Q&As on combination rapid antigen self-tests

Combination RATs test a nasal swab, saliva, or oral fluid sample for multiple viruses that cause respiratory disease (e.g., COVID-19, Influenza A and Influenza B).

Combination RATs can be used anywhere, including at home or work. They can be used without the involvement of a doctor or health professional. Most tests produce a result within 10-20 minutes.

The tests are more reliable when used by a person with symptoms (e.g., symptoms of COVID-19, symptoms of Influenza), and less reliable when used by a person without symptoms.

Rapid antigen tests are generally best performed within the first 7 days from when symptoms first appear for COVID-19 and within the first 4 days from when symptoms first appear for Influenza.

IMPORTANT: Combination RATs are not as accurate as tests done in the laboratory (called PCR tests).

A list of all COVID-19 rapid antigen self-tests and combination self-tests that are approved for supply in Australia is available on the TGA website along with the manufacturer’s instructions for how to use each test. This list is regularly updated as new tests are approved or if tests are cancelled or withdrawn. Only tests approved by the Therapeutic Goods Administration (TGA) are legally permitted to be sold in Australia.

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

Each combination RAT is slightly different. It is important to follow the steps in the instructions provided with the test you use.

For tests that use a saliva sample, do not eat, drink, smoke, brush your teeth or chew gum for 10–30 minutes (refer to the instructions for your test for the recommended timing) before collecting the sample as it may produce an incorrect result.

Not using the test properly may produce an incorrect result.

All tests are for single use only which means you can only use each test ONCE and then it must be thrown away. Do not ever use a test more than once or attempt to use one test on different people.

Wash your hands after completing the test and disposing of the test kit contents.

Most results will be displayed in a window on the device. Separate lines report the result for each virus (e.g., COVID-19, Influenza A, Influenza B). The instructions provided with the test will explain what the result means.

For example, the results could look like this:

• Lines appear only in the control regions (C) and no lines appear in any of the test regions (e.g., T, A and B): Negative result
• Lines appear in the control regions (C) and in any or all the test regions (e.g., T, A and B): Positive result. Even a faint line in a test region is considered positive.
• Lines do not appear in the control regions (C): Invalid result

If you get a positive result for COVID-19, it is recommended that you stay at home. As different States and Territories may have different recommendations for testing and for reporting positive results, check the information provided by your state or territory health department to find out what you need to do. This includes whether a confirmatory PCR is required, whether you need to report your result and quarantine requirements, and any other specific medical advice.

Individuals with a positive result for Influenza or who are unwell must consult a medical practitioner for follow-up clinical care.

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

If you get a negative result for COVID-19, it is less likely that you have COVID-19 but continue to follow all public health advice on limiting the spread of the virus. If you feel unwell or have symptoms you should get a PCR test as soon as possible.

If you get a negative result for Influenza, it is less likely that you have Influenza but continue to follow all public health advice on limiting the spread of the virus. If you feel unwell or have symptoms you should see a medical practitioner for follow-up clinical care as soon as possible.

Home use tests may produce an ‘invalid’ result, which means it has not worked correctly. If this happens, you should throw it away and do another test, or if you are unwell and have symptoms, contact a medical practitioner for follow-up clinical care.

You should also report the ‘invalid’ result to the supplier or sponsor.

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. Check your state or territory Health Departments website for information.

Tests on children should always be done or supervised by an adult. See the instructions provided with the test for any safety instructions for using the test on a child.

You should follow the instructions provided with your test on how to dispose of it. Some tests come with a plastic bag to place the contents of the test (including the swab) 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 bin.

Wash your hands carefully after completing the test and disposing of the test kit contents.

Rapid antigen self-tests 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, incorrect use of the test, phase of the infection and the viral load will impact the accuracy of the test.

Where there are low rates of infection 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 infection in the community increase there is less likelihood of false positive results.

Problems or issues with a self-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 supplier must report serious adverse events with the use or performance of the device, and all complaints associated with false positive and false negative results to the TGA.

There are two kinds of tests for infectious diseases such as COVID-19 and Influenza:

• 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 infectious diseases 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 infectious diseases such as COVID-19 and Influenza including polymerase chain reaction (PCR) tests.

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

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 and multiplex (COVID-19 and Influenza) 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 for COVID-19 and within the first 4 days from when symptoms first appear for Influenza. 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 may require further testing by a PCR test to confirm if a person is infected and follow-up care by a medical practitioner.

• Point of Care Tests

Rapid antigen point of care tests 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

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.

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

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
• 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.

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 business and isolation of staff if a positive result is received from a rapid antigen test
• 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 combination 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 combination rapid antigen self-tests and testing service providers need to make sure that any advertising to consumers, businesses or organisations complies with the Therapeutic Goods Advertising Code.

The Advertising Code specifies several 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 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. 

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

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.

All importers of COVID-19 and combination 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.