The In Vitro Diagnostics Assessment Team acknowledges that there have been inconsistencies in the intended use statements presented in various Instructions for Use (IFUs) of prequalified malaria Rapid Diagnostic Tests (RDTs) and misalignments with the World Health Organization guidelines for malaria. For example, some intended use claims for prequalified products may include a screening function of the test and/or may suggest the use of such products in asymptomatic patients and/or may recommend confirmation of test results with microscopy or PCR. This applies mainly to products which were prequalified several years ago.
WHO through its Prequalification Unit and Global Malaria Programme is taking the necessary measures to standardize the intended use claims to align with the international standards and guidance, and the WHO guidelines for malaria. Therefore, prequalification public reports for malaria RDTs will be amended as an interim measure for users of the RDTs to follow the recommendations stated in the WHO guidelines for malaria, accessible at the link below:
WHO will work with manufacturers of prequalified malaria RDTs and manufacturers of products undergoing prequalification assessment to ensure the best resolution of the above-described issues.