We have published guidance to assist sponsors and manufacturers in preparing their documentation for applications for COVID-19 rapid antigen self-tests.
The guidance has been updated to:
reflect current advice regarding confirmatory testing and reporting requirements for COVID-19 rapid antigen test results due to the differing testing and reporting requirements of the State and Territory jurisdictions based on their public health orders.
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).
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.