학술논문
Determining the lower limit of detection required for HCV viral load assay for test of cure following direct‐acting antiviral‐based treatment regimens: Evidence from a global data set
Document Type
article
Author
Morgan, Jake R; Marsh, Elizabeth; Savinkina, Alexandra; Shilton, Sonjelle; Shadaker, Shaun; Tsertsvadze, Tengiz; Kamkamidze, George; Alkhazashvili, Maia; Morgan, Timothy; Belperio, Pam; Backus, Lisa; Doss, Waheed; Esmat, Gamal; Hassany, Mohamed; Elsharkawy, Aisha; Elakel, Wafaa; Mehrez, Mai; Foster, Graham R; Kinge, Constance Wose; Chew, Kara W; Chasela, Charles S; Sanne, Ian M; Thanung, Yin M; Loarec, Anne; Aslam, Khawar; Balkan, Suna; Easterbrook, Philippa J; Linas, Benjamin P
Source
Journal of Viral Hepatitis. 29(6)
Subject
Language
Abstract
Achieving global elimination of hepatitis C virus requires a substantial scale-up of testing. Point-of-care HCV viral load assays are available as an alternative to laboratory-based 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 weeks post-treatment (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-sponsored 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-level virological treatment failure (defined as