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6.0 Surveillance and Research

Posted in: HBV

Laboratories performing HBV testing must notify the relevant State and Territory health authorities of any new HBsAg positive laboratory diagnosis in accordance with the relevant legislation/regulations. In some states and territories medical practitioners must also notify the relevant State and Territory health authorities.

Where information is available to identify newly acquired HBV infection, such as detection of HBsAg in a patient shown to be negative within the last 24 months; or detection of HBsAg and IgM to hepatitis B core antigen (IgM anti-HBc), in the absence of prior evidence of HBV infection; or detection of HBV by nucleic acid testing, and IgM anti-HBc, in the absence of prior evidence of HBV infection, these cases should be reported to the local State or Territory health authorities as a case of newly acquired HBV infection.

6.1 Delinked blood surveys

Delinked anonymous surveys are studies in which specimens taken for other purposes (e.g. residual serum following routine diagnostic testing) are tested for markers of HBV infection and/or immunity without consent after they have been coded so that the results cannot be linked 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 should be subject to scientific justification and be endorsed by an institutional ethics committee in accordance with the requirements prescribed by the NHMRC.

6.2 Use of unregistered in-vitro diagnostic devices

Before the introduction of the new regulatory framework for IVDs in 2010, hepatitis B tests were not required to be registered with the ARTG. For legal supply in Australia under the new regulatory framework, IVDs must be included in the ARTG by 1 July 2014. IVDs not currently supplied in Australia may be required to be used in international collaborative research. Application must be made to the TGA under the Clinical Trial or Special Access Scheme to allow for use of these IVDs where they are used for a therapeutic purpose, e.g. to 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.

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Australian national notifiable diseases case definitions

 

 

 

 

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National HBV Testing Policy v1.2 (PDF)

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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