[voidmain]

Some clarification based on what I've been able to put together (caveat: I'm not an expert in this area)

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-...

[garmaine]

What you say is correct, but is conflating a separate issue.

You are correct that FDA approval is required for a clinical test, and for that a CDC test kit must be used (even though the biochemistry involved is trivial and a grad student with access to the right tools could put together their own kit...)

An entirely separate issue is that the CDC has used its emergency powers to restrict usage of these kits--you cannot use the kit to test a patient unless the CDC gives the OK for doing so. Even though for a long time many of these kits were not being used to available capacity...

[voidmain]

My understanding was that prior to Friday, CDC Atlanta's comically limited RT-PCR capacity was backlogged even under the "see-no-evil" testing criteria, and that approximately no other labs were able to do tests (since validation of the CDC issued tests failed). If there was also unused lab capacity that is good to know, do you have a source?