{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T03:11:28Z","timestamp":1791515488834,"version":"4.3.4"},"reference-count":14,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2025,10,13]],"date-time":"2025-10-13T00:00:00Z","timestamp":1760313600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Viral Hepatitis"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Improved HCV diagnosis and linkage to care is crucial to achieve WHO 2030 elimination targets. Simplification of diagnostics remains key. We evaluated the performance of Elecsys HCV Duo antigen\/antibody immunoassay in patients using public healthcare in Cape Town, South Africa. 253 HCV seropositive and 214 seronegative samples were tested, and results correlated with standard\u2010of\u2010care (SOC) serology, HCV RNA, viral genotype, patient demographics, and disease markers. Thirteen patients on antiviral therapy were also evaluated. Elecsys HCV Duo antibody was equivalent to SOC serology, while antigen had 100% negative percent agreement in non\u2010viraemic samples. One incident infection with viral load (VL) of 54,000\u2009IU\/mL was antigen positive\/antibody negative. Overall, antigen detection was 63.2% in RNA\u2010positive samples. VL strongly predicted reactivity, with antigen positive rates of 17.5% (&lt;\u20095 log IU\/mL), 75.8% (5\u20136 log IU\/mL), 89.4% (6\u20137 log IU\/mL), and 100% (&gt;\u20097 log IU\/mL). Detection in genotype\u20101 infections was significantly better, at 69.6% (95% CI 59.5\u201379.7) than non\u2010genotype\u20101 at 43.2% (95% CI 28.7\u201357.7). In treated patients, antigen mirrored RNA clearance but was only reliable if positive at baseline. Elecsys HCV Duo detected active infection in 63% of viraemic patients, 70% with genotype 1. In our cohort, 49% of new patients would require VL testing.<\/jats:p>","DOI":"10.1111\/jvh.70095","type":"journal-article","created":{"date-parts":[[2025,10,13]],"date-time":"2025-10-13T17:21:20Z","timestamp":1760376080000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Performance Evaluation of the Elecsys HCV Duo Immunoassay in the Public Healthcare Setting in Cape Town, South Africa"],"prefix":"10.1111","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0056-7547","authenticated-orcid":false,"given":"Diana R.","family":"Hardie","sequence":"first","affiliation":[{"name":"Division of Medical Virology, Department of Pathology University of Cape Town Medical School  Cape Town South Africa"},{"name":"National Health Laboratory Service  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen N. J.","family":"Korsman","sequence":"additional","affiliation":[{"name":"Division of Medical Virology, Department of Pathology University of Cape Town Medical School  Cape Town South Africa"},{"name":"National Health Laboratory Service  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4804-3774","authenticated-orcid":false,"given":"Ziyaad","family":"Valley\u2010Omar","sequence":"additional","affiliation":[{"name":"Division of Medical Virology, Department of Pathology University of Cape Town Medical School  Cape Town South Africa"},{"name":"National Health Laboratory Service  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nadia","family":"Petersen","sequence":"additional","affiliation":[{"name":"Western Cape Blood Services  Cape Town South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Russell","family":"Cable","sequence":"additional","affiliation":[{"name":"Western Cape Blood Services  Cape Town South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. Wendy","family":"Spearman","sequence":"additional","affiliation":[{"name":"Division of Hepatology, Department of Medicine University of Cape Town Medical School and Groote Schuur Hospital  Cape Town South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Sonderup","sequence":"additional","affiliation":[{"name":"Division of Hepatology, Department of Medicine University of Cape Town Medical School and Groote Schuur Hospital  Cape Town South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,10,13]]},"reference":[{"key":"e_1_2_11_2_1","first-page":"225","article-title":"Global Hepatitis Report 2024: Action for Access in Low\u2010 and Middle\u2010Income Countries","volume":"16","author":"World Health Organisation","year":"2024","journal-title":"World Health Organisation"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajg.2021.07.002"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.7196\/SAMJ.2020.v110i2.14195"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(19)32320\u20107"},{"key":"e_1_2_11_6_1","unstructured":"World Health Organisation \u201cGlobal Health Sector Strategy on Viral Hepatitis 2016\u20132021. Towards Ending Viral Hepatitis \u201d(2016) https:\/\/www.who.int\/publications\/i\/item\/WHO\u2010HIV\u20102016.06."},{"key":"e_1_2_11_7_1","unstructured":"World Health Organization \u201cWHO Guidelines on Hepatitis B and C Testing \u201d(2017) https:\/\/www.who.int\/publications\/i\/item\/9789241549981."},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/rmv.2436"},{"key":"e_1_2_11_9_1","unstructured":"Elecsys HCV\u2010Duo kit insert \u201cRoche Diagnostics GmbH Sandhofer Strasse 116 D\u201068305 Mannheim 2023\u201d."},{"key":"e_1_2_11_10_1","volume-title":"South African National Department of Health National Guidelines for the Management of Viral Hepatitis in South Africa (2020)","author":"Do H. S. A. N.","year":"2020"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.00832\u201024"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0313771"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/jvh.13337"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0287694"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0282013"}],"container-title":["Journal of Viral Hepatitis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jvh.70095","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,13]],"date-time":"2025-11-13T11:14:24Z","timestamp":1763032464000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jvh.70095"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,13]]},"references-count":14,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2025,11]]}},"alternative-id":["10.1111\/jvh.70095"],"URL":"https:\/\/doi.org\/10.1111\/jvh.70095","archive":["Portico"],"relation":{},"ISSN":["1352-0504","1365-2893"],"issn-type":[{"value":"1352-0504","type":"print"},{"value":"1365-2893","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,13]]},"assertion":[{"value":"2025-07-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-09-25","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-13","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70095"}}