1. Utility of a buccal swab point-of-care test for the IFNL4 genotype in the era of direct acting antivirals for hepatitis C virus.
- Author
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Sy, Aminata, McCabe, Leanne, Hudson, Emma, Ansari, Azim M., Pedergnana, Vincent, Lin, Shang-Kuan, Santana, S., Fiorino, Marzia, Ala, Aftab, Stone, Ben, Smith, M., Nelson, Mark, Barclay, Stephen T., McPherson, Stuart, Ryder, Stephen D., Collier, Jane, Barnes, Eleanor, Walker, Ann Sarah, Pett, Sarah L., and Cooke, Graham
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HEPATITIS C virus , *GENOTYPES , *POINT-of-care testing , *ANTIVIRAL agents , *HEPATITIS C , *PLANT viruses - Abstract
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. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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