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by garmaine
2304 days ago
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The CDC doesn't run the tests. The hospitals and independent labs do. There has been some issues with the test kits distributed by the CDC, but since the virus genome has been sequenced you don't actually need a test kit (it's just a faster process if you have one). However the CDC has enacted emergency powers to make it illegal for hospitals to use their own testing equipment, which they have in-house, to test their own patients unless they first get CDC approval. And the CDC has ridiculously stringent requirements for approving these tests. As a result, the only confirmed case of community-spread COVID-19 in the US is in Northern California, because the UC Davis hospital basically said "go fuck yourself" to the CDC and tested anyway. This is not because COVID-19 is not spreading throughout the community--it is!--but rather because the CDC's stringent testing requirements prevent testing of any case that cannot be rationalized away as having been caught elsewhere. If you don't test for the virus, then you don't confirm the presence of the virus, so there is no virus, amirite? |
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The CDC developed a testing protocol (crudely, a set of 3 conserved RNA sequences of the virus to chemically "grep" for). The protocol is here [1] and I think anyone with suitable equipment (an RT-PCR machine and an oligonucleotide synthesizer to make the primers and probes?) could run tests using just the information on that web page, though they would probably also want known positive samples of the virus to validate against. And there are lots of labs with suitable equipment. But as that page says, it is not legal to do this clinically.
The CDC also sent out test kits [2]. These are just vials of primer/probe pairs synthesized from the short sequences on the above page, and a fake positive control to validate with. These were authorized by the FDA, and so are legal to use. But apparently somehow they screwed up the production of primer #3 (or maybe the sequence itself is wrong), and so almost all the labs were not able to validate the test. After several weeks the CDC has still not fixed this problem, but labs are now allowed to run tests using just primer 1 and 2, so testing capacity is rapidly increasing (though of course who knows how sensitive or specific the tests are).
The federal organization preventing labs from running tests is the FDA [3], not the CDC. It is also the FDA who would have to approve the commercially produced test kits.
[1] https://www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-panel-p... [2] https://www.fda.gov/media/134922/download [3] https://www.fda.gov/emergency-preparedness-and-response/mcm-...