Round 1 - Foundation for Innovative New Diagnostics

More documents

Recommendations

Info

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 2008 3 . 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 Unpublished data assessing large numbers of products in a standardized way through field trials, WHO and various partners embarked on a Malaria Rapid Diagnostic Test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 Committee 4 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 Figure 1: Mode of action of antigen-detecting malaria RDTs a b c Bound Ab Free labelled Ab Parasite Ag captured by labelled Ab Lysing agent and labelled Ab Buffer/ flushing agent Parasitized blood Control line (bound Ab)* Test line (bound Ab)* Nitrocellulose strip *Not normally visible Blood and labelled Ab flushed along strip 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. Labelled Ab–Ag complex captured by bound Ab of test band Labelled Ab captured by bound Ab of control band Captured Ag–labelled Ab complex Captured labelled Ab 4 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: Round 1 (2008)
Figure 2: Network of specimen collection, characterization and testing sites HTD CDC CIDEIM UL IPB DMR IPC RITM IMT IHRDC IPM AMI Collection and testing site Specimen characterization Global specimen bank Areas where malaria transmission occurs Areas with limited risk of malaria transmission No malaria This map is intended as a visual aid only and not as a definitive source of information about malaria endemicity. Source: © WHO, 2009. All rights reserved. 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). 3. Objectives • Evaluate malaria RDTs to produce performance data that can guide procurement of RDTs for use in the field. Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: Round 1 (2008) 5
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 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 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:
Page 94 and 95:
Page 96 and 97:
Table A4.13: Heat stability testing
Page 98 and 99:
Page 100 and 101:
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
show all

Round 1 - Foundation for Innovative New Diagnostics

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?