Down-Classification of Hepatitis C Virus Diagnostics: Implications for Screening and Diagnosis.
editorial · Level V
Where this comes from
- Record sourced from PubMed, PMID 37739784.
- Also identified by DOI 10.1093/infdis/jiad299 and PMC identifier 11078310.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
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.
Medical subject headings
- Hepatitis C
- Hepacivirus
- Hepatitis C Antibodies