TY - JOUR T1 - Development and clinical validation of the Genedrive point-of-care test for qualitative detection of hepatitis C virus JF - Gut JO - Gut SP - 2017 LP - 2024 DO - 10.1136/gutjnl-2017-315783 VL - 67 IS - 11 AU - Alba Llibre AU - Yusuke Shimakawa AU - Estelle Mottez AU - Shaun Ainsworth AU - Tan-Phuc Buivan AU - Rick Firth AU - Elliott Harrison AU - Arielle R Rosenberg AU - Jean-François Meritet AU - Arnaud Fontanet AU - Pablo Castan AU - Antonio Madejón AU - Mark Laverick AU - Allison Glass AU - Raquel Viana AU - Stanislas Pol AU - C Patrick McClure AU - William Lucien Irving AU - Gino Miele AU - Matthew L Albert AU - Darragh Duffy Y1 - 2018/11/01 UR - http://gut.bmj.com/content/67/11/2017.abstract N2 - Objective Recently approved direct acting antivirals provide transformative therapies for chronic hepatitis C virus (HCV) infection. The major clinical challenge remains to identify the undiagnosed patients worldwide, many of whom live in low-income and middle-income countries, where access to nucleic acid testing remains limited. The aim of this study was to develop and validate a point-of-care (PoC) assay for the qualitative detection of HCV RNA.Design We developed a PoC assay for the qualitative detection of HCV RNA on the PCR Genedrive instrument. We validated the Genedrive HCV assay through a case–control study comparing results with those obtained with the Abbott RealTime HCV test.Results The PoC assay identified all major HCV genotypes, with a limit of detection of 2362 IU/mL (95% CI 1966 to 2788). Using 422 patients chronically infected with HCV and 503 controls negative for anti-HCV and HCV RNA, the Genedrive HCV assay showed 98.6% sensitivity (95% CI 96.9% to 99.5%) and 100% specificity (95% CI 99.3% to 100%) to detect HCV. In addition, melting peak ratiometric analysis demonstrated proof-of-principle for semiquantification of HCV. The test was further validated in a real clinical setting in a resource-limited country.Conclusion We report a rapid, simple, portable and accurate PoC molecular test for HCV, with sensitivity and specificity that fulfils the recent FIND/WHO Target Product Profile for HCV decentralised testing in low-income and middle-income countries. This Genedrive HCV assay may positively impact the continuum of HCV care from screening to cure by supporting real-time treatment decisions.Trial registration number NCT02992184. ER -