SURVEILLANCE AND RESEARCH

Hepatitis C testing is routinely carried out at clinical sites such as sexual health clinics, Aboriginal Community Controlled Health Services, prisons, primary healthcare clinics, community clinics serving people who inject drugs, and blood transfusion services. The number of people tested and the proportion with hepatitis C or the rate of new hepatitis C infections are reported on a regular basis from some of these sites and are included in surveillance reports to monitor hepatitis C prevalence and incidence across various population groups. Emergency Department hepatitis C testing has recently been piloted as an additional surveillance setting.^77,78

The Australian Needle and Syringe Program Survey is coordinated by The Kirby Institute and has been conducted over one week each year since 1995.⁷⁹ During the designated survey week, the staff of needle and syringe programs in a national network of sites ask all clients who attend to complete a brief, self-administered questionnaire and provide a finger-prick dried blood spot sample. The specimens are tested anonymously under code, and the results cannot be linked back to individual people.

HCV antibody prevalence has been monitored since 1995, with the addition of HCV RNA testing of dried blood spot samples since 2015 to monitor viraemic prevalence in relation to hepatitis C elimination strategies.⁸⁰ The survey also provides estimates of previous hepatitis C testing, including antibody and RNA testing, and the impact of the DAA therapy era on hepatitis C incidence.⁸¹

Retrospective analysis of stored samples, particularly for the testing of new diagnostic technology or testing epidemiological hypotheses must only be conducted on delinked or de-identified samples and be subject to appropriate ethical review and in accordance with relevant laws.³⁰

Hepatitis C in-vitro diagnostic devices must be approved by the TGA and included in the ARTG before they can be used in Australia. Note that these in-vitro diagnostic devices may be approved for specific intended uses, such as for blood samples, but not for other sample types like dried blood spots, or they may be approved solely for diagnosis and not for monitoring. Unapproved in-vitro diagnostic devices (those not included in the ARTG) or off-label use in-vitro diagnostic devices (those not approved for a particular intended use) may be required in special circumstances and for international collaborative research. To access an unapproved in-vitro diagnostic device, an application must be made to the TGA under the Clinical Trial or Special Access Scheme.⁸² In-vitro diagnostic devices for research only (e.g. where results are de-identified and not used to determine individual treatment) are exempt from inclusion in the ARTG under Item 1.3, Schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2002.⁸³

As at March 2025, hepatitis C testing in-vitro diagnostic devices for use with dried blood spots are not approved by the TGA. However, there are various provisions for exemptions, such as for a clinical trial, that allow for regulated access to unapproved devices. These studies are currently in the development and validation phase. If a dried blood spot test returns a positive result for hepatitis C, it should be confirmed with standard hepatitis C testing.