Alba Llibre
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
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
PATRICK MCCLURE PATRICK.MCCLURE@NOTTINGHAM.AC.UK
Assistant Professor
WILLIAM IRVING mrzwi@nottingham.ac.uk
Professor of Virology
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.
Citation
Llibre, A., Shimakawa, Y., Mottez, E., Ainsworth, S., Buivan, T.-P., Firth, R., …Duffy, D. (2018). Development and clinical validation of the Genedrive point-of-care test for qualitative detection of hepatitis C virus. Gut, 67(11), 2017-2024. https://doi.org/10.1136/gutjnl-2017-315783
Journal Article Type | Article |
---|---|
Acceptance Date | Mar 14, 2018 |
Online Publication Date | Apr 3, 2018 |
Publication Date | 2018-11 |
Deposit Date | Apr 11, 2018 |
Publicly Available Date | Apr 11, 2018 |
Journal | Gut |
Print ISSN | 0017-5749 |
Electronic ISSN | 1468-3288 |
Publisher | BMJ Publishing Group |
Peer Reviewed | Peer Reviewed |
Volume | 67 |
Issue | 11 |
Pages | 2017-2024 |
DOI | https://doi.org/10.1136/gutjnl-2017-315783 |
Keywords | Gastroenterology |
Public URL | https://nottingham-repository.worktribe.com/output/923339 |
Publisher URL | http://gut.bmj.com/content/early/2018/04/03/gutjnl-2017-315783 |
Contract Date | Apr 11, 2018 |
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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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