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1.0 Introduction

Posted in: HCV

1.1 Background and context

Australia has a high quality, comprehensive multi-sector pathology service. The regulatory and quality framework for HCV diagnostic testing has evolved with a focus on formal laboratory settings.

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.

Diagnostic 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 could be used outside of the diagnostic laboratory, such as for research or clinical trials (refer chapter 6.0) or those for point-of-care testing (refer chapter 10.0). These tests may therefore be outside the regulatory framework offered by NATA accreditation and/or RCPA standards.

Hepatitis C infection remains a major public health problem in Australia. Since testing began in 1990, it is estimated that over 300,000 people have been exposed to the hepatitis C virus (HCV). There were 10,790 hepatitis C notifications in Australia in 2015.1 Influenced by multiple factors, infection persists in between 55–85% of those infected. In 2015, an estimated 227,306 Australians were living with chronic hepatitis C. Cirrhosis develops within 20 years in 5–10% of this group (usually associated with other co- morbidities such as co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV), obesity, insulin resistance, alcohol intake > 40g/day) and in a further 10–15% after 40 years.2 Hepatocellular carcinoma will develop in 3–5% of people per annum who develop cirrhosis.3

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 HCV. New treatments, subsidised on the Pharmaceutical Benefits Scheme (PBS) in 2016, will greatly improve HCV sustained viral responses and will increase demand for treatment.  Oral pan-genotype medications will reduce the need for some testing both pre and during therapy in future. Therefore, this edition of the Testing Policy document seeks to define the current best practice for testing for exposure to the virus and for defining the current infective status of the person pre, during and post-treatment.

HCV testing can provide people with information regarding exposure to the virus. Appropriate testing indicates whether they have cleared the virus spontaneously or with antiviral therapy or have an ongoing (chronic) infection.

The benefits of reliable, timely testing are numerous, both for the person and for public health. Detection of HCV infection followed by appropriate education can effectively reduce onward transmission by empowering people living with HCV to modify risk behaviour, modify disease progression through earlier referral for advice and/or 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 infected people in Australia remain undiagnosed.

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 Policy document assumes that all staff involved in the testing process are appropriately trained.

The previous HCV testing policy was released in 20124 and this version was updated in 2016. Differences in this version 1.2 include:

  • Updated monitoring treatment (see section 2.4)
  • More commentary on testing in Aboriginal and Torres Strait Islander populations and people who inject drugs (see section 3)

1.2 Purpose, scope and objectives

This Policy sets out the framework for providing quality testing and removing real and perceived barriers to testing. It identifies requirements and provides guidance and/or links regarding procedures for the provision of HCV testing.

The Policy is aligned with the Fourth National Hepatitis C Strategy 2014–20175 which identifies the need for a coordinated, accessible and affordable HCV testing system that aims to:

  • increase testing of hepatitis C in priority populations
  • improve referral and access to high-quality support services at the time of diagnosis for people with or at risk of hepatitis C to initiate a pathway to care
  • assess the feasibility, accessibility and cost-effectiveness of the range of existing and emerging testing methods
  • implement targeted initiatives for priority populations and local health care services to promote awareness and increase testing

This HCV testing policy will undergo regular review to take account of the continuing rapid change in the knowledge base, particularly related to treatment protocols.

1.3 Principles of HCV testing

The eight basic principles that guide HCV testing in Australia are:

  • confidential, voluntary testing with informed consent and post-test discussion as fundamental to Australia’s response to HCV;
  • testing is critical to understanding the epidemiology of HCV infection in the community;
  • testing must be accessible to all those who are or have been at risk of HCV infection;
  • testing will be of the highest possible standard and provided in a timely manner;
  • testing is of benefit to the person being tested;
  • testing can be critical to interruption of transmission and can support harm minimisation;
  • testing to monitor people with HCV before, during and after treatment is an integral part of their care; and
  • people should not be 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). De-identified testing should be provided to protect privacy where relevant.

1.4 Policy implementation

Testing policies and practices must comply with all relevant Commonwealth and State and Territory anti-discrimination and public health legislation, and other relevant laws and regulations, including those governing Commonwealth funding of pathology tests.6,7,8

Policies relating to HCV testing, specific to individual States, Territories or institutions, should be consistent with the purpose, objectives and principles of this Policy.

1.4.1 Voluntary confidential testing

In Australia, HCV testing is voluntary and confidential. Testing is provided through a range of settings from general practice to specialist HCV, liver and infectious diseases services.

1.4.2 Mandatory or compulsory testing

  • Mandatory testing refers to situations where people may not either participate in certain activities or access certain services unless they agree to be tested. Circumstances in which mandatory testing are currently required under separate policy or legislation include:

−      as a condition of blood, tissue and organ donation;9

−      under the migration Health Requirements applicable to specified visa subclasses;10

−      as a condition for entering training or service in the armed forces;11

−      as a condition for purchasing some types of insurance;12 and

−      in the context of a legal instruction, including in forensic or coronial settings.

  • 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 hepatitis C positive persistently behaves in a way that places others at risk of infection). Compulsory testing should only be used when there are no alternatives. 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 pertaining to privacy of health information.

 1.4.3 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 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.13

1.4.4 Introduction of new technologies and strategies

Introduction of new technologies14 or strategies to target new priority populations15 must be accompanied by appropriate workforce development to ensure that those providing or offering HCV testing are equipped with:

  • up-to-date information about HCV infection, pathophysiology, immunology and epidemiology;
  • latest information about HCV treatment and management;
  • procedures associated with using any new technology; and
  • information related to referral pathways to care and support services (see section 10.0 Point of Care tests for HCV in community settings).

Quick links to resources on this page

AASLD Practice Guidelines: Diagnosis, Management, and Treatment of Hepatitis C: An Update

EASL Clinical Practice Guidelines: management of hepatitis C virus infection

Third National Hepatitis C Strategy 2010–2013

Commonwealth funding of pathology tests

Medicare Benefits Schedule

Department of Immigration and Citizenship. Fact Sheet 22—The Health Requirement

Communication from Department of Defence on pre-enlistment blood screening

HIV/AIDS Legal Centre

National Health and Medical Research Council: National Statement on Ethical Conduct in Human Research

Therapeutics Goods Administration

Department of Health and Ageing: Implementation Plan: National Strategies 2010 – 2013

1. The Kirby Institute. 2016 Annual Surveillance Report of HIV, viral hepatitis, STIs. Available at: http://kirby.unsw.edu.au/sites/default/files/hiv/resources/2016%20BBVSTI%20Annual%20Surveillance%20Report.pdf (Cited 14 November 2016).
2. Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 2009;49(4):1335-74. Available at: http://www.ashm.org.au/images/hcv/diagnosis_of_hep_c_update%20aug%20
_09pdfaasld.pdf (Cited 23 March 2012).
3. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol 2011; 55(2):245-64. Available at: http://www.ashm.org.au/images/hcv/easl_guidelines.pdf (Cited 23 March 2012).
4. Australian Government Department of Health and Ageing. National Hepatitis C Testing Policy. Hepatitis C Subcommittee of the Ministerial Advisory Committee on AIDS, Sexual Health and Hepatitis; the Blood Borne Virus and Sexually Transmissible Infections Subcommittee of the Australian Population Health Development Committee. 2007. Available at: http://www.health.gov. au/internet/main/publishing.nsf/Content/phd-hepc-testing-policy-may07 (Cited 23 March 2012).
5. Australian Government Department of Health and Ageing. Fourth National Hepatitis C Strategy 2014–2017. Canberra: Commonwealth of Australia; 2014. Available at: http://www.health.gov.au/internet/main/publishing.nsf/Content/A68444CDED77B3A9CA257BF0001CFD80/$File/Hep-C-Strategy2014-v3.pdf (Cited 14 November 2016).
6. National Anti-Discrimination Information Gateway. Commonwealth and State and Territory anti-discrimination and public health legislation [internet]. Available at: http://www. antidiscrimination.gov.au/www/nadig/nadig.nsf (Cited 9 March 2012).
7. Commonwealth funding of pathology tests [internet]. Available at: http://www.health.gov.au/ internet/main/publishing.nsf/Content/health-pathology-aboutus-index.htm (Cited 9 March 2012).
8. Australian Government Department of Health and Ageing. Medicare Benefits Schedule. Available at: http://www9.health.gov.au/mbs/search.cfm (Cited 22 March 2012).
9. Organ Donation. Legislation and guidelines for organ and tissue donation. Available at: http://www. health.gov.au/internet/main/publishing.nsf/content/health-organ-legislation.htm (Cited 9 March 2012).
10. Australian Government. Department of Immigration and Citizenship. Fact Sheet 22—The Health Requirement. Available at: http://www.immi.gov.au/media/fact-sheets/22health.htm (Cited 9 March 2012).
11. National HIV Testing Policy 2011. Available at: testingportal.ashm.org.au/resources/practitioners/ Armed_Forces_HIV_resource.pdf (Cited 9 March 2012).
12. HIV/AIDS Legal Centre Inc. (NSW). Available at: www.halc.org.au/disclosure.html (Cited 9 March 2012).
13. National Health and Medical Research Council, Australian Research Council, Australian Vice- Chancellors’ Committee. National Statement on Ethical Conduct in Human Research (2007) (updated September 2009). Available at: www.nhmrc.gov.au/_files_nhmrc/publications/attachments/ e72.pdf (Cited 9 March 2012).
14. Australian Government. Department of Health and Ageing. Therapeutics Goods Administration. Medical devices safety. Available at: www.tga.gov.au/safety/information-devices.htm (Cited 23 March 2012).
15. Australian Government. Department of Health and Ageing. Implementation Plan: National Strategies 2010 – 2013. Third National Aboriginal and Torres Strait Islander Blood Borne Viruses and Sexually Transmissible Infections Strategy, National Hepatitis B Strategy, Sixth National HIV Strategy, Second National Sexually Transmissible Infections Strategy, Third National Hepatitis C Strategy. 2012. Available at: http://www.health.gov.au/internet/main/publishing.nsf/Content/ohp-national- strategies-2010 (Cited 23 March 2012).

 

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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