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HIV testing in Australia
- Clinical performance requirements and risk mitigation strategies for HIV
- HIV PoCT conditions of approval in the ARTG
- Consultation: Supply of in vitro diagnostic devices for self-testing (home testing) for the presence of human immunodeficiency virus in Australia
- HIV self-tests in Australia: Supply restrictions lifted
Tests for HIV are in vitro diagnostic medical devices (IVDs) and must be approved by the TGA and included in the Australian Register of Therapeutic Goods (ARTG) before they can be legally supplied in Australia. There are different types of HIV tests including, laboratory tests, Point of Care Test (PoCT) and self-tests.
Laboratory tests include donor and diagnostic screening tests and reference tests intended to be used in a laboratory environment by trained laboratory professionals. Samples that are positive (i.e. reactive) when tested with a screening test then undergo confirmatory or additional supplementary testing in accordance with a validated testing algorithm to confirm the positive status before the result is accepted as a true positive. A laboratory test is the only method used to confirm the diagnosis of HIV.
Point of Care Test (PoCT)
HIV PoCT is a rapid presumptive screening test for HIV intended to be performed in a clinical setting (i.e. outside the laboratory environment), near to or at the side of the patient by a health professional or appropriately trained user who can interpret the test and provide appropriate clinical support. Confirmation of a positive result is required using a diagnostic laboratory test. False negative results can occur, particularly if testing is performed soon after possible exposure to the virus (e.g. if test is performed within 3 months of possible exposure to the virus).
The ban on the supply of HIV self-tests in Australia was lifted in July 2014. The effect of this is that HIV self-tests can now be included in the ARTG and legally supplied in Australia, subject to satisfying the applicable regulatory requirements. Currently, one HIV self test has been included on the ARTG.
HIV self-tests are rapid presumptive screening tests for HIV intended to be used in the home or similar environment by a person who does not have formal training in a medical field or discipline related to HIV testing. Confirmation of a positive result is required using a diagnostic laboratory test and can be arranged through a medical practitioner. False negative results can occur, particularly if testing is performed soon after possible exposure to the virus (e.g. if test is performed within 3 months of possible exposure to the virus). Medical advice should be sought if there is a risk that you have been exposed to HIV.
It is recognised that individuals can purchase tests for personal use via the internet from overseas suppliers. However, these tests have not have been evaluated by the TGA to determine their safety and performance.