Ann: Therapeutic Goods Administration Registration Submitted, page-163

I may have posted along these lines before but I think its worth repeating if I have.

Here is a very recent post on the Medical Device Network site:

India’s Central Drugs Standard Control Organisation has granted emergency use approval to LumiraDx’s SARS-CoV-2 Antigen test. Designed to identify antigen nucleocapsid protein of SARS-CoV-2 virus from a nasal swab sample, the test provides results in less than 12 minutes from sample application. In clinical trials, the test was found to have a 97.6% positive agreement and 96.6% negative agreement in individuals within the initial twelve days of the first onset of symptoms. LumiraDx SARS-CoV-2 Antigen test is already available in the US and Europe.

If I am interpreting this correctly it seems to be typical of what I think may be a trend to quote RATs sensitivity data from trials using using symptomatic patients. This of course would elevate the figures. My understanding is that ADOs generally quoted stats (at least on HC) include presymptomatic as well. Pity to lose a major selling point if true!