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

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 nucl...

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Autores principales: Llibre, Alba, Shimakawa, Yusuke, Mottez, Estelle, Ainsworth, Shaun, Buivan, Tan-Phuc, Firth, Rick, Harrison, Elliott, Rosenberg, Arielle R, Meritet, Jean-François, Fontanet, Arnaud, Castan, Pablo, Madejón, Antonio, Laverick, Mark, Glass, Allison, Viana, Raquel, Pol, Stanislas, McClure, C Patrick, Irving, William Lucien, Miele, Gino, Albert, Matthew L, Duffy, Darragh
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6176522/
https://www.ncbi.nlm.nih.gov/pubmed/29615488
http://dx.doi.org/10.1136/gutjnl-2017-315783
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author Llibre, Alba
Shimakawa, Yusuke
Mottez, Estelle
Ainsworth, Shaun
Buivan, Tan-Phuc
Firth, Rick
Harrison, Elliott
Rosenberg, Arielle R
Meritet, Jean-François
Fontanet, Arnaud
Castan, Pablo
Madejón, Antonio
Laverick, Mark
Glass, Allison
Viana, Raquel
Pol, Stanislas
McClure, C Patrick
Irving, William Lucien
Miele, Gino
Albert, Matthew L
Duffy, Darragh
author_facet Llibre, Alba
Shimakawa, Yusuke
Mottez, Estelle
Ainsworth, Shaun
Buivan, Tan-Phuc
Firth, Rick
Harrison, Elliott
Rosenberg, Arielle R
Meritet, Jean-François
Fontanet, Arnaud
Castan, Pablo
Madejón, Antonio
Laverick, Mark
Glass, Allison
Viana, Raquel
Pol, Stanislas
McClure, C Patrick
Irving, William Lucien
Miele, Gino
Albert, Matthew L
Duffy, Darragh
author_sort Llibre, Alba
collection PubMed
description 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.
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spelling pubmed-61765222018-10-11 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-François Fontanet, Arnaud Castan, Pablo Madejón, Antonio Laverick, Mark Glass, Allison Viana, Raquel Pol, Stanislas McClure, C Patrick Irving, William Lucien Miele, Gino Albert, Matthew L Duffy, Darragh Gut Hepatology 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. BMJ Publishing Group 2018-11 2018-04-03 /pmc/articles/PMC6176522/ /pubmed/29615488 http://dx.doi.org/10.1136/gutjnl-2017-315783 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Hepatology
Llibre, Alba
Shimakawa, Yusuke
Mottez, Estelle
Ainsworth, Shaun
Buivan, Tan-Phuc
Firth, Rick
Harrison, Elliott
Rosenberg, Arielle R
Meritet, Jean-François
Fontanet, Arnaud
Castan, Pablo
Madejón, Antonio
Laverick, Mark
Glass, Allison
Viana, Raquel
Pol, Stanislas
McClure, C Patrick
Irving, William Lucien
Miele, Gino
Albert, Matthew L
Duffy, Darragh
Development and clinical validation of the Genedrive point-of-care test for qualitative detection of hepatitis C virus
title Development and clinical validation of the Genedrive point-of-care test for qualitative detection of hepatitis C virus
title_full Development and clinical validation of the Genedrive point-of-care test for qualitative detection of hepatitis C virus
title_fullStr Development and clinical validation of the Genedrive point-of-care test for qualitative detection of hepatitis C virus
title_full_unstemmed Development and clinical validation of the Genedrive point-of-care test for qualitative detection of hepatitis C virus
title_short Development and clinical validation of the Genedrive point-of-care test for qualitative detection of hepatitis C virus
title_sort development and clinical validation of the genedrive point-of-care test for qualitative detection of hepatitis c virus
topic Hepatology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6176522/
https://www.ncbi.nlm.nih.gov/pubmed/29615488
http://dx.doi.org/10.1136/gutjnl-2017-315783
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