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A review on performance assessment of malaria rapid diagnostic test in the field

Chika Celen Okangba, Wellington Aghoghovwia Oyibo

Abstract


Malaria rapid diagnostics tests (MRDTs) has increased the availability of parasite-based diagnosis and improve the overall management of febrile patients in malaria endemic areas. The World Health Organization (WHO) / Federal Ministry of Health (FMOH) recommends malaria case management based on parasite based diagnosis in all cases. The laboratory-based evaluation provides a comparative measure of MRDTs performance in a standardized way to distinguish between well and poorly performing tests to inform procurement decisions of malaria control programmes. Overall improvement has been noted in the field performance of RDTs since the implementation of product and lot testing of MRDTs in the past three years by WHO- Foundation for Innovative New Diagnostics (FIND).  Several   MRDTs demonstrated consistent detection of malaria at low parasite densities (200parasites/μl), have low false positive rates, are stable at tropical temperatures, are relatively easy to use, and can detect P. falciparum, P. vivax infections, or both in the recent product testing, indicating product improvement by the manufacturers. Performance between products varied widely at low parasite density (200 parasites/μl); however, the majority of products showed a high level of detection at 2000 or 5000 parasites/μl. Test performance varied between lots, and widely between similar products, confirming the advisability of lot-testing post-purchase and prior to use in the field. There is need for manufacturers to have adequate reference materials for product development. The WHO-FIND Malaria RDT Evaluation Programme, in collaboration with the CDC, offers quality standard panels to manufacturers to assist in this process.

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