Procurement and Supply Chain Management Toolkit
Guide to the Global Fund's Policies on Procurement and Supply ManagementProcurement of Rapid Diagnostic Tests (RDTs)
As with microscopy, assurance of quality is essential when procuring Malaria Rapid Diagnostic Tests (RDTs). An initiative to assess quality assurance of RDTs is being carried out by:
- WHO - Western Pacific Regional Office,
- WHO - the Special Programme for Research and Training in Tropical Diseases (TDR) and
- the Foundation for Innovative New Diagnostics (FIND).
Read more about the malaria RDT evaluation programme
WHO has a Fast Track procedure for prequalification of diagnostics.
"Some diagnostics submitted for WHO prequalification have been previously assessed by one or more National Regulatory Authorities. Prior regulatory approval can play an important role in accelerating the WHO prequalification assessment. Where the same evidence is required for both stringent regulatory review and for WHO prequalification, the potential exists for WHO to conduct an abbreviated assessment — the fast track procedure. The aim of the fast track procedure is to avoid duplication of effort and reduce the time to prequalify products."
For more information, see the Diagnostics and Laboratory Technology web site or read the "Fast Track Procedure - Information for Manufacturers"
WHO has published a manual entitled: "Good practices for selecting and procuring RDTs for malaria". This manual, designed as a practical 12-step checklist, provides guidance on the selection and procurement of quality rapid diagnostic tests for malaria. Drawing on the results of the WHO/TDR-FIND-CDC Product Testing Programme, the manual aims to strengthen the capacity of national and international procurement officers. It covers all aspects of the procurement cycle, with special emphasis on product specifications, selection criteria for different epidemiological settings, different quantification methodologies based on malaria surveillance and consumption data, as well as quality control through lot of testing.
Other important resources include:
- WPRO page on selecting and purchasing malaria RDTs
- Interactive RDT selection tool on FIND website
- Mechanism of action of RDTs described on WPRO web site