PixoTest Rapid Antigen Test FAQs

Why has the TGA imposed conditions on supply for rapid antigen tests?

The TGA has approved a significant number of rapid antigen tests.

So that they are appropriately used, and the results interpreted correctly, they can currently only be legally supplied under specific conditions. These include for use by trained health practitioners, and trained staff under their supervision, to ensure a suitable health practitioner is available to provide immediate clinical advice and treatment if required.

The conditions were recently updated to clarify:

• in what circumstances the tests can be supplied
• who can perform the test; and
• the requirements for supervision of testing.

These conditions reflect the importance of correct interpretation of results, advice and treatment being available at the time of testing. The requirement for healthcare professional involvement and the prohibition on self-testing reflect the critical importance of immediate notification of positive cases to state and territory health authorities so that contact tracing and processes to manage outbreaks can immediately start.

In a potential later scenario, where low level community transmission is being tolerated in a vaccinated population, it may be appropriate to review these requirements.

 

Can tests be performed by persons who are not health practitioners?

Yes, but the testing needs to be performed under the overall supervision of a health practitioner, medical practitioner or paramedic and the person performing the test has been trained in the correct use and interpretation of the tests.

Use of the test by untrained persons and testing performed outside the supervision of a health practitioner would mean that the person or organisation could be liable if something goes wrong with the performance or interpretation of the test.

For information on relevant health practitioner see the question, 'What is meant by health practitioner?'

 

Where or who can the tests be supplied to?

The tests can be supplied for use by specified health practitioners at the point of care to the following:

1. Registered medical practitioners or paramedics, or an organisation, business or institution that employs or engages a registered medical practitioner or paramedic to perform or oversee performance of the test.
2. Residential care (disability and rehabilitation facilities) and aged care facilities that employ or engage health practitioners (for example, nurses) to conduct or perform the test. If the residential care or aged care facilities provide care in the home this condition would also allow for performance of the test to be conducted by a health practitioner or paramedic.
3. Organisations, businesses, or institutions (that do not have the primary function of providing healthcare services) that employ or engage health practitioners or paramedics to conduct or oversee performance of the tests. For example, rapid antigen tests are being used in the mining sector consistent with these conditions.

The tests can also be supplied to accredited laboratories and to Commonwealth, state or territory government departments, in cooperation with their relevant health departments.

 

What is meant by health practitioner? Is this the same as a healthcare professional? 

Health practitioner is defined in Section 3 of the Therapeutic Goods Act 1989 (the Act) and is not necessarily the same as a healthcare professional. The conditions of inclusion on rapid antigen tests refer specifically to a health practitioner and not 'healthcare professional'.

Health Practitioner as defined by the Therapeutic Goods Act 1989 means:

The list above includes medical practitioners, pharmacists, and nurses along with others, but not for example pharmacy assistants, dental assistants, or personal care workers in aged care. Paramedics are not included in the definition of Health Practitioner in the Act but have been specified as a suitable health practitioner for the purposes of supply and use of rapid antigen tests.

The registration or licensing of a health practitioner, can be checked through the Australian Health Practitioner Agency (AHPRA). For the purposes of rapid antigen testing health practitioner also includes a person registered under a law of a state or territory to practice paramedicine (as specified in the conditions of inclusion).

A health practitioner, including a medical practitioner or paramedic, who performs or supervises rapid antigen testing, takes on full responsibility for all testing conducted under their supervision including keeping records of such training. For further information see question 'What are the responsibilities of the health practitioner?'

 

Is it okay for the sample for testing to be self-collected? Does self-collection of a specimen also need to be supervised?

Yes, samples may be self-collected but this must be supervised. This is an important step in the testing process.

Where a sample is self-collected by an individual, the collection must be supervised to verify patient identification and ensure an appropriate sample is collected. Poor sample collection is a common cause of error and can result in false negative results. Whoever is performing the actual rapid antigen test must also be able to verify which person the sample was collected from.

It is important to note the following if self-collection of a sample is necessary this must be conducted under the direct supervision of a person who has been trained in sample collection.

Further information on self-collection of specimens can be found in advice from members of the Public Health Laboratory Network.

 

Click here  to read the Therapeutic Good Administration's full list of Q&As regarding conditions of supply for rapid antigen tests.