Q&As on COVID-19 rapid antigen self-tests

A list of all COVID-19 rapid antigen self-tests (home use tests) that are approved for supply in Australia is available on the TGA website along with the manufacturer's instructions for how to use the tests. This list is regularly updated as new tests are approved or if tests are cancelled or withdrawn.

Home use tests can be purchased on-line, from pharmacies or from any other retail outlet that stocks the test. Further information is available in the consumer fact sheet (pdf,393kb).

All importers of COVID-19 test kits must apply for, and be granted, an import permit for all consignments of COVID-19 test kits that are imported into Australia, unless the importer can demonstrate that the goods are for personal use only or, for lateral flow test kits, meet the import conditions published on the Australian Biosecurity Import Conditions (BICON).

For further information and to apply for an import permit, refer to BICON import permits.

Home use tests can be purchased on-line, from pharmacies or from any other retail outlet that stock the tests.

Different state and territory jurisdictions may have differing recommendations on testing and reporting requirements based on any public health orders that may be in place. Contact the relevant state or territory government or see their websites for any local requirements that are required for rapid antigen testing including self-tests.

There are two kinds of tests for COVID-19:

• Tests that detect the presence of the virus that include nucleic acid tests that detect genetic material of the virus and tests that detect specific viral proteins. They are usually performed on a swab sample taken from your throat, nose, nasal secretions (snot) or sometimes on saliva.
• Tests that detect whether your body has produced antibodies to the virus. This is usually done by taking a sample of your blood and testing your blood for specific antibodies. Antibody tests are not suitable for the diagnosis of COVID-19 and generally provide historic information about whether you have been exposed to the virus.

Nucleic acid tests

These tests detect the presence of the genetic material, called nucleic acids, of the actual virus. They are good at detecting the virus early in the infection and can sometimes even detect the virus in a person before they become unwell. There are several types of nucleic acid tests that can be used to detect COVID-19 including polymerase chain reaction (PCR) tests.

PCR tests are generally considered better at detecting the presence of the COVID-19 and are currently the gold standard for diagnosis of COVID-19.

Nucleic acid tests are complicated to do and usually need specialist scientists to run the tests in a laboratory to get an accurate result. There are now some COVID-19 nucleic tests available that can be used outside of a laboratory by trained health professionals. Most of these systems give results quickly but cannot do many tests at once.

Rapid Antigen Tests

These tests can detect the presence of specific proteins of the virus. They are most accurate when used to test symptomatic individuals. Although they are not as good at detecting virus as a nucleic acid test.

Rapid antigen tests are generally best performed within the first 7 days from when symptoms first appear. They are not as accurate if you do not have symptoms and can produce false negative or false positive results.

Most tests produce a result within 10-20 minutes. A positive result requires further testing by a PCR test to confirm if a person is infected with COVID-19.

• Point of Care Tests

  Rapid antigen point of care tests are test that can be performed by health practitioners, or trained persons under their supervision. This ensures a suitable health practitioner, or trained person under their supervision is available to ensure an adequate sample is collected, the results are interpreted correctly, and immediate clinical advice and treatment can be provided if required.

  For more information on supply of point of care rapid antigen tests see rapid antigen point-of-care testing in Australia.

• Rapid Antigen Self-Tests (home use tests)

  These are tests that can be used unsupervised at home without the involvement of a health practitioner. The person collects the sample, performs the test and interprets the results by themselves.

  For more information on supply of self-test rapid antigen tests see COVID-19 rapid antigen self-tests in Australia.

If you get a positive test result, contact your GP if you require medical assistance.

As different States and Territories may have different recommendations for testing and for reporting positive results see their website for any local requirements including;

• whether confirmatory PCR testing is required;
• any specific health advice; and
• how and whether the result is required to be reported to your State or Territory health department.

It should also be noted that you can't just repeat the test in the hope the second test will be negative.

Rapid antigen self-tests are can detect the virus in the acute phase of infection - especially just before you show symptoms and in the first week of symptoms becoming apparent – but they are not as accurate as PCR tests. It is very important to follow the instructions for both sample collection and performance of the test. Poor sample collection and incorrect use of the test will impact the accuracy of the test.

Where there are low rates of COVID-19 in the community, the tests are less accurate as there is a higher risk of false positive and false negative results. However, as the rates of COVID-19 in the community increase there is less likelihood of false positive results.

If you get a positive result, follow the relevant State or Territory health authority advice on what you need to do next. It is not acceptable to just repeat the test in the hope of the second test being negative.

If you have symptoms or feel unwell but get a negative result with a self-test you should always seek further PCR testing by contacting the appropriate state/territory health department.

Problems or issues with a self-test (home use test) can be reported back to the place where you purchased the test or to the supplier of the test via the customer support contact information provided in the instructions provided with the test.

You can also report the problem directly to the TGA via the on-line form.

The sponsor/supplier is required to report serious adverse events related to the use or performance of the device, and all complaints associated with false positive and false negative results to the TGA.

Retailers, distributors, and others who wish to repackage or relabel COVID-19 rapid antigen tests should make sure that they are aware of their obligations under the Therapeutic Goods Act 1989 (the Act).

Repackaging should only occur under authority of the sponsor and manufacturer.

Distributors and vendors should only repackage and relabel a medical device at the direction of the sponsor, and with appropriate arrangements in place with the manufacturer of the device as stated on its label.

In all instances, the person who is undertaking the repackaging or relabelling activities must:

• be authorised to perform those tasks on behalf of the manufacturer;
• have a formal quality agreement in place with the manufacturer; and
• carry out the packaging and labelling steps in a secure and controlled environment in accordance with the manufacturer's documented procedures.

Any updated packaging and labelling to be supplied with the devices must be TGA-approved versions that have undergone review as part of a regulatory submission.

If a person repackages and relabels a medical device without complying with the above requirements, this can result in the repackaged medical device legally being a different device from the one included in the Australian Register of Therapeutic Goods. As a result, the person who repackages and then on-sells that device may be breaking the law.

In community settings where there are low rates of COVID-19 there is a high risk of false positive and false negative results. The likelihood of false positives decreases as the rate of COVID-19 in the community rises.

Incorrect results can also be obtained if an inadequate sample is collected or the test is performed incorrectly. It is very important to follow the instructions for use for both sample collection and performance of the test.

For any positive result, you should follow the relevant State or Territory directions around rapid antigen testing, including any requirements for individuals to report a positive result. If you have symptoms but get a negative result with a self-test you should also seek further PCR testing by contacting the appropriate state/territory health department.

COVID-19 rapid antibody self-tests are prohibited and cannot be supplied in Australia.

Antibody self-testing is not suitable for diagnosis of COVID-19 and provides retrospective information only on whether a person may have been previously infected with the virus.

As a general rule, you should follow the instructions provided with your home use test on how to dispose of it. Some tests come with a plastic bag for placing the contents of the swab etc into before placing this in the household rubbish bin.

If no bag is provided you can still place the used items from the test into a small plastic bag which is then sealed. This bag should then go straight into another bag which should be sealed and then disposed of in the household rubbish.

Wash your hands after disposal in line with good COVID safe practices.

Yes, a company, business, organisation, or institution can purchase rapid antigen self-tests for their workers to use at home or on site.

It is important that any business considering implementing rapid antigen testing takes into consideration the implications of testing in these environments, including:

• processes to maintain confidentiality of patient information
• a procedure for possible closure of the busines and isolation of staff if a positive result is received from a rapid antigen test, and
• any state and territory directions around rapid antigen testing, including reminding individuals who test positive that they may be legally required to report a positive test result to their state or territory health department.

Businesses or organisations wanting to implement rapid antigen point of care testing and even self-testing of their workers should refer to the additional guidance on our website that provides further information on what processes and protocols you need to have in place to safely conduct testing in your work place. Businesses that choose to use a COVID-19 rapid self-test do not need to comply with the requirements for supervision of testing. However other general information included in this guidance such as test choice, test performance and safe implementation of testing, is still applicable when considering how to implement rapid antigen testing.

Different state and territory jurisdictions may have differing testing requirements for essential workers, based on their public health orders. Contact the relevant state or territory government or see their websites for how often mandatory tests are required.

Suppliers of COVID-19 rapid antigen self-tests and testing service providers need to make sure that any advertising to consumers (including advertising to businesses or organisations) is compliant with the Therapeutic Goods Advertising Code.

The Advertising Code specifies a number of requirements for these types of advertisements. For example, it requires advertisements to be balanced, accurate, substantiated and not misleading. Additionally, under the Advertising Code, advertisements:

• must be consistent with the directions/instructions for use of the advertised product
• must not exaggerate the efficacy or performance of the product or encourage inappropriate use
• must not be likely to lead people to delay necessary medical attention and
• must not be inconsistent with public health campaigns.

Importantly, it is a legal requirement to not state or imply that the advertised goods are approved or endorsed by the TGA or any other government authority.

Additionally, representations used in advertising that refer to COVID-19 require approval or authorisation by the TGA. The TGA has authorised legally-binding requirements for what advertisements for COVID-19 rapid antigen self-tests can and cannot say through a permission made under section 42DK of the Therapeutic Goods Act 1989, the Therapeutic Goods (Restricted Representations - COVID-19 Rapid Antigen Tests) Permission 2022.

We have published guidance which explains how parties can lawfully advertise COVID-19 rapid antigen self-tests for supply to consumers and meet the requirements set out in the advertising permission.

The TGA will take action in relation to any advertisements that do not meet the requirements.

Further information can be found at the Advertising Therapeutic Goods Hub.

There is also guidance available for advertising of rapid antigen point-of-care tests.

A sponsor can authorise a distributor to supply the rapid antigen self-tests on their behalf. This is usually via a contractual arrangement between the sponsor and distributor.

A distributor is acting on behalf of the sponsor and can only supply the device in accordance with the conditions. A distributor must also maintain records relating to all supply of rapid antigen self-tests and be able to provide this information to the sponsor.

The sponsor remains responsible for supply of the device and all post-market monitoring and reporting responsibilities.