The "lab in good standing" thing is something I'd like to understand better. Can you explain more what that means, or who is using it as a tool to guide funding/business to their favorite/campaign donor's labs?
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.
As someone who bids on government contracts for a living, I can see through this opaque maze like it was made of glass. What a shitshow. Example from my biz: Our product is primarily web-based, and lives in the cloud. At first, that was in our own managed data center. But recently we have moved to the Google Cloud Platform. People are naturally security-conscious, so they ask of we are "SOC2 Certified", which is a security standard that covers key physical and electronic security best-practices. (Like required password strength, and servers are in locked cages with restricted access.) Google is SOC2 certified. But for BOTH of us to get SOC2 certification, Google and my company would have to launch a joint effort for about 6 months, to go through every detail of our installations and everywhere our systems touch, write up all the documentation, submit it, and receive our certification in 2-3 months. So around 9 months of work, if everything goes well. And we would have to re-do that exercise every year, or every time either one of us upgraded or changed any of the systems that had been examined. So we say, "our software runs in SOC2-certified data centers" when people ask if we are "SOC2 certified". Because they have no idea what they are asking for; they just googled "good security standard" and came up with the buzzword "SOC2". So I can TOTALLY see how an "EUA approved lab" is something that is absolutely necessary to have and at the same time, unclearly defined. A low-level functionary was protecting their hide one day and wrote an extra line of text somewhere, and now it's policy.
I'm 100% sure that getting EUA certification has everything to do with having the proper documentation in place and proving to FDA that you do. FDA is a good organization, and I know they're doing their best under very difficult circumstances right now. If they start letting everyone do Covid tests without documentation, they're opening everyone up to lawsuits when John Doe tests negative and he goes out and infects Jane Smith's grandma who then dies. I'm also 100% sure getting EUA cert doesn't mean that your test is necessarily that good, but rather that you have a good handle on its sensitivity and specificity. For what it's worth, if your test isn't CLIA certified, you can't get reimbursed for it, so it's a big deal to hospitals too.
I am so so grateful for everything the FDA is doing these days. It just makes my life harder that I can't accept any test that comes across my desk. But I know those poor bastards are working an insane amount to verify as many tests as they possibly can to alleviate the stresses on the current approved tests.