Quality assurance of malaria rapid diagnostic tests: An aid in malaria elimination
Loading...
Date
2023-01
Journal Title
Journal ISSN
Volume Title
Publisher
Wolters Kluwer – Medknow
Abstract
Background & 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.
Description
Keywords
Malaria, Plasmodium falciparum, Plasmodium vivax, quality assurance rapid diagnostic kits
Citation
Srivastava 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): 23-29