Conditions of Supply for Rapid Antigen Tests

The Australian Government Department of Health Therapeutic Goods Administration (TGA) stipulates the conditions of supply for rapid antigen tests in Australia. 

Use

In Australia, rapid antigen tests can currently only be legally supplied under specific conditions. This is to ensure that the authorised tests are appropriately used and the results are interpreted correctly.

These conditions include that the tests are used by trained health practitioners and/or trained staff under their supervision. This is to ensure a suitable health practitioner is available to provide immediate clinical advice and treatment if required.

The requirement for the involvement of a health care professional and the prohibition on self-testing reflect the critical importance of immediate notification of positive cases to state and territory health authorities. In the event of a positive case, contact tracing and response processes must be immediately enacted to manage outbreaks.

Training

As a minimum, the supplier of the test needs to provide training to the health practitioners performing or overseeing testing. Once trained, a health practitioner can train persons under their supervision to conduct the test. The health practitioner would be responsible for maintaining records of this training.

Face-to-face training is preferable but interactive online training is acceptable.

Frequently Asked Questions

Currently, in Australia, there are two types of tests sold.

COVID-19 rapid antigen point-of-care tests can be only sold to businesses, institutions and other organisations. The businesses who do buy them, require a registered Australian Health Professional to administer and oversee testing, either on site or virtually.

COVID-19 rapid antigen self-tests (for home use) can be purchased by anyone for use at home by individuals.
COVID-19 rapid antigen point-of-care tests must be conducted by either a registered Australian Health Professional or an employee of the business trained in the use of tests by a registered Health Professional.

COVID-19 rapid antigen self-tests can be used by anyone on themselves.
Yes, we only carry tests that are included on the Australian Register of Therapeutic Goods.
The shelf life for our tests is between 6 and 18 months, depending on the manufacturer. This information can be found on the boxes and/or manufacturers' websites.

A person who receives a positive rapid antigen test result needs to have an urgent PCR test to confirm the presence of COVID-19. When a person has a positive rapid antigen test result, they must be notified immediately to the appropriate State or Territory Health Department.

Generally, the relevant Health Department will advise on safe transport to a local COVID-19 testing facility where they will have priority access to a PCR test. The person with a positive rapid antigen test result must remain in isolation until a definitive result is available.

Where someone receives a negative test result, it must be recorded with the testing supervisor. The person who produced the negative result can then continue to follow the latest health advice and restrictions in your area.

Yes. If you view COVID-19 as the tree, the variants are just limbs on that same tree, so it is all part of the same family, which is why the tests do detect the variants.

Yes. The tests are safe to use for these age groups.

One test is good for a one-time use, but an individual can be tested as many times as you'd like. Health guidelines typically recommend for a company or institution-level screening, is 2-3 times per week per employee, but in high risk settings that can go up to once a day.

The PCR test is viewed as the gold standard of diagnostic testing, but for the screening that we're using these rapid antigen tests for, the accuracy tends to be 95% and above. There's a small chance of false positives and almost a 0% chance of false negatives. If you are testing more frequently, the accuracy of screening overall goes up.

 

Yes. COVID-19 rapid antigen self-tests included on the Australian Register of Therapeutic Goods can be performed at home.

Yes, you should have policies and procedures in place to conduct rapid testing. Great sources for these documents are the TGA guidelines and your state/territory health department.

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