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b_b  ·  1427 days ago  ·  link  ·    ·  parent  ·  post: I'm helping with disease investigation in this pandemic. AMA!

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.