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Gut. 2018 Nov;67(11):2017-2024. doi: 10.1136/gutjnl-2017-315783. Epub 2018 Apr 3.

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

Author information

1
Immunobiology of Dendritic Cells, Institut Pasteur, Paris, France.
2
Inserm U1223, Institut Pasteur, Paris, France.
3
Unité d'Epidémiologie des Maladies Emergentes, Institut Pasteur, Paris, France.
4
Centre for Translational Research, Institut Pasteur, Paris, France.
5
INSERM UMS20, Institut Pasteur, Paris, France.
6
genedrive pIc, Manchester, UK.
7
Université Paris Descartes, EA4474 "Hepatitis C Virology", AP-HP, Hôpital Cochin, Service de Virologie, Paris, France.
8
PACRI Unit, Conservatoire National des Arts et Métiers, Paris, France.
9
Hospital Universitario La Paz, Madrid, Spain.
10
Liver Unit, Hospital Universitario La Paz, CIBERehd, IdiPAZ, Madrid, Spain.
11
Lancet Laboratories, Johannesburg, South Africa.
12
Gastrointestinal and Liver Disorders Theme, NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust, University of Nottingham, Nottingham, UK.
13
Department of Cancer Immunology, Genentech Inc, San Francisco, California, USA.
#
Contributed equally

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.

TRIAL REGISTRATION NUMBER:

NCT02992184 .

KEYWORDS:

Chronic Viral Hepatitis; Diagnostic Virology; Hepatitis C

PMID:
29615488
PMCID:
PMC6176522
DOI:
10.1136/gutjnl-2017-315783
[Indexed for MEDLINE]
Free PMC Article

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