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What do you mean by "no scalable diagnostic capability"? There are of several tests on the market already, as well as several protocols for in-house PCRs. I agree that rapid tests would be valuable and a welcome addition. But real-time PCR is easily scalable technology.
It's not the tests themselves that pose a problem it's the fact that the capacity to perform them isn't in place. Here's a good overall background - there are many others:https://nymag.com/intelligencer/2020/02/why-has-the-us-cdc-done-so-little-coronavirus-testing.html …
There’s always been more than ample “capacity” in place, the issue was the narrowness in what was previously approved. That’s why this announcement is actually quite important: it addressed the most rate limiting issue in the US.
Yup, agreed - and yes, this announcement is very important to help resolve the issue. However, we are two months into the epidemic and making these decisions now is being very late to the game - plus what's described in the announcement still needs to be developed and implemented
This strikes me as extremely odd and if course poses a problem it true "The novel coronavirus has been declared a public-health emergency, which means that other tests from commercial and academic labs can’t be used without Food and Drug Administration approval."
Why can't a clinical laboratory use an in-house test or ROU labelled commercial test, with appropriate controls?
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