• Bina Srivastava, Supriya Sharma, Naseem Ahmed, Preeti Kumari, Renuka Gahtori, Swati Sinha, Sandeep Kumar, M Sanalkumar, Paras Mahale, Deendayal Swarnkar, and Anupkumar R Anvikar.
• Department of Parasite Host Biology, Indian Council of Medical Research-National Institute of Malaria Research, New Delhi, India.
• Indian J Med Res. 2023 Jan 1; 157 (1): 232923-29.

Background & ObjectivesIndia targets malaria elimination by 2030 in a phased manner, so malaria's assured diagnosis is crucial. Introduction of rapid diagnostic kits in India in 2010 has revolutionized malaria surveillance. The storage temperature of rapid diagnostic tests (RDTs), kit components and handling in transportations impact the results of RDTs. Therefore, quality assurance (QA) is required before it reaches end-users. The Indian Council of Medical Research-National Institute of Malaria Research (ICMR-NIMR) has a World Health Organization (WHO) recognized lot-testing laboratory facility to assure the quality of RDTs.MethodsThe ICMR-NIMR receives RDTs from different manufacturing companies as well as various agencies such as National and State Programmes and Central Medical Services Society. The WHO standard protocol is followed to conduct all the tests, including long-term and post-dispatch testing.ResultsA total of 323 lots tested during January 2014-March 2021 were received from different agencies. Amongst them, 299 lots passed the quality of test and 24 failed. In long-term testing, 179 lots were tested and only nine failed. A total of 7741 RDTs were received from end-users for post-dispatch testing of which 7540 qualified the QA test with a score of 97.4 per cent.Interpretation & ConclusionsRDTs received for quality testing showed compliance with QA evaluation of malaria RDTs based on the protocol recommended by the WHO. However, continuous monitoring of the quality of RDTs is required under QA programme. Quality-assured RDTs have a major role, especially in areas where low parasitaemia of parasites persists.

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