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Hepatitis B and C viruses IVD self-tests

Clinical performance requirements and risk mitigation strategies
18 March 2021
Download Hepatitis B and C viruses IVD  self-tests


The purpose of this document is to provide manufacturers and sponsors with guidance on the Therapeutic Goods Administration's (TGA) expectations concerning clinical performance requirements (i.e. clinical sensitivity and specificity) and risk mitigations for in vitro diagnostic medical devices (IVDs) intended to be used as self-tests for hepatitis B virus (HBV) and hepatitis C virus (HCV).

  • Purpose
  • Background
  • Public health context
  • Clinical performance characteristics and risk mitigation strategies for IVD self-testing
  • Clinical requirements for HBV and HCV self-tests
  • Usability studies
  • Risks
  • Mitigation strategies

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