Specifically, all malaria rapid diagnostic tests that diagnose P. falciparum-only through detection of histidine rich protein 2 (HRP2) are required to be prequalified for WHO procurement.
Concerning all other types of malaria RDTs1 – Including combination RDTs (detect and distinguish between more than one Plasmodium spp) and Pan-only detecting RDTs – WHO procurement requirements will remain the same – valid ISO 13485:2003, application for WHO prequalification submitted, and acceptable performance indicators in the latest round of WHO product testing – until 31 December 2018, when it is expected that more manufacturers will have successfully completed the prequalification process. A full list of products meeting the criteria listed above is available in Annex 1 of the Recommended selection criteria for procurement of malaria rapid diagnostic tests (RDTs) and this list will be updated in July 2018 when the results of WHO malaria RDT product testing round 8 are released.
The WHO prequalification of IVDs programme will continue to accept new applications for all types of antigen-detecting malaria RDTs.
RDT procurers and national malaria control programmes are encouraged to review their policies for future malaria RDT procurements and to align them with these revised recommendations. Use of current malaria RDT stocks and existing contractual agreements need not be interrupted to meet these new requirements for P. falciparum-only RDTs.
Note:
1 Including combination RDTs (detect and distinguish between more than one Plasmodium spp) and Pan-only detecting RDTs.