COVID-19 Rapid antigen tests

Guidance on performance requirements and risk mitigation strategies

Last updated

15 June 2023

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).

Please contact us at COVIDtests@tga.gov.au or phone 1800 141 144 if you need further information.

Purpose
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
  - Symptomatic testing
  - Asymptomatic screening
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
  - Inter-reader variability
  - 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
- Additional conditions may be applied
- Post-market review