6.0 Surveillance and Research

Posted in: HIV

Laboratories performing confirmatory testing must notify the relevant state and territory health authorities of any new positive laboratory diagnosis in accordance with the relevant legislation and regulations.[i]

Where information is available to identify and monitor rates of newly acquired HIV infection, these cases should be reported to the local state or territory health authority as appropriate. Laboratory evidence of acute or recent HIV infection is useful to monitor rates of incident HIV infection and to evaluate interventions.

6.1 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 HIV infection without consent after they have been coded, so that the results cannot be linked back to the individual who originally provided the specimen. The survey method should be considered for Australian surveillance purposes only where there is no other feasible method for reasonably obtaining appropriate data; and must be subject to scientific justification and be endorsed by an institutional ethics committee (IEC) in accordance with the requirements prescribed by the NHMRC.[ii]

6.2 Identity unlinked HIV testing

Research using identity unlinked HIV testing can provide useful epidemiological data. In such studies, specimens used must be endorsed by an appropriate IEC in accordance with requirements prescribed by the NHMRC.[iii]

6.3 Data linkage projects

An increasing amount of clinical data is becoming available as a result of the development of electronic data storage. Linkage projects which link to HIV notification data can provide timely and relevant feedback on practice. Linkage to data including Medicare data, cancer registries, enhanced notification data and treatment and testing data must be endorsed by an appropriate IEC in accordance with requirements prescribed by the NHMRC.[iv]

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 be conducted only on delinked or de-identified samples or be subject to appropriate ethical review and be endorsed by an IEC in accordance with the NHMRC.[v]

6.5 Use of unregistered in-vitro diagnostic devices

In-vitro diagnostic devices (IVDs) not currently approved by the TGA for in use in Australia may be required to be used in research, e.g. dried blood spot kits and tests which use alternate samples. Application must be made to the TGA under the Clinical Trial or Special Access Scheme[vi] to allow for use of these IVDs where they are used for a therapeutic purpose, e.g. to screen or diagnose infection or determine treatment for a patient. IVDs to be used for research only, e.g. where results are de-identified and not used to determine patient treatment, are exempt under Clause 1.3, Schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2002.[vii]

[i] Australasian Society for HIV Medicine (ASHM). Guide to Australian HIV laws and policies for healthcare professionals. Notification. January 2011. Available at:  (Cited 9 July 2015)

[ii] Australian Government. National Health and Medical Research Council. Australian human research ethics.

Available at: (Cited 5 May 2015)

[iii] Ibid.

[iv] Ibid.

[v] Ibid

[vi] Australian Government. Department of Health and Ageing. Therapeutic Goods Administration. Standards, guidelines and publications: medical devices and IVDs. Available at: (Cited 5 May 2015)

[vii] Australian Government. ComLaw. Therapeutic Goods (Medical Devices) Regulations 2002: F2012C00424.

Available at: (Cited 5 May 2015)