{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T02:42:08Z","timestamp":1778640128463,"version":"3.51.4"},"reference-count":15,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,3,6]]},"abstract":"<jats:title>ABSTRACT.<\/jats:title>\n<jats:p>Since 2010, malaria rapid diagnostic tests (RDTs) are widely used to detect malaria. The Indian Council of Medical Research\u2013National Institute of Malaria Research performed lot testing (LT) according to WHO procedures since 2016. Lot testing is performed to evaluate the lot-to-lot variation in performance of malaria RDTs. Four sets of positive quality control (QC) panels for <jats:italic>P. falciparum<\/jats:italic> (<jats:italic>Pf<\/jats:italic>) and <jats:italic>P. vivax<\/jats:italic> (<jats:italic>Pv<\/jats:italic>) and 10 negative panels tested RDTs. RDTs were reported as pass, failed, or deferred on the basis of WHO criteria. In the past 5\u2009years, 275 lots containing 15,488 RDT kits for malaria diagnosis were subjected to LT. The monovalent RDTs (<jats:italic>n =<\/jats:italic> 1,216), based on either <jats:italic>Pf<\/jats:italic> histidine rich protein 2 (HRP2) or Pan-<jats:italic>Plasmodium<\/jats:italic> lactate dehydrogenase (Pan-pLDH) antigens, showed 90.4% sensitivity and 100% specificity, whereas RDTs based on HRP2 + Pan-pLDH or HRP2 + pLDH (<jats:italic>n =<\/jats:italic> 13,924) had sensitivity 95.6% and specificity 99.5%, respectively. RDTs based on PfHRP2 + Pv-pLDH + Pan-pLDH (<jats:italic>n =<\/jats:italic> 348) had 100% sensitivity and specificity. In a comparison between HRP2 + pLDH or HRP2 + Pan-pLDH to HRP2 + pLDH + Pan-pLDH RDTs, it was found that the sensitivity of PfHRP2 with Pan-pLDH RDTs (<jats:italic>n =<\/jats:italic> 2,382) was only 83%. Of the 275 lots analyzed, 15 lots of PfHRP2 with Pan-pLDH were deferred. The QC panel for <jats:italic>Pf<\/jats:italic> revealed a faint Pan band in the tested lots, which is a cause for concern. The results of deferred lots were reported to concerned government agencies. Quality-compromised RDTs may lead to an incorrect diagnosis. It is critical to have a QC system in place for effective malaria management.<\/jats:p>","DOI":"10.4269\/ajtmh.23-0339","type":"journal-article","created":{"date-parts":[[2024,2,13]],"date-time":"2024-02-13T20:51:36Z","timestamp":1707857496000},"page":"431-435","source":"Crossref","is-referenced-by-count":1,"title":["Benefits of Lot Testing to Improve the Quality of Malaria Rapid Diagnostic Tests in India"],"prefix":"10.4269","volume":"110","author":[{"given":"Bina","family":"Srivastava","sequence":"first","affiliation":[{"name":"Indian Council of Medical Research, National Institute of Malaria Research, Dwarka, New Delhi, India;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Supriya","family":"Sharma","sequence":"additional","affiliation":[{"name":"Indian Council of Medical Research, National Institute of Malaria Research, Dwarka, New Delhi, India;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deendayal","family":"Swarnkar","sequence":"additional","affiliation":[{"name":"Indian Council of Medical Research, National Institute of Malaria Research, Dwarka, New Delhi, India;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naseem","family":"Ahmed","sequence":"additional","affiliation":[{"name":"Indian Council of Medical Research, National Institute of Malaria Research, Dwarka, New Delhi, India;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Neena","family":"Valecha","sequence":"additional","affiliation":[{"name":"Independent Malaria Technical Expert, New Delhi, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anupkumar R.","family":"Anvikar","sequence":"additional","affiliation":[{"name":"Indian Council of Medical Research, National Institute of Malaria Research, Dwarka, New Delhi, India;"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2795","reference":[{"key":"b1"},{"key":"b2","series-title":"J Vector Borne Dis","first-page":"60","article-title":"Malaria elimination: using past and present experience to make malaria-free India by 2030","volume":"56","author":"Lal","year":"2019"},{"key":"b3","series-title":"Malar J","first-page":"8","article-title":"Limitations of microscopy to differentiate Plasmodium species in a region co-endemic for Plasmodium falciparum, Plasmodium vivax and Plasmodium knowlesi","volume":"12","author":"Barber","year":"2013"},{"key":"b4"},{"key":"b5","series-title":"Am J Trop Med Hyg","first-page":"281","article-title":"Free market availability of rapid diagnostics will empower communities to control malaria in India","volume":"105","author":"Rahi","year":"2021"},{"key":"b6"},{"key":"b7","series-title":"Indian J Med Res","first-page":"23","article-title":"Quality assurance of malaria rapid diagnostic tests: an aid in malaria elimination","volume":"157","author":"Srivastava","year":"2023"},{"key":"b8","year":"2016"},{"key":"b9","year":"2020"},{"key":"b10","series-title":"Malar J","first-page":"1","article-title":"Impact of Plasmodium falciparum gene deletions on malaria rapid diagnostic test performance","volume":"19","author":"Gatton","year":"2020"},{"key":"b11","series-title":"Malar J","first-page":"1","article-title":"Keep the quality high: the benefits of lot testing for the quality control of malaria rapid diagnostic tests","volume":"19","author":"Incardona","year":"2020"},{"key":"b12","series-title":"Malar J","first-page":"171","article-title":"Evaluation of a rapid diagnostic test (CareStart Malaria HRP-2\/pLDH (Pf\/pan) Combo Test) for the diagnosis of malaria in a reference setting","volume":"9","author":"Maltha","year":"2010"},{"key":"b13","series-title":"Malar J","first-page":"1","article-title":"Pan-Plasmodium band sensitivity for Plasmodium falciparum detection in combination malaria rapid diagnostic tests and implications for clinical management","volume":"14","author":"Gatton","year":"2015"},{"key":"b14","series-title":"Malar J","first-page":"43","article-title":"Use of a three-band HRP2\/pLDH combination rapid diagnostic test increases diagnostic specificity for falciparum malaria in Ugandan children","volume":"13","author":"Hawkes","year":"2014"},{"key":"b15","series-title":"Am J Trop Med Hyg","first-page":"1092","article-title":"Comparison of HRP2- and pLDH-based rapid diagnostic tests for malaria with longitudinal follow-up in Kampala, Uganda","volume":"76","author":"Hopkins","year":"2007"}],"container-title":["The American Journal of Tropical Medicine and Hygiene"],"original-title":[],"link":[{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/110\/3\/article-p431.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.ajtmh.org\/downloadpdf\/journals\/tpmd\/110\/3\/article-p431.xml","content-type":"text\/html","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/www.ajtmh.org\/downloadpdf\/journals\/tpmd\/110\/3\/article-p431.xml","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,3,6]],"date-time":"2024-03-06T13:56:52Z","timestamp":1709733412000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/110\/3\/article-p431.xml"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,3,6]]},"references-count":15,"journal-issue":{"issue":"3"},"URL":"https:\/\/doi.org\/10.4269\/ajtmh.23-0339","relation":{},"ISSN":["0002-9637","1476-1645"],"issn-type":[{"value":"0002-9637","type":"print"},{"value":"1476-1645","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,3,6]]}}}