The competition, page-329

It'd be way too time consuming to collate all the data from the doherty reports. There are issues such as inconsistencies across batches for AtomoRapid, or insufficient kits to test Wantai SARS-CoV-2 Ab Rapid Test kit properly.

But going by available data, Wantai scored 84.2% sensitivity / 98.0% specificity. The IFU (instructions) said 94.70% / 98.89%. So a full 10% difference. They didn't pull it from market, they instructed them to change the IFU.

So going by that, you'd have to be REALLY far off your stated sensitivity to get a fail. 9 failed. 8 chinese, 1 Korean.

That looks pretty lax to me. If a 10% difference can't get you removed from the market of require further validation at least, then that is pathetic.

I wonder what'll happen to all the substandard RATs.