For more information and background on HCV IVD regulation and quality assurance, refer to the TGA.
Laboratories that perform HCV testing:
- must be NATA accredited for medical testing58
- must participate in an external quality assessment scheme (EQAS)59
- must comply with the National Pathology Accreditation Advisory Council (NPAAC) standards60
- should contribute testing statistics to the National Serology Reference Laboratory (NRL) to ensure the completeness of test denominator data.61
The TGA has regulatory responsibility for IVDs through the Therapeutic Goods Act 1989 (the Act) and its associated regulations.62 All commercially supplied IVDs must be listed on the Australian Register of Therapeutic Goods (ARTG). Before inclusion on the ARTG, all commercially supplied IVDS are evaluated to ensure they are safe and perform as intended.
Laboratory users of commercially available hepatitis C assay kits can determine which assays are currently registered for use in Australia by searching the publicly accessible ARTG at https://www.ebs.tga.gov.au/
To obtain a complete list of all available assays enter either 'hepatitis C' into the 'Search for' field. Avoid using the abbreviation 'HCV', as only partial lists will be displayed. To find a particular assay, you may search by either the sponsor or assay name. Users of commercially available assays should seek advice from the sponsors of these kits to determine the purpose for which the assay is registered.
IVD manufacturers, sponsors and the TGA have responsibility for post-market monitoring of the IVDs. Corrective action must be initiated by the manufacturer and sponsor of an IVD in consultation with the TGA. This correction must occur as soon as practicable after becoming aware of information relating to any adverse events, malfunction or deterioration in the performance, or inadequacy in the design production and labelling of an IVD. Users are encouraged to report any issues with an IVD to the sponsor and the TGA. Reports to the TGA can be submitted through the TGA’s Incident Reporting Investigation Scheme (IRIS) at: https://www.tga.gov.au/medical-device-incident-reporting-investigation-scheme-iris