Quality assurance of malaria rapid diagnostic tests: An aid in malaria elimination

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dc.contributor.authorSrivastava, Binaen_US
dc.contributor.authorSharma, Supriyaen_US
dc.contributor.authorAhmed, Naseemen_US
dc.contributor.authorKumari, Preetien_US
dc.contributor.authorGahtori, Renukaen_US
dc.contributor.authorSinha, Swatien_US
dc.contributor.authorKumar, Sandeepen_US
dc.contributor.authorSanalkumar, M.en_US
dc.contributor.authorMahale, Parasen_US
dc.contributor.authorSwarnkar, Deendayalen_US
dc.contributor.authorAnvikar, Anupkumar R.en_US
dc.date.accessioned2023-08-19T04:51:48Z
dc.date.available2023-08-19T04:51:48Z
dc.date.issued2023-01
dc.description.abstractBackground & objectives: India 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. Methods: The 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. Results: A 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 & conclusions: RDTs 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.en_US
dc.identifier.affiliationsDepartment of Parasite Host Biology, Indian Council of Medical Research-National Institute of Malaria Research, New Delhi, Indiaen_US
dc.identifier.citationSrivastava Bina, Sharma Supriya, Ahmed Naseem, Kumari Preeti, Gahtori Renuka, Sinha Swati, Kumar Sandeep, Sanalkumar M., Mahale Paras, Swarnkar Deendayal, Anvikar Anupkumar R.. Quality assurance of malaria rapid diagnostic tests: An aid in malaria elimination. Indian Journal of Medical Research. 2023 Jan; 157(1): 23-29en_US
dc.identifier.issn0971-5916
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/223526
dc.languageenen_US
dc.publisherWolters Kluwer – Medknowen_US
dc.relation.issuenumber1en_US
dc.relation.volume157en_US
dc.source.urihttps://doi.org/10.4103/ijmr.ijmr_2262_21en_US
dc.subjectMalariaen_US
dc.subjectPlasmodium falciparumen_US
dc.subjectPlasmodium vivaxen_US
dc.subjectquality assurance rapid diagnostic kitsen_US
dc.titleQuality assurance of malaria rapid diagnostic tests: An aid in malaria eliminationen_US
dc.typeJournal Articleen_US
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