Weekend Read, page-3

BinaxNOW performance in the field
Today, BinaxNOW demonstrates overall performance of 84.6% positive agreement (sensitivity) and 98.5% negative agreement (specificity) in people seven days or less post-symptom onset at all Ct counts. In our studies, it further shows performance of 95.6% positive agreement (sensitivity) in people seven days or less post-symptom onset with Ct counts of 33 or below.

Pretty average performance and they got FDA approval ??.. suggests we will not have any issues getting FDA approval ... don't think ADO will have any issues getting their saliva test to be above these results imvho... so again .. i dont see any roadblocks on the FDA front for our tests..