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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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.
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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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I’m hoping for an ELISA assay soon. Like the rapid flu and strep tests widely available at point of care
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They exist but aren’t yet approved.
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