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).
Public health context
Clinical performance characteristics and risk mitigation strategies for IVD self-testing
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.