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The use of point of care tests for HIV in Australia

8 July 2014

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.

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Content last updated: Tuesday, 8 July 2014

Content last reviewed: Tuesday, 8 July 2014

Web page last updated: Tuesday, 8 July 2014

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