RT Journal Article
SR Electronic
T1 Development and clinical validation of the Genedrive point-of-care test for qualitative detection of hepatitis C virus
JF Gut
JO Gut
FD BMJ Publishing Group Ltd and British Society of Gastroenterology
SP 2017
OP 2024
DO 10.1136/gutjnl-2017-315783
VO 67
IS 11
A1 Alba Llibre
A1 Yusuke Shimakawa
A1 Estelle Mottez
A1 Shaun Ainsworth
A1 Tan-Phuc Buivan
A1 Rick Firth
A1 Elliott Harrison
A1 Arielle R Rosenberg
A1 Jean-François Meritet
A1 Arnaud Fontanet
A1 Pablo Castan
A1 Antonio Madejón
A1 Mark Laverick
A1 Allison Glass
A1 Raquel Viana
A1 Stanislas Pol
A1 C Patrick McClure
A1 William Lucien Irving
A1 Gino Miele
A1 Matthew L Albert
A1 Darragh Duffy
YR 2018
UL http://gut.bmj.com/content/67/11/2017.abstract
AB 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.