Round 1 - Foundation for Innovative New Diagnostics

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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. No. of positive results from two lots 20 15 10 5 0 Baseline 35°C 45°C CareStart Malaria HRP2 (Pf) First Response Malaria Ag HRP2 Immunoquick Malaria Falciparum Malaria Plasmodium falciparum Rapid test Device (Whole blood) Parahit-f DIPSTICK FOR FALCIPARUM MALARIA SD BIOLINE Malaria Ag Pf Parahit-f TEST DEVICE FOR FALCIPARUM MALARIA Paracheck Pf Rapid Test for P. falciparum Malaria (Dipstick) Paracheck Pf Rapid Test for P. falciparum Malaria (Device) Malaria Rapid Pf ICT Malaria Pf Rapid Test (ML01) Hexagon Malaria FirstSign – Malaria Pf Card Test Advantage P.f. Malaria Card ADVANCED QUALITY TM One Step Malaria (p.f.) Test (whole blood) ADVANCED QUALITY TM MALARIA (p.f) POCT Figure 21: Heat stability of P. falciparum (HRP2) test specific line of P. falciparum tests against a high density P. falciparum sample (2000 parasites/μl) . Positivity rate at baseline, and after 60 days incubation. No. of positive results from two lots 20 15 Baseline 35°C 45°C ADVANCED QUALITY TM MALARIA (p.f) POCT Advantage P.f. Malaria Card, CareStart Malaria HRP2 (Pf) First Response Malaria Ag HRP2 ICT Malaria Pf Rapid Test (ML01) Immunoquick Malaria Falciparum Malaria Plasmodium falciparum Rapid test Device (Whole blood) Malaria Rapid Pf Paracheck Pf Rapid Test for P. falciparum Malaria (Dipstick) Parahit-f DIPSTICK FOR FALCIPARUM MALARIA SD BIOLINE Malaria Ag Pf Parahit-f TEST DEVICE FOR FALCIPARUM MALARIA Paracheck Pf Rapid Test for P. falciparum Malaria (Device) Hexagon Malaria FirstSign – Malaria Pf Card Test ADVANCED QUALITY TM One Step Malaria (p.f.) Test (whole blood) 32 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: Round 1 (2008)
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. No. of positive results from two lots 20 15 10 5 0 Baseline 35°C 45°C SD BIOLINE Malaria Ag Pf/Pan Binax Now Malaria First Response Malaria Ag Combo (PLDH/HRP2) ICT Malaria Combo Cassette Test (ML02) Immunoquick Malaria +4 Malaria Rapid Combo Malaria Rapid Dual SD BIOLINE Malaria Ag Quickstick Malaria Antigen Test Parascreen Rapid Test for Malaria Pan/Pf (Device) ParahitTotal Device Rapid Test for P. falciparum and Pan Malarial Species OptiMAL- IT OnSight – ParaQuick (Pan, Pf) One Step Malaria Antigen Strip Malascan Rapid Test for Malaria Pf/Pan (Device) Malaria P.F/VIVAX Hexagon Malaria Combi FirstSign – ParaView-2 (Pv + Pf) Card Test Advantage Mal Card AZOG Malaria pf (HRP-II)/pv (pLDH) Antigen Detection Test Device Wondfo One Step Malaria Pf/Pan Whole Blood Test CareStart Malaria HRP2/pLDH (Pf/PAN) COMBO Figure 23: Heat stability of P. falciparum (HRP2) test specific line in combination tests against a high density P. falciparum sample (2000 parasites/μl). Positivity rate at baseline, and after 60 days incubation. No. of positive results from two lots 20 15 10 5 0 Baseline 35°C 45°C Advantage Mal Card CareStart Malaria HRP2/pLDH (Pf/PAN) COMBO First Response Malaria Ag Combo (PLDH/HRP2) ICT Malaria Combo Cassette Test (ML02) Immunoquick Malaria +4, Malaria Rapid Combo Malascan Rapid Test for Malaria Pf/Pan (Device) OnSight – ParaQuick (Pan, Pf) SD BIOLINE Malaria Ag Quickstick Malaria Antigen Test One Step Malaria Antigen Strip OptiMAL- IT Malaria P.F/VIVAX Hexagon Malaria Combi FirstSign – ParaView-2 (Pv + Pf) Card Test AZOG Malaria pf (HRP-II)/pv (pLDH) Antigen Detection Test Device ParahitTotal Device Rapid Test for P. falciparum and Pan Malarial Species Wondfo One Step Malaria Pf/Pan Whole Blood Test Parascreen Rapid Test for Malaria Pan/Pf (Device) SD BIOLINE Malaria Ag Pf/Pan Binax Now Malaria 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. No. of positive results from two lots 20 15 10 Parabank Rapid Test for Malaria Pan (Device) CareStart Malaria pLDH (PAN) Advantage Pan Malaria Card 5 0 Baseline 35°C 45°C Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: Round 1 (2008) 33
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 34 and 35: 10.3.2. P. vivax detection rate P.
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 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
Page 84 and 85: 200 parasites/µl 2000 or 5000 para
Page 86 and 87: Table A4.7a: P. falciparum test lin
Page 88 and 89: Table A4.9: False positive rate of
Page 90 and 91: Table A4.10 False positive rate of
Page 92 and 93: Table A4.11: False positive rate of
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Table A4.12: 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
Page 106 and 107:
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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