Rapid diagnostic tests
WHO recommends prompt parasite-based diagnosis in all patients suspected of malaria before treatment is administered. Malaria rapid diagnostic tests (RDTs) have the potential to greatly improve the quality of management of malaria infections, especially in remote areas with limited access to good quality microscopy services.
RDTs are relatively simple to perform and interpret, they rapidly provide results, require limited training, and allow for the diagnosis of malaria at the community level.
Various types of RDTs on the market
Malaria RDTs detect specific antigens (proteins) produced by malaria parasites that are present in the blood of infected individuals. Some RDTs detect a single species (either P. falciparum or P. vivax), some detect multiple species (P. falciparum, P. vivax, P. malariae and P. ovale) and some further distinguish between P. falciparum and non-P. falciparum infection, or between specific species. Blood for the test is commonly obtained from a finger-prick and results are available within 15-30 minutes. Though there are variations among the more than 200 malaria RDT products on the market, the principles of the tests are similar.
Expansion in RDT use
In recent years, RDT testing has been significantly expanded around the world. Manufacturers surveyed by WHO for the World Malaria Report 2015 reported a total of 314 million RDT sales in 2014. Of these, 62% were P. falciparum-specific tests and 38% were combination tests. Most RDTs are deployed in the WHO African Region, where the disease burden is highest.
Quality assurance and performance testing of RDTs
To assist ministries of health in endemic countries, UN agencies and major procurers, WHO, the Foundation for Innovative New Diagnostics (FIND) and the Centers for Disease Control and Prevention established a pre-purchase (Product Testing) and post-purchase (Lot Testing) evaluation scheme for RDTs in 2007.
This work is being performed in collaboration with several research and public health institutions in endemic countries. As a result of the periodic evaluations of RDT performance completed through this programme, the quality of RDTs has improved dramatically in recent years.
Further guidance on product selection and procurement
WHO recommendations for RDT procurement eligibility require that RDTs consistently detect at least 75% of low parasite density samples from the corresponding product testing evaluation panel (i.e. at least a 75% "panel detection score"); have a false positive rate of less than 10%, and fewer than 5% invalid tests. WHO provides further guidance to countries on product selection, procurement, implementation (including training) of malaria RDTs for country programmes.
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- Information note on recommended selection criteria for procurement of malaria rapid diagnostic tests (RDTs) (2016)
- Malaria rapid diagnostic test performance. Results of WHO product testing of malaria RDTs: Round 6 (2015)
- Guidelines for the treatment of malaria. Third edition (2015)
- Good practices for selecting and procuring rapid diagnostic tests for malaria (2011)
- Universal access to malaria diagnostic testing: an operational manual (2011)
- Guidance on conducting field trials (2009)
- Transporting, storing and handling malaria rapid diagnostic tests at central and peripheral storage facilities (2009)
- Transporting, storing and handling malaria rapid diagnostic tests in health clinics (2009)