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Development and clinical validation of the Genedrive point-of-care test for qualitative detection of hepatitis C virus

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.; Duffy, Darragh

Authors

Alba Llibre

Yusuke Shimakawa

Estelle Mottez

Shaun Ainsworth

Tan-Phuc Buivan

Rick Firth

Elliott Harrison

Arielle R. Rosenberg

Jean-Francois Meritet

Arnaud Fontanet

Pablo Castan

Antonio Madejon

Mark Laverick

Allison Glass

Raquel Viana

Stanislas Pol

C. Patrick McClure

William Lucien Irving

Gino Miele

Matthew L. Albert

Darragh Duffy



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.

Journal Article Type Article
Journal Gut
Print ISSN 0017-5749
Electronic ISSN 1468-3288
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
APA6 Citation Llibre, A., Shimakawa, Y., Mottez, E., Ainsworth, S., Buivan, T., Firth, R., …Duffy, D. (in press). Development and clinical validation of the Genedrive point-of-care test for qualitative detection of hepatitis C virus. Gut, doi:10.1136/gutjnl-2017-315783
DOI https://doi.org/10.1136/gutjnl-2017-315783
Publisher URL http://gut.bmj.com/content/early/2018/04/03/gutjnl-2017-315783
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc/4.0





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