Round 1 - Foundation for Innovative New Diagnostics

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Malaria Rapid Diagnostic Test Per<strong>for</strong>mance Results of WHO product testing of malaria RDTs: <strong>Round</strong> 1 (2008) 3
Page 1: Malaria Rapid Diagnostic Test Perfo
Page 5 and 6: Contents Acknowledgements d V Abbre
Page 7 and 8: figures Figure E1: Summary performa
Page 9 and 10: Tables Table 1: Table 2: Manufactur
Page 11 and 12: Acknowledgements The evaluation des
Page 13 and 14: 1. Executive Summary differentiate
Page 15 and 16: Ease of use requirements will also
Page 17 and 18: Figure 2: Network of specimen colle
Page 19 and 20: Participating manufacturers receive
Page 21 and 22: Table 2: Characteristics of Plasmod
Page 23 and 24: 5. Data management The receipt of p
Page 25 and 26: 8.3. Band intensity All positive te
Page 27 and 28: Table 3: Summary performance of mal
Page 29 and 30: Detection rate ‡ (%) False positi
Page 31 and 32: Positive tests results for P. falci
Page 33 and 34: 10.3. Phase 2 - Wild type P. falcip
Page 35 and 36: 10.3.4. P. falciparum and P. vivax
Page 37 and 38: 10.3.5. Band intensity Although RDT
Page 39 and 40: Figure 14: Plasmodium spp. (pan or
Page 41 and 42: Figure 16 and 17 illustrates that h
Page 43 and 44: Figure 19: Wild type P. vivax detec
Page 45 and 46: Figure 22: Heat stability of P. fal
Page 47 and 48: Figure 28: Heat stability of pan-li
Page 49 and 50: Product Manufacturer ICT Malaria Co
Page 51 and 52: clinically significant infections (
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and may be used as pan or all-speci
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16. References 1. WHO, World Malari
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AnnexeS Malaria Rapid Diagnostic Te
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Manufacturer Product name Plasmodiu
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Manufacturer J. Mitra & Co. Pvt. Lt
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Manufacturer Unimed International,
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ANNEX 2: MALARIA RDT GUIDE TO RESUL
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Type C: Malaria Generic Pan-Pf RDT
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Type E: Malaria Generic Pv-Pf RDT R
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P. falciparum samples (n=20) Total
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Table A3.3: Distribution of test ba
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Annex 4: Phase 2 Results Table A4.1
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Table A4.1a: Lot variability in pos
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Table A4.3: Reader variability in d
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200 parasites/µl 2,000 or 5,000 pa
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Table A4.6 Detection rate ‡ of P.
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Table A4.7 P. falciparum test line
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Table A4.8: Combination test pan li
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Table A4.9a: False positive rate of
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Table A4.10a: False positive rate o
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Table A4.13a: Heat stability testin
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CHOOSING SPECIFIC PRODUCT FROM RDT
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Summary of introduction plan (see f
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Figure A6.1 Example malaria RDT imp
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Round 1 - Foundation for Innovative New Diagnostics

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