Utility of a buccal swab point-of-care test for the IFNL4 genotype in the era of direct acting antivirals for hepatitis C virus.

Autor: Sy A; MRC Clinical Trials Unit, University College London, London, United Kingdom., McCabe L; MRC Clinical Trials Unit, University College London, London, United Kingdom., Hudson E; Peter Medawar Building for Pathogen Research, Oxford, United Kingdom., Ansari AM; Peter Medawar Building for Pathogen Research, Oxford, United Kingdom., Pedergnana V; Peter Medawar Building for Pathogen Research, Oxford, United Kingdom., Lin SK; Peter Medawar Building for Pathogen Research, Oxford, United Kingdom., Santana S; Peter Medawar Building for Pathogen Research, Oxford, United Kingdom., Fiorino M; Mortimer Market Centre, Central and NorthWest London NHS Foundation Trust, London, United Kingdom.; Institute for Global Health, University College London, London, United Kingdom., Ala A; Clinical and Experimental Medicine, University of Surrey, Guilford, United Kingdom., Stone B; Infectious Diseases, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom., Smith M; Hepatology, Brighton and Sussex Medical School, Brighton, United Kingdom., Nelson M; HIV Medicine, Chelsea & Westminster NHS Trust, London, United Kingdom., Barclay ST; Gastroenterology, Glasgow Royal Infirmary, Glasgow, United Kingdom., McPherson S; Hepatology, Newcastle Upon Tyne Hospitals NHS Trust, Newcastle upon Tyne, United Kingdom., Ryder SD; Hepatology, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom., Collier J; Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, United Kingdom., Barnes E; Peter Medawar Building for Pathogen Research, Oxford, United Kingdom.; Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, United Kingdom., Walker AS; MRC Clinical Trials Unit, University College London, London, United Kingdom., Pett SL; MRC Clinical Trials Unit, University College London, London, United Kingdom.; Mortimer Market Centre, Central and NorthWest London NHS Foundation Trust, London, United Kingdom.; Institute for Global Health, University College London, London, United Kingdom., Cooke G; Department of Infectious Disease, Imperial College London, London, United Kingdom.; NIHR Biomedical Research Centre, Imperial College NHS Trust, London, United Kingdom.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2023 Jan 23; Vol. 18 (1), pp. e0280551. Date of Electronic Publication: 2023 Jan 23 (Print Publication: 2023).
DOI: 10.1371/journal.pone.0280551
Abstrakt: Background: The CC genotype of the IFNL4 gene is known to be associated with increased Hepatitis C (HCV) cure rates with interferon-based therapy and may contribute to cure with direct acting antivirals. The Genedrive® IFNL4 is a CE marked Point of Care (PoC) molecular diagnostic test, designed for in vitro diagnostic use to provide rapid, real-time detection of IFNL4 genotype status for SNP rs12979860.
Methods: 120 Participants were consented to a substudy comparing IFNL4 genotyping results from a buccal swab analysed on the Genedrive® platform with results generated using the Affymetix UK Biobank array considered to be the gold standard.
Results: Buccal swabs were taken from 120 participants for PoC IFNL4 testing and a whole blood sample for genetic sequencing. Whole blood genotyping vs. buccal swab PoC testing identified 40 (33%), 65 (54%), and 15 (13%) had CC, CT and TT IFNL4 genotype respectively. The Buccal swab PoC identified 38 (32%) CC, 64 (53%) CT and 18 (15%) TT IFNL4 genotype respectively. The sensitivity and specificity of the buccal swab test to detect CC vs non-CC was 90% (95% CI 76-97%) and 98% (95% CI 91-100%) respectively.
Conclusions: The buccal swab test was better at correctly identifying non-CC genotypes than CC genotypes. The high specificity of the Genedrive® assay prevents CT/TT genotypes being mistaken for CC, and could avoid patients being identified as potentially 'good responders' to interferon-based therapy.
Competing Interests: The authors have declared that no competing interests exist.
(Copyright: © 2023 Sy et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Databáze: MEDLINE
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