REPORT: Malaria RDT Product Testing - Round 6 results (WHO, 2015)
WHO recommends that malaria case management be based on parasite diagnosis in all cases. The use of antigen-detecting rapid diagnostic tests (RDTs) is a vital part of this strategy, forming the basis for extending access to malaria diagnosis by providing parasite-based diagnosis in areas where good-quality microscopy cannot be maintained.
The data generated by a WHO and FIND programme to evaluate and compare the performance of commercially available malaria RDTs are guiding procurement decisions, which, in turn, have shifted markets towards better-performing tests and helped to improve manufacturing quality.
The results of WHO malaria RDT product testing form the basis for procurement criteria and constitute the laboratory evaluation component of WHO prequalification for malaria RDTs. This report provides the results of the sixth round of product testing, performed at the CDC in 2014 and 2015, with data on the performance of 41 products. This round adds to the evaluations of rounds 1–5, which should be considered as a single evaluation except for the results of products tested in previous rounds that were resubmitted for testing, which replace those reported previously.
Product testing is part of the WHO–FIND malaria RDT evaluation programme, which develops methods for evaluation and provides data on antigen-detecting malaria RDTs. The programme is a collaboration among many institutions in malaria-endemic and non-endemic countries, with a global specimen bank and testing performed at the CDC. The data in this report are used to guide procurement decisions by WHO, other global health agencies and national governments. Product testing is part of a continuing programme to improve the quality of RDTs and to support widespread, reliable malaria diagnosis in areas where malaria is prevalent.
A seventh round of product testing began in November 2015, and the results will be published in 2017.
The evaluation programme is funded by WHO and FIND, through a grant from UNITAID.