Product testing

Product testing is designed to rank rapid diagnostic tests (RDT) performance and guide procurement decisions for countries and malaria RDT procurement agencies. It is not designed to detect RDTs that perform poorly before they are sent to the field (this is the aim of the WHO-FIND malaria lot-testing programme).

Reference materials against which to test RDTs have so far not been available, and even manufacturers themselves are sometimes unsure of the performance of the tests that they release for sale. Geographic variability in the parasites themselves also means that these tests may underperform in some regions. Lastly, many of the RDTs are susceptible to degradation at temperatures commonly found in malaria-endemic countries.

Over the past two years, a globally-representative reference collection of blood from individuals infected with malaria has been established, and blood dilutions have been carefully made to standardize the concentration of malaria parasites in each sample. These materials have been characterized by PCR to establish parasite species and by ELISA to determine the concentration of parasite antigen in the dilutions. Nucleic acid sequencing of the relevant variable genes has been carried out. These blood samples form a stable reference panel that can be used to reproducibly evaluate RDTs. Rapid test manufacturers that operate according to international quality standards (ISO 13485:2003) have been invited to submit their RDTs for evaluation using the reference materials. Companies have enlisted more than four dozen products for testing. All of the submitted RDTs will be tested using the reference materials, and also subjected to heat-stability studies.

The product testing exercise is the result of extensive collaboration between WHO, FIND and agencies from all over the world. Reference materials have been created at Research Institute for Tropical Medicine in the Philippines, Pasteur Institute of Cambodia, Kenya Medical Research Institute, University Cayetano Heredia in Peru, University of Lagos in Nigeria, the Institute Pasteur in the Central African Republic, Institute Pasteur in Madagascar, Department of Medical Research (Lower Myanmar) in Myanmar, Ifakara Health Research and Development Centre of Tanzania, and the Centro Internacional de Entrenamiento e Investigaciones Medicas of Colombia. Genetic characterization of the parasites has been carried out at the Queensland Institute for Medical Research, and parasitologic characterization at the Hospital for Tropical Diseases in London. Species confirmation and Product testing is being performed at the US Centers for Disease Control and Prevention in Atlanta.

Related information on WHO-FIND malaria RDT evaluation programme