https://hotair.com/archives/john-s-2/2020/04/20/heres-didnt-coronavirus-testing-february/Here’s Why We Didn’t Have Coronavirus Testing In FebruaryJOHN SEXTONPosted at 1:01 pm on April 20, 202
Like a lot of partisan claims, there is some truth to this one. ... February could have been a moment to ramp up testing in order to see more clearly how quickly the virus was spreading and it’s true it didn’t happen. Over the weekend the Washington Post published a deep dive on the problems at the Centers for Disease Control which cost the U.S. about a month of progress. Effort by the CDC to create a coronavirus test began in mid-January after China published the genetic sequence of the virus:
The test kits featured two components that focused on separate regions of the virus’s genome, a standard approach. However, the CDC also outfitted the kits with a third component, a pan-coronavirus segment. That addition sought to identify a wider family of coronaviruses, of which covid-19 is the most recent strain to be observed in humans. ...
The addition of the third test segment might not have mattered except that it wound up creating a significant problem. The CDC decided to manufacture the test kids “in house†rather than rely on outside labs. And during that process, the reagents used in the third segment of the test became contaminated. ... when the CDC sent out the initial batch of test kits, nearly all of them gave false positives on the third segment. ...
...
... In theory, the labs could have continued to use the test without that problematic third segment but that would require special permission from the FDA. Until that was granted, the labs had to use the test as designed. ...
At the public health labs, officials struggled to figure out what was wrong. Some labs determined that the test would work without the third component. But under the CDC’s emergency instructions, health officials had to use the test as it had been designed.
On February 23, a top FDA official named Timothy Stenzel finally went to the CDC lab in Atlanta to sort out what was going on.
... The shortcomings with the test kits were attributable to what the FDA described as a “manufacturing issue.’’
Stenzel advised CDC officials to stop making the kits in-house…
The FDA on Feb. 26 informed the CDC by email that the labs could begin testing samples while skipping the third component.
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... While all of this was happening, competent outside labs were stalled in creating their own alternative tests because once the U.S. declared a public health emergency, which it did in late January, the FDA had to approve any outside tests. Anyone who wanted to create their own test would face reams of FDA paperwork to secure an “emergency use authorization,†something many hospital labs didn’t begin to know how to get:
My emphasis. The WashPost article this blogpost draws from is probably behind the WashPost's paywall. This seems a pretty even-handed summary of at least some key points. My summary of the summary:
* The CDC went not-invented-here and decided to produce kits in-house. The people who set up the manufacturing line screwed up;
* Once the defective kits were "out there", bureaucratic red tape, CYA, and bureaucratic red tape hobbled recovery;
* Regs had to be suspended - red tape cut - to get the testing ball rolling again.
Going a step past the conclusion in the final paragraph, Trump's "the buck stops here" was not to take the blame for what some "scientist" in Atlanta screwed up, but to enable/oversee recovery from that "scientist"'s error. That he did.
