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We had been making due with Lab Developed Tests (LDTs). They work fine but they're only allowed to be used at the lab that developed them and we're going to ne
by Symmetry 7y ago
We had been making due with Lab Developed Tests (LDTs). They work fine but they're only allowed to be used at the lab that developed them and we're going to need tests that can be run at hospitals.
The CDC can legally issue emergency tests that can be distributed the way we need to. But for these to be used the FDA had to issue an Emergency Use Authorization (EUA). And that couldn't happen until the Health and Human Services Department (HHS) declared this was an emergency. All of which happened.
But When the HHS declared an emergency the situation is legally considered to important for LDTs to be used, which would normally be fine. But the original CDC tests had a reagent that was incorrectly manufactured. That's being fixed but last I heard the working testing kits hadn't been distributed yet.
This is sort of a huge problem because testing for a particular viral RNA sequence isn't especially hard and it should be within the capability of even a large hospital to develop their own tests, though there is a chance they'd mess up the way the CDC did. Our whole bureaucratic structure in the US isn't set up to deal with a new disease emerging quickly and we really need to fix this.
- tanilama 7y agoThanks for the information. The slated bureaucracy is eye-opening.