RE: Most boring share ever15 Aug 2022 08:26
Let’s face it, it’s a terrible update. The EU customer won’t (in my view) materialise and both of the other covid opps are stuck with regulators. Taiwan has added nothing to its EUA list since May, and Vatic are losing staff and been deathly silent. In that last respect, I did note page 4 of the last FDA virtual town hall;
Q: I was curious if the FDA has any recommendations or advice for saliva-based antigen home tests?
A: So we've seen quite a bit of attempts at saliva-based antigen tests. I don't know exactly why it's been such a challenge. You know, there are a lot of advantages if it would work, but it may be that there's a concentration that's needed, such as with a molecular test.
So some of the molecular tests have not worked quite well in saliva, but that may be due to the concentration effect in extraction. So if you want to attempt it, you would just follow the recommendations, if you want, for antigen test validation. The comparator for saliva would be a nasopharyngeal swab using a high sensitivity molecular central lab test.
I would double check with the FDA before using a comparator test to make sure that it's high sensitivity enough. And then thirty positives and thirty negatives if you're going for symptomatic individuals.
We have recommended to others that want to pursue saliva. If this is a new test, we would recommend that you also consider as a backup and anterior nares swab. So that if you should have any issues with saliva, at least you have anterior nares.
https://www.fda.gov/media/160670/download