Ensuring quality of diagnostic testing
Malaria Rapid Diagnostic Test
The problem
Microscopy for malaria is technically demanding, and extending high-quality microscopy services to the community level has been difficult to achieve. Thus, the advent of rapid diagnostic tests (RDT) that can detect malaria antigens in a fingerprick blood sample has been an important advance. Their appropriate use will be critical in implementing WHO recommendations to confirm parasitemia in all patients over 5 being treated with ACT (Artemisinin Combination Therapy). From a single manufacturer 15 years ago, the field has grown to include over 50 manufacturers of such tests. This profusion of choice, and the variable quality of products reaching patients in developing countries, has made it difficult for national malaria control programs to determine which tests to purchase, and has left users uncertain whether they can always rely on the test result. The degradation of these tests on exposure to heat during shipping and storage compounds this problem. Mechanisms are urgently needed which can
- indicate which RDTs are manufactured with the quality and performance needed by public health programs,
- determine whether lots of RDTs are performing up to expectations after being shipped to countries but before dissemination to remote field sites, and
- provide clinic technicians and health workers with a means to verify that the RDTs they are using are still of acceptable quality.
Once accuracy of these tests is assured, other issues of RDT usage can be properly addressed and the full impact of malaria RDTs, a potential revolution for the management of febrile disease in malaria-endemic regions, can be realized.
FIND malaria program at a glance [pdf 571kb]
Some solutions
FIND and the WHO are collaborating to develop quality assurance systems to ensure that RDTs are working efficiently, are delivered to health workers, and that adequate materials to support training and good practice are implemented even in the remotest areas. FIND is also working to improve the next generation of malaria diagnostics.
Together with the WHO, FIND is implementing an accelerated three-stage solution to ensure that well-performing malaria RDTs are used in national disease control programs.
Stage 3: Positive control wells