A trial? we'd be dumb to do that just for the TGA. we respond in January, there's no time for one.
The manufacturers of these kinds of tests have provided the TGA with study data to validate the performance of the kits, including in-silico analysis, recombinant protein studies, live virus studies, and inactivated virus studies against the Alpha, Beta, Gamma, Delta, Delta Plus, Kappa, Epsilon, Eta, Iota, Zeta, Theta and Lambda variants.
https://www.tga.gov.au/post-market-review-antigen-and-rapid-antigen-tests
Ann: TGA Registration Update, page-1675
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