193.
77.
415.
56
One
Step
Mal
aria
Ant
igen
Str
ipIN
D Di
agno
stic
Inc.
02.
41 (8
3)1.
2 (1
67)
0 (4
1)0
(42)
0 (8
3)1.
851.
851.
85
OnSi
ght –
Par
aQui
ck (P
an, P
f) Te
stAm
geni
x In
tern
atio
nal,
Inc.
00
00
(41)
0 (4
2)0
(83)
0 (5
3)1.
89 (5
3)0.
94 (1
06)
OptiM
AL-I
TDi
aMed
AG
0 (8
3)0
0 (1
67)
0 (4
1)0
(42)
0 (8
3)3.
85 (5
2)3.
73.
77 (1
06)
Para
hit-
Tota
l Dev
ice
Rapi
d te
st fo
r P. f
alci
paru
m a
nd P
an m
alar
ial s
peci
es.
Span
Dia
gnos
tics
Ltd.
00
00
(42)
0 (4
2)0
3.7
1.85
2.78
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
00
00
(42)
0 (4
2)0
00
(53)
0 (1
07)
Quic
kstic
k M
alar
ia A
ntig
en T
est
Inno
vate
k M
edic
al In
c.0
2.41
(83)
1.2
(167
)0
(41)
0 (4
2)0
(83)
1.85
1.85
1.85
SD B
IOLI
NE
Mal
aria
Ag
Stan
dard
Dia
gnos
tics,
Inc.
1.19
00.
60
(42)
0 (4
2)0
00
0
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
an
Stan
dard
Dia
gnos
tics,
Inc.
01.
190.
60
(39)
0 (4
2)0
(81)
0 (5
3)0
0 (1
07)
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
2.41
(83)
5.95
4.19
(167
)0
(41)
2.38
(42)
1.2
(83)
5.77
(52)
7.41
6.6
(106
)
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
1.19
2.38
1.79
0 (4
2)0
(42)
00
00
Care
Star
t Mal
aria
pLD
H (P
AN)
Acce
ss B
io, I
nc.
4.76
8.33
6.55
2.38
(42)
11.9
(42)
7.14
3.7
1.85
2.78
Para
bank
Rap
id T
est f
or M
alar
ia P
an (D
evic
e)Ze
phyr
Bio
med
ical
s3.
61 (8
3)2.
382.
99 (1
67)
2.38
(42)
0 (4
2)1.
197.
55 (5
3)3.
75.
61 (1
07)
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spe
cies
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)83
Tabl
e A4
.12a
: Fal
se p
osit
ive
rate
of
pan
test
line
res
ults
on
all m
alar
ia-n
egat
ive
sam
ples
bas
ed o
n a
dela
yed
seco
nd r
eadi
ng w
hen
spec
ified
by
the
man
ufac
ture
r
Prod
uct
Man
ufac
ture
r
Perc
enta
ge o
f fa
lse
posi
tive
pan
tes
t lin
es o
n ”c
lean
” ne
gati
ve s
ampl
es
Perc
enta
ge o
f fa
lse
posi
tive
pan
tes
t lin
es
on s
ampl
es c
onta
inin
g no
n-Pl
asm
odiu
m
infe
ctio
us a
gent
s
Perc
enta
ge o
f fa
lse
posi
tive
pan
tes
t lin
es o
n sa
mpl
es c
onta
inin
g im
mun
olog
ical
fac
tors
Lot
1
(n=8
4)Lo
t 2
(n
=84)
Ove
rall
(n=1
68)
Lot
1 (n
=42)
Lot
2 (n
=42)
Ove
rall
(n=8
4)Lo
t 1
(n=5
4)Lo
t 2
(n=5
4)O
vera
ll (n
=108
)
Pf &
Pan
/Pf
& P
v
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
1.19
11.9
6.55
016
.67
8.33
9.26
25.9
317
.59
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nost
ics,
Inc.
0 (3
1)0
(31)
0 (6
2)0
(9)
0 (1
4)0
(23)
7.14
(28)
10.5
3 (1
9)8.
51 (4
7)
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s1.
190
0.6
00
03.
77.
415.
56
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
1.19
1.19
1.19
00
00
00
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
3.66
(82)
5.95
4.82
(166
)0
(41)
9.52
4.82
(83)
10 (5
0)9.
269.
62 (1
04)
Pan
only
Para
bank
Rap
id T
est f
or M
alar
ia P
an (D
evic
e)Ze
phyr
Bio
med
ical
s1.
22 (8
2)1.
191.
2 (1
66)
2.38
01.
197.
410
3.7
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spe
cies
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)8 4
Tabl
e A4
.13:
Hea
t st
abili
ty t
esti
ng r
esul
ts f
or P
f te
st li
ne o
n P.
fal
cipa
rum
sam
ples
at
low
par
asit
e de
nsit
y (2
00 p
aras
ites
/μl)
. Pos
itiv
ity
rate
at
base
line,
and
aft
er 6
0 da
ys
incu
bati
on a
t 35
°C a
nd 4
5°C
Prod
uct
Man
ufac
ture
r
Base
line
test
ing
35°C
45°C
Lot
1 (n
=10)
Lot
2 (n
=10)
Lot
1 (n
=10)
Lot
2 (n
=10)
Lot
1 (n
=10)
Lot
2 (n
=10)
No.
po
si-ti
ve
No.
in
valid
Mea
n ba
nd
inte
nsit
y
No.
po
si-ti
ve
No.
in
valid
Mea
n ba
nd
inte
nsit
y
No.
po
si-ti
ve
No.
in
valid
Mea
n ba
nd
inte
nsit
y
No.
po
si-ti
ve
No.
in
valid
Mea
n ba
nd
inte
nsit
y
No.
po
si-ti
ve
No.
in
valid
Mea
n ba
nd
inte
nsit
y
No.
po
si-ti
ve
No.
in
valid
Mea
n ba
nd
inte
nsit
y
Pf o
nly
test
sAD
VAN
CED
QUAL
ITY
TM M
ALAR
IA (p
.f) P
OCT
InTe
c Pr
oduc
ts, I
nc.
100
1.1
60
19
01.
2210
02
80
1.13
100
1.4
ADVA
NCE
D QU
ALIT
Y TM
One
Ste
p M
alar
ia (p
.f.) T
est
(who
le b
lood
)In
Tec
Prod
ucts
, Inc
.10
01
60
17
01
100
1.7
70
1.14
20
1
Adva
ntag
e P.
f. M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
100
1.9
90
2.78
100
2.1
100
2.8
100
2.8
100
2.4
Care
Star
t Mal
aria
HRP
2 (P
f)Ac
cess
Bio
, Inc
.10
03.
710
02
100
3.6
100
1.7
100
310
02.
6Fi
rst R
espo
nse
Mal
aria
Ag
HRP
2Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
100
310
03
100
210
03.
110
02.
510
02.
8Fi
rstS
ign
– M
alar
ia P
f Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
40
1.25
00
N/A
10
12
01
00
N/A
02
N/A
Hex
agon
Mal
aria
Hum
an G
mbH
60
1.17
40
10
0N
/A7
01
70
15
01.
2IC
T M
alar
ia P
f Rap
id T
est (
ML0
1)IC
T Di
agno
stic
s10
01.
810
01.
810
02.
310
01.
810
02
90
1.78
Imm
unoq
uick
Mal
aria
Fal
cipa
rum
Bios
ynex
100
2.1
100
210
02
100
2.3
100
210
02.
6M
alar
ia P
lasm
odiu
m fa
lcip
arum
Rap
id te
st D
evic
e (W
hole
bl
ood)
ACON
Lab
orat
orie
s, In
c.10
02
100
2.3
100
2.1
100
2.4
100
210
02.
3
Mal
aria
Rap
id P
fVi
sion
Bio
tech
(Pty
) Ltd
.10
01.
610
01.
910
01.
210
01.
87
01
100
1.4
Para
chec
k Pf
Rap
id T
est f
or P
. fal
cipa
rum
Mal
aria
(Dev
ice)
Orch
id B
iom
edic
al S
yste
ms
100
28
01.
639
01.
785
21.
44
01
60
1.33
Para
chec
k Pf
Rap
id T
est f
or P
. fal
cipa
rum
Mal
aria
(D
ipst
ick)
Orch
id B
iom
edic
al S
yste
ms
100
1.4
90
1.11
100
1.8
100
1.4
80
1.5
91
1.33
Para
hit-
f DIP
STIC
K FO
R FA
LCIP
ARU
M M
ALAR
IASp
an D
iagn
ostic
s Lt
d.10
01.
210
02
100
110
02.
110
01.
810
02
Para
hit-
f TES
T DE
VICE
FOR
FAL
CIPA
RUM
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
90
15
01
60
14
01
60
12
01
SD B
IOLI
NE
Mal
aria
Ag
Pf
Stan
dard
Dia
gnos
tics,
Inc.
100
310
02.
610
03
100
310
02.
210
02.
9Pf
line
of
com
bina
tion
tes
tsAd
vant
age
Mal
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.10
01.
510
01.
810
01.
710
02
10
110
01.
4 A
ZOG
Mal
aria
pf (
HRP
-II)/
pv (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
eAZ
OG, I
nc.
80
14
01
70
16
01
60
11
01
Bina
x N
ow M
alar
iaIn
vern
ess
Med
ical
Inno
vatio
ns, I
nc.
100
1.8
100
210
02.
310
02
100
2.1
100
2.5
Care
Star
t Mal
aria
HRP
2/pL
DH (P
f/PA
N) C
OMBO
Acce
ss B
io, I
nc.
100
2.8
100
39
13
100
110
02.
510
02.
2Fi
rst R
espo
nse
Mal
aria
Ag
Com
bo (P
LDH
/HRP
2)Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
100
310
03
100
310
03
100
2.5
100
3Fi
rstS
ign
– Pa
raVi
ew-2
(Pv
+ Pf
) Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
100
1.5
90
15
01
90
1.33
01
N/A
02
N/A
Hex
agon
Mal
aria
Com
biH
uman
Gm
bH8
01
50
14
11
70
15
01
50
1IC
T M
alar
ia C
ombo
Cas
sett
e Te
st (M
L02)
ICT
Diag
nost
ics
100
2.2
100
2.5
100
2.4
100
2.1
100
210
02.
6Im
mun
oqui
ck M
alar
ia +
4Bi
osyn
ex10
02.
710
02.
910
03
100
210
02.
910
03.
1
Mal
aria
P.F
/VIV
AXDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nost
ics,
Inc.
82
2.5
55
2.4
19
42
83.
53
73
19
3
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
100
2.4
100
210
02.
210
02.
110
02.
210
02.
2M
alar
ia R
apid
Dua
lVi
sion
Bio
tech
(Pty
) Ltd
.10
01.
910
01.
710
02.
110
02.
310
01.
810
01.
9M
alas
can
Rapi
d Te
st fo
r Mal
aria
Pf/
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
100
19
01.
449
01.
679
01.
3310
01
70
1.71
One
Step
Mal
aria
Ant
igen
Str
ipIN
D Di
agno
stic
Inc.
30
10
0N
/A0
0N
/A0
4N
/A0
0N
/A0
2N
/AOn
Sigh
t – P
araQ
uick
(Pan
, Pf)
Amge
nix
Inte
rnat
iona
l, In
c.10
01.
310
02.
310
02
80
1.75
80
1.75
40
1Op
tiMAL
- IT
DiaM
ed A
G6
01
00
N/A
10
11
01
00
N/A
09
N/A
Para
hitT
otal
Dev
ice
Rapi
d Te
st fo
r P. f
alci
paru
m a
nd P
an
Mal
aria
l Spe
cies
Span
Dia
gnos
tics
Ltd.
80
1.13
50
18
01
70
13
01
20
2
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
100
1.6
90
2.22
80
1.75
80
1.88
70
12
01
Quic
kstic
k M
alar
ia A
ntig
en T
est
Inno
vate
k M
edic
al In
c.3
01
00
N/A
00
N/A
04
N/A
00
N/A
02
N/A
SD B
IOLI
NE
Mal
aria
Ag
Stan
dard
Dia
gnos
tics,
Inc.
20
15
01
80
14
01
90
16
01
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
anSt
anda
rd D
iagn
ostic
s, In
c.10
02.
810
02.
310
01.
710
02
100
210
02.
9W
ondf
o On
e St
ep M
alar
ia P
f/Pa
n W
hole
Blo
od T
est
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
., Lt
d10
01
100
1.1
91
1.89
100
2.1
100
110
01.
8Pf
- P
lasm
odiu
m fa
lcip
arum
Pv
- P
lasm
odiu
m v
ivax
pan
- Pl
asm
odiu
m s
peci
es
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)8 5
Tabl
e A4
.13a
: Hea
t st
abili
ty t
esti
ng r
esul
ts f
or p
an t
est
line
of c
ombi
nati
on R
DTs
on P
. fal
cipa
rum
sam
ples
at
low
par
asit
e de
nsit
y (2
00 p
aras
ites
/μl)
. Pos
itiv
ity
rate
at
base
line,
and
aft
er 6
0 da
ys in
cuba
tion
at
35°C
and
45°
C
Prod
uct
Man
ufac
ture
r
Base
line
test
ing
35°C
45°C
Lot
1 (n
=10)
Lot
2 (n
=10)
Lot
1 (n
=10)
Lot
2 (n
=10)
Lot
1 (n
=10)
Lot
2 (n
=10)
No.
po
si-
tive
No.
in
valid
Mea
n ba
nd
inte
n-si
ty
No.
po
si-
tive
No.
in
valid
Mea
n ba
nd
inte
n-si
ty
No.
po
si-
tive
No.
in
valid
Mea
n ba
nd
inte
n-si
ty
No.
po
si-
tive
No.
in
valid
Mea
n ba
nd
inte
n-si
ty
No.
po
si-
tive
No.
in
valid
Mea
n ba
nd
inte
n-si
ty
No.
po
si-
tive
No.
in
valid
Mea
n ba
nd
inte
n-si
ty
Pf &
Pan
/Pv
& P
anAd
vant
age
Mal
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.8
01
30
15
01
40
18
01
00
N/A
AZO
G M
alar
ia p
f (H
RP-I
I)/pv
(pLD
H) A
ntig
en
Dete
ctio
n Te
st D
evic
eAZ
OG, I
nc.
00
N/A
80
10
0N
/A7
01
00
N/A
50
2
Bina
x N
ow M
alar
iaIn
vern
ess
Med
ical
Inno
va-
tions
, Inc
.0
0N
/A1
01
00
N/A
00
N/A
00
N/A
00
N/A
Care
Star
t Mal
aria
HRP
2/pL
DH (P
f/PA
N)
COM
BOAc
cess
Bio
, Inc
.10
01
100
19
11
100
1.8
100
1.4
100
1
Firs
t Res
pons
e M
alar
ia A
g Co
mbo
(PLD
H/
HRP
2)Pr
emie
r Med
ical
Cor
pora
-tio
n Lt
d.9
01
100
16
01
80
110
01
100
1
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.0
0N
/A0
0N
/A0
0N
/A0
0N
/A0
1N
/A0
2N
/AH
exag
on M
alar
ia C
ombi
Hum
an G
mbH
00
N/A
00
N/A
01
N/A
00
N/A
00
N/A
00
N/A
ICT
Mal
aria
Com
bo C
asse
tte
Test
(ML0
2)IC
T Di
agno
stic
s0
0N
/A1
01
10
20
0N
/A0
0N
/A0
0N
/AIm
mun
oqui
ck M
alar
ia +
4Bi
osyn
ex0
0N
/A0
0N
/A0
0N
/A0
0N
/A0
0N
/A0
0N
/A
Mal
aria
P.F
/VIV
AXDi
agno
stic
Aut
omat
ion
/ Co
rtez
Dia
gnos
tics,
Inc.
02
N/A
05
N/A
09
N/A
08
N/A
07
N/A
09
N/A
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
30
10
0N
/A2
01
40
10
0N
/A0
0N
/AM
alar
ia R
apid
Dua
lVi
sion
Bio
tech
(Pty
) Ltd
.0
0N
/A0
0N
/A0
0N
/A3
01.
333
00
N/A
00
N/A
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s0
0N
/A0
0N
/A0
0N
/A1
01
00
N/A
00
N/A
One
Step
Mal
aria
Ant
igen
Str
ipIN
D Di
agno
stic
Inc.
30
10
0N
/A0
0N
/A0
4N
/A0
0N
/A0
2N
/AOn
Sigh
t – P
araQ
uick
(Pan
, Pf)
Amge
nix
Inte
rnat
iona
l, In
c.0
0N
/A0
0N
/A0
0N
/A0
0N
/A0
0N
/A0
0N
/AOp
tiMAL
- IT
DiaM
ed A
G6
01
00
N/A
10
12
01
00
N/A
09
N/A
Para
hitT
otal
Dev
ice
Rapi
d Te
st fo
r P. f
alci
pa-
rum
and
Pan
Mal
aria
l Spe
cies
Span
Dia
gnos
tics
Ltd.
00
N/A
10
10
0N
/A0
0N
/A0
0N
/A0
0N
/A
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf
(Dev
ice)
Zeph
yr B
iom
edic
als
10
10
0N
/A0
0N
/A0
0N
/A0
0N
/A0
0N
/A
Quic
kstic
k M
alar
ia A
ntig
en T
est
Inno
vate
k M
edic
al In
c.3
01
00
N/A
00
N/A
04
N/A
00
N/A
02
N/A
SD B
IOLI
NE
Mal
aria
Ag
Stan
dard
Dia
gnos
tics,
Inc.
00
N/A
00
N/A
40
15
01
90
16
01
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
anSt
anda
rd D
iagn
ostic
s, In
c.0
0N
/A0
0N
/A0
0N
/A1
01
90
17
01.
43W
ondf
o On
e St
ep M
alar
ia P
f/Pa
n W
hole
Bl
ood
Test
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
., Lt
d9
01
50
18
11
100
110
01
40
1.25
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
80
12
01
60
17
01
90
15
01
Care
Star
t Mal
aria
pLD
H (P
AN)
Acce
ss B
io, I
nc.
100
1.1
100
1.1
100
110
01
80
110
01
Para
bank
Rap
id T
est f
or M
alar
ia P
an (D
evic
e)Ze
phyr
Bio
med
ical
s0
0N
/A1
01
01
N/A
00
N/A
01
N/A
00
N/A
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spe
cies
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)8 6
Tabl
e A4
.14:
Hea
t st
abili
ty t
esti
ng r
esul
ts f
or P
f te
st li
ne o
n P.
fal
cipa
rum
sam
ples
at
high
par
asit
e de
nsit
y (2
000
para
site
s/μl
). P
osit
ivit
y ra
te a
t ba
selin
e, a
nd a
fter
60
days
incu
bati
on a
t 35
°C a
nd 4
5°C
Prod
uct
Man
ufac
ture
r
Base
line
test
ing
35°C
45°C
Lot
1 (n
=10)
Lot
2 (n
=10)
Lot
1 (n
=10)
Lot
2 (n
=10)
Lot
1 (n
=10)
Lot
2 (n
=10)
No.
po
si-ti
ve
No.
in
valid
Mea
n ba
nd
inte
nsit
y
No.
po
si-ti
ve
No.
in
valid
Mea
n ba
nd
inte
nsit
y
No.
po
si-ti
ve
No.
in
valid
Mea
n ba
nd
inte
nsit
y
No.
po
si-ti
ve
No.
in
valid
Mea
n ba
nd
inte
nsit
y
No.
po
si-ti
ve
No.
in
valid
Mea
n ba
nd
inte
nsit
y
No.
po
si-ti
ve
No.
in
valid
Mea
n ba
nd
inte
nsit
y
Pf o
nly
test
sAD
VAN
CED
QUAL
ITY
TM M
ALAR
IA (p
.f) P
OCT
InTe
c Pr
oduc
ts, I
nc.
100
3.6
100
2.9
100
3.1
100
3.7
100
2.9
100
2.8
ADVA
NCE
D QU
ALIT
Y TM
One
Ste
p M
alar
ia (p
.f.) T
est
(who
le b
lood
)In
Tec
Prod
ucts
, Inc
.10
02.
510
03.
39
02.
6710
02.
610
03.
110
02.
4
Adva
ntag
e P.
f. M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
100
410
03.
910
04
100
410
04
100
3.9
Care
Star
t Mal
aria
HRP
2 (P
f)Ac
cess
Bio
, Inc
.10
04
100
410
04
100
410
04
100
3.8
Firs
t Res
pons
e M
alar
ia A
g H
RP2
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.10
04
100
410
03.
910
04
100
3.9
100
4Fi
rstS
ign
– M
alar
ia P
f Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
100
2.8
100
2.8
90
1.11
90
2.67
100
1.4
90
2.67
Hex
agon
Mal
aria
Hum
an G
mbH
90
2.11
100
2.6
100
2.3
100
2.5
100
2.3
100
2.9
ICT
Mal
aria
Pf R
apid
Tes
t (M
L01)
ICT
Diag
nost
ics
100
3.8
100
410
03.
710
04
100
3.2
100
3.5
Imm
unoq
uick
Mal
aria
Fal
cipa
rum
Bios
ynex
100
410
04
100
3.9
100
3.9
100
410
04
Mal
aria
Pla
smod
ium
falc
ipar
um R
apid
test
Dev
ice
(Who
le b
lood
)AC
ON L
abor
ator
ies,
Inc.
100
3.2
100
410
04
100
3.9
100
310
03.
9
Mal
aria
Rap
id P
fVi
sion
Bio
tech
(Pty
) Ltd
.10
03.
110
03.
810
02.
910
03.
210
02.
410
03.
1Pa
rach
eck
Pf R
apid
Tes
t for
P. f
alci
paru
m M
alar
ia
(Dev
ice)
Orch
id B
iom
edic
al S
yste
ms
100
1.9
100
3.7
73
3.71
100
3.5
100
3.1
100
3.8
Para
chec
k Pf
Rap
id T
est f
or P
. fal
cipa
rum
Mal
aria
(D
ipst
ick)
Orch
id B
iom
edic
al S
yste
ms
100
310
03
100
310
03.
310
02.
410
03.
4
Para
hit-
f DIP
STIC
K FO
R FA
LCIP
ARU
M M
ALAR
IASp
an D
iagn
ostic
s Lt
d.10
03.
910
03.
910
03
100
410
03.
310
04
Para
hit-
f TES
T DE
VICE
FOR
FAL
CIPA
RUM
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
100
2.7
100
2.7
91
2.44
100
2.4
90
2.67
100
2.9
SD B
IOLI
NE
Mal
aria
Ag
Pf
Stan
dard
Dia
gnos
tics,
Inc.
100
410
04
100
410
04
100
410
04
Pf li
ne o
f co
mbi
nati
on t
ests
Adva
ntag
e M
al C
ard
J. M
itra
& C
o. P
vt. L
td.
91
3.33
100
3.8
100
3.9
100
3.8
90
2.44
100
3.2
AZO
G M
alar
ia p
f (H
RP-I
I)/pv
(pLD
H) A
ntig
en D
etec
-tio
n Te
st D
evic
eAZ
OG, I
nc.
100
210
02.
710
02.
210
02.
710
02.
910
02.
4
Bina
x N
ow M
alar
iaIn
vern
ess
Med
ical
Inno
vatio
ns, I
nc.
100
3.6
100
3.8
100
410
03.
810
03.
99
14
Care
Star
t Mal
aria
HRP
2/pL
DH (P
f/PA
N) C
OMBO
Acce
ss B
io, I
nc.
100
410
04
100
410
04
100
3.9
100
3.9
Firs
t Res
pons
e M
alar
ia A
g Co
mbo
(PLD
H/H
RP2)
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.10
04
100
410
04
100
410
04
100
4Fi
rstS
ign
– Pa
raVi
ew-2
(Pv
+ Pf
) Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
100
410
03.
49
12.
4410
03.
910
02.
35
12.
6H
exag
on M
alar
ia C
ombi
Hum
an G
mbH
100
2.7
100
2.8
100
3.1
72
2.57
100
2.1
90
3IC
T M
alar
ia C
ombo
Cas
sett
e Te
st (M
L02)
ICT
Diag
nost
ics
100
410
04
100
410
04
100
3.8
100
4Im
mun
oqui
ck M
alar
ia +
4Bi
osyn
ex10
04
100
410
04
100
410
03.
910
03.
7
Mal
aria
P.F
/VIV
AXDi
agno
stic
Aut
omat
ion
/ Cor
tez
Dia-
gnos
tics,
Inc.
64
47
34
36
3.67
64
3.67
19
10
9N
/A
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
100
410
04
100
410
03.
910
03.
910
04
Mal
aria
Rap
id D
ual
Visi
on B
iote
ch (P
ty) L
td.
100
410
03.
810
03.
310
03.
210
03.
710
03.
4M
alas
can
Rapi
d Te
st fo
r Mal
aria
Pf/
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
100
2.8
100
310
03.
310
03.
310
03
100
3On
e St
ep M
alar
ia A
ntig
en S
trip
IND
Diag
nost
ic In
c.10
01
30
110
01
00
N/A
00
N/A
05
N/A
OnSi
ght –
Par
aQui
ck (P
an, P
f)Am
geni
x In
tern
atio
nal,
Inc.
100
3.8
100
3.9
100
3.8
100
410
03.
810
04
OptiM
AL-
ITDi
aMed
AG
100
210
01.
610
01.
99
01.
330
0N
/A0
8N
/APa
rahi
tTot
al D
evic
e Ra
pid
Test
for P
. fal
cipa
rum
and
Pa
n M
alar
ial S
peci
esSp
an D
iagn
ostic
s Lt
d.10
03.
49
02.
5610
03.
310
02.
510
01.
810
02.
7
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
100
3.9
100
410
03.
610
03.
710
03.
49
13.
33Qu
icks
tick
Mal
aria
Ant
igen
Tes
tIn
nova
tek
Med
ical
Inc.
100
13
01
100
10
0N
/A0
0N
/A0
5N
/ASD
BIO
LIN
E M
alar
ia A
gSt
anda
rd D
iagn
ostic
s, In
c.10
02
100
1.9
100
210
01.
910
01.
910
02
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
anSt
anda
rd D
iagn
ostic
s, In
c.10
04
100
410
03.
910
04
91
410
04
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
100
49
12.
8910
03.
810
03.
910
02.
710
04
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spe
cies
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)87
Tabl
e A4
.14a
: Hea
t st
abili
ty t
esti
ng r
esul
ts f
or p
an t
est
line
of c
ombi
nati
on R
DTs
on P
. fal
cipa
rum
sam
ples
at
high
par
asit
e de
nsit
y (2
000
para
site
s/μl
). P
osit
ivit
y ra
te a
t ba
selin
e, a
nd a
fter
60
days
incu
bati
on a
t 35
°C a
nd 4
5°C
Prod
uct
Man
ufac
ture
r
Base
line
test
ing
35°C
45°C
Lot
1 (n
=10)
Lot
2 (n
=10)
Lot
1 (n
=10)
Lot
2 (n
=10)
Lot
1 (n
=10)
Lot
2 (n
=10)
No.
po
siti
ve
No.
in
valid
Mea
n ba
nd
inte
n-si
ty
No.
po
siti
ve
No.
in
valid
Mea
n ba
nd
inte
n-si
ty
No.
po
siti
ve
No.
in
valid
Mea
n ba
nd
inte
n-si
ty
No.
po
siti
ve
No.
in
valid
Mea
n ba
nd
inte
n-si
ty
No.
po
siti
ve
No.
in
valid
Mea
n ba
nd
inte
n-si
ty
No.
po
siti
ve
No.
in
valid
Mea
n ba
nd
inte
n-si
ty
Pan
line
of c
ombi
nati
on t
ests
Ad
vant
age
Mal
Car
dJ.
Mitr
a &
Co.
Pvt
. Ltd
.10
01.
610
01.
810
02
100
210
01.
910
02
AZO
G M
alar
ia p
f (H
RP-I
I)/pv
(pLD
H)
Antig
en D
etec
tion
Test
Dev
ice
AZOG
, Inc
.8
11
100
14
01
100
10
0N
/A4
02.
5
Bina
x N
ow M
alar
iaIn
vern
ess
Med
ical
Inno
vatio
ns,
Inc.
100
19
01.
569
01.
4410
01.
86
01
91
1.56
Care
Star
t Mal
aria
HRP
2/pL
DH (P
f/PA
N)
COM
BOAc
cess
Bio
, Inc
.10
02.
910
02.
410
02.
610
02
100
2.3
100
2.5
Firs
t Res
pons
e M
alar
ia A
g Co
mbo
(P
LDH
/HRP
2)Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
100
2.9
100
2.8
100
1.8
100
2.4
100
2.2
100
2.4
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.0
0N
/A0
0N
/A0
1N
/A0
0N
/A0
0N
/A0
1N
/A
Hex
agon
Mal
aria
Com
biH
uman
Gm
bH0
0N
/A0
0N
/A0
0N
/A0
2N
/A0
0N
/A0
0N
/AIC
T M
alar
ia C
ombo
Cas
sett
e Te
st (M
L02)
ICT
Diag
nost
ics
90
19
01.
2210
01.
95
01
100
1.1
50
2Im
mun
oqui
ck M
alar
ia +
4Bi
osyn
ex10
01
100
19
01.
117
01
60
110
01.
7
Mal
aria
P.F
/VIV
AXDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nost
ics,
Inc.
04
N/A
03
N/A
06
N/A
04
N/A
09
N/A
09
N/A
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
100
1.4
90
110
01.
410
01.
66
01.
339
01.
33M
alar
ia R
apid
Dua
lVi
sion
Bio
tech
(Pty
) Ltd
.9
01
30
12
01
30
1.33
00
N/A
30
3.33
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s5
01
80
16
01
50
11
01
20
5
One
Step
Mal
aria
Ant
igen
Str
ipIN
D Di
agno
stic
Inc.
100
13
01
100
10
0N
/A0
0N
/A1
55
OnSi
ght –
Par
aQui
ck (P
an, P
f)Am
geni
x In
tern
atio
nal,
Inc.
100
1.5
100
1.6
100
1.8
100
1.6
90
1.11
100
1.2
OptiM
AL-
ITDi
aMed
AG
100
210
01.
610
01.
610
01.
21
01
18
2Pa
rahi
tTot
al D
evic
e Ra
pid
Test
for P
. fa
lcip
arum
and
Pan
Mal
aria
l Spe
cies
Span
Dia
gnos
tics
Ltd.
00
N/A
00
N/A
00
N/A
00
N/A
00
N/A
00
N/A
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf
(Dev
ice)
Zeph
yr B
iom
edic
als
80
19
01.
676
01.
338
01.
58
01.
258
11.
5
Quic
kstic
k M
alar
ia A
ntig
en T
est
Inno
vate
k M
edic
al In
c.10
01
30
110
01
00
N/A
00
N/A
15
5SD
BIO
LIN
E M
alar
ia A
gSt
anda
rd D
iagn
ostic
s, In
c.7
01
40
110
01
100
110
01
90
1.2
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
anSt
anda
rd D
iagn
ostic
s, In
c.10
01
80
12
01
70
19
11
90
1.33
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le
Bloo
d Te
stG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
100
39
12
100
3.6
100
3.7
100
1.8
100
3
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
100
2.4
100
2.6
100
2.1
100
2.7
100
2.8
100
2.8
Care
Star
t Mal
aria
pLD
H (P
AN)
Acce
ss B
io, I
nc.
100
2.8
100
3.4
100
2.4
100
2.5
100
210
02.
9Pa
raba
nk R
apid
Tes
t for
Mal
aria
Pan
(D
evic
e)Ze
phyr
Bio
med
ical
s7
01
100
1.8
100
1.4
80
1.25
81
1.62
60
1.5
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spe
cies
Tabl
e A4
.14:
Hea
t st
abili
ty t
esti
ng r
esul
ts f
or P
f te
st li
ne o
n P.
fal
cipa
rum
sam
ples
at
high
par
asit
e de
nsit
y (2
000
para
site
s/μl
). P
osit
ivit
y ra
te a
t ba
selin
e, a
nd a
fter
60
days
incu
bati
on a
t 35
°C a
nd 4
5°C
Prod
uct
Man
ufac
ture
r
Base
line
test
ing
35°C
45°C
Lot
1 (n
=10)
Lot
2 (n
=10)
Lot
1 (n
=10)
Lot
2 (n
=10)
Lot
1 (n
=10)
Lot
2 (n
=10)
No.
po
si-ti
ve
No.
in
valid
Mea
n ba
nd
inte
nsit
y
No.
po
si-ti
ve
No.
in
valid
Mea
n ba
nd
inte
nsit
y
No.
po
si-ti
ve
No.
in
valid
Mea
n ba
nd
inte
nsit
y
No.
po
si-ti
ve
No.
in
valid
Mea
n ba
nd
inte
nsit
y
No.
po
si-ti
ve
No.
in
valid
Mea
n ba
nd
inte
nsit
y
No.
po
si-ti
ve
No.
in
valid
Mea
n ba
nd
inte
nsit
y
Pf o
nly
test
sAD
VAN
CED
QUAL
ITY
TM M
ALAR
IA (p
.f) P
OCT
InTe
c Pr
oduc
ts, I
nc.
100
3.6
100
2.9
100
3.1
100
3.7
100
2.9
100
2.8
ADVA
NCE
D QU
ALIT
Y TM
One
Ste
p M
alar
ia (p
.f.) T
est
(who
le b
lood
)In
Tec
Prod
ucts
, Inc
.10
02.
510
03.
39
02.
6710
02.
610
03.
110
02.
4
Adva
ntag
e P.
f. M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
100
410
03.
910
04
100
410
04
100
3.9
Care
Star
t Mal
aria
HRP
2 (P
f)Ac
cess
Bio
, Inc
.10
04
100
410
04
100
410
04
100
3.8
Firs
t Res
pons
e M
alar
ia A
g H
RP2
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.10
04
100
410
03.
910
04
100
3.9
100
4Fi
rstS
ign
– M
alar
ia P
f Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
100
2.8
100
2.8
90
1.11
90
2.67
100
1.4
90
2.67
Hex
agon
Mal
aria
Hum
an G
mbH
90
2.11
100
2.6
100
2.3
100
2.5
100
2.3
100
2.9
ICT
Mal
aria
Pf R
apid
Tes
t (M
L01)
ICT
Diag
nost
ics
100
3.8
100
410
03.
710
04
100
3.2
100
3.5
Imm
unoq
uick
Mal
aria
Fal
cipa
rum
Bios
ynex
100
410
04
100
3.9
100
3.9
100
410
04
Mal
aria
Pla
smod
ium
falc
ipar
um R
apid
test
Dev
ice
(Who
le b
lood
)AC
ON L
abor
ator
ies,
Inc.
100
3.2
100
410
04
100
3.9
100
310
03.
9
Mal
aria
Rap
id P
fVi
sion
Bio
tech
(Pty
) Ltd
.10
03.
110
03.
810
02.
910
03.
210
02.
410
03.
1Pa
rach
eck
Pf R
apid
Tes
t for
P. f
alci
paru
m M
alar
ia
(Dev
ice)
Orch
id B
iom
edic
al S
yste
ms
100
1.9
100
3.7
73
3.71
100
3.5
100
3.1
100
3.8
Para
chec
k Pf
Rap
id T
est f
or P
. fal
cipa
rum
Mal
aria
(D
ipst
ick)
Orch
id B
iom
edic
al S
yste
ms
100
310
03
100
310
03.
310
02.
410
03.
4
Para
hit-
f DIP
STIC
K FO
R FA
LCIP
ARU
M M
ALAR
IASp
an D
iagn
ostic
s Lt
d.10
03.
910
03.
910
03
100
410
03.
310
04
Para
hit-
f TES
T DE
VICE
FOR
FAL
CIPA
RUM
MAL
ARIA
Span
Dia
gnos
tics
Ltd.
100
2.7
100
2.7
91
2.44
100
2.4
90
2.67
100
2.9
SD B
IOLI
NE
Mal
aria
Ag
Pf
Stan
dard
Dia
gnos
tics,
Inc.
100
410
04
100
410
04
100
410
04
Pf li
ne o
f co
mbi
nati
on t
ests
Adva
ntag
e M
al C
ard
J. M
itra
& C
o. P
vt. L
td.
91
3.33
100
3.8
100
3.9
100
3.8
90
2.44
100
3.2
AZO
G M
alar
ia p
f (H
RP-I
I)/pv
(pLD
H) A
ntig
en D
etec
-tio
n Te
st D
evic
eAZ
OG, I
nc.
100
210
02.
710
02.
210
02.
710
02.
910
02.
4
Bina
x N
ow M
alar
iaIn
vern
ess
Med
ical
Inno
vatio
ns, I
nc.
100
3.6
100
3.8
100
410
03.
810
03.
99
14
Care
Star
t Mal
aria
HRP
2/pL
DH (P
f/PA
N) C
OMBO
Acce
ss B
io, I
nc.
100
410
04
100
410
04
100
3.9
100
3.9
Firs
t Res
pons
e M
alar
ia A
g Co
mbo
(PLD
H/H
RP2)
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.10
04
100
410
04
100
410
04
100
4Fi
rstS
ign
– Pa
raVi
ew-2
(Pv
+ Pf
) Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
100
410
03.
49
12.
4410
03.
910
02.
35
12.
6H
exag
on M
alar
ia C
ombi
Hum
an G
mbH
100
2.7
100
2.8
100
3.1
72
2.57
100
2.1
90
3IC
T M
alar
ia C
ombo
Cas
sett
e Te
st (M
L02)
ICT
Diag
nost
ics
100
410
04
100
410
04
100
3.8
100
4Im
mun
oqui
ck M
alar
ia +
4Bi
osyn
ex10
04
100
410
04
100
410
03.
910
03.
7
Mal
aria
P.F
/VIV
AXDi
agno
stic
Aut
omat
ion
/ Cor
tez
Dia-
gnos
tics,
Inc.
64
47
34
36
3.67
64
3.67
19
10
9N
/A
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
100
410
04
100
410
03.
910
03.
910
04
Mal
aria
Rap
id D
ual
Visi
on B
iote
ch (P
ty) L
td.
100
410
03.
810
03.
310
03.
210
03.
710
03.
4M
alas
can
Rapi
d Te
st fo
r Mal
aria
Pf/
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
100
2.8
100
310
03.
310
03.
310
03
100
3On
e St
ep M
alar
ia A
ntig
en S
trip
IND
Diag
nost
ic In
c.10
01
30
110
01
00
N/A
00
N/A
05
N/A
OnSi
ght –
Par
aQui
ck (P
an, P
f)Am
geni
x In
tern
atio
nal,
Inc.
100
3.8
100
3.9
100
3.8
100
410
03.
810
04
OptiM
AL-
ITDi
aMed
AG
100
210
01.
610
01.
99
01.
330
0N
/A0
8N
/APa
rahi
tTot
al D
evic
e Ra
pid
Test
for P
. fal
cipa
rum
and
Pa
n M
alar
ial S
peci
esSp
an D
iagn
ostic
s Lt
d.10
03.
49
02.
5610
03.
310
02.
510
01.
810
02.
7
Para
scre
en R
apid
Tes
t for
Mal
aria
Pan
/Pf (
Devi
ce)
Zeph
yr B
iom
edic
als
100
3.9
100
410
03.
610
03.
710
03.
49
13.
33Qu
icks
tick
Mal
aria
Ant
igen
Tes
tIn
nova
tek
Med
ical
Inc.
100
13
01
100
10
0N
/A0
0N
/A0
5N
/ASD
BIO
LIN
E M
alar
ia A
gSt
anda
rd D
iagn
ostic
s, In
c.10
02
100
1.9
100
210
01.
910
01.
910
02
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
anSt
anda
rd D
iagn
ostic
s, In
c.10
04
100
410
03.
910
04
91
410
04
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
100
49
12.
8910
03.
810
03.
910
02.
710
04
Pf -
Pla
smod
ium
falc
ipar
um
Pv -
Pla
smod
ium
viv
axpa
n -
Plas
mod
ium
spe
cies
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)8 8
Tabl
e A4
.15:
Hea
t st
abili
ty t
esti
ng r
esul
ts f
or P
f (o
r pa
n† ) t
est
line
on p
aras
ite
nega
tive
sam
ples
. Po
siti
vity
rat
e at
bas
elin
e, a
nd a
fter
60
days
inc
ubat
ion
at 3
5°C
and
45°C
Prod
uct
Man
ufac
ture
r
Base
line
test
ing
35°C
45°C
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
No.
po
siti
ve
No.
in
valid
No.
po
siti
ve
No.
in
valid
No.
po
siti
ve
No.
in
valid
No.
po
siti
ve
No.
in
valid
No.
po
siti
ve
No.
in
valid
No.
po
siti
ve
No.
in
valid
Pf o
nly
ADVA
NCE
D QU
ALIT
Y TM
MAL
ARIA
(p.f)
POC
T In
Tec
Prod
ucts
, Inc
.2
00
02
04
02
03
0AD
VAN
CED
QUAL
ITY
TM O
ne S
tep
Mal
aria
(p.f.
) Tes
t (w
hole
blo
od)
InTe
c Pr
oduc
ts, I
nc.
20
00
10
10
00
00
Adva
ntag
e P.
f. M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
00
00
00
00
00
00
Care
Star
t Mal
aria
HRP
2 (P
f)Ac
cess
Bio
, Inc
.0
00
00
00
00
00
0Fi
rst R
espo
nse
Mal
aria
Ag
HRP
2Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
00
00
00
00
00
01
Firs
tSig
n –
Mal
aria
Pf C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.0
00
00
00
00
00
0H
exag
on M
alar
iaH
uman
Gm
bH0
00
00
00
00
00
1IC
T M
alar
ia P
f Cas
sett
e Te
st (M
L01)
ICT
Diag
nost
ics
00
00
00
00
00
00
Imm
unoq
uick
Mal
aria
Fal
cipa
rum
Bios
ynex
00
01
00
00
00
00
Mal
aria
Pla
smod
ium
falc
ipar
um R
apid
test
Dev
ice
(Who
le b
lood
)AC
ON L
abor
ator
ies,
Inc.
00
00
00
00
00
00
Mal
aria
Rap
id P
fVi
sion
Bio
tech
(Pty
) Ltd
.0
00
00
00
00
00
0Pa
rach
eck
Pf R
apid
test
for P
. fal
cipa
rum
Mal
aria
(Dev
ice)
Or
chid
Bio
med
ical
Sys
tem
s1
00
00
00
00
00
0Pa
rach
eck
Pf R
apid
test
for P
. fal
cipa
rum
Mal
aria
(Dip
stic
k)
Orch
id B
iom
edic
al S
yste
ms
20
00
10
00
00
00
Para
hit-
f DIP
STIC
K FO
R FA
LCIP
ARU
M M
ALAR
IASp
an D
iagn
ostic
s Lt
d.0
00
00
00
00
00
0Pa
rahi
t-f T
EST
DEVI
CE F
OR F
ALCI
PARU
M M
ALAR
IASp
an D
iagn
ostic
s Lt
d.0
00
00
10
00
00
0SD
BIO
LIN
E M
alar
ia A
g Pf
St
anda
rd D
iagn
ostic
s, In
c.0
00
00
00
00
00
0Pf
& P
an/P
f &
Pv
Adva
ntag
e M
al C
ard
J. M
itra
& C
o. P
vt. L
td.
10
00
00
00
00
00
AZOG
Mal
aria
pf (
HRP
-II)
/pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
AZOG
, Inc
.0
00
00
00
00
00
0Bi
nax
Now
Mal
aria
In
vern
ess
Med
ical
Inno
vatio
ns, I
nc.
00
00
00
00
00
10
Care
Star
t Mal
aria
HRP
2/pL
DH (P
f/PA
N) C
OMBO
Acce
ss B
io, I
nc.
00
00
00
00
00
00
Firs
t Res
pons
e M
alar
ia A
g Co
mbo
(PLD
H/H
RP2)
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.0
00
00
00
00
00
0Fi
rstS
ign
– Pa
raVi
ew-2
(Pv
+ Pf
) Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
00
00
00
00
00
02
Hex
agon
Mal
aria
Com
biH
uman
Gm
bH0
00
00
00
00
00
0IC
T M
alar
ia C
ombo
Cas
sett
e Te
st (M
L02)
ICT
Diag
nost
ics
00
00
00
00
00
00
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
00
00
00
00
00
00
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nos-
tics,
Inc.
00
00
04
03
03
02
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
00
00
00
00
00
00
Mal
aria
Rap
id D
ual
Visi
on B
iote
ch (P
ty) L
td.
00
00
00
00
00
01
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s0
00
00
00
00
00
0On
e St
ep M
alar
ia A
ntig
en S
trip
IND
Diag
nost
ic In
c.0
00
00
00
40
00
1On
Sigh
t – P
araQ
uick
(Pan
, Pf)
Test
Amge
nix
Inte
rnat
iona
l, In
c.0
00
00
00
00
00
0Op
tiMAL
-IT
DiaM
ed A
G0
00
00
00
00
00
4Pa
rahi
t-To
tal D
evic
e Ra
pid
test
for P
. fal
cipa
rum
and
Pan
mal
aria
l spe
cies
.Sp
an D
iagn
ostic
s Lt
d.0
00
00
00
00
00
0Pa
rasc
reen
Rap
id T
est f
or M
alar
ia P
an/P
f (De
vice
)Ze
phyr
Bio
med
ical
s0
00
00
00
01
00
0Qu
icks
tick
Mal
aria
Ant
igen
Tes
tIn
nova
tek
Med
ical
Inc.
00
00
00
04
00
01
SD B
IOLI
NE
Mal
aria
Ag
Stan
dard
Dia
gnos
tics,
Inc.
00
00
00
00
00
00
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
an
Stan
dard
Dia
gnos
tics,
Inc.
00
00
00
00
00
00
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
00
00
20
10
01
10
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
00
00
00
00
00
00
Care
Star
t Mal
aria
pLD
H (P
AN)
Acce
ss B
io, I
nc.
00
00
00
00
00
10
Para
bank
Rap
id T
est f
or M
alar
ia P
an (D
evic
e)Ze
phyr
Bio
med
ical
s0
00
00
00
00
00
0Pf
- P
lasm
odiu
m fa
lcip
arum
Pv
- P
lasm
odiu
m v
ivax
pan
- Pl
asm
odiu
m s
peci
es
† - F
or p
an-o
nly
test
s
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)89
Tabl
e A4
.15a
: Hea
t st
abili
ty t
esti
ng r
esul
ts f
or p
an t
est
line
of c
ombi
nati
on R
DTs
on n
egat
ive
sam
ples
. Pos
itiv
ity
rate
at
base
line,
and
aft
er 6
0 da
ys in
cuba
tion
at
35°C
an
d 45
°C
Prod
uct
Man
ufac
ture
r
Base
line
test
ing
35°C
45°C
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
No.
po
siti
veN
o.
inva
lidN
o.
posi
tive
No.
in
valid
No.
po
siti
veN
o.
inva
lidN
o.
posi
tive
No.
in
valid
No.
po
siti
veN
o.
inva
lidN
o.
posi
tive
No.
in
valid
Pan
line
of c
ombi
nati
on t
ests
Adva
ntag
e M
al C
ard
J. M
itra
& C
o. P
vt. L
td.
10
00
00
00
00
00
AZO
G M
alar
ia p
f (H
RP-I
I)/pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
AZOG
, Inc
.0
04
00
00
00
02
0Bi
nax
Now
Mal
aria
Inve
rnes
s M
edic
al In
nova
tions
, Inc
.0
00
00
00
00
00
0Ca
reSt
art M
alar
ia H
RP2/
pLDH
(Pf/
PAN
) COM
BOAc
cess
Bio
, Inc
.0
00
00
00
04
00
0Fi
rst R
espo
nse
Mal
aria
Ag
Com
bo (P
LDH
/HRP
2)Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
00
00
00
00
00
00
Firs
tSig
n –
Para
View
-2 (P
v +
Pf) C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.0
00
00
00
00
00
2H
exag
on M
alar
ia C
ombi
Hum
an G
mbH
00
00
00
00
00
00
ICT
Mal
aria
Com
bo C
asse
tte
Test
(ML0
2)IC
T Di
agno
stic
s0
00
00
00
00
00
0Im
mun
oqui
ck M
alar
ia +
4Bi
osyn
ex0
00
00
00
00
00
0M
alar
ia P
.F/V
IVAX
Diag
nost
ic A
utom
atio
n / C
orte
z Di
agno
stic
s, In
c.0
00
00
40
30
30
2M
alar
ia R
apid
Com
boVi
sion
Bio
tech
(Pty
) Ltd
.0
00
00
01
00
00
0M
alar
ia R
apid
Dua
lVi
sion
Bio
tech
(Pty
) Ltd
.0
00
00
00
00
00
1M
alas
can
Rapi
d Te
st fo
r Mal
aria
Pf/
Pan
(Dev
ice)
Zeph
yr B
iom
edic
als
00
00
00
00
00
00
One
Step
Mal
aria
Ant
igen
Str
ipIN
D Di
agno
stic
Inc.
00
00
00
04
00
01
OnSi
ght –
Par
aQui
ck (P
an, P
f)Am
geni
x In
tern
atio
nal,
Inc.
00
00
00
00
00
00
OptiM
AL-
ITDi
aMed
AG
00
00
00
00
00
04
Para
hitT
otal
Dev
ice
Rapi
d Te
st fo
r P. f
alci
paru
m a
nd P
an M
alar
ial S
peci
esSp
an D
iagn
ostic
s Lt
d.0
00
00
00
00
00
0Pa
rasc
reen
Rap
id T
est f
or M
alar
ia P
an/P
f (De
vice
)Ze
phyr
Bio
med
ical
s0
00
00
00
01
00
0Qu
icks
tick
Mal
aria
Ant
igen
Tes
tIn
nova
tek
Med
ical
Inc.
00
00
00
04
00
01
SD B
IOLI
NE
Mal
aria
Ag
Stan
dard
Dia
gnos
tics,
Inc.
00
00
00
00
00
00
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
anSt
anda
rd D
iagn
ostic
s, In
c.0
00
00
00
00
00
0W
ondf
o On
e St
ep M
alar
ia P
f/Pa
n W
hole
Blo
od T
est
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
., Lt
d0
00
00
00
00
10
0Pf
- P
lasm
odiu
m fa
lcip
arum
Pv
- P
lasm
odiu
m v
ivax
pan
- Pl
asm
odiu
m s
peci
es
Tabl
e A4
.15:
Hea
t st
abili
ty t
esti
ng r
esul
ts f
or P
f (o
r pa
n† ) t
est
line
on p
aras
ite
nega
tive
sam
ples
. Po
siti
vity
rat
e at
bas
elin
e, a
nd a
fter
60
days
inc
ubat
ion
at 3
5°C
and
45°C
Prod
uct
Man
ufac
ture
r
Base
line
test
ing
35°C
45°C
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
No.
po
siti
ve
No.
in
valid
No.
po
siti
ve
No.
in
valid
No.
po
siti
ve
No.
in
valid
No.
po
siti
ve
No.
in
valid
No.
po
siti
ve
No.
in
valid
No.
po
siti
ve
No.
in
valid
Pf o
nly
ADVA
NCE
D QU
ALIT
Y TM
MAL
ARIA
(p.f)
POC
T In
Tec
Prod
ucts
, Inc
.2
00
02
04
02
03
0AD
VAN
CED
QUAL
ITY
TM O
ne S
tep
Mal
aria
(p.f.
) Tes
t (w
hole
blo
od)
InTe
c Pr
oduc
ts, I
nc.
20
00
10
10
00
00
Adva
ntag
e P.
f. M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
00
00
00
00
00
00
Care
Star
t Mal
aria
HRP
2 (P
f)Ac
cess
Bio
, Inc
.0
00
00
00
00
00
0Fi
rst R
espo
nse
Mal
aria
Ag
HRP
2Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
00
00
00
00
00
01
Firs
tSig
n –
Mal
aria
Pf C
ard
Test
Uni
med
Inte
rnat
iona
l, In
c.0
00
00
00
00
00
0H
exag
on M
alar
iaH
uman
Gm
bH0
00
00
00
00
00
1IC
T M
alar
ia P
f Cas
sett
e Te
st (M
L01)
ICT
Diag
nost
ics
00
00
00
00
00
00
Imm
unoq
uick
Mal
aria
Fal
cipa
rum
Bios
ynex
00
01
00
00
00
00
Mal
aria
Pla
smod
ium
falc
ipar
um R
apid
test
Dev
ice
(Who
le b
lood
)AC
ON L
abor
ator
ies,
Inc.
00
00
00
00
00
00
Mal
aria
Rap
id P
fVi
sion
Bio
tech
(Pty
) Ltd
.0
00
00
00
00
00
0Pa
rach
eck
Pf R
apid
test
for P
. fal
cipa
rum
Mal
aria
(Dev
ice)
Or
chid
Bio
med
ical
Sys
tem
s1
00
00
00
00
00
0Pa
rach
eck
Pf R
apid
test
for P
. fal
cipa
rum
Mal
aria
(Dip
stic
k)
Orch
id B
iom
edic
al S
yste
ms
20
00
10
00
00
00
Para
hit-
f DIP
STIC
K FO
R FA
LCIP
ARU
M M
ALAR
IASp
an D
iagn
ostic
s Lt
d.0
00
00
00
00
00
0Pa
rahi
t-f T
EST
DEVI
CE F
OR F
ALCI
PARU
M M
ALAR
IASp
an D
iagn
ostic
s Lt
d.0
00
00
10
00
00
0SD
BIO
LIN
E M
alar
ia A
g Pf
St
anda
rd D
iagn
ostic
s, In
c.0
00
00
00
00
00
0Pf
& P
an/P
f &
Pv
Adva
ntag
e M
al C
ard
J. M
itra
& C
o. P
vt. L
td.
10
00
00
00
00
00
AZOG
Mal
aria
pf (
HRP
-II)
/pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
AZOG
, Inc
.0
00
00
00
00
00
0Bi
nax
Now
Mal
aria
In
vern
ess
Med
ical
Inno
vatio
ns, I
nc.
00
00
00
00
00
10
Care
Star
t Mal
aria
HRP
2/pL
DH (P
f/PA
N) C
OMBO
Acce
ss B
io, I
nc.
00
00
00
00
00
00
Firs
t Res
pons
e M
alar
ia A
g Co
mbo
(PLD
H/H
RP2)
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.0
00
00
00
00
00
0Fi
rstS
ign
– Pa
raVi
ew-2
(Pv
+ Pf
) Car
d Te
stU
nim
ed In
tern
atio
nal,
Inc.
00
00
00
00
00
02
Hex
agon
Mal
aria
Com
biH
uman
Gm
bH0
00
00
00
00
00
0IC
T M
alar
ia C
ombo
Cas
sett
e Te
st (M
L02)
ICT
Diag
nost
ics
00
00
00
00
00
00
Imm
unoq
uick
Mal
aria
+4
Bios
ynex
00
00
00
00
00
00
Mal
aria
P.F
/Viv
axDi
agno
stic
Aut
omat
ion
/ Cor
tez
Diag
nos-
tics,
Inc.
00
00
04
03
03
02
Mal
aria
Rap
id C
ombo
Visi
on B
iote
ch (P
ty) L
td.
00
00
00
00
00
00
Mal
aria
Rap
id D
ual
Visi
on B
iote
ch (P
ty) L
td.
00
00
00
00
00
01
Mal
asca
n Ra
pid
Test
for M
alar
ia P
f/Pa
n (D
evic
e)Ze
phyr
Bio
med
ical
s0
00
00
00
00
00
0On
e St
ep M
alar
ia A
ntig
en S
trip
IND
Diag
nost
ic In
c.0
00
00
00
40
00
1On
Sigh
t – P
araQ
uick
(Pan
, Pf)
Test
Amge
nix
Inte
rnat
iona
l, In
c.0
00
00
00
00
00
0Op
tiMAL
-IT
DiaM
ed A
G0
00
00
00
00
00
4Pa
rahi
t-To
tal D
evic
e Ra
pid
test
for P
. fal
cipa
rum
and
Pan
mal
aria
l spe
cies
.Sp
an D
iagn
ostic
s Lt
d.0
00
00
00
00
00
0Pa
rasc
reen
Rap
id T
est f
or M
alar
ia P
an/P
f (De
vice
)Ze
phyr
Bio
med
ical
s0
00
00
00
01
00
0Qu
icks
tick
Mal
aria
Ant
igen
Tes
tIn
nova
tek
Med
ical
Inc.
00
00
00
04
00
01
SD B
IOLI
NE
Mal
aria
Ag
Stan
dard
Dia
gnos
tics,
Inc.
00
00
00
00
00
00
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
an
Stan
dard
Dia
gnos
tics,
Inc.
00
00
00
00
00
00
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
tG
uang
zhou
Won
dfo
Biot
ech
Co.,
Ltd
00
00
20
10
01
10
Pan
only
Adva
ntag
e Pa
n M
alar
ia C
ard
J. M
itra
& C
o. P
vt. L
td.
00
00
00
00
00
00
Care
Star
t Mal
aria
pLD
H (P
AN)
Acce
ss B
io, I
nc.
00
00
00
00
00
10
Para
bank
Rap
id T
est f
or M
alar
ia P
an (D
evic
e)Ze
phyr
Bio
med
ical
s0
00
00
00
00
00
0Pf
- P
lasm
odiu
m fa
lcip
arum
Pv
- P
lasm
odiu
m v
ivax
pan
- Pl
asm
odiu
m s
peci
es
† - F
or p
an-o
nly
test
s
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)9 0
ANNEX 5: EXAMPLE ALGORITHM FOR SELECTING A MALARIA RDT
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)91
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)92
ANNEX 6: INTRODUCING RDT-BASED MALARIA DIAGNOSIS INTO NATIONAL PROGRAMMES
As parasite-based diagnosis is introduced at smaller clinics and village level for case management, a large number of challenges arise not only in logistical administration but also in managing the health-seeking and health-providing behaviour of patients and health workers. These can be addressed by a systematic approach to planning, implementation, monitoring and evaluation of the diagnostic programme; a process that must commence well before RDTs are procured. The following information is derived from existing WHO documents addressing this area.22 More information may be obtained at www.wpro.who.int/sites/rdt .
Many health workers and communities will have been taught that “fever equals malaria unless proven otherwise”. Introducing RDTs will demonstrate that this is not the case. To have an impact on anti-malarial diagnosis and treatment, RDTs must be seen to provide an accurate diagnosis by both health workers and patients alike, that is, they must be as good or better than those relied on previously. A health worker will also need a good alternative to anti-malarial medicines for the management of parasite-negative febrile patients. To achieve and maintain confidence in RDT-based diagnosis, a good quality assurance system must be in place (detailed elsewhere on this website). There must be satisfactory education of health workers, and widespread community sensitization. Knowledge of other causes of fever will be necessary to develop appropriate management algorithms for parasite-negative cases.
At the national level, regulatory requirements may need to be developed to control the importation and
22 Developed by WHO Regional Office for the Western Pacific and the WHO Global Malaria Programme, with support from the Uganda Ministry of Health (National Malaria Control Programme), Management Sciences for Health (MSH), and other partners.
use of malaria RDTs, and new procedures for storage, distribution and inventory management, such as those used for medicines, may need to be developed. If changing from a different product or mode of diagnosis, an adequate phase-out plan for this must also be developed.
This requires a clear strategic plan to be developed well in advance of RDT introduction, with a clear timeline to ensure that the various components of the RDT programme are in place at the right time. A focal person, or persons, will be needed to coordinate the overall implementation plan and ensure that the various agencies that may be involved understand the process and their particular roles. To achieve this, funding for the programme must include a significant component for planning and coordination, sensitization/IEC, training, quality assurance, monitoring and supervision, and logistics, in addition to procurement. Without this, much of the funds expended on RDTs may be wasted, and a loss of confidence in RDT-based diagnosis may hinder the process of strengthening appropriate malaria case management.
An example of a national implementation plan is shown below. This will need to be modified considerably for each programme, preferably through a collaborative process involving all the major agencies concerned in its implementation. Budgeting for all the components of the programme at the outset is vital. An example of components to be considered in an overall budget is shown in Figure A6.1.
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)93
Summary of introduction plan (see following page)
Program planning and management Identify key stakeholders, and secure commitment for introduction of RDTs Establish working group and develop terms of reference Identify specific focal person(s) responsible for day to day oversight of the implementation plan Develop a timeline, scope, and budget for implementation Identify human and other resource needs, and a strategy for accessing them Review and update, if needed, case-management algorithms for malaria and other causes of febrile illness
Policy and regulatory issues Develop appropriate regulatory documents if required Register RDT products
Procurement of RDTs Develop product specifications and packaging requirements Develop product short-list Conduct quantification (estimation of needs) Procure RDTs Procure sharps boxes, gloves etc.
Logistics Develop distribution plan Train logistics and storage personnel in handling and distribution of RDTs Implement a system for data collection and information flows Arrange for appropriate transport and storage Review and strengthen inventory management, as needed Develop a plan for discontinuation and disposal of other diagnostic supplies, if appropriate
Quality Assurance Develop mechanisms for assessing samples at a national level (lot-testing), and regular (and random) testing
at the level of use (e.g. microscopy-sentinel sites) Implement post-marketing surveillance
Training and communication Develop appropriate training and supervision materials Train health workers in case management and managing commodities Train in RDT use Develop and implement a program for community education/ sensitization
Monitoring and Evaluation Implement effective supervision and monitoring Strengthen recording and reporting procedures
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)94
Reco
mm
ende
d se
quen
ce o
f ac
tivi
ties
for
impl
emen
tatio
n of
RDT
-bas
ed d
iagn
osis
in a
nat
iona
l mal
aria
pro
gram
me
and
the
rela
tive
tim
e al
lotm
ent.
24
RDT
IMPL
EMEN
TATI
ON
TIM
ELIN
E
Prog
ram
me
plan
ning
and
man
agem
ent
Appo
int
mal
aria
dia
gnos
is c
oord
inat
or(s
)
Polic
y re
com
men
dati
ons
Writ
ten
MoH
end
ores
men
t
Guid
elin
esW
ritte
nM
oH e
ndor
sem
ent
Case
man
agem
ent
of f
ever
of
unkn
own
orig
in
Case
man
agem
ent
of m
alar
ia
RDT
(and
mic
rosc
opy)
qua
lity
assu
ranc
e
RDT
tran
spor
t an
d st
orag
e
Deci
de d
istr
icts
for
init
ial /
pha
sed
impl
emen
tati
on
Feve
r m
anag
emen
t al
gorit
hmW
ritte
nM
oH e
ndor
sem
ent
Dete
rmin
e/de
sign
ate
tran
spor
t an
d st
orag
e m
etho
ds
Regu
alto
ry is
sues
Writ
e Re
g. A
utho
rity
and
NM
CP r
oles
Writ
e re
gist
rati
on c
riter
ia
Regi
ster
RDT
proc
urem
ent
and
logi
stic
s
Sele
ct 3
-4 p
rodu
cts
Sam
ples
for
eas
e-of
-use
ass
essm
ent
Fina
l dec
isio
n on
RDT
Neg
otia
te s
peci
ficat
ions
wit
h m
anuf
actu
rer
Proc
urem
ent
Depe
nden
t on
reg
istr
atio
n pr
oces
s
Rece
ive
first
bat
ch (
of s
tagg
ered
del
iver
y)La
ter
batc
h
Dist
ribut
ion
to fi
eld
Proc
ure
glov
esPr
ocur
e sh
arps
box
es
Proc
ure
othe
r as
soci
ated
mat
eria
ls
Qua
lity
Assu
ranc
e
Writ
e se
ntin
el s
ite
SOP
Dete
rmin
e se
ntin
el s
ites
Set-
up s
enti
nel s
ites
Set
upM
onit
orin
g
Lot-
test
ing
Post
-mar
keti
ng s
urve
illan
ce
Trai
ning
and
com
mun
icat
ion
Cond
uct
case
man
agem
ent
trai
ning
for
fev
erM
ay b
e co
nduc
ted
earli
er, o
r al
read
y in
pla
ceM
odif
y RD
T in
stru
ctio
ns a
nd t
rain
ing
man
ual
Fiel
d-te
st m
odfie
d tr
aini
ng/in
stru
ctio
nsTr
aini
ng o
f tr
aine
rsCo
mm
unit
y se
nsit
izat
ion
Gene
ral h
ealt
h ca
re p
rovi
ders
edu
cati
on
Mon
itor
ing
and
eval
uati
on
Deve
lop
appr
opria
te r
ecor
d fo
rms
and
proc
edur
esRe
gula
r su
perv
isio
nPo
st-i
ntro
duct
ion
prog
ram
me
revi
ew24
tim
e re
quire
men
ts w
ill v
ary
betw
een
prog
ram
mes
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)95
Figure A6.1 Example malaria RDT implementation budget
Below is an example of major components of a programme budget to be considered when introducing RDTs into a malaria programme. Without adequate provision for each of these factors, it is likely that an RDT-based diagnostics programme will fail to achieve its goals. These components should therefore be addressed in proposals for programme funding, or provisions should be made for them in collaborating programmes.
Procurement of RDTs
Training, drugs / supplies for non-malarial fever
Community education
Training and supervision
Monitoring accuracy in field
Testing and laboratory monitoringProcurement of gloves, sharps disposal containers etc.
Transport and storage
Reco
mm
ende
d se
quen
ce o
f ac
tivi
ties
for
impl
emen
tatio
n of
RDT
-bas
ed d
iagn
osis
in a
nat
iona
l mal
aria
pro
gram
me
and
the
rela
tive
tim
e al
lotm
ent.
24
RDT
IMPL
EMEN
TATI
ON
TIM
ELIN
E
Prog
ram
me
plan
ning
and
man
agem
ent
Appo
int
mal
aria
dia
gnos
is c
oord
inat
or(s
)
Polic
y re
com
men
dati
ons
Writ
ten
MoH
end
ores
men
t
Guid
elin
esW
ritte
nM
oH e
ndor
sem
ent
Case
man
agem
ent
of f
ever
of
unkn
own
orig
in
Case
man
agem
ent
of m
alar
ia
RDT
(and
mic
rosc
opy)
qua
lity
assu
ranc
e
RDT
tran
spor
t an
d st
orag
e
Deci
de d
istr
icts
for
init
ial /
pha
sed
impl
emen
tati
on
Feve
r m
anag
emen
t al
gorit
hmW
ritte
nM
oH e
ndor
sem
ent
Dete
rmin
e/de
sign
ate
tran
spor
t an
d st
orag
e m
etho
ds
Regu
alto
ry is
sues
Writ
e Re
g. A
utho
rity
and
NM
CP r
oles
Writ
e re
gist
rati
on c
riter
ia
Regi
ster
RDT
proc
urem
ent
and
logi
stic
s
Sele
ct 3
-4 p
rodu
cts
Sam
ples
for
eas
e-of
-use
ass
essm
ent
Fina
l dec
isio
n on
RDT
Neg
otia
te s
peci
ficat
ions
wit
h m
anuf
actu
rer
Proc
urem
ent
Depe
nden
t on
reg
istr
atio
n pr
oces
s
Rece
ive
first
bat
ch (
of s
tagg
ered
del
iver
y)La
ter
batc
h
Dist
ribut
ion
to fi
eld
Proc
ure
glov
esPr
ocur
e sh
arps
box
es
Proc
ure
othe
r as
soci
ated
mat
eria
ls
Qua
lity
Assu
ranc
e
Writ
e se
ntin
el s
ite
SOP
Dete
rmin
e se
ntin
el s
ites
Set-
up s
enti
nel s
ites
Set
upM
onit
orin
g
Lot-
test
ing
Post
-mar
keti
ng s
urve
illan
ce
Trai
ning
and
com
mun
icat
ion
Cond
uct
case
man
agem
ent
trai
ning
for
fev
erM
ay b
e co
nduc
ted
earli
er, o
r al
read
y in
pla
ceM
odif
y RD
T in
stru
ctio
ns a
nd t
rain
ing
man
ual
Fiel
d-te
st m
odfie
d tr
aini
ng/in
stru
ctio
nsTr
aini
ng o
f tr
aine
rsCo
mm
unit
y se
nsit
izat
ion
Gene
ral h
ealt
h ca
re p
rovi
ders
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MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)9 6
NOTES:
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)97
NOTES:
MALARIA RAPID DIAGNOSTIC TEST PERFORMANCE – Results of WHO product testing of malaria RDTs: Round 1 (2008)98
NOTES:
ISBN 978 92 4 159807 1
DOI: 10.2471/TDR.09.978-924-1598071
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