We have published guidance to assist sponsors and manufacturers in preparing their documentation for applications for COVID-19 rapid antigen tests.
The guidance has been updated to:
reflect that the analytical and clinical performance requirements for COVID-19 rapid antigen self-tests are also considered applicable to rapid antigen point-of-care tests (as these are the same category of rapid antigen tests used at the point-of-care).
Public health context
Performance characteristics and risk mitigation strategies for COVID-19 rapid antigen tests
Analytical requirements for rapid antigen tests
Clinical characteristics and clinical performance requirements for rapid antigen tests
Requirements for COVID-19 rapid antigen self-tests
Usability studies for self-tests
Usability and user comprehension
Confirmation of sensitivity and specificity in the hands of lay persons
Invalid test rate
Risks for rapid antigen tests
Risk mitigation strategies for self-tests
Requirements for the instructions for use (IFU)
Associated software and mobile applications
Post-market monitoring and standard conditions of inclusion
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.