Background and context

Human Immunodeficiency Virus (HIV) is a major global public health threat, with 37.9 million estimated to be living with HIV as at the end of 20181. In Australia, it was estimated that 28,180 people were living with HIV as at the end of 20182. Among people living with HIV in Australia in 2017, 74.9% were estimated to be men who were exposed to HIV through sex with other men, 22.4% were people exposed through heterosexual sex, and 2.1% were people exposed through injecting drugs3. Late diagnosis of HIV can lead to increased morbidity and mortality among those diagnosed, and unwitting transmission of HIV to others.

The HIV testing landscape in Australia

Australia has a high-quality, comprehensive multi‐sector pathology service. Until recent years, Australia’s policy for HIV testing had an exclusive focus on testing in formal laboratory settings. A review of the National HIV Testing Policy was necessitated by the recent Therapeutic Goods Administration (TGA) approval of an HIV self-test; the adoption of the Eighth National HIV Strategy 2018‐2022, which set a target to increase the proportion of people with HIV (in all priority populations) who are diagnosed to 95%; and the ongoing high rate of late HIV diagnoses in some sub‐populations.

HIV tests supplied in Australia must pass evaluation by the TGA before entry onto the Australian Register of Therapeutic Goods (ARTG). The TGA can place conditions on this entry. The TGA has established guidance on clinical performance requirements for manufacturers and suppliers of HIV tests.

The National Pathology Accreditation Advisory Council (NPAAC) sets quality standards for pathology laboratories and the National Association of Testing Authorities (NATA) and the Royal College of Pathologists of Australasia (RCPA) accredit medical testing facilities against these standards. Professional standards for pathology practice are established by NPAAC and the RCPA. Some tests can be used outside of the laboratory, such as HIV point-of-care tests or HIV self-tests. They may therefore be performed outside the laboratory accreditation framework offered by NATA/RCPA.

The Medical Services Advisory Committee (MSAC) advises which tests should be subsidised through the Medicare Benefits Schedule (MBS). It can also recommend any restrictions on eligibility. Tests for blood-borne viruses, including HIV tests, undergo the most stringent of pathology test evaluations. Accreditation by NATA/RCPA is required in order for pathology services to be eligible for the MBS rebates.

The policy aims to provide guidance to health-care workers to ensure that users of HIV tests, both inside and outside of the laboratory setting, are aware of the need to check that the device (i.e. test) being used is:

  • fit for purpose and approved by the TGA (unless otherwise exempt)
  • of an appropriate quality
  • where relevant, used by individuals who are appropriately trained
  • in the case of self‐testing, supplied with appropriate information and instructions to enable individuals to perform and interpret tests independently and with confidence
  • subject to procedures to ensure public safety and confidence.