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In previous studies, we developed and field-tested a lateral flow assay (LFA) quantitatively detecting human IgM against <jats:italic>M. leprae<\/jats:italic>-specific phenolic glycolipid I (anti-PGL-I), a marker for both active and past infection. This rapid test utilizes luminescent, background-free, up-converting reporter particles (UCP) and immunochromatography (i.e. the UCP-LF test platform) for accurate quantitation of anti-PGL-I IgM without operator bias. The aim of this study was to evaluate the final version of this quantitative UCP-based rapid test (i.e. PGL-I QURapid), using serum and fingerstick blood (FSB).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>The test comprises a lateral flow strip, in a standard plastic or biodegradable cassette. It can be provided with a humanized, recombinant control to monitor test performance and calculate accurate anti-PGL-I IgM levels. The performance of this QUR-test was assessed using serum and FSB from patients with leprosy <jats:italic>(n<\/jats:italic>\u2009=\u2009214), tuberculosis (<jats:italic>n<\/jats:italic>\u2009=\u200920), buruli ulcer (<jats:italic>n<\/jats:italic>\u2009=\u200919), leishmaniasis (<jats:italic>n<\/jats:italic>\u2009=\u200914), non-tuberculous mycobacterial (<jats:italic>n<\/jats:italic>\u2009=\u200935) infections, as well as healthy Dutch individuals (<jats:italic>n<\/jats:italic>\u2009=\u2009710) and humanized, recombinant anti-PGL-I IgM antibodies. Plot receiver operating characteristic curves were created and sensitivity (Sn), specificity (Sp) and the area under the curve were calculated to evaluate test performance.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Test results classified multibacillary leprosy patients with 95.0% Sn and 100% Sp using serum and 91.5% Sn and 99.8% Sp using FSB. Qualitative test results could be read after 2\u00a0min flow time, with accurate quantitation from 10\u00a0min onwards. The new anti-PGL-I IgM control supports production of batches with predetermined seropositivity thresholds and monitoring of the PGL-I\u00a0QUR-test in various settings.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>The operational version of the PGL-I QURapid with point-of-care applicability, meets the WHO target product profile criteria. Thus, this QUR-test is ready for public health implementations.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Graphical Abstract<\/jats:title>\n                \n              <\/jats:sec>","DOI":"10.1186\/s40249-024-01262-9","type":"journal-article","created":{"date-parts":[[2024,12,1]],"date-time":"2024-12-01T23:01:28Z","timestamp":1733094088000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Rapid test for Mycobacterium leprae infection: a practical tool for leprosy"],"prefix":"10.1186","volume":"13","author":[{"given":"Louise","family":"Pierneef","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anouk","family":"van Hooij","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danielle","family":"de Jong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gaby","family":"Wassenaar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Els","family":"Verhard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisa","family":"Tjon Kon Fat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nadine","family":"Engel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marufa","family":"Khatun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Santosh","family":"Soren","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abu Sufian","family":"Chowdhury","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colette","family":"van Hees","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Corstjens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annemieke","family":"Geluk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,12,2]]},"reference":[{"issue":"2","key":"1262_CR1","doi-asserted-by":"publisher","first-page":"338","DOI":"10.1128\/CMR.19.2.338-381.2006","volume":"19","author":"DM Scollard","year":"2006","unstructured":"Scollard DM, Adams LB, Gillis TP, Krahenbuhl JL, Truman RW, Williams DL. 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BMRC\/NREC\/2010-2013\/1534 and MEC-2012-589, the Netherlands), leishmaniasis (MEC 2012-047 & MEC-2015-306 & B21.048, the Netherlands), TB (METC P07.048, the Netherlands), NTM (METC P207\/99, the Netherlands) and BU samples (FWA00001824; Ghana). The BCG-CORONA trial was registered at clinicaltrials.gov (identifier: NCT04328441) and the Dutch Trial Registry (trialregister.nl, identifier Trial NL8477) and the study protocol was approved by the IRB of the LUMC (NL73249.041.20). The studies were conducted in accordance with local legislation and institutional requirements. All participants gave broad consent.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"88"}}