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1.0 Introduction

Posted in: HIV

1.1 Purpose and Scope

This policy brings together in one place the principles, aims and arrangements for HIV testing in Australia and is consistent with the aims of the Seventh National HIV Strategy2014-2017. It fulfils three main purposes:

  • To bring together and reference standards for registered HIV tests and their usage in Australia
  • To explore and describe how Australia will consider new testing technologies as these emerge and provide a framework against which new technologies for HIV diagnosis will be evaluated for use in Australia, and
  • To maintain an Expert Reference Group (ERG) which comes together from time to time to consider issues relating to HIV testing and which provides advice to governments and regulators about what is best practice. Its membership reflects the breadth of stakeholders with an interest in HIV testing.

The policy has broad scope and applies to laboratory, point of care and self-testing for HIV infection. It is also flexible, allowing for the consideration of new technologies as these emerge. Through the work of the ERG, it should also allow for the identification of standards, legislation or processes which may need to be modified to keep in step with evolving evidence, expectations and attitudes toward HIV testing.

This policy recognises that HIV testing is vital to stopping the transmission of HIV. It is also a precursor to the initiation of treatment for HIV. It provides a framework for best practice approaches to appropriate high quality HIV testing in the Australian context.

1.2 Background and context

Australia has a high quality, comprehensive multi-sector pathology service. The regulatory and quality framework for HIV testing has evolved with a focus on formal laboratory settings. The advent of point of care HIV testing and the prospect of HIV self-testing has necessitated a review of that framework.

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. Accreditation is required in order for pathology services to be eligible for the Medicare Benefits Schedule (MBS) rebates.  Professional standards for pathology practice are established by the RCPA.

Tests used in Australia must pass evaluation by the Therapeutic Goods Administration (TGA), prior to entry onto the Australian Register of Therapeutic Goods (ARTG) and the TGA can place conditions on this entry. The Medical Services Advisory Committee (MSAC) advises which tests should be subsidised through the MBS. It also can recommend any restrictions on eligibility. Tests for blood borne viruses including HIV tests undergo the most stringent of pathology test evaluations.

Some tests can be used outside of the laboratory and others may involve self-sample collection and self-interpretation of results. They may therefore be outside the regulatory framework offered by NATA accreditation and/or RCPA standards. TGA has established performance standards for HIV testing. This policy framework ensures that devices for use outside of the laboratory, like those used within the laboratory:

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

1.3 Principles for HIV Testing

The key principles which guide HIV screening and diagnostic testing in Australia are that testing is conducted ethically, is voluntary and performed with the informed consent of and is beneficial to the person being tested , and provides for an understanding of the epidemiology of HIV infection in the population and a measurement against which to evaluate National Strategy goals.

In relation to evaluation, quality and performance:

  • Tests are evaluated on the basis of being fit-for-purpose and meet the published sensitivity and specificity criteria established by the TGA.
  • Reactive screening tests performed in a laboratory or point-of-care setting, require confirmatory testing from an accredited pathology laboratory.
  • Persons performing HIV testing are required to undertake training appropriate to the steps in the process for which they are responsible, including for: gaining informed consent, collecting the sample, interpreting any result, conveying that result and collecting a sample for confirmatory testing if required.

In relation to access, availability and confidentiality:

  • There should be no barriers to the implementation of quality, cost effective, HIV testing and screening.
  • Testing must be accessible to all those at risk of HIV infection.
  • Anonymous testing should be available to individuals, subject to the need to obtain sufficient demographic information from those being tested to allow accurate aggregate information to contribute to surveillance.
  • HIV rapid testing should be targeted to individuals at high risk of HIV infection, who are not currently accessing standard testing or who access it at a suboptimal frequency based on their risk of exposure to HIV.
  • All screening and diagnostic test results must remain confidential and only shared with individuals with a clinical need to know in accordance with jurisdictional legal and policy restrictions on sharing of information regarding a person’s HIV positive status.
  • Test results should be conveyed to the person being tested in a timely manner which will be contingent of the nature of the test performed.
  • Where regulations or legislation allow for restrictions to be placed on individuals who are aware they have HIV[1], a reactive result by the initial HIV test, including an HIV point of care test or HIV self-test, will be considered evidence of HIV infection unless reference testing subsequently shows the individual to be free of HIV. Consequently pending the outcome of confirmatory testing, individuals who are reactive on a screening test should adhere to the transmission restrictions placed upon a person with confirmed HIV infection.
  • Testing practices must comply with all relevant Commonwealth and State and Territory anti-discrimination and public health legislation, and other relevant laws and regulations,[i] including those governing Commonwealth funding of pathology tests, storage of medical and personal information and confidentiality and privacy protections[ii]


[1] Refer to Chapter 15 of the HIV, Viral Hepatitis and STIs: A Guide for Primary Care Practitioners which outlines legal responsibilities across States and Territories



[i] National Anti-Discrimination Information Gateway [internet]. Commonwealth and State and Territory

anti-discrimination and public health legislation. Available at: http://www.antidiscrimination.gov.au/nadig/nadig.nsf (Cited 5 May 2015).

[ii] Commonwealth funding of pathology tests [internet]. Available at: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-pathology-aboutus-index.htm (Cited 5 May 2015).

 

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Development of this site and the 2014 and 2017 revisions of the testing policies was supported by: Australian Government Department of Health and Ageing