Ann: TGA Registration Update, page-411

Because it's required by other jurisdictions where we have distributor agreements to get our foot in the door.

In general, false-positives are a very low risk for RATs which is probably why they didn't even display that data.

False-positives aren't a big problem. PCR can rule those out. In the case of saliva sampling, perhaps foreign substances can cause this. Nasal sampling won't be affected by stuff that you put into your mouth.

From looking at IFUs, it seems that you need to test a minimum of 100 people and the TGA lets you in. we've had multiple clinical trials already. we don't need X amount of positives for the reader specifically. The idea is not for ADO to store personal data anyhow. That'd be done by authorities or practices.