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
Who can buy the test kits?
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.
Who is allowed to conduct the tests?
COVID-19 rapid antigen self-tests can be used by anyone on themselves.
Are your products TGA approved?
What is the shelf life of the test kits?
What do you do if you test positive to COVID-19?
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.
What do you do if you test negative to COVID-19?
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.
Do the tests work on all variants of COVID-19?
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.
Is this good for children and adolescents?
Yes. The tests are safe to use for these age groups.
Is there a maximum number of times the test can be performed on somebody?
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.
How effective are they compared to the PCR test?
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.
Can these tests be performed at home?
Do businesses need to have policies and procedures in place to perform tests?
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.
