From the 1st November 2021, Rapid antigen tests will be available for the general public for use at home in Australia. Meaning you will be able to purchase them directly from our retail stores (physical and online).

On 1 October 2021 the Therapeutic Goods Administration (TGA) made a new regulation that allows companies to formally apply for TGA regulatory approval to legally supply their self-tests for use at home in Australia after 1 November 2021.

To ensure the reliable use of these tests at home it is important they are easy to use and interpret. Any consumer who has a positive rapid antigen test result should immediately have a confirmatory PCR test at a COVID-19 testing centre and isolate until further notice.

All states.

Home use tests for COVID-19 is test using a nasal swab sample or saliva sample for the presence of the virus that causes COVID-19.

A home use test can be used by people in the home, workplace or elsewhere without the involvement of a doctor or health practitioner. Most home use tests produce a result within 10-20 minutes. The tests are most reliable when used by a person who has symptoms of COVID-19. They are not as reliable when used to test someone who does not have symptoms.

IMPORTANT - Home use tests are not as accurate as the tests done in the laboratory (called PCR tests). It is important that:

• If the home use test is NEGATIVE but you are unwell, you should consider to go to a testing site to have a PCR test. This will confirm whether your symptoms are or are not COVID-19.

Different states and territories may have different recommendations for testing and for reporting positive results, based on their public health orders. Please see their websites for any local reporting requirements.

This will depend on what you have been told by your employer or school, or on the recommendations or requirements in the state or territory where you live.

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. Please contact the relevant state or territory government or see their websites for any local requirements that are required for self-tests.

Information can be found at Local state and territory health departments.

There are two kinds of tests for COVID-19:

1. 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.

2. 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.

Yes, they can be used. However, it needs to be supervised by a pharmacist, this service is available at VITAL+ for $55. Please click here to learn more.

A number of different home use tests are available and each one is different. It is very important to follow the steps in the instructions provided with the test you use. 

Not using the test properly can result in incorrect results.

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.

You can see the videos above to see how two types of tests are done.

Most home use test kit results will be shown in a window and the instructions provided with the test will explain what the result means.

Result appearance may differ between test kits.

If you get a positive result you must let health authorities know. Contact your state or territory health department to find out about quarantine requirements.

If you get a negative result it is less likely that you have COVID-19 but you still need to follow all public health advice on limiting the spread of COVID-19. If you feel unwell or have symptoms you should get a PCR test at a testing site as soon as possible to confirm you do not have COVID-19.

As well as positive and negative results, a test may produce an ‘invalid’ result, which means it has not worked correctly. If this happens, you should throw the test away and either perform a new test or get a laboratory PCR test done at a testing site.

Home use tests are not as accurate as laboratory PCR tests, but they are very helpful because they provide results quickly. They can also pick up the COVID-19 virus very early in the infection, sometimes before you have symptoms.

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 and incorrect use of the test will impact the accuracy of the test.

In parts of Australia where there are low rates of COVID-19, the tests are less accurate as there is a higher risk of both false positive and false negative results.

In community settings where there are low rates of COVID-19 there is a high risk of false positive and false negative results.

This risk increases 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.

Positive home use test results must be confirmed by a PCR test at a laboratory or testing site. It is not acceptable to just repeat the test in the hope of the second test being negative.

A symptomatic person who has a negative result with a home use test should always seek further PCR testing to confirm they do not have COVID-19. 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 us at sales@vitalpharmacysupplies.com.au

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

The sponsor/supplier is required to report to the TGA all complaints related to the use of performance of the device.

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

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 carefully after completing the test and disposing of the test kit contents, 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:

- a procedure for notification of positive results to the relevant state or territory health authority so a follow up PCR test can be performed, and contact tracing initiated

- 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.

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.

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