All of the reagents and devices necessary are listed in the link above and commercially available. The test is portable; you don't need a full lab to conduct it, just portable incubators, pipettes, and somewhere to keep reagents clean + cold.
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This protocol assumes you already have extracted RNA from the sample. RNA extraction kits are in short supply: there is only one approved manufacturer (Qiagen) though a second (Roche) has recently been approved.https://www.the-scientist.com/news-opinion/rna-extraction-kits-for-covid-19-tests-are-in-short-supply-in-us-67250 …
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Even to qualify for the FDA's Emergency Use Authorization requires validation of the entire testing workflow. As I understand, it would be illegal (?) to test patients without an EAU.https://www.modernhealthcare.com/technology/labs-face-challenges-creating-diagnosis-testing-covid-19 …
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Sarah Constantin Retweeted Ian Quigley
So while, as Ian tweeted earlier, you don't need an RNA test kit to do an RNA extraction (https://twitter.com/allmeasures/status/1238089400296202243 …) if you gave patients a COVID-19 test based on the "old-fashioned" phenol/chloroform RNA extraction method, that wouldn't be automatically approved.
Sarah Constantin added,
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I'm struggling to figure out what would happen, concretely, to a doctor who tested patients with unapproved tests, or a laboratory that provided them. (Fines? Loss of license? what are the penalties here?)
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Replying to @s_r_constantin
This is exactly what happened to the Washington flu research group who found community spread back in February. FDA cease & desisted them.
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Replying to @St_Rev @s_r_constantin
It shouldn't be a problem any longer, though. The FDA has granted blanket approval to any lab to develop and use their own tests. Any lab that already has the capability to do genetic testing routinely could start testing for CV19 within days. And many have.
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Replying to @random_eddie @St_Rev
Not how that works. The FDA allows you to apply for an emergency use authorization, not to just start testing. The EAU is still, apparently, fairly difficult to obtain, just easier than clinical trials.
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Replying to @s_r_constantin @St_Rev
(not an expert, just read some stuff) I think the FDA allows you to start testing even before applying for an EUA, but you still have to apply for it later, so you still have to meet the requirements for an EUA, including rigorous validation (which is apparently a big obstacle).
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At least, that’s what their published guidance seems to say. What they’re saying to individual labs... ???
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Within 15 days of testing is what I’ve seen.
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