National Hepatitis C Testing Policy May 2007
In discussing hepatitis C testing in this policy a number of tests conducted at different times or together are described. These tests indicate whether an individual has come into contact with the hepatitis C virus (HCV), and if they have, whether they have cleared the virus (spontaneously or with previous interventions) or are chronically infected.
It is crucial, therefore that those people responsible for implementing the policy, particularly those performing pre-test and post-test discussions, have the skills and knowledge to fully communicate the significance of each of the tests available.
Principles of hepatitis C testingThe seven basic principles that guide hepatitis C testing in Australia are that:
- confidential, voluntary testing with informed consent and pre-test and post-discussion is fundamental to Australia’s response to hepatitis C;
- testing is of the highest possible standard;
- testing is of benefit to the person being tested;
- testing is accessible to all those at risk of HCV infection;
- testing is critical to understanding the epidemiology of HCV infection in the community;
- testing can be critical to interruption of transmission and can support harm minimisation; and
- testing to monitor people with HCV before, during or after treatment is an integral part of their care.
Indications for hepatitis C testing
- Testing for hepatitis C provides considerable useful information for the individual, through engagement with the healthcare worker and at a population health level.
- There are benefits associated with testing which can outweigh the risks provided that the hepatitis C testing principles are followed.
- Testing is indicated for individuals with clinical or biochemical evidence of liver disease and/or the extrahepatic manifestations of HCV infection.
- Testing is indicated for individuals who have been exposed to risk factors associated with transmission of HCV most importantly injecting drug use and imprisonment.
- In the presence of other factors that confer a lesser risk of infection the indication for testing is decided on a case-by-case basis.
Transmission and infection control in healthcare settings
- Hepatitis C testing of health care workers should be conducted in accordance with the general principles set out in this document with regard to privacy, confidentiality and access to appropriate health care and support services.
- Hepatitis C testing of all health care workers is not recommended.
- Health care workers who perform exposure prone procedures (EPPs) must undergo hepatitis C testing so that they are aware of their HCV status.
- Health care workers who test positive for HCV RNA must not perform EPPs.
- Testing should be considered for health care workers following occupational exposure to blood or body substances, for example through needlestick injury.
Aboriginal and Torres Strait Islanders
- Strategies to improve access to testing need to be developed locally and reflect local HCV transmission routes, risk practices and patterns of health service use.
- Local pre-test and post-test discussion guidelines should take into account local issues of stigma and shame.
- Fear of breaches of patient confidentiality may be reduced through the development and publication of local confidentiality policies and the use of short-incubation tests as appropriate.
- Specific State and Territory and regional initiatives are needed to improve access to confidential testing and continuity of care for Aboriginal and Torres Strait Islander people moving through the corrections system.
Surveillance and research
- Systematic surveillance of newly diagnosed cases of HCV infection is a key component of the Australian response to the HCV epidemic.
- The results of anti-HCV antibody testing have been used to analyse hepatitis C prevalence and incidence, including the results of hepatitis C testing carried out at sentinel sites and for the annual Needle and Syringe Program (NSP) Survey.
Access to diagnostic testing
- Testing should be accessible to all who are or have been at risk of infection.
- A number of tests are required to determine the meaning of a positive antibody test as no single screening test is specific enough to inform clinical decisions.
- There are a range of barriers that may impact on access to hepatitis C testing by people who inject drugs, people from culturally and linguistically diverse backgrounds, Aboriginal and Torres Strait Islander peoples, people in custodial settings and people who live in rural and remote areas.
Pre-test and post-test discussions
- The terms ‘pre-test and post-test discussion’ are used in place of ‘hepatitis C test discussion and post-test counselling’.
- The healthcare worker delivering the test result should use their best judgement in establishing the most appropriate way to communicate the test result. Factors to consider include the person’s testing history, gender, cultural beliefs and practices, behaviour, ongoing risk, understanding of hepatitis C, language and literacy level.
- Pre-test and post-test discussions form an integral part of hepatitis C testing. Provision of information and support associated with testing is consistent with the goal of the second National Hepatitis C Strategy, which includes minimising the personal and social impacts of hepatitis C infection.
- Home based tests are not approved in Australia, and home-based testing is not supported.
- Test results should be given in person, wherever possible.
Diagnostic strategies for hepatitis C
- Past exposure to HCV is determined by testing for HCV antibodies (anti-HCV) in serum or plasma.
- A sample not reactive in the screening immunoassay can be generally regarded as anti-HCV negative.
- A sample reactive in the screening immunoassay should be subject to a minimum of one alternative supplemental immunoassay to confirm the result.
- A sample strongly reactive in two complementary immunoassays can be reported as positive.
- Current HCV infection is usually determined by qualitative testing for HCV RNA.
- Qualitative HCV RNA testing should be a standard component of the diagnostic work-up of all anti-HCV positive individuals.
- The major role of HCV genotype and viral load testing is in guiding treatment dose and duration.
- It is routine to perform a number of tests to determine the meaning of a positive antibody test as no single screening test provides enough information to inform clinical decisions
Quality assuring HCV testing
- The Therapeutic Goods Administration (TGA) has regulatory responsibility for in-vitro diagnostic devices (IVDs) ie pathology assays. The Therapeutic Goods Act 1989 provides a national framework to ensure the safety, quality and performance of these therapeutic goods. Only assays that are registered by the TGA may be used for testing for HCV.
- In accordance with the conditions applied by the TGA to the registration of HCV assays, sponsors may only supply HCV IVDs to laboratories that participate in quality assurance programs prescribed by the TGA.
- Laboratories that perform hepatitis C testing must meet National Pathology Accreditation Advisory Council (NPAAC) standards, and have current National Association of Testing Authorities/Royal College of Pathologists Australasia (NATA/RCPA) Medical Testing accreditation that includes hepatitis C testing in the scope of the accreditation.
Funding of hepatitis C testing
- There is a Medicare Benefits Schedule (MBS) rebate for anti-HCV antibody testing.
- There is a MBS rebate for qualitative and quantitative nucleic acid testing and genotype testing.
- Some States and Territories provide free and de-identified hepatitis C testing when used to inform treatment or clinically indicated.