Round 1 - Foundation for Innovative New Diagnostics

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Table 6: Ease of use description of 41 malaria rapid diagnostic tests Product Manufacturer Pf only ADVANCED QUALITY TM MALARIA (p.f) POCT ADVANCED QUALITY TM One Step Malaria (p.f.) Test (whole blood) Mixing wells involved Retractable needle Blood safety † Instruction quality ‡ Strip exposed Score (max. 3) No diagram Diagram of result InTec Products, Inc. 1 1 1 3 1 4 1 15:00 pipette cassette English InTec Products, Inc. 1 1 1 3 1 4 1 15:00 pipette cassette English Advantage P.f. Malaria Card J. Mitra & Co. Pvt. Ltd. 1 0 1 2 2 4 1 20:00 loop cassette English CareStart Malaria HRP2 (Pf) Access Bio, Inc. 1 0 1 2 2 4 1 20:00 capillary cassette English First Response Malaria Ag HRP2 FirstSign – Malaria Pf Card Test Premier Medical Corporation Ltd. Unimed International, Inc. Diagram of result & method Score (max.2) Combined score (max. 5) Number of timed steps Total time to result Blood transfer device Format Language of instruction 1 0 1 2 2 4 1 20:00 capillary cassette English Items included in package* test, buffer, lancet, pipette, alcohol swab test, buffer, lancet, pipette, alcohol swab test, buffer, loop, lancet, alcohol swab test, buffer, swab, lancet, capillary test, buffer, lancet, pipette, alcohol swab 1 0 1 2 1 3 1 15:00 loop cassette English test, buffer, loop Hexagon Malaria Human GmbH 1 0 1 2 1 3 1 15:00 capillary cassette English, German test, buffer, capillary ICT Malaria Pf Cassette Test (ML01) Immunoquick Malaria Falciparum Malaria Plasmodium falciparum Rapid test Device (Whole blood) Malaria Rapid Pf Paracheck Pf Rapid test for P. falciparum Malaria (Device) Paracheck Pf Rapid test for P. falciparum Malaria (Dipstick) Parahit-f DIPSTICK FOR FALCIPARUM MALARIA Parahit-f TEST DEVICE FOR FALCIPARUM MALARIA SD BIOLINE Malaria Ag Pf Pf & Pan/Pf & Pv ICT Diagnostics 1 0 1 2 2 4 1 15:00 pipettte cassette English Biosynex 1 0 0 1 2 3 1 10:00 none dipstick English, French ACON Laboratories, Inc. Vision Biotech (Pty) Ltd. Orchid Biomedical Systems Orchid Biomedical Systems test, buffer, lancet, pipette, alcohol swabs test, buffer, test tubes, rack 0 0 1 1 2 3 2 16:00 pipette cassette English test, buffer, well, pipette 1 0 1 2 2 4 1 15:00 pipette cassette English test, buffer, lancet, alcohol swabs, pipette 1 0 1 2 1 3 1 15:00 loop cassette English test, buffer, loop 1 0 0 1 1 2 1 15:00 loop dipstick English test, buffer, loop Span Diagnostics Ltd. 1 0 0 1 2 3 1 15:00 capillary dipstick English Span Diagnostics Ltd. 1 0 1 2 2 4 1 15:00 capillary cassette English Standard Diagnostics, Inc. 1 0 1 2 2 4 1 15:00 loop cassette English Advantage Mal Card J. Mitra & Co. Pvt. Ltd. 1 0 1 2 2 4 1 20:00 loop cassette English AZOG Malaria pf (HRP-II) / pv (pLDH) Antigen Detection Test Device Binax Now Malaria CareStart Malaria HRP2/ pLDH (Pf/PAN) COMBO First Response Malaria Ag Combo (PLDH/HRP2) FirstSign – ParaView-2 (Pv + Pf) Card Test test, buffert,capillary, lancet, alchol swabs test, buffer, capillary, alcohol swab, lancet test, buffer, alcohol swab, lancet, loop test, buffer, loop, lancet, alcohol swabs AZOG, Inc. 1 0 1 2 2 4 1 20:00 none cassette English test, buffer Inverness Medical Innovations, Inc. 1 0 1 2 2 4 2 ~16:00 capillary card English, Italian Portugese, French, German, Swedish, Dutch, Greek, Norwegian, Danish Access Bio, Inc. 1 0 1 2 2 4 1 20:00 capillary cassette English Premier Medical Corporation Ltd. Unimed International, Inc. 1 0 1 2 2 4 1 20:00 capillary cassette English test, buffer, capillary test, buffer, swab, lancet, capillary test, buffer, lancet, pipette, alcohol swab 1 0 1 2 1 3 1 15:00 loop cassette English test, buffer, loop Hexagon Malaria Combi Human GmbH 1 0 1 2 1 3 1 15:00 capillary cassette English, German test, buffer, capillary 36 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: Round 1 (2008)
Product Manufacturer ICT Malaria Combo Cassette Test (ML02) Mixing wells involved Retractable needle Blood safety † Instruction quality ‡ Strip Exposed Score (max. 3) No diagram Diagram of result ICT Diagnostics 1 0 1 2 2 4 1 15:00 pipette cassette English Diagram of result & method Score (max.2) Combined score (max. 5) Number of timed steps Total time to result Blood transfer device Format Language of instruction Immunoquick Malaria +4 Biosynex 1 0 0 1 2 3 1 10:00 none dipstick English, French Malaria P.F/Vivax Malaria Rapid Combo Malaria Rapid Dual Malascan Rapid Test for Malaria Pf/Pan (Device) One Step Malaria Antigen Strip OnSight – ParaQuick (Pan, Pf) Test Diagnostic Automation / Cortez Diagnostics, Inc. Vision Biotech (Pty) Ltd. Vision Biotech (Pty) Ltd. Items included in package* test, buffer, lancet, pipette, alcohol swabs test, buffer, test tubes, test rack 1 0 1 2 2 4 1 15:00 none cassette English test, buffer 1 0 1 2 2 4 1 15:00 pipette cassette English 1 0 1 2 2 4 1 15:00 pipette cassette English Zephyr Biomedicals 1 0 1 2 1 3 1 15:00 loop cassette English IND Diagnostic Inc. 0 0 0 0 2 2 4 19:00 pipette dipstick English Amgenix International, Inc. test, buffer, lancet, alcohol swabs, pipette test, buffer, lancet, alcohol swabs, pipette test, buffer, loop, alchohol swab, lancet test, buffer, wells, pipette 1 0 1 2 1 3 1 15:00 loop cassette English test, buffer, loop OptiMAL-IT DiaMed AG 0 0 0 0 2 2 4 22 capillary hybrid Parahit-Total Device Rapid test for P. falciparum and Pan malarial species Parascreen Rapid Test for Malaria Pan/Pf (Device) Quickstick Malaria Antigen Test SD BIOLINE Malaria Ag SD BIOLINE Malaria Ag Pf/Pan Wondfo One Step Malaria Pf/Pan Whole Blood Test Pan only Advantage Pan Malaria Card CareStart Malaria pLDH (PAN) English, Spanish, French, Portugese, German, Italian Span Diagnostics Ltd. 1 0 1 2 2 4 1 15:00 capillary cassette English Zephyr Biomedicals 1 0 1 2 1 3 1 15:00 loop cassette English Innovatek Medical Inc. 0 0 0 0 2 2 4 19:00 pipette dipstick English Standard Diagnostics, Inc. Standard Diagnostics, Inc. Guangzhou Wondfo Biotech Co., Ltd 1 0 1 2 2 4 1 15:00 loop cassette English 1 0 1 2 2 4 1 15:00 loop cassette English 1 1 1 3 2 5 1 15:00 none cassette English J. Mitra & Co. Pvt. Ltd. 1 0 1 2 2 4 1 20:00 loop cassette English Access Bio, Inc. 1 0 1 2 2 4 1 20:00 capillary cassette English Parabank Rapid Test for Zephyr Biomedicals 1 0 1 2 1 3 1 15:00 loop cassette English Malaria Pan (Device) † - Mixing wells involved Yes=0; No=1 Retractable needle Yes=1; No=0 Strip Exposed, not within card or cassette Exposed=0; Covered=1 ‡ - No diagrams =0 Diagrams of result =1 Diagrams of result and method=2 * - These are not necessarily standard contents. Procurers should verify what materials accompany test kits with the manufacturer and ensure they procure all the required accessories at the same time. test, buffer, lancet, capillary test, buffer, capillary, alcohol swab, lancet test, buffer, loop, alchohol swab, lancet test, buffer, wells, pipette test, buffer, alcohol swab, lancet, loop test, buffer, alcohol swab, lancet, loop test, buffer, alcohol swab, lancet test, buffer, loop, lancet, alcohol swab test, buffer, swab, lancet, capillary test, buffer, loop, alcohol swab, lancet Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: Round 1 (2008) 37
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 44 and 45: 11. Heat stability A single P. falc
Page 46 and 47: Figure 25: Heat stability of pan-li
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 96 and 97: Table A4.13: Heat stability testing
Page 98 and 99:
Table A4.14: Heat stability testing
Page 100 and 101:
Table A4.15: Heat stability testing
Page 102 and 103:
ANNEX 5: Example algorithm for sele
Page 104 and 105:
ANNEX 6: INTRODUCING RDT-BASED MALA
Page 106 and 107:
Recommended sequence of activities
Page 110:
ISBN 978 92 4 159807 1 DOI: 10.2471
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Round 1 - Foundation for Innovative New Diagnostics

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