Malaria

Changes to WHO recommended procurement criteria for malaria rapid diagnostic tests

8 December 2017

Following the public announcement to rapid diagnostic test manufacturers, procurement agencies and national malaria control programmes shared on 31 May 2016, WHO, through its Prequalification Team and Global Malaria Programme, would like to announce that the criteria used to determine procurement eligibility for antigen detecting malaria rapid diagnostic tests (RDTs) have been revised.

Specifically, all malaria rapid diagnostic tests that diagnose P. falciparum-only through detection of histidine rich protein 2 (HRP2) will be required to be prequalified for WHO procurement starting 1 January 2018.

Concerning all other types of malaria RDTs,1 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 1 July 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).

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.