1.0 Introduction

Posted in: HBV

1.1 Background and context

Serological testing for hepatitis B has been available in Australia for several decades and in recent years HBV DNA testing has become an integral part of the HBV clinical management pathway. The purpose of this document is to define appropriate diagnostic testing pathways using currently available technologies. It is relevant for all health professionals ordering and interpreting tests for hepatitis B. It is not intended to be a resource for people with or at risk of hepatitis B.

HBV infection is a major public health issue in Australia. It is estimated that there are currently over 213,000 people in Australia with HBV infection with many more having been exposed.1 The impact of this disease is and will continue to be significant, as the prevalence of HBV-related cirrhosis and incidence of attributable hepatocellular carcinoma (HCC) continue to increase in this country.2 The majority of newly reported infections in Australia are chronic (having persisted for more than 6 months’ duration), occurring in people from high prevalence countries who were infected at birth or during childhood. The two main priority populations for hepatitis B testing are:

  • adults and children from culturally and linguistically diverse (CALD) backgrounds, particularly those born in countries of intermediate and high HBV prevalence (see section 3.1, figure 1)  
  • Aboriginal and Torres Strait Islander people.

Australia has implemented a universal vaccination program for hepatitis B to reduce the risk of transmission of HBV infection. Universal neonatal vaccination commenced in all States and Territories in May 2000. State and Territory Departments of Health operated catch-up vaccination programs for early adolescents but these programs did not test for current HBV infection before administering vaccine doses and may have led individuals in the targeted age cohort with chronic infection to believe they were immune.

Universal blood donor screening for HBV infection (hepatitis B surface antigen [HBsAg] and in June 2010 HBV DNA) also remains an important strategy for reducing HBV transmission in Australia.

HBV testing and notification policies provide an individual, his or her health professional and the public health services of a State or Territory with information regarding exposure to the virus. Appropriate testing indicates whether exposed individuals have cleared the virus spontaneously or whether they have acute or chronic infection. Testing also allows an assessment of the phase of the chronic HBV infection and this directs decisions on appropriate timing for initiation of antiviral therapy. Chronic hepatitis B infection can lead to cirrhosis and/or HCC in up to 25% of those affected. Ongoing monitoring and timely treatment can help prevent the onset of serious liver disease including HCC.  Diagnosis of HBV infection followed by appropriate vaccination and education of at-risk contacts can effectively reduce transmission. Vaccination of at-risk contacts is not only cost effective, it is cost saving.  Despite the public health and individual benefits of testing, it is estimated that up to 44% of people with HBV infection in Australia remain undiagnosed. 3 The 2nd National Hepatitis B Strategy 2014-2017sets a target for the proportion diagnosed to increase to 80%.

It is crucial that people responsible for implementing this Policy (particularly those obtaining informed consent (see section 4.0) and conveying test results (see section 5.0) have the necessary skills and knowledge to fully communicate the significance of each of the available tests to the person being assessed. In 2006 the Australian Bureau of Statistics conducted a health literacy survey5 that identified that only 43% of Australians had an adequate or better level of health literacy. This proportion drops to approximately one quarter in people whose first language is not English. A lack of health literacy can affect the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.6, 7

This policy document assumes that all health professionals involved in the testing process are appropriately trained.

1.2 Purpose, scope and objectives

The aim of this Policy is to provide advice on appropriate testing pathways using currently available technologies for all health professionals ordering and interpreting tests for hepatitis B. It does not provide management guidelines. It is not intended to be a resource for people with or at risk of hepatitis B. The Policy is aligned with the 2nd National Hepatitis B Strategy 2014-20174 which identifies the need for a coordinated, accessible and affordable HBV testing system that allows for:

  • access to appropriately resourced services for people at risk of acquiring HBV infection and for those diagnosed with HBV infection to optimise monitoring and clinical management, and to ensure timely referral to treatment;
  • the reduction of HBV transmission through knowledge of one’s status;
  • the reduction of transmission from a mother with HBV infection to her newborn;
  • monitoring the response to vaccination against HBV at an individual and community level;
  • documenting the epidemic to aid the development of evidence-based public health interventions;
  • the improvement of the health of people who have chronic HBV infection.

This Policy sets out the framework for providing relevant and accurate testing and removing actual and perceived barriers to testing. It identifies requirements and provides guidance regarding procedures for the provision of HBV testing.

Changes in the understanding of HBV infection and advances in treatment strategies that are based on test results are occurring rapidly. Accordingly, this HBV testing policy will undergo review by the National Hepatitis B Testing Policy Expert Reference Committee every 12 months to ensure information provided is accurate and current.  

1.3 Principles of hepatitis B testing

The basic principles that guide HBV testing in Australia:

  • Confidential, voluntary testing with informed consent (see section 4.0) and use of an appropriate process to convey the test result (see section 5.0) are fundamental to Australia’s response to hepatitis B.
  • Testing is critical to understanding the epidemiology of HBV infection in the community.
  • Testing must be accessible to all those who are or have been at risk of HBV infection.
  • Testing will be of the highest possible standard and provided in a timely manner to individuals at every stage of their infection.
  • Testing is of benefit to the person being tested (e.g. diagnosis is accompanied by provision of, or referral to, culturally and language-appropriate education, management, treatment (where relevant) and care and support services).
  • Anonymous testing should be considered in instances where confidentiality is harder to maintain e.g. in small communities.
  • People should have access to culturally appropriate information in their preferred language supported by access to a free professional interpreter when their primary staff contact is not familiar with their language.

1.4 Policy implementation

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.

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

(The word must has been used when the statement reflects something which is in legislation. The word should has been used to reflect best practice or a higher quality service.)

1.4.1 Voluntary confidential testing

Voluntary confidential testing is the standard form of service delivery for HBV testing in Australia. It involves the provision of information on the testing process, the obtaining of informed consent (see section 4.0) for the testing and conveying the test results in an appropriate and meaningful way (see section 5.0).

1.4.2 Mandatory or compulsory testing

Mandatory testing refers to situations where people are prevented from participating in certain activities or from having access to 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 donation;8
  • under the migration health requirements applicable to specified visa subclasses;9
  • as a condition for entering training or service in the armed forces; 
  • as a condition for purchasing some types of insurance;
  • in the context of a legal instruction, including in forensic or coronial settings;

To all reasonable extents, the processes involved in mandatory 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 testing for research must be independently judged by a Human Research Ethics Committee constituted in accordance with the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research.10

1.4.4 Introduction of new technologies and strategies

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

  • up-to-date information about HBV infection, pathophysiology, immunology and epidemiology;
  • latest information about hepatitis B monitoring, clinical management and treatment;
  • procedures associated with using any new technology;
  • information related to referral pathways to culturally and language-appropriate care and support services;
  • knowledge of the testing process, of how to obtain informed consent for the testing (see section 4.0) and of conveying the test results in an appropriate and meaningful way (see section 5.0).

Workforce development is particularly relevant in relation to point-of-care testing which is more advanced in relation to human immunodeficiency virus (HIV) than to either HBV or hepatitis C virus (HCV) in Australia (see section 2.1 (C)).  

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National HBV Testing Policy v1.2 (PDF)

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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