{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T20:17:12Z","timestamp":1791231432323,"version":"4.1.0"},"reference-count":31,"publisher":"Public Library of Science (PLoS)","issue":"4","license":[{"start":{"date-parts":[[2025,4,8]],"date-time":"2025-04-08T00:00:00Z","timestamp":1744070400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"LOEWE Zentrum Druid","award":["LOEWE\/1\/10\/519\/03\/03.001(0016)\/53"],"award-info":[{"award-number":["LOEWE\/1\/10\/519\/03\/03.001(0016)\/53"]}]},{"name":"Ahfad University for Women","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["www.plosntds.org"],"crossmark-restriction":false},"short-container-title":["PLoS Negl Trop Dis"],"abstract":"<jats:p>East-African countries suffer from a high incidence of Visceral Leishmaniasis (VL). Despite the availability of several diagnostic tests for VL, diagnosis remains a challenge in these countries. Due to the inefficiency of current diagnostics, a novel rapid diagnostic test (RDT) (INgezim Leishma-CROM) based on a recombinant multi-epitope kinesin antigen, rKLi8.3, was compared with the currently used rK39 RDT (IT-LEISH) in Eastern Sudan.<\/jats:p>\n                  <jats:sec id=\"sec001\" sec-type=\"materials|methods\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This study enrolled 107 VL suspects who attended a health centre in Gedaref between October 2022 and June 2023. Diagnostic accuracy was assessed by comparing the performance of the new index test (INgezimLeishma-CROM) with the comparator test (IT-LEISH) and parasitological examination as reference standard.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\" sec-type=\"results\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 107 VL suspects screened by parasitological examination, 77 VL patients were smear positive and 30 were smear negative. Independent serological testing of these patients using INgezim Leishma-CROM showed a sensitivity of 98.7% [95% CI 92.23-99.97] and specificity of 92.5% [95% CI 75.71-99.09]. For IT-LEISH, both sensitivity [95% CI 84.39-97.20] and specificity [95% CI 75.71-99.09] were 92.5%. INgezim Leishma-CROM demonstrated increased diagnostic accuracy (97.2%) compared to IT-LEISH RDT (92.5%). Both RDTs gave positive results in 2 cases from the smear negative group that were previously treated for VL. All other non-VL cases (malaria, typhoid, brucellosis) were negative in both RDTs, showing 100% specificity, while VL patients co-infected with malaria were positive in both tests. Within the smear-negative group, 3 VL symptomatic cases that had been previously treated but still show clinical signs were all positive with INgezim Leishma-CROM but only 2 cases were positive with IT-LEISH.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pntd.0012905","type":"journal-article","created":{"date-parts":[[2025,4,8]],"date-time":"2025-04-08T13:41:18Z","timestamp":1744119678000},"page":"e0012905","update-policy":"https:\/\/doi.org\/10.1371\/journal.pntd.corrections_policy","source":"Crossref","is-referenced-by-count":2,"title":["Diagnostic performance of a novel point-of-care test for the diagnosis of visceral leishmaniasis in Sudan: A Comparative Accuracy Study"],"prefix":"10.1371","volume":"19","author":[{"given":"Elfadil","family":"Abass","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Durria","family":"Mansour","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zaki","family":"Abdalla","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hassan","family":"Altaher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mootaz","family":"Sliman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hussam","family":"Osman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rabie Ali","family":"Babiker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed","family":"Salah","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elmohaned","family":"Omer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elwaleed","family":"Elamin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Visekruna","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2141-7756","authenticated-orcid":true,"given":"Ulrich","family":"Steinhoff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rouzbeh","family":"Mahdavi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2025,4,8]]},"reference":[{"issue":"7","key":"pntd.0012905.ref001","doi-asserted-by":"crossref","DOI":"10.3390\/pathogens12070969","article-title":"From infection to death: An overview of the pathogenesis of visceral leishmaniasis","volume":"12","author":"C Costa","year":"2023","journal-title":"Pathogens"},{"issue":"12","key":"pntd.0012905.ref002","doi-asserted-by":"crossref","first-page":"1539","DOI":"10.1093\/cid\/ciw742","article-title":"Diagnosis and Treatment of Leishmaniasis: Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA) and the American Society of Tropical Medicine and Hygiene (ASTMH)","volume":"63","author":"N Aronson","year":"2016","journal-title":"Clin Infect Dis"},{"issue":"3","key":"pntd.0012905.ref003","doi-asserted-by":"crossref","first-page":"307","DOI":"10.1080\/00034983.1997.11813143","article-title":"Phlebotomine sandflies in a focus of visceral leishmaniasis in a border area of eastern Sudan","volume":"91","author":"DA Elnaiem","year":"1997","journal-title":"Ann Trop Med Parasitol"},{"issue":"2","key":"pntd.0012905.ref004","doi-asserted-by":"crossref","first-page":"229","DOI":"10.1080\/00034983.1998.11813284","article-title":"Infection rates ofLeishmania donovaniinPhlebotomus orientalisfrom a focus of visceral leishmaniasis in eastern Sudan","volume":"92","author":"DA Elnaiem","year":"1998","journal-title":"Annals of Tropical Medicine & Parasitology"},{"issue":"22","key":"pntd.0012905.ref005","first-page":"287","article-title":"Leishmaniasis in high-burden countries: an epidemiological update based on data reported in 2014","volume":"91","year":"2016","journal-title":"Wkly Epidemiol Rec"},{"key":"pntd.0012905.ref006","article-title":"Global leishmaniasis surveillance.","volume-title":"2019\u20132020, a baseline for the 2030 roadmap","author":"World Health Organization (WHO)","year":"2021"},{"key":"pntd.0012905.ref007","doi-asserted-by":"crossref","unstructured":"Al-Salem W, Herricks JR, Hotez PJ. 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