{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,8]],"date-time":"2026-06-08T11:49:15Z","timestamp":1780919355128,"version":"3.54.1"},"reference-count":55,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2022,4,27]],"date-time":"2022-04-27T00:00:00Z","timestamp":1651017600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Japan Society for the Promotion of Science (JSPS)","award":["15H05283"],"award-info":[{"award-number":["15H05283"]}]},{"name":"Japan Society for the Promotion of Science (JSPS)","award":["17H01685"],"award-info":[{"award-number":["17H01685"]}]},{"name":"Japan Society for the Promotion of Science (JSPS)","award":["15H05283"],"award-info":[{"award-number":["15H05283"]}]},{"name":"Japan Society for the Promotion of Science (JSPS)","award":["17H01685"],"award-info":[{"award-number":["17H01685"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Microorganisms"],"abstract":"<jats:p>Clinical diagnosis has become a challenge amidst a surge of cutaneous leishmaniasis in Southern Sri Lanka. The routine diagnostic method, slit-skin smear (SSS), has variable sensitivity, leading to undiagnosed cases. Improved diagnostics are urgently needed. We assessed a new in-house ELISA method for its diagnostic capabilities against ITS-1 nested PCR (gold standard\u2014Gs). A cohort of 190 clinical CL cases was examined by SSS microscopy, anti-rKRP42 IgG ELISA (serum- and urine-based), and rK39-Immunochromatographic strip test. Validation was done using non-endemic sera, and cutoffs were developed using the receiver operating curve. The sensitivity of SSS for case detection was 77.9% (authors) and 76.3% (technicians). ELISA vs. Gs demonstrated sensitivity (Sn) = 94.4%; specificity (Sp) = 50.0%; positive predictive value (PPV) = 97.1%; negative predictive value (NPV) = 33.3%; Kappa agreement (Kp) = 0.39\/p &lt; 0.01. Comparison of the combination method (SSS by technicians and ELISA) vs. Gs showed: Sn = 98.9%; Sp = 30.0; PPV = 96.2; NPV 60.0%; Kp = 0.378\/p &lt; 0.01. All methods performed better compared to SSS (29.4%) where the clinical diagnosis was doubtful (PCR = 94.15%; serum ELISA = 88.2%; combination = 94.1%; p &lt; 0.01 for all). High serum anti-rKRP42 titers were seen in those with multiple lesions. Anti-rKRP42 urine ELISA was suboptimal as a diagnostic test. A 9% rate of positivity was seen for rk39-ICT, and positives recorded high anti-rKRP42 titers. The diagnostic accuracy can be increased above the level of the Gs by combining SSS and ELISA. Advanced studies are required to understand the association between rk39-ICT positivity and high anti-rKRP42 titers.<\/jats:p>","DOI":"10.3390\/microorganisms10050921","type":"journal-article","created":{"date-parts":[[2022,4,27]],"date-time":"2022-04-27T22:20:20Z","timestamp":1651098020000},"page":"921","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Validation of an In-House ELISA Method in the Diagnosis of Cutaneous Leishmaniasis Caused by Leishmania donovani in Hambantota District, Sri Lanka"],"prefix":"10.3390","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8895-5415","authenticated-orcid":false,"given":"Nirmitha Lalindi","family":"De Silva","sequence":"first","affiliation":[{"name":"Department of Parasitology, Faculty of Medicine, University of Ruhuna, Galle 80000, Sri Lanka"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Viraji Nefertiti Hiromel","family":"De Silva","sequence":"additional","affiliation":[{"name":"Base Hospital Tangalle, Tangalle 82200, Sri Lanka"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arachchige Theja Hemapala","family":"Deerasinghe","sequence":"additional","affiliation":[{"name":"District General Hospital Hambantota, Hambantota 82000, Sri Lanka"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6259-616X","authenticated-orcid":false,"given":"Upeksha Lakmini","family":"Rathnapala","sequence":"additional","affiliation":[{"name":"School of Biosciences, University of Melbourne, Melbourne, VIC 3010, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5429-9536","authenticated-orcid":false,"given":"Hirotomo","family":"Kato","sequence":"additional","affiliation":[{"name":"Division of Medical Zoology, Department of Infection and Immunity, Jichi Medical University, Tochigi 329-0498, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Makoto","family":"Itoh","sequence":"additional","affiliation":[{"name":"Department of Microbiology and Immunology, Aichi Medical University School of Medicine, Aichi 480-1195, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hidekazu","family":"Takagi","sequence":"additional","affiliation":[{"name":"Department of Microbiology and Immunology, Aichi Medical University School of Medicine, Aichi 480-1195, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mirani Vasanthamala","family":"Weerasooriya","sequence":"additional","affiliation":[{"name":"Department of Parasitology, Faculty of Medicine, University of Ruhuna, Galle 80000, Sri Lanka"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4981-8914","authenticated-orcid":false,"given":"Thishan Channa","family":"Yahathugoda","sequence":"additional","affiliation":[{"name":"Department of Parasitology, Faculty of Medicine, University of Ruhuna, Galle 80000, Sri Lanka"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,4,27]]},"reference":[{"key":"ref_1","unstructured":"(2020, April 15). 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