3 ms·
Great link, this is what everyone's looking for. There's quite a bit of data here, definitely over my head, but I think page 24 has details on the specificity
by adanto6840 6y ago
Great link, this is what everyone's looking for. There's quite a bit of data here, definitely over my head, but I think page 24 has details on the specificity and sensitivity via results of the clinical study.
Screenshot of just that part: https://imgur.com/a/G5JVS2V https://imgur.com/a/G5JVS2V
Edit: From the EUA itself (linked by someone else above), I find these conditions on their marketing to be hilarious:
"No descriptive printed matter, advertising, or promotional materials, relating to the use of your product may represent or suggest that this test is safe or effective for the detection of SARS-CoV-2."
Which is then immediately followed by (emphasis added):
"Z. All descriptive printed matter, advertising, and promotional materials, relating to the use
of your product shall clearly and conspicuously state that:
· This home test kit has not been FDA cleared or approved;
· This home test kit has been authorized by FDA under an EUA;
· This home test kit has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and ..."
Which is it -- authorized for the safe & effective detection of SARS-Cov-2, or authorized for sale but NOT safe and/or effective? Also, the EUA requires them to build a "results reporting website/portal" within 4-months.
Idk, it sure seems like a non-zero amount of subjective bureaucracy to me.
- cameldrv 6y agoYes, it's authorized for sale under an EUA, but it's not been proven safe and effective according to the normal 510k process. "Safe and Effective" is essentially a legal term that means it's passed this process.