{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T06:50:45Z","timestamp":1791442245058,"version":"4.3.3"},"reference-count":24,"publisher":"Public Library of Science (PLoS)","issue":"11","license":[{"start":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T00:00:00Z","timestamp":1763683200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"COR-NTD","award":["OPP1190754"],"award-info":[{"award-number":["OPP1190754"]}]},{"DOI":"10.13039\/100000200","name":"United States Agency for International Development","doi-asserted-by":"crossref","award":["COR-NTD"],"award-info":[{"award-number":["COR-NTD"]}],"id":[{"id":"10.13039\/100000200","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["www.plosntds.org"],"crossmark-restriction":false},"short-container-title":["PLoS Negl Trop Dis"],"abstract":"\n Introduction<\/jats:title>\n \n Onchocerciasis is a neglected tropical disease caused by\n Onchocerca volvulus<\/jats:italic>\n and is primarily controlled through mass drug administration (MDA) of ivermectin. Current diagnostic tests perform sub-optimally for onchocerciasis elimination programs. According to the WHO, a test needs a sensitivity of \u226560% and a specificity of \u226599.8% for mapping, and a sensitivity of \u226589% and a specificity of \u226599.8% for MDA stopping decisions. We assessed the performance of the commercially available Ov16 SD Bioline rapid diagnostic test (RDT) and three novel RDTs: DDTD biplex type A, type C, and the monoplex type GADx.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n The study included 319 pregnant\/post-partum women in Maridi, an onchocerciasis-endemic area in South Sudan. Locally trained healthcare workers conducted RDT with whole blood and skin snip testing. Ov16 SD Bioline RDT was also performed using dried blood spots (DBS). Diagnostic performances were evaluated using three individual reference tests (anti-Ov16 ELISA, O-150 qPCR, skin snip microscopy) and two composite reference standards. DBS were tested for\n Mansonella spp.<\/jats:italic>\n using qPCR to account for potential false positives.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Anti-Ov16 ELISA detected\n O. volvulus<\/jats:italic>\n antibodies in 49.6% (123\/248) participants, while\n O. volvulus<\/jats:italic>\n infection was documented by skin snip microscopy in 31.9% (46\/144) participants and in 41.8% (50\/141) by qPCR.\n Mansonella spp.<\/jats:italic>\n infection prevalence was 13.4% (34\/253). Monoplex RTDs (Ov16 SD Bioline, GADx) detected\n O. volvulus<\/jats:italic>\n antibodies in >60%, while the biplex tests (DDTD A and C) detected 50% seropositivity. Estimated sensitivities of RDTs ranged from 69.4% (Ov16 SD Bioline) to 48.9% (DDTD A), while specificity ranged from 73.2% (DDTD C) to 42.5% (Ov16 SD Bioline).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n O. volvulus<\/jats:italic>\n and\n Mansonella spp.<\/jats:italic>\n prevalence was high among pregnant and post-partum women in Maridi. The novel RDTs demonstrated sensitivities within the range of the commercially available Ov16 SD Bioline RDT, meeting the WHO threshold for onchocerciasis mapping but not for MDA stopping decisions. No RDT met the specificity threshold of 99.8%, although some exhibited slightly higher specificity than Ov16 SD Bioline RDT. This suboptimal specificity raises concerns, underscoring the need for better diagnostic tools to support onchocerciasis elimination efforts.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1371\/journal.pntd.0013736","type":"journal-article","created":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T18:28:33Z","timestamp":1763749713000},"page":"e0013736","update-policy":"https:\/\/doi.org\/10.1371\/journal.pntd.corrections_policy","source":"Crossref","is-referenced-by-count":5,"title":["Performance of novel onchocerciasis rapid diagnostic tests in a field setting in South Sudan"],"prefix":"10.1371","volume":"19","author":[{"given":"Amber","family":"Hadermann","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen Raimon","family":"Jada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Trevisan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abdurezak","family":"Seid","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte","family":"Lubbers","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lu\u00eds-Jorge","family":"Amaral","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marina","family":"Saleeb","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yak Yak","family":"Bol","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katja","family":"Polman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph Nelson","family":"Siewe Fodjo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-0691-3697","authenticated-orcid":true,"given":"Robert","family":"Colebunders","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2025,11,21]]},"reference":[{"issue":"8","key":"pntd.0013736.ref001","article-title":"Effect of onchocerciasis elimination measures on the incidence of epilepsy in Maridi, South Sudan: a 3-year longitudinal, prospective, population-based study","volume":"11","author":"SR Jada","year":"2023","journal-title":"Lancet Glob Health"},{"key":"pntd.0013736.ref002","doi-asserted-by":"crossref","first-page":"206","DOI":"10.12688\/openreseurope.16093.2","article-title":"Rapid diagnostic testing for onchocerciasis in Maridi (South Sudan) before and after improving elimination strategies: a repeated cross-sectional survey","volume":"3","author":"A Hadermann","year":"2024","journal-title":"Open Res Eur"},{"issue":"6","key":"pntd.0013736.ref003","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pntd.0009489","article-title":"How does onchocerciasis-related skin and eye disease in Africa depend on cumulative exposure to infection and mass treatment?","volume":"15","author":"NVS Vinkeles Melchers","year":"2021","journal-title":"PLoS Negl Trop Dis"},{"issue":"2","key":"pntd.0013736.ref004","doi-asserted-by":"crossref","first-page":"145","DOI":"10.1002\/epi4.12054","article-title":"Onchocerciasis-associated epilepsy: from recent epidemiological and clinical findings to policy implications","volume":"2","author":"R Colebunders","year":"2017","journal-title":"Epilepsia Open"},{"issue":"4","key":"pntd.0013736.ref005","doi-asserted-by":"crossref","first-page":"906","DOI":"10.4269\/ajtmh.15-0695","article-title":"Detection of Onchocerca volvulus in skin snips by microscopy and real-time polymerase chain reaction: implications for monitoring and evaluation activities","volume":"94","author":"EA Thiele","year":"2016","journal-title":"Am J Trop Med Hyg"},{"key":"pntd.0013736.ref006","volume-title":"Guidelines for stopping mass drug administration and verifying elimination of human onchocerciasis: criteria and procedures","author":"World Health Organisation","year":"2016"},{"issue":"1","key":"pntd.0013736.ref007","doi-asserted-by":"crossref","first-page":"154","DOI":"10.1186\/s13071-017-2090-z","article-title":"Skin snips have no role in programmatic evaluations for onchocerciasis elimination: a reply to Bottomley et al","volume":"10","author":"ML Eberhard","year":"2017","journal-title":"Parasit Vectors"},{"issue":"10","key":"pntd.0013736.ref008","doi-asserted-by":"crossref","DOI":"10.1128\/JCM.00706-19","article-title":"Diagnostic identification and differentiation of microfilariae","volume":"57","author":"BA Mathison","year":"2019","journal-title":"J Clin Microbiol"},{"key":"pntd.0013736.ref009","author":"WHO","year":"2021"},{"key":"pntd.0013736.ref010","unstructured":"WHO. Report of the Third Meeting of the WHO Onchocerciasis Technical Advisory Subgroup; 2019 [cited 2025 Jun 14]. Available from: https:\/\/www.who.int\/publications\/i\/item\/9789240006638"},{"key":"pntd.0013736.ref011","unstructured":"WHO. Onchocerciasis: diagnostic target product profile to support preventive chemotherapy. [cited 2025 Jun 14]. 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