Ensuring only test kits of the highest quality are registered for use in Australia
The pre-market evaluation of HIV and HCV test kits has been conducted by NRL under contract to the Therapeutic Goods Administration (TGA) since 1989 and 1996 respectively. The evaluations assess the performance of test kits under local conditions, using samples representative of the Australian population. The focus is on the quality of test kit performance, not test kit manufacture.
Under the Therapeutic Goods (Medical Devices) Regulations 2002 (made under the Therapeutic Goods Act 1989) all test kits must be included on the Australian Register of Therapeutic Goods (ARTG) in order for them to be supplied in Australia. Test kits are classified according to the extent of either personal or public risk associated with use of the device. Test kits intended to be used for screening blood or tissue donations are considered to be associated with high personal and public risk and therefore, are categorised in the highest risk class being Class 4. Class 3 are those that are associated with either a moderate public health risk or a high individual risk, including test kits for notifiable diseases.
As of the 1st July 2010 the scope of evaluations undertaken by NRL was expanded to include test kits for infectious diseases other than HIV and HCV.
Depending on the IVD classification, an evaluation will consist of either dossier review on its own or in conjunction with laboratory-based performance testing.
Dossier Review
Manufacturer’s evidence is examined to ensure that key performance quality and safety criteria are met and that the evidence presented, and the means by which it was gathered, are scientifically sound.
Performance Testing
Performance testing is usually only conducted on Class 4 test kits. It proceeds in three stages.
Stage One
A review of the dossier supplied by the test kit sponsor. If the data reviewed at Stage One are considered adequate, the evaluation proceeds to either stage Two or Three.
Stage Two
This is an optional stage when test kits have met the assessment criteria at Stage One but require assessment of a particular aspect of test performance prior to large scale testing at Stage Three.
Stage Three
The final stage is a comprehensive examination of the overall performance characteristics of the test kit, including specificity, sensitivity, reproducibility, linearity, etc. The evaluation sample panel is tailored to the test kit type and reflects the laboratory setting and population in which the test kit will be used. Stage Three performance testing may be conducted as a multi-site evaluation where appropriate.
Regardless of the classification, a test kit must comply with all relevant Essential Principles (as specified in the Regulations). At the completion of an evaluation NRL prepares a report for TGA and explains whether the performance of the test kit is satisfactory and whether it conforms to the relevant Essential Principles.
NRL Evaluations capture a "point-in-time" assessment of test kit performance. The test kit's ongoing performance in the marketplace is monitored through NRL Quality Assurance.
For further information please contact info@nrl.gov.au.
NRL Evaluations Brochure - (click to download and print)
