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Down-Classification of Hepatitis C Virus Diagnostics: Implications for Screening and Diagnosis.

Norah A Terrault
Published in: The Journal of infectious diseases (2023)
In November 2021, the U.S. Food and Drug Administration (FDA) reclassified two types of hepatitis C 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.
Keyphrases
  • hepatitis c virus
  • human immunodeficiency virus
  • nucleic acid
  • machine learning
  • deep learning
  • drug administration
  • palliative care
  • sars cov
  • quality improvement
  • high throughput
  • real time pcr