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
Arielle R. Rosenberg
C. Patrick McClure
William Lucien Irving
Matthew L. Albert
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|
|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|
|Copyright Statement||Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc/4.0|
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc/4.0