HCV testing is routinely carried out at clinical sites such as sexual health clinics, Aboriginal Community Controlled Health Services, prisons, primary healthcare sites, drug-user community clinics, and blood transfusion services. The number of people tested and the proportion with diagnosed HCV infection are reported on a regular basis from some of these sites (e.g. blood transfusion services) and included in surveillance networks (e.g. ACCESS) to monitor HCV prevalence and incidence across various population groups.
The Australian Needle and Syringe Program Survey is coordinated by The Kirby Institute and has been carried out over one week each year since 1995.48 During the designated survey week, needle and syringe programs staff 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 sample (DBS). The subjects are assured that the specimens are tested anonymously under code, so the results cannot be linked back to individuals.
HCV antibody prevalence has been monitored since 1995, with the addition of HCV RNA testing of DBS samples since 2015 to monitor viraemic prevalence in relation to HCV elimination strategies.49 The survey also provides estimates of previous HCV testing, including antibody and RNA testing.
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.
IVDs not currently approved for use in Australia may be required in international collaborative research. Note that IVDs that may be approved by TGA for use with blood samples may not be approved for alternative sample types such as dried blood spot (DBS) tests. Application must be made to the TGA 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).50 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 2002.51
DBS testing is not a TGA approved IVD, however there are various provisions for exemption, such as for a clinical trial, that allow for regulated access to unapproved devices. DBS testing is available in NSW by participating in the NSW DBS Research Study either online or through registered sites.52 These studies are in development and validation phase. If the DBS test is positive for hepatitis C, this should be confirmed by standard HCV testing.