Llibre, Alba, Shimakawa, Yusuke, Mottez, Estelle, Ainsworth, Shaun, Buivan, Tan-Phuc, Firth, Rick, Harrison, Elliott, Rosenberg, Arielle R., Meritet, Jean-Francois, Fontanet, Arnaud, Castan, Pablo, Madejon, Antonio, Laverick, Mark, Glass, Allison, Viana, Raquel, Pol, Stanislas, McClure, C. Patrick, Irving, William Lucien, Miele, Gino, Albert, Matthew L. and Duffy, Darragh
(2018)
Development and clinical validation of the Genedrive
point-of-care test for qualitative detection of hepatitis
C virus.
Gut
.
ISSN 1468-3288
Abstract
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.
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