6.0 Surveillance and Research

Posted in: HCV

Laboratories performing HCV testing must notify the relevant State and Territory health authorities of any new positive laboratory diagnosis in accordance with the relevant legislation.36

6.1 Sentinel site surveillance for HCV

HCV testing is routinely carried out at a number of sentinel sites such as sexual health clinics, Aboriginal Community Controlled Health Services, prisons, primary health care sites, drug-user organisations and blood transfusion services. The numbers of people tested and the proportion with diagnosed HCV infection are reported on a regular basis from these sites and provide estimates of HCV prevalence and incidence across various population groups.

6.2 Special annual survey

The Australian Needle and Syringe Program Survey is coordinated by The Kirby Institute (formerly NCHECR) and has been carried out over one week each year since 1995.41 During the designated survey week, needle and syringe programs staff ask all clients who attend to complete a brief, self-administered questionnaire and provide a finger- prick blood sample. The subjects are assured that the specimens are tested under code, so the results cannot be linked back to individuals.

This survey, however, provides limited information on comparisons of HCV infections between jurisdictions and over time.

6.3 Delinked blood surveys

Delinked anonymous surveys are studies in which specimens taken for other purposes (e.g. the neonatal heel-prick specimen survey in 1989–90) are tested for HCV infection without consent after they have been coded so that the results cannot be linked back to the individual who originally provided the specimen. This survey method should be considered for Australian surveillance purposes only where there is no other feasible method for reasonably obtaining appropriate data and should be subject to scientific justification and be endorsed by an institutional ethics committee in accordance with the requirements prescribed by the NHMRC.

6.4 Use of stored blood for research on diagnostic technologies

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/or be subject to appropriate ethical review.

6.5 Use of unregistered Invitro Diagnostic Devices (IVDs)

IVDs not currently approved for use in Australia may be required in international collaborative research. Application must be made to the Therapeutic Goods Administration (TGA)42 under the Clinical Trial or Special Access Scheme when IVDs are intended for therapeutic use (e.g. to diagnose infection or determine treatment for an individual). IVDs for research only (e.g. where results are de-identified and not used to determine individual treatment) are exempt under Clause 1.3, Schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2002.43

Quick links to resources on this page

Notification Forms

Prevalence of HIV, HCV and injecting and sexual behavior among Needle and Syringe Program attendees

Therapeutics Goods Administration

Therapeutic Goods Medical Devices Regulations

41. The Kirby Institute and The University of New South Wales. The Australian Needle and Syringe Program Survey (ANSPS). Prevalence of HIV, HCV and injecting and sexual behavior among Needle and Syringe Program attendees. National Data Reports. Available at: au/nchecrweb.nsf/page/Australian+NSP+Survey (Cited 23 March 2012).
42. Australian Government. Department of Health and Ageing. Therapeutics Goods Administration [internet]. Available at: (Cited 23 March 2012).
43. Australian Government. ComLaw. Therapeutic Goods (Medical Devices) Regulations 2002: F2011C00295. Available at: (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