Introduction - Testing Portal

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.

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 Eighth National HIV Strategy 2018-2022. 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
To maintain an Expert Reference Committee (ERC) 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 ERC, 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 and 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.

This policy supports the World Health Organization (WHO) in adhering to five key components in relation to testing, also known as the "5 Cs"⁴:

Consent
Confidentiality
Counselling
Correct test results
Connection/linkage to prevention, care and treatment.

The key principles which guide HIV screening and diagnostic testing in Australia are that testing:

is conducted ethically
is voluntary, not harmful to the person being tested, and is performed with the informed consent of the person being tested, as with all pathology testing
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, selection, quality and performance

Tests are evaluated on the basis of being fit-for-purpose and meeting the TGA’s public guidance on clinical performance requirements.
HIV point-of-care tests should be selected for use with particular populations, taking into account the characteristics of the population being tested, in particular the expected HIV prevalence, incidence and likely proportion of recent infection (i.e. acute) cases, based on an understanding of HIV epidemiology in the sub-population and the sensitivity and specificity of the test to be used.
Due to the longer window period (the period of time after infection and before seroconversion during which markers of infection are still absent or too scarce to be detectable) compared to laboratory tests, when HIV point-of-care tests are used, consideration should be given to undertake a complete sexual health screen. This includes parallel laboratory-based venous HIV testing (e.g. in high incidence populations such as gay, bisexual and other men who have sex with men, and for testing patients following a recent HIV risk exposure).
HIV testing in the context of the initial assessment and management of patients on pre-exposure prophylaxis (PrEP) should be performed on gold standard laboratory tests (i.e. 4^th generation immunoassays and other tests available at reference laboratories).
All reactive screening tests, whether performed in a laboratory setting, point-of-care setting or by self-testing, require further confirmatory testing by a NATA-accredited reference 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 and meeting consent requirements within their relative jurisdiction, collecting the sample, interpreting any result, conveying that result, and collecting a sample for confirmatory testing if necessary.
Persons performing HIV testing should strive to provide high-quality testing services, and quality assurance mechanisms should be in place to ensure the provision of correct test results. Quality assurance may include both internal and external measures and should include support from a recognised quality assurance provider.

In relation to access, availability and confidentiality

Barriers to accessing quality, safe, and cost-effective HIV testing and screening should be minimised.
Testing must be accessible to all those at risk of HIV infection regardless of immigration or insurance status. This may require access to specialist services such as translators to ensure access for and consent of people from a non-English speaking background.
Anonymous testing should be available to individuals, subject to the need to obtain de-identified demographic information from those being tested to inform surveillance.
HIV rapid testing (i.e. point-of-care testing) is offered in clinical settings, and in community settings which may include trained peer-to-peer test facilitators.
HIV self-testing is testing technology that can be performed by an individual in the absence of a health-care provider or trained operator.
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.
Services offering testing should ensure that test results are conveyed to the person being tested in a timely manner, which will be contingent on the nature of the test performed. It would be reasonable to expect negative screening tests for HIV to be available within two business days however confirmatory tests for reactive samples may take some days longer.
Where regulations or legislation allow for restrictions to be placed on individuals who are aware they have HIV,⁵ 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 be made aware of likelihood of the test being a true positive, based on the type of test used and the result. Practitioners should seek specific advice from their laboratory if necessary, and testing services using point of care tests should be aware of the positive predictive value of the test used. The person tested should also be made aware of the transmission restrictions placed upon a person with confirmed HIV infection.⁶ These restrictions may be through the use of public health powers and/or legislation in some jurisdictions.
Testing practices must comply with all relevant Commonwealth and State and Territory antidiscrimination and public health legislation, and other relevant laws and regulations⁵ including those governing Commonwealth funding of pathology tests, storage of medical and personal information and confidentiality and privacy protections.⁷