Abstract In November 2021, the United States Food and Drug Administration reclassified 2 types of hepatitis C virus (HCV) diagnostic tests (HCV antibody and HCV nucleic acid) from class III to class II, providing a less burdensome pathway to market for diagnostic companies. This down-classification is anticipated to facilitate innovation in HCV diagnostics, particularly for new point-of-care viral detection assays, and ultimately support HCV elimination efforts by increasing the ease of screening as well as test-and-treat models of HCV care.
All Keywords
【저자키워드】 Elimination, Screening, point-of-care, Anti-HCV, HCV RNA,
【저자키워드】 Elimination, Screening, point-of-care, Anti-HCV, HCV RNA,