Australia – TGA posts guidance to support self-testing for infectious diseases

Australia’s Therapeutic Goods Administration (TGA) has released guidance documents to support the expansion of self-testing in Australia, addressing clinical performance requirements and risk mitigation strategies for self-tests for seasonal influenza, hepatitis B and C, and chlamydia, gonorrhoea and syphilis.

Australia banned self-testing for serious diseases in 2010. An exception was granted for self-tests for HIV in 2014 but otherwise testing for serious diseases continued to require the involvement of a healthcare professional. With the original ban needing to be remade after 10 years under Australian law, TGA sought feedback on allowing self-testing against more diseases in 2019. Positive feedback led a change in the law last year.

Now, TGA has released three guidance documents aimed at companies that want to take advantage of the more permissive rules on self-testing. The documents discuss clinical requirements, usability studies, risks and mitigation strategies for self-tests of three different sets of infectious diseases…