Oh that's a fun one. A facility reported a non-EUA lab and I wanted to be sure so I asked them to send me the actual lab result. The FDA has a site for EUA lookups (below) that I'm not sure how often is updated. Often I hope... But if the lab paperwork itself said something about that EUA approval, I'd have called the lab and asked for the letter of approval as it was not and still is not on FDA's website. That "good standing" was the wording on the result. Looking on FDA's website for that exact wording I can't find it, but there's this page stating "Specifically, last month, as part of our broader strategy, the FDA issued a policy explaining that FDA does not intend to object when developers of serological tests market or use their tests without prior FDA review where: 1) the tests are validated by the developer to determine that they are accurate and reliable, 2) notification of the developer’s validation is provided to FDA, and 3) the tests are labeled appropriately, including that they are not to be used as a sole basis for diagnosis." - Whether or not the specific lab I experienced yesterday had wording stating it should not be the sole basis for diagnosis I do not remember. That is another fun game if the facility is using the positive result even in the person is asymptomatic. Fun times. I'm going to keep looking more for that test's wording on FDA's site. That would be fun.

What does that "validated by the developer" look like? Who the hell knows. I couldn't begin to guess where to find that information, I don't have time at work to look, and I will not spend my days off doing that. Maybe that's available on a website somewhere for the general public to audit, but that would surprise me, because trade secrets or some bullshit.

As to who is using the labs, a lot of people are no doubt. It's something we need to watch for as results are sent in. The extra fun part only the lab or the test kit need to be EUA certified, not both. So in the case of this facility, neither are, but I had a coworker who had test kits that were approved, even while the lab wasn't. We were told to count and upload those. Now most of the time we don't get both the lab and the test kit manufacturer. But when we get a result from one who is not, we try to ask the facility to fax the paperwork to us so we can look into it. That's how my coworker and I ran into that fun lab vs testkit vs EUA game.

Per our health dept physicians, false negatives run 25-30%. Should those have gotten EUA approval? When should that EUA approval be removed because we have better standards? When facility of 300 tests every person, they have 200+ and 100-, they cohort those positives and negatives to try to keep the other 100 healthy and conserve PPE, but 25 or 30 of those negatives are really positive and now it can easily spread through the extra population, what should be done? This is why at some point we say just assume everyone has it. It's why cohorting is recommended for a time, but at some point there's just no point. CDC guidance on cohorting in correctional facilities.

Does the lab you're using have EUA approval? Check FDA's site here.