INTRODUCTION - Testing Portal

Background and context

Hepatitis B serology testing and hepatitis B virus (HBV) DNA testing is important to identify people living with chronic hepatitis B and to provide best quality healthcare. This document recommends testing pathways for hepatitis B. It provides a clear guide for testing that can be accessed by health professionals as well as links to further information for people with hepatitis B.

The prevalence of hepatitis B infection in Australia

HBV infection is a major global public health threat with over 250 million people living with chronic infection.¹ In 2017, it was estimated that 221,420 people, or 1% of the population in Australia were living with HBV infection.² Late diagnosis of hepatitis B is a missed opportunity for preventing liver cirrhosis, liver cancer and death from liver failure. Liver cancer is the fastest increasing cause of cancer death in Australia.³

The majority of hepatitis B infections in Australia are chronic (having persisted for more than 6 months duration) and occur in people born in countries of intermediate and high prevalence who contracted the infection at birth or during early childhood. Over 60% of people in Australia with hepatitis B are from two priority populations:

adults and children from culturally and linguistically diverse (CALD) backgrounds, particularly people born in countries of intermediate and high HBV prevalence, including all indigenous peoples from overseas countries (see Priority populations for HBV testing)
Aboriginal and Torres Strait Islander people.

Other priority populations for testing include anyone at risk of blood borne infection including people who are HIV positive, men who have sex with men, sex workers, people who inject drugs and people who have been incarcerated (see Indications for HBV testing).

In recognition of the global public health impact of hepatitis B, the World Health Organization (WHO) has set clear hepatitis B elimination targets of a 90% reduction in new infections and a 65% reduction in hepatitis B-related mortality WHO recommends achieving these targets with ambitious goals of diagnosing 90% persons living with hepatitis B, linking 80% to care and treating 80% of those eligible by 2030. The Third National Hepatitis B strategy sits within this global context and sets short-term targets of 80% of people living with hepatitis B diagnosed, 50% of those diagnosed linked to care, and 20% on treatment to achieve a 30% reduction in mortality by 2022.⁴

Australia has implemented prevention interventions including promotion of standard precautions; blood donor screening; vaccination programs for adolescents and universal birth dose and infant vaccination in 2000 and these strategies have reduced incidence among Australian-born children and adolescents. With ongoing high coverage of infant hepatitis B programs in many countries, the prevalence of chronic hepatitis B in migrants to Australia will fall in coming decades.²

The importance of hepatitis B testing

Hepatitis B testing is essential to ensure people living with hepatitis B infection are diagnosed, adequately informed and counselled, effectively linked to care and treatment in a timely manner to avoid adverse health outcomes and prevent ongoing transmission.⁶ It is vital to ensure people at risk of exposure are vaccinated to prevent transmission. Appropriate testing indicates whether an individual has:

current hepatitis B infection (acute or chronic)
cleared the virus spontaneously (natural immunity)
immunity through previous hepatitis B vaccination.

Hepatitis B testing determines the severity and stage of infection, and these results direct decisions about whether antiviral therapy is indicated.⁵ Despite the public health and individual benefits of testing, it is estimated that around 30% of people with HBV infection in Australia remain undiagnosed.²⁵

This Policy supports adherence to WHO in adhering to 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).

The aim of this Policy is to recommend evidence-based hepatitis B testing pathways; it does not provide hepatitis B management guidelines. The Policy is aligned with priorities in the 3rd National Hepatitis B Strategy 2018-2022⁴ which identifies that greater knowledge of hepatitis B across priority populations, the affected people and health professionals is essential to create a supportive environment for testing as well as a need for equitable access to testing services. Key areas for action related to testing contained in the Third National Hepatitis B Strategy 2018-2022 are to:

further develop and deliver evidence-based risk assessment and hepatitis B testing pathways for key priority populations
increase voluntary hepatitis B testing among priority populations in primary health and community settings
review and promote national training and clinical guidelines for testing, treatment, monitoring and care, including guidance on pregnancy and follow up for babies born to mother with hepatitis B; and testing for hepatitis B before initiating chemotherapy, immunosuppressive therapies or treatment for chronic hepatitis C.

This Hepatitis B Testing Policy will undergo review by the National Hepatitis B Testing Policy Expert Reference Committee every 12 months to ensure the information provided is accurate and current.

The basic principles that guide hepatitis B testing in Australia are in accordance with the WHO’s 5 C approach to testing outlined above:⁵

Confidential, voluntary testing with informed consent (see Informed consent for testing) and use of an appropriate process to convey the test result (see Conveying hepatitis B test results) are fundamental to Australia’s response to hepatitis B.
It is recommended that people have access to culturally appropriate information in their preferred language supported by access to an accredited interpreter when their primary staff contact is not familiar with their language.
Testing is recommended to 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).

It is recommended that testing policies and practices 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 hepatitis B testing, specific to individual States, Territories or institutions, should be consistent with the purpose, objectives and principles of this Policy*.

Voluntary confidential testing

Voluntary confidential testing is the standard form of service delivery for hepatitis B testing in Australia. It involves providing information about the testing process; obtaining informed consent (see Informed consent for testing) for the testing, and conveying the test results to the patient in an appropriate and meaningful way (see Conveying hepatitis B test results).

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 donation⁶
Under the migration health requirements applicable to specified visa subclasses⁷
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
As a condition of health professionals performing exposure prone procedures (EPP).⁸

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.

De-identified testing

There may be circumstances where, on public health grounds (e.g. prevalence studies), de-identified 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.⁹

Introduction of new technologies and strategies

It is recommended that introduction of new technologies or strategies (e.g. point-of-care testing or opt out testing in clinical settings) to increase testing be accompanied by appropriate community consultation, ethical consideration and workforce development to ensure that:

testing strategies are informed by the communities being tested
those offering hepatitis B testing are equipped with relevant skills with the health professional performing hepatitis B testing trained in:

up-to-date information about hepatitis B infection
procedures associated with using 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 testing (see Informed consent in testing) and of conveying the test results to the patient in an appropriate and meaningful way (see Conveying hepatitis B test results).

*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.