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Warning to consumers and advertisers about COVID-19 test kits

25 August 2021

Update on 25 August 2021: Advertisements for rapid antigen test kits for COVID-19 can be advertised in the public domain with certain conditions consistent with the legal permission issued under s42DK of the Therapeutic Goods Act 1989. However, the supply of rapid antigen tests for self-testing of COVID-19 (without the direct supervision of a healthcare professional), is still prohibited under the Therapeutic Goods (Medical Devices - Excluded Purposes) Specification 2020.

Warning to consumers about home self-test kits

The Therapeutic Goods Administration (TGA) warns consumers to be cautious when seeking to purchase products claiming to be home self-tests for COVID-19, either online or through other means.

In Australia, the advertising and supply of self-tests for serious infectious diseases, such as COVID-19, is prohibited under therapeutic goods legislation. COVID-19 tests are designed to be used under the direction of a health professional. Home tests may give a false positive or false negative result, which could be extremely dangerous for yourself and others if relied on.

Testing for COVID-19 should only be conducted in an accredited pathology laboratory, or by a relevant healthcare practitioner or trained staff under their supervision. This is to make sure that they are appropriately used, and the results interpreted correctly, and to ensure a suitable health practitioner is available to provide immediate clinical advice and treatment if required.

Warning to advertisers about test kits

In response to the COVID-19 pandemic, the TGA has taken measures to ensure Australia has laboratory and point of care tests available that are able to detect COVID-19 infections. These measures are designed to facilitate the legal importation, manufacture and supply of these tests. The measures do not exempt these test kits from the operation of the TGA advertising framework.

Representations used in advertising that refer to a serious disease, such as COVID-19, are 'restricted representations' and must be approved by the TGA before being used in an advertisement. However, the TGA has issued a legal permission (under section 42DK of the Act) which enables sponsors and other advertisers of COVID-19 rapid antigen tests to use the 'restricted representations' specified in the permission. It is important to note that this permission does not facilitate the advertising of COVID-19 test kits to consumers for self-testing.

In addition to complying with the requirements set out in the permission, advertisers must ensure that any publicly accessible advertising of COVID-19 test kits is compliant with the Therapeutic Goods Advertising Code (No.2) 2018 (the Code).

Notwithstanding the above, advertisements for COVID-19 test kits directed exclusively to health professionals are exempt from the advertising requirements set out in Part 5-1 of the Act, including the requirement to comply with the Code. However, appropriate measures must be in place to ensure the advertisement is only accessible by health professionals (e.g. use of firewalls, or a requirement to register to gain access to online advertising). If the online advertising can be viewed by the public, it will not be considered directed exclusively to health professionals.

The TGA refers advertisers to its warning in relation to illegal advertising of therapeutic goods. The TGA will take action in relation to any advertisements that do not meet the requirements, including those that seek to mislead consumers. Penalties apply.