WHO-2015_Procedures-malaria-RDT-productlot-testing

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Annex 2. Changes in malaria RDT manufacture and corresponding assessment of required product performance Area of modification Product change Resubmit to WHO product testing as new product Requires equivalence testing at an independent laboratory Notification required Test kit Type (e.g. cassette, dipstick) X Format Length/size Number of wells X X Placement of wells X Monoclonal antibodies Target Source (clone) Source (manufacturer) X X X Type (material) X Dye conjugate Source X Size X Nitrocellulose Composition New nitrocellulose manufacturer X X Buffer Change in constituents Change in concentrations X X Blood transfer device Type X Process Timing Steps Reading X X Volumes Blood Buffer X X 20
Abbreviations CDC EOI FIND ISO RDT United States Centers for Disease Control and Prevention expression of interest Foundation for Innovative New Diagnostics International Organization for Standardization rapid diagnostic test (for the purposes of this document, immunochromatographic lateral flow devices for the detection of malaria parasite antigens) Procedures for product testing and lot testing. Information for RDT manufacturers and procurers WHO–FIND Malaria Rapid Diagnostic Test (RDT) Evaluation Programme 21
Page 1 and 2: Global Malaria Programme Procedures
Page 3 and 4: Table of contents Glossary 3 Introd
Page 5 and 6: Glossary The definitions given in t
Page 7 and 8: Fig. 1. WHO-FIND programmes for tes
Page 9 and 10: the right to limit the number of ac
Page 11 and 12: products per manufacturer on the fi
Page 13 and 14: Step 1.10. Manufacturers’ reports
Page 15 and 16: 2. WHO-FIND Malaria RDT Lot Testing
Page 17 and 18: one of the lot-testing laboratories
Page 19 and 20: more information on the WHO prequal
Page 21: Annexes Annex 1. Internal heat stab

WHO-2015_Procedures-malaria-RDT-productlot-testing

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