During the pandemic, the TGA has approved more than 60 different...

During the pandemic, the TGA has approved more than 60 different rapid antigen tests for point of care ie. supervised (non home) use within Australia.

The TGA is currently reassessing RATS for approval for home usage from November 1st.

Presumably many of the 60+ previously approved products would be in the queue for TGA reassessment to allow addition to the November 1st list. As a consequence, I suspect Eugeni approval might take a bit longer than anticipated.

In addition to the three Hangzhou RATS already given the go ahead for Nov 1st on Wednesday, the TGA has today added two more to the list.

https://www.tga.gov.au/covid-19-rapid-antigen-self-tests-are-approved-australia

Of most interest to me are the sensitivity and specificity data of the newly approved tests, as a guide to what the TGA will require going forward.

For the 2 new additions the following data is from the explanatory notes accompanying each test.

1. Hangzhou RightSign


2. SD Biosensor


Clearly Anteotechs 97.3% sensitivity and 99.6% specificity continue to stack up exceptionally well.

Hopefully just a matter of time now.

Usual bias.
Herro