Ensuring quality and access for malaria diagnosis: how can it be achieved?

Increasing use of higher cost antimalarial drugs necessitates a move to parasite-based diagnosis for malaria. This offers further benefits to management of non-malarial fevers through early exclusion of malaria.Rapid diagnostic tests (RDTs) are the only practical method to provide parasite-based early diagnosis in remote and poorly resourced areas, where most malaria cases and malaria mortality occurs.Widespread introduction of RDTs requires considerable planning, and often significant changes in the way malaria and non-malarial febrile infections are addressed at a community level, with an emphasis on developing capacity to manage multiple diseases rather than purely vertical programmes.To be useful, malaria RDTs must be sensitive, simple to use and stable at ambient temperatures in the tropics. Published trials indicate that current products frequently do not achieve these standards, but limitations in trial design and reporting reduce the opportunity to identify faults requiring further development or changes in management practice.There is an urgent need to demonstrate and publish data on the quality of the rapidly expanding RDT product range, and to address the limited capacity for internal quality control and product development of the manufacturing sector.The development of a product testing and quality control network by the WHO and various partner institutions aims to demonstrate product capabilities to guide procurement and selection of products for field evaluations, and to develop the capacity to monitor RDT sensitivity after procurement and in the field.Guidelines for field trials published with this review set minimum standards for field trials that, if followed, should allow more confidence in field trials results, identification of the reasons for RDT failure in trials, and comparison of performance between trials.