- The Therapeutic Goods Administration (TGA) has regulatory responsibility for in-vitro diagnostic devices (IVDs) ie pathology assays. The Therapeutic Goods Act 1989 provides a national framework to ensure the safety, quality and performance of these therapeutic goods. Only assays that are registered by the TGA may be used for testing for HCV.
- In accordance with the conditions applied by the TGA to the registration of HCV assays, sponsors may only supply HCV IVDs to laboratories that participate in quality assurance programs prescribed by the TGA.
- Laboratories that perform hepatitis C testing must meet National Pathology Accreditation Advisory Council (NPAAC) standards, and have current National Association of Testing Authorities/Royal College of Pathologists Australia (NATA/RCPA) Medical Testing accreditation that includes
hepatitis C testing in the scope of the accreditation.
For more information and background on the quality assurance of hepatitis C testing, including categorisation systems and quality assurance programs, refer to Appendix 6.
9.1 Performance evaluation of hepatitis C test kitsThe Therapeutic Goods Administration (TGA) has regulatory responsibility for
in-vitro diagnostic (IVD) test kits through the Therapeutic Goods Act 1989 and its associated regulations. The TGA conducts a full pre-market evaluation on test kits for the hepatitis C virus and HIV to demonstrate that they meet the quality, safety and efficacy standards required for registration in Australia. The TGA currently contracts the performance evaluation of assays to the NRL.
The TGA is developing a new regulatory framework for IVDs. It is proposed that the framework will be implemented during 2007-2008. Pre-market performance evaluation of all new HCV assays will remain a requirement.
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Post-market quality assurance of HCV IVDsThe TGA also has responsibility for post-market surveillance of IVD performance. The TGA has the power to remove from the market any IVD that is not performing to the expected standard or that is known or demonstrated to be defective.
A condition of TGA registration of HCV and HIV test kits is that tests may only be used in laboratories participating in the Quality Assurance Program coordinated by the NRL. This program includes:
- the external quality assessment scheme (EQAS);
- the quality control program (QC); and
- specificity monitoring.
It is proposed that a quality control program will be utilised as the TGA's major post-market monitoring tool.
9.2 Categorisation of HCV IVDs for regulatory purposesThe TGA has the authority to impose conditions on the registration of products including the category describing the approved intended use of a HCV assay. Tests are categorized as being suitable either for routine screening (those with a performance that is suitable for blood donor screening and determining the HCV antibody status of a sample) or for reference (or supplemental) tests (those that are used to clarify the nature of the reactivity of a sample following initial standard tests). Tests are further categorised as Level 1 to 4, as outlined in Appendix 6.
This additional level of categorisation enables the TGA to recognise a wide range of test functions. Technological advances have led to the production of test kits that are suitable for purposes other than screening and confirmation of diagnosis, such as surveillance and monitoring, and possibly for use in emergency situations.
The advantages of the hepatitis C testing categorisation system (outlined at Appendix 6) is that it provides:
- a wider choice of testing protocols;
- indications of current usage;
- possible models for accommodating new technologies;
- a framework for establishing the extent of evaluation for each type of test kit; and
- a categorisation that can be generalised to other areas of serology.
9.3 Quality assurance of hepatitis C testingTo assure high quality testing, the performance of the laboratory must also be monitored. Laboratories that perform HCV testing must comply with National Pathology Accreditation Advisory Council (NPAAC) standards. Failure to meet these standards poses a perceived risk to public health and patient safety. 9 Evidence of continued compliance with these standards can be demonstrated by ongoing accreditation by National Association of Testing Authorities/Royal College of Pathologists of Australasia (NATA/RCPA) Medical Testing.
The NPAAC standard "Standards and Guidelines for Laboratory Testing of Antibodies to the Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) 2006" describes the minimal standards expected when testing for HCV antibodies. The NPAAC document "Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection and Analysis 2006" describes minimal practice to be followed when testing for HCV nucleic acid.
Good laboratory practice also prescribes the regular use of quality control testing and enrolment in relevant External Quality Assessment Schemes. These are mandatory requirements of the laboratory based quality management standard ISO 15189. These quality assurance tools provide the laboratory with both internal and external assessment of the testing process. In Australia, the major providers of these quality assurance programs are the NRL and the RCPA QAP P/L SQAP.
HCV testing should only be performed in laboratories holding current NATA/RCPA medical testing accreditation that includes hepatitis C testing in the scope of the accreditation.
8This Chapter represents the assurance mechanisms currently in place. Should this situation change in the future, this Chapter will need to be updated accordingly.
9NPAAC Standard "Standards and Guidelines for Laboratory Testing of Antibodies to the Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV)" 2006