TGA advice for consumers on purchasing COVID-19 rapid antigen tests

The Therapeutic Goods Administration (TGA) is urging consumers to only purchase COVID-19 rapid antigen tests (RATs) that are approved for use in Australia to avoid the risk of poor test performance that could arise from using unapproved, repackaged or repurposed RATs.

Before RATs can be legally supplied in Australia, they must be assessed by the TGA to ensure they have the necessary specificity and sensitivity and meet Australia's other regulatory requirements. Once the product has been approved it is entered in the Australian Register of Therapeutic Goods (ARTG).

We are aware that unapproved RATs are being sold to Australians and the TGA is taking strong enforcement action against unlawful activities resulting in unapproved RATs being imported, sold or advertised in Australia. "We are concerned that some consumers may be relying on RATs that have not been approved in Australia, and subsequently do not work as intended," TGA Head John Skerritt said.

If consumers identify any of the following at the time of purchase, a check should be conducted to ensure that the product is approved by the TGA (refer to the TGA website) for self-use and also:

• the product appears to have been relabelled or repackaged into single items from a larger pack and does not contain all the required parts or instructions for use
• the product is not a point-of-care test kit only intended for use in professional settings by health practitioners or suitably trained staff, and not for self-use
• the packaging or label of the product:
  • does not contain an Australian address, sponsor details, or the ARTG number
  • is not in English.

Before purchasing RATs, consumers can check the list of COVID-19 rapid antigen self-tests that are approved in Australia for up-to-date information.

Consumers can find useful tips in the fact sheet obtaining approved COVID-19 rapid antigen tests, including information on what to avoid, with visual examples of unapproved RATs.

If consumers have any concerns about a business supplying, advertising or importing unapproved RATs, or about those being sold in retail outlets, you can:

• report a perceived breach or questionable practice
• make a report about non-compliant advertising.

Contact for members of the media:

• Email: news@health.gov.au
• Phone: 02 6289 7400