Types of HIV Testing

This policy covers laboratory-based testing and non-laboratory-based testing. The TGA has produced guidance to assist and inform its evaluation of HIV tests:

TGA Clinical Performance Requirements and Risk Mitigation Strategies for HIV Tests

This guidance sets out differential performance requirements for laboratory tests, HIV point-of-care tests and HIV self-tests. It recognises that a lower performance threshold may be acceptable in a test which is part of a screening protocol requiring confirmatory testing, and that confirmatory testing must be able to demonstrate the highest quality and performance. It also specifies the need for training. It is essential that those using any test are familiar with its limitations and can communicate these limitations to the person being tested or, in the case of a self-test, that the package insert addresses these limitations.

This TGA guidance document is prospective and relates to any tests which may be submitted to the TGA for evaluation.