Round 1 - Foundation for Innovative New Diagnostics

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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. 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) † 100 75 50 Detection rate (%) 25 200 (aldolase) 200 (pLDH) 200 (pLDH + aldolase) 2000 (aldolase) 2000 (pLDH) 2000 (pLDH + aldolase) 0 Advantage Mal Card Advantage Pan Malaria Card CareStart Malaria pLDH (PAN) OptiMAL-IT CareStart Malaria HRP2/pLDH (Pf/PAN) COMBO First Response Malaria Ag Combo (PLDH/HRP2) OnSight – ParaQuick (Pan Pf) Test SD BIOLINE Malaria Ag SD BIOLINE Malaria Ag Pf/Pan AZOG Malaria pf (HRP-II) /pv (pLDH) Antigen Detection Test Device Immunoquick Malaria +4 Parabank Rapid Test for Malaria Pan (Device) Wondfo One Step Malaria Pf/Pan Whole Blood Test Parascreen Rapid Test for Malaria Pan/Pf (Device) Binax Now Malaria Malaria Rapid Combo Malaria Rapid Dual FirstSign – ParaView-2 (Pv + Pf) Card Test Hexagon Malaria Combi ICT Malaria Combo Cassette Test (ML02) Malaria P.F/Vivax Malascan Rapid Test for Malaria Pf/Pan (Device) One Step Malaria Antigen Strip Parahit-Total Device Rapid test for P. falciparum and Pan malarial species Quickstick Malaria Antigen Test † - 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 22 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: Round 1 (2008)
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. Figure 10: Phase 2 † wild type P. falciparum detection rate and positivity rate at 200 parasites/μl 100 75 50 25 Positivity rate (HRP2) Positivity rate (pLDH) Detection rate (HRP2) Detection rate (pLDH) 0 First Response Malaria Ag Combo (PLDH/HRP2) First Response Malaria Ag HRP2 CareStart Malaria HRP2 (Pf) Advantage P.f. Malaria Card CareStart Malaria HRP2/pLDH (Pf/PAN) COMBO SD BIOLINE Malaria Ag Pf SD BIOLINE Malaria Ag Pf/Pan Immunoquick Malaria +4 CareStart Malaria pLDH (PAN) Malaria Plasmodium falciparum Rapid test Device (Whole blood) Binax Now Malaria Immunoquick Malaria Falciparum Malaria Rapid Combo ICT Malaria Combo Cassette Test (ML02) ICT Malaria Pf Cassette Test (ML01) Parahit-f DIPSTICK FOR FALCIPARUM MALARIA AZOG Malaria pf (HRP-II) /pv (pLDH) Antigen Detection Test Device Malaria Rapid Dual Paracheck Pf Rapid test for P.falciparum Malaria (Dipstick) Malaria P.F/Vivax Advantage Pan Malaria Card Malaria Rapid Pf ADVANCED QUALITY TM One Step Malaria (p.f.) Test (whole blood) Malascan Rapid Test for Malaria Pf/Pan (Device) Advantage Mal Card Wondfo One Step Malaria Pf/Pan Whole Blood Test OnSight – ParaQuick (Pan ADVANCED QUALITY TM MALARIA (p.f) POCT Paracheck Pf Rapid test for P. falciparum Malaria (Device) Parascreen Rapid Test for Malaria Pan/Pf (Device) FirstSign – ParaView-2 (Pv + Pf) Card Test Hexagon Malaria Combi Hexagon Malaria Parahit-f TEST DEVICE FOR FALCIPARUM MALARIA OptiMAL-IT Parahit-Total Device Rapid test for P. falciparum and Pan malarial species. FirstSign – Malaria Pf Card Test SD BIOLINE Malaria Ag One Step Malaria Antigen Strip Parabank Rapid Test for Malaria Pan (Device) Quickstick Malaria Antigen Test 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 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: Round 1 (2008) 23
Page 1: Malaria Rapid Diagnostic Test Perfo
Page 4 and 5: WHO Library Cataloguing-in-Publicat
Page 6 and 7: 10.3. Phase 2 - Wild type P. falcip
Page 8 and 9: Figure 24: Figure 25: Figure 26: Fi
Page 10 and 11: Table A4.5a: Distribution of Pan/Pv
Page 12 and 13: Abbreviations ACT AMI Artemisinin-b
Page 14 and 15: Figure E1: Summary performance of m
Page 16 and 17: and sometimes poor study methods, a
Page 18 and 19: 4. Materials and methods 4.1. Test
Page 20 and 21: Figure 4a: Origin of P. falciparum
Page 22 and 23: c. Ease of use assessment: After be
Page 24 and 25: 7. Ethical considerations Each spec
Page 26 and 27: 10. Results 10.1. Summary In Round
Page 28 and 29: Table 3a: Summary performance of ma
Page 30 and 31: Table 4a: Summary performance of ma
Page 32 and 33: 10.2. Phase 1 - P. falciparum cultu
Page 36 and 37: Figure 11: Phase 2 † wild type P.
Page 38 and 39: Figure 13: P. falciparum (P. falcip
Page 40 and 41: Figure 15: Plasmodium spp. (pan or
Page 42 and 43: Figure 18: Wild type P. falciparum
Page 44 and 45: 11. Heat stability A single P. falc
Page 46 and 47: Figure 25: Heat stability of pan-li
Page 48 and 49: Table 6: Ease of use description of
Page 50 and 51: 13. Discussion of key findings simu
Page 52 and 53: under field conditions, loss of par
Page 54 and 55: 14.2. Lot testing Complementary to
Page 56 and 57: 44 Malaria Rapid Diagnostic Test Pe
Page 58 and 59: Manufacturer Access Bio, Inc. ACON
Page 60 and 61: Manufacturer Innovatek Medical Inc.
Page 62 and 63: Manufacturer ICT Diagnostics Span D
Page 64 and 65: Manufacturer Product name Plasmodiu
Page 66 and 67: Type B: Malaria Generic Major Plasm
Page 68 and 69: Type D: Malaria Generic Pf-Pan RDT
Page 70 and 71: Annex 3: Phase 1 Results Table A3.1
Page 72 and 73: Table A3.2: Detection rate of 20 P.
Page 74 and 75: Table A3.3a: Distribution of test b
Page 76 and 77: P. falciparum samples (n=79) P. viv
Page 78 and 79: Table A4.2: Reader variability in d
Page 80 and 81: Table A4.4: Distribution of test ba
Page 82 and 83: Table A4.5: Distribution of pan/Pv
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200 parasites/µl 2000 or 5000 para
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Table A4.7a: P. falciparum test lin
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Table A4.9: False positive rate of
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Table A4.10 False positive rate of
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Table A4.13: Heat stability testing
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ANNEX 5: Example algorithm for sele
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ANNEX 6: INTRODUCING RDT-BASED MALA
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Recommended sequence of activities
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ISBN 978 92 4 159807 1 DOI: 10.2471
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Round 1 - Foundation for Innovative New Diagnostics

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