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Llibre, Alba and Shimakawa, Yusuke and Mottez, Estelle and Ainsworth, Shaun and Buivan, Tan-Phuc and Firth, Rick and Harrison, Elliott and Rosenberg, Arielle R. and Meritet, Jean-Francois and Fontanet, Arnaud and Castan, Pablo and Madejon, Antonio and Laverick, Mark and Glass, Allison and Viana, Raquel and Pol, Stanislas and McClure, C. Patrick and Irving, William Lucien and Miele, Gino and 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

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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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