4 ms·
I still don’t understand why the FDA was telling labs not to develop their own tests. After publication of the primers, it’s standard work to create an rtPCR.
by projektfu 6y ago
I still don’t understand why the FDA was telling labs not to develop their own tests. After publication of the primers, it’s standard work to create an rtPCR. And being a lab developed test it should be out of the jurisdiction of the FDA.
- James_Henry 6y agoIf I recall correctly, it is due to the declaration of a state of emergency. Usually only a lab would need certification, but the emergency made it necessary for every test to be certified. Don't quote me on this though, I'll try and find a source.