Rapid diagnostic tests

The World Health Organization currently recommends that everyone suspected of malaria be tested prior to treatment. Rapid diagnostic tests (RDTs) that are accurate, relatively inexpensive and can be used in field conditions make this possible. TDR is supporting the assessment of the quality, reliability and heat stability of these tests. Countries, other UN agencies and major purchasers need these results to decide which tests are the best ones for their needs. TDR also researches how best to use RDTs, particularly among vulnerable populations, and provides training materials.

RDTs in pregnancy

In partnership with the Foundation for Innovative New Diagnostics, a study in Tororo, Uganda and Bobo-Dioulasso, Burkina Faso, is determining whether screening pregnant women for malaria with RDTs may detect placental infection, which often has no symptoms and is associated with low birth weight and higher rates of infant mortality and poor development. This study is particularly important as the effectiveness of the preventive malaria treatment being given to pregnant women – sulphadoxine-pyrimethamine (SP) – is being threatened by parasite resistance to the drug.

Test evaluation

The performance and quality of commercially available RDTs is evaluated on a regular basis through the RDT evaluation programme, jointly coordinated by TDR, the WHO Global Malaria Programme, the Foundation for Innovative New Diagnostics and the US Centers for Disease Control. Since 2008, three reports have been published and 120 products evaluated. Overall, there has been an improvement in RDT performance and a growing demand from manufacturers for these comparative results. The findings serve as a tool for countries to make informed choices from among the dozens of commercially available tests, so that they can purchase and use rapid diagnostics that are best suited to local conditions. These performance evaluations also inform prioritization for diagnostic test entry into WHO procurement and prequalification schemes.

Malaria lot testing programme

TDR supports the external quality assessments of the two WHO-recognized malaria rapid diagnostic test lot testing facilities (Institut Pasteur Cambodia, Research Institute of Tropical Medicine, the Philippines). WHO as well as other major RDT procurers have incorporated lot testing requirements into their quality assurance policies. Ensuring the proficiency and quality of testing at these facilities is paramount to global RDT scale up and also serves as an important incentive to manufacturers to produce quality products.

Malaria specimen bank

With the oversight of a technical review group, TDR is responsible for the maintenance and utilization of the WHO Malaria Specimen Bank comprised of parasitized blood samples from several malaria endemic countries. The Bank is housed at the US Centers for Disease Control and is the present resource for wild-type and culture isolates used in WHO Malaria RDT Product Testing and WHO-FIND Lot Testing. Pre-defined P.falciparum culture panels are also made available to manufacturers, test developers and academics to assist in the development and evaluation of malaria diagnostic tests and quality control activities.