Core HIV Rapid Test

Safety advisory

8 July 2014

The Therapeutic Goods Administration (TGA) is aware that some Australian consumers may have purchased the CORE HIV Rapid Test over the internet or from retail outlets in Australia.

Under the Therapeutic Goods Act 1989 HIV tests must undergo thorough evaluation of their safety and performance before they can be included in the Australian Register of Therapeutic Goods (ARTG) for legal supply in Australia. To date, the CORE HIV Rapid Test has NOT been registered or included in the ARTG, and there is a risk that the test may not perform as intended or may risk the health and safety of the user.

Consumers who are concerned that they may have been exposed to HIV should consult a doctor and should avoid using self-testing devices whose safety and performance cannot be assured.