TGA approves rapid antigen testing from November

By Jackson Graham

September 28, 2021

Greg Hunt
Greg Hunt. (AAP Image/Lukas Coch)

Rapid COVID-19 antigen testing can be used in Australian homes from November after the Therapeutic Goods Administration approved that use. 

Federal health minister Greg Hunt said on Tuesday the move would supplement the PCR testing done at state clinics with the availability of home testing.  

“This is an important additional protection for Australians — home testing to support Australians and to support the national plan,” Hunt said. 

He said now the TGA needed to approve individual tests as safe and effective, and state and territory governments determine how the tests are to be used. 

“At this stage they have had over 70 applications of interest and 33 tests have already been approved for supervised use,” Hunt said. 

“They will now be considered and made available if found to be safe and effective.” 

A new TGA regulation by October 1 will allow companies to formally apply for approval for rapid antigen self-tests and to legally supply tests by November 1. 

In a statement the TGA said systems needed to be in place in states and territories to enable reliable use of testing in homes as early as possible, including processes for PCR tests to confirm a positive result following self testing. 

Rapid antigen tests are widely in use in Europe and the United States but the TGA says they are not as accurate as PCR tests. 

According to the TGA the self-tests can detect the virus in the acute phase of infection, particularly in the week before symptoms present and in the first week of symptoms appearing. 


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