Devices that have not been approved by the TGA cannot be used in Australia. The TGA website includes a list of all registered rapid antigen test kits.
The TGA outlines its regulations around the sale of rapid antigen test kits and conditions of supply. The TGA website publishes frequently asked questions about the supply of rapid antigen tests, which should be reviewed before proceeding with rapid antigen testing.
The two key types of rapid antigen tests are:
- Point-of-Care (PoC) test that is implemented on-site and requires medical supervision.
- Self-test kits that can be done at home and do not require medical supervision
- Your business should familiarise themselves with the differences between PoC tests and self-tests from either the Business.gov.au or TGA websites.