- All > Quality and Safety: Medicines > Quality Assurance
- All > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- All > Diagnostics and Laboratory Technology > Evaluation of Diagnostics
- Keywords > diagnosis - laboratory tests
- Keywords > good quality in vitro diagnostics (IVDs)
- Keywords > guidelines and standards
- Keywords > labelling
- Keywords > prequalification - In Vitro Diagnostics assessment
- Keywords > prequalification – diagnostic assessment
- Keywords > procurement - RDTs for malaria
- Keywords > product testing - malaria RDTs
- Keywords > rapid diagnostic test (RDT)
- Keywords > in vitro Diagnostic (IVD)
(2017; 164 pages)
WHO estimates that 3.2 billion people are at risk for malaria. In 2015, there were an estimated 212 million new cases (with an uncertainty range of 148 million to 304 million) and an estimated 429 000 deaths (with an uncertainty range of 235 000 to 639 000). Approximately 90% of these deaths occurred in sub-Saharan Africa and just over 70% were of children under 5 years. Malaria remains endemic in 91 countries and territories and while parasite-based diagnosis is increasing, national surveys between 2013 and 2015 suggest approximately 31% of suspected malaria cases in sub-Saharan Africa were not confirmed with a diagnostic test, resulting in over-use of antimalarial drugs and poor disease monitoring.
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 number of RDTs available and the scale of their use have increased rapidly over the past few years. However, limitations of field trials and the heterogeneous nature of malaria transmission have limited the availability of the good-quality data on performance that national malaria programmes require to make informed decisions on procurement and implementation, and it is difficult to extrapolate the results of field trials to different populations and times. Therefore, in 2006, the WHO Special Programme for Research and Training in Tropical Diseases (TDR) and the Foundation for Innovative New Diagnostics (FIND) launched a programme to systematically evaluate and compare the performance of commercially available malaria RDTs.
The results of WHO’s malaria RDT product testing have been published annually since 2009 and form the basis of the procurement criteria of WHO, other United Nations agencies, the Global Fund to Fight AIDS, Tuberculosis and Malaria, national governments and non-governmental organizations. The data have guided procurement decisions, which, in turn, have shifted markets towards better-performing tests and are driving overall improvements in the quality of manufacturing.
WHO’s malaria RDT product testing constitutes the laboratory evaluation component of WHO malaria RDT prequalification, but meeting WHO prequalification criteria has not previously been a requirement for a WHO recommendation on procurement. As of 1 January 2018, WHO prequalification, comprising a dossier and inspections of manufacturing sites as well as a laboratory evaluation, will determine the eligibility of malaria RDTs for procurement. Therefore, all manufacturers that submit products to Round 8 and future rounds will be required also to submit applications for WHO prequalification.