[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?