Contact TGA: info@tga.gov.au | 1800 020 653 | More contact info Translate | Subscribe

The use of point of care tests for HIV in Australia

17 December 2012

In Australia the confirmed diagnosis of HIV can only be made using laboratory tests that are authorised for use by the TGA.

After extensive evaluation of safety and performance the TGA has registered a point of care test for HIV for use in Australia as a preliminary screening test. The test can be used outside the laboratory by appropriately trained health professionals however all positive results must be confirmed through referral to a laboratory.

The TGA has placed strict conditions on the sponsor as part of the registration.

In vitro diagnostic medical devices (IVDs)

Tests for HIV are known as IVDs (in vitro diagnostic medical devices). IVDs for HIV must be approved by the TGA for entry on the Australian Register of Therapeutic Goods (ARTG) before they can be legally supplied in Australia.

HIV point of care tests

HIV point of care tests are performed, near to or at the side of a patient by a trained health professional, using an appropriately designed IVD. These health professionals have received training so they can interpret test results and provide appropriate counselling to patients.

There is currently one HIV point of care test IVD registered in the ARTG. This product is not approved for self-testing by individuals.

For inclusion in the ARTG a product must meet acceptable standards of safety and performance. The TGA will evaluate applications that are received from manufacturers and sponsors of HIV point of care test IVDs.

Self-testing

An IVD for self-testing is a device or test designed to be used at home by a lay person.

According to the current therapeutic goods legislation, IVDs for HIV that are intended to be used exclusively for self-testing cannot be included in the ARTG and therefore cannot be legally supplied in Australia. This is because tests conducted at home have a different risk profile (even if the IVD for a point of care test and self-testing are identical). Tests conducted at home:

  • deprive patients of important pre-test discussion and post-test counselling and, if necessary, discussion of treatment options
  • have the potential to undermine the strategic management of infectious diseases through the national reporting of notifiable diseases.

Self-tests for HIV are available over the Internet and can be legally imported into Australia, if they are for personal use. However, users are warned that these self-tests have not been evaluated by the TGA to determine their safety and performance. The test results may be unreliable, in that the tests may indicate that:

  • you have HIV when you do not (false positive)
  • you do not have HIV when you do (false negative).

The use of approved HIV tests that are available through health professionals is recommended.

Top of page

Content last updated: Monday, 17 December 2012

Content last reviewed: Monday, 17 December 2012

Web page last updated: Tuesday, 18 December 2012

URL: http://www.tga.gov.au/consumers/information-devices-hiv-rapid-tests.htm