Ann: Quarterly Update / Appendix 4C, page-164

On the money. MDCG, IMDRF, same thing. An external body is the reason that we aren't being approved. There are new international regulations being put in place as a result of substandard junk being allowed into the market. This is not a part of the standard TGA procedure, but we are being put through it.

0-7 days is essentially the same thing as a Cq range. The TGA wants to know how sensitive the test is based on viral load is the gist of it. The choice of days is stupid in my opinion. That's layman's terms. The figures should be denoted in viral load/ml. This can increase or decrease per variant. So days is the wrong metric to be using. Viral load can adjust for that and can be converted into days. Yet another stuffup by the people in charge.

Not only do we have to break down sensitivities, but we have to deal with stored samples as well.

It's 2 years too late though. This situation should never have been allowed to arise. And the TGA are doing an absolutely horrid job at filtering through applications currently. Other manufacturers of home-tests don't seem to be held to the same standards and appear to be just pushed through regardless of glaring fallacies in their IFUs.

The positive thing here is that we are going to be recognised internationally according to the highest and latest standards when we finally do gain accreditation.

I'm now going to read the rest of the release.