Introduction - Testing Portal

Hepatitis C infection remains a major public health problem in Australia. There were 7,602 hepatitis C notifications in Australia in 2023.² In Australia, sharing of unsterile injecting equipment is the predominant mode of transmission, with most new and existing infections occurring among people who inject drugs. Given that no prisons in Australia provide sterile needles or syringes, there is an increased risk of HCV transmission among people who inject drugs while incarcerated.⁶Population groups that are over-represented in custodial settings, including people who inject drugs and Aboriginal and Torres Strait Islander people, bear a disproportionate burden of infection and re-infection.

In approximately 30% (15–40%) of people, acute infection is followed by viral clearance, with the remaining 70% (55–85%) progressing to chronic infection.⁷ At the end of 2023, it was estimated that 68,890 people in Australia were living with current HCV infection.² Cirrhosis develops within 20 years in 5–10% of this group [usually associated with other comorbidities such as co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV), obesity, insulin resistance, metabolic dysfunction-associated steatotic liver disease (MASLD) or metabolic dysfunction-associated fatty liver disease (MAFLD), or alcohol intake over 40 g a day] and in a further 10–15% after 40 years.⁸ Hepatocellular carcinoma will develop in 1–5% of people per annum who develop cirrhosis.⁹

Preventive interventions have proven effective in decreasing HCV transmission and therapeutic interventions are effective in improving quality of life and clinical outcomes for people with hepatitis C infection. New treatments subsidised on the Pharmaceutical Benefits Scheme (PBS) since March 2016 have greatly improved HCV sustained viral responses (SVR) and from 2016 to 2022, over 100,000 people achieved a sustained response to their treatment.¹⁰From 2016 to 2022, primary care physicians and nurse practitioners prescribed over 50% of all treatments for HCV in Australia. Annual treatment numbers have declined since 2016, and a concerted effort is now needed to identify those still in need of treatment.²

This edition of the Testing Policy seeks to define the current best practice for testing for exposure (or re-exposure) to HCV and for defining the current infective status of a person before, during and after treatment.

HCV testing can provide people with information regarding exposure to the virus. Appropriate testing indicates whether the person being tested has been exposed to HCV, has cleared the virus or has a current (chronic) infection. A point-of-care HCV RNA test was approved by the TGA and included in the Australian Register of Therapeutic Goods (ARTG) on 1 September 2020.¹¹ This test can provide confirmatory HCV RNA results within one hour, reducing the time taken for a complete diagnosis and the initiation of the care cascade. Additionally, a point-of-care HCV antibody test was approved by the TGA and included in the ARTG on 17 May 2024.¹²

The benefits of high-quality, reliable and timely testing are numerous, both for the person being tested and for public health. Detection of HCV infection followed by appropriate education can effectively reduce onward transmission, modify disease progression through earlier referral for advice and treatment, and protect the blood, tissue, and organ donation supply. Despite the public health and individual benefits of testing, a significant but undocumented number of people with HCV infection in Australia remain undiagnosed. Many others previously diagnosed are lost to follow-up or otherwise disengaged from HCV care and need to be found again.

It is therefore crucial that those people responsible for implementing this Policy (particularly those obtaining informed consent and providing test results) have the necessary skills and knowledge to fully communicate the significance of each of the available tests to the person being tested. This National Testing Policy assumes that all staff involved in the testing process are appropriately trained and deemed competent.

The main aim of this Policy is to recommend evidence-based testing pathways for the diagnosis of hepatitis C. This Policy is intended to support health professionals to provide current, innovative and effective testing and care for people at risk of, or living with, hepatitis C.

The Policy has broad scope and applies to laboratory and point-of-care testing for HCV infection. It is adaptable, and through the work of the Expert Reference Committee, allows for timely consideration of emerging technologies and the identification of regulations, legislation or procedures which may need to be modified to reflect evolving evidence, attitudes and expectations regarding HCV testing.

This Policy presents the principles, aims and arrangements for HCV testing in Australia and is aligned with the Sixth National Hepatitis C Strategy 2025-2030⁴ which identifies the need to implement approaches that maximise the number of people living with hepatitis C who are diagnosed, including regular testing for HCV among priority populations and in priority settings.

The principles that guide HCV testing in Australia are aligned with the WHO five key components in relation to testing, also known as the 5 Cs.⁵

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

HCV testing in Australia should ensure:

confidential, voluntary testing with informed consent and post-test discussion
testing is accessible to all those who are or have been at risk of HCV infection
testing is of the highest possible standard and provided in a timely manner, with appropriate access to care
testing is of benefit to the person being tested
testing is critical to understanding the epidemiology of HCV infection in the community
testing is critical to interruption of transmission and supports harm reduction
testing to monitor people with HCV before, during and after treatment is an integral part of care
testing is undertaken in a culturally appropriate manner
people are not denied testing because of fear of having their name associated with an HCV test (e.g. in a small community where confidentiality is harder to maintain, or in prison where access to prevention is limited and risk of re-infection is high among people who inject drugs). While recognising that the law in Australia often obliges notifications of infections to be identifiable, testing should always be conducted in ways that respect and maintain the person’s privacy.

HCV testing policies and practices must comply with all relevant Commonwealth, State and Territory anti-discrimination and public health legislation, and other relevant laws and regulations, including those governing Commonwealth funding of pathology tests.^13-15

Individual State, Territory and institutional HCV testing policies should be consistent with the purpose, objectives and principles of this Policy, as well as with relevant legislation, and the common law.

Australia has a high quality, comprehensive multi-sector pathology service whose regulatory and quality framework for HCV diagnostic testing has evolved with a focus on formal laboratory settings, with linkage to the Medicare Benefits Schedule (MBS) rebate for tests performed in an accredited laboratory. However, since 2023, the National Hepatitis C Point-of-Care Testing Program has established high quality, point-of-care testing in many high prevalence settings (e.g. alcohol and other drug services, prisons) so the use of high quality point-of care testing is now regarded as a crucial part of the testing processes needed to optimise HCV diagnosis and treatment in Australia.

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 for pathology services to be eligible for the MBS rebates. Professional standards for pathology practice are established by the RCPA.

Tests for diagnosing HCV are categorised as Class 4 in-vitro diagnostic medical devices (IVDs) due to their significant public health risk. Consequently, these diagnostic tests must undergo rigorous validation and receive approval from the TGA, before being included in the ARTG. Additionally, to ensure their continued safety and performance, the TGA may impose conditions on their inclusion. The Medical Services Advisory Committee (MSAC) advises which tests should be subsidised through the MBS. It can also recommend any restrictions on eligibility. See Section 9.2, Pre-market regulatory requirements for hepatitis C in-vitro devices.

Some tests are performed outside the diagnostic laboratory, e.g. in research or clinical trials or in settings where point-of-care testing is being implemented. These uses may therefore be outside the regulatory framework offered by NATA accreditation and RCPA standards for MBS rebate, however high quality point-of-care testing relies on alignment with best-practice processes described in the regulatory documents.

Voluntary confidential testing

Voluntary, confidential testing with informed consent is the standard for HCV testing in Australia. Testing is provided through a range of settings from general practice, remote and community clinics to specialist hepatitis, liver and infectious diseases services.
Mandatory and compulsory testing

Mandatory testing refers to situations where people may either not participate in certain activities or not access certain services unless they agree to be tested. Circumstances in which mandatory testing is currently required under separate policy or legislation include:
as a condition of blood, tissue and organ donation¹⁶
under the migration health requirements applicable to specified visa subclasses
as a condition for entering training or service in the armed forces¹⁸
as a condition for purchasing some types of insurance¹⁹
in the context of a legal instruction, including in forensic, coronial or occupational settings.²⁰
Compulsory testing refers to situations where a person has no choice in being tested, (e.g. in the context of a forensic or coronial inquiry, or under legislation in some jurisdictions that allows for forced testing of individuals accused of certain offences, or if a person suspected on reasonable grounds of being positive for HCV infection persistently acts in a way that is perceived to place others at risk of infection). Compulsory testing should only be used when there are no alternatives and where authorised by law. The right of appeal against a decision or order to be tested should always exist.

To all extents reasonable, the processes involved in mandatory or compulsory testing should be in accordance with the principles in this Policy and basic human rights, including rights pertaining to privacy of health information.

Anonymous delinked testing

There may be circumstances where, on public health grounds (e.g. prevalence studies), anonymous delinked testing is legitimately performed in accordance with this Policy. Such testing should occur only where there is compelling scientific justification. This reason must be independently judged by an Ethics Committee constituted in accordance with the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research.²¹

Introduction of new technologies and strategies

Introduction of new technologies²² or strategies to target new priority populations²³will continue to evolve (e.g. validating additional point-of-care tests and the use of dried blood spot sampling). In every case, the introduction of new testing processes must be accompanied by appropriate workforce development to ensure that those providing HCV testing are equipped with:

up-to-date information about hepatitis C, pathophysiology, immunology and epidemiology
the latest information about HCV treatment and management
procedures associated with using any new technology

information related to referral pathways to care and support services (see section 2.0, Types of HCV testing and diagnostic strategies and section 5.3, Referral for further support).