{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T03:30:00Z","timestamp":1792467000427,"version":"4.5.0"},"reference-count":37,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2022,3,30]],"date-time":"2022-03-30T00:00:00Z","timestamp":1648598400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000026","name":"National Institute on Drug Abuse","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000026","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Viral Hepatitis"],"published-print":{"date-parts":[[2022,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Achieving global elimination of hepatitis C virus requires a substantial scale\u2010up of testing. Point\u2010of\u2010care HCV viral load assays are available as an alternative to laboratory\u2010based assays to promote access in hard to reach or marginalized populations. The diagnostic performance and lower limit of detection are important attributes of these new assays for both diagnosis and test of cure. Therefore, our objective was to determine an acceptable LLoD for detectable HCV viraemia as a test for cure, 12\u00a0weeks post\u2010treatment (SVR12). We assembled a global data set of patients with detectable viraemia at SVR12 from observational databases from 9 countries (Egypt, the United States, United Kingdom, Georgia, Ukraine, Myanmar, Cambodia, Pakistan, Mozambique) and two pharmaceutical\u2010sponsored clinical trial registries. We examined the distribution of HCV viral load at SVR12 and presented the 90th, 95th, 97th and 99th percentiles. We used logistic regression to assess characteristics associated with low\u2010level virological treatment failure (defined as &lt;1000\u00a0IU\/mL). There were 5973 cases of detectable viraemia at SVR12 from the combined data set. Median detectable HCV RNA at SVR12 was 287,986\u00a0IU\/mL. The level of detection for the 95th percentile was 227\u00a0IU\/mL (95% CI 170\u2013276). Females and those with minimal fibrosis were more likely to experience low\u2010level viraemia at SVR12 compared to men (adjusted odds ratio AOR\u00a0=\u00a01.60 95% confidence interval [CI] 1.30\u20131.97 and those with cirrhosis (AOR\u00a0=\u00a01.49 95% CI 1.15\u20131.93). In conclusion, an assay with a level of detection of 1000\u00a0IU\/mL or greater may miss a proportion of those with low\u2010level treatment failure.<\/jats:p>","DOI":"10.1111\/jvh.13672","type":"journal-article","created":{"date-parts":[[2022,3,12]],"date-time":"2022-03-12T17:44:51Z","timestamp":1647107091000},"page":"474-486","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Determining the lower limit of detection required for HCV viral load assay for test of cure following direct\u2010acting antiviral\u2010based treatment regimens: Evidence from a global data set"],"prefix":"10.1111","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1559-3983","authenticated-orcid":false,"given":"Jake R.","family":"Morgan","sequence":"first","affiliation":[{"name":"Department of Health Law, Policy, and Management Boston University School of Public Health  Boston Massachusetts 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USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6435-7450","authenticated-orcid":false,"given":"Pam","family":"Belperio","sequence":"additional","affiliation":[{"name":"United States Department of Veteran\u2019s Affairs  Long Beach California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Backus","sequence":"additional","affiliation":[{"name":"United States Department of Veteran\u2019s Affairs  Long Beach California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Waheed","family":"Doss","sequence":"additional","affiliation":[{"name":"National Committee for Control of Viral Hepatitis NCCVH  Cairo Egypt"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gamal","family":"Esmat","sequence":"additional","affiliation":[{"name":"Endemic Medicine and Hepatogastroentrology Department, Cairo University  Cairo 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Tropical Medicine Research Institute  Cairo Egypt"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Graham R.","family":"Foster","sequence":"additional","affiliation":[{"name":"Barts Liver Centre Blizard Institute QMUL  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Constance","family":"Wose Kinge","sequence":"additional","affiliation":[{"name":"Implementation Science Unit Right to Care  Centurion South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4865-4348","authenticated-orcid":false,"given":"Kara W.","family":"Chew","sequence":"additional","affiliation":[{"name":"Department of Medicine Division of Infectious Diseases David Geffen School of Medicine at University of California Los Angeles  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles S.","family":"Chasela","sequence":"additional","affiliation":[{"name":"Implementation Science Unit 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South Africa Department of Epidemiology and Biostatistics School of Public Health Faculty of Health Sciences University of the Witwatersrand  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian M.","family":"Sanne","sequence":"additional","affiliation":[{"name":"Right to Care Centurion. South Africa, and Clinical HIV Research Unit School of Clinical Medicine Faculty of Health Sciences University of the Witwatersrand  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yin M.","family":"Thanung","sequence":"additional","affiliation":[{"name":"Community Partners International  Yangon Myanmar"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0877-2358","authenticated-orcid":false,"given":"Anne","family":"Loarec","sequence":"additional","affiliation":[{"name":"M\u00e9decins Sans Fronti\u00e8res  Maputo Mozambique"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Khawar","family":"Aslam","sequence":"additional","affiliation":[{"name":"M\u00e9decins Sans Fronti\u00e8res  Karachi Pakistan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suna","family":"Balkan","sequence":"additional","affiliation":[{"name":"M\u00e9decins Sans Fronti\u00e8res  Paris 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