LyrArc Article Gist
This important WSJ report shows how the CDC labs failed to come with the test after contamination of a component and failure of the third part of the three part test components. In the absence of a working test from CDC where delays cost three weeks of February the private labs all over the country and state labs could have developed their own test, yet HHS and FDA required approval for these labs to develop their own test and use it.
From Feb. 8 when state and city public health labs detected problems with the CDC test to Feb 29 when solutions were developed including simply excluding the third part of the three component test, and letting labs around the country do their own test, were 3 crucial weeks that let the virus spread out of control.
The CDC, HHHS, and the FDA and their managers and heads of departments bear responsibility for these errors. Week after week the delays continued, instead the two component test which detects if the genetic material in the sample is coronavirus material, could simply have been approved at the outset instead of the approval for this given weeks later. The third component of the test checks if the virus mutated, according to this report. There is no explanation why the labs all over the U.S. were not allowed to go ahead on February 9 itself or within a few days after that to develop their own tests once it was clear the CDC test did not work on that day. CDC officials failed to recognize that there was a possibility that they may not be able to fix the faulty third component of the test and the risks if they gave false reassurances.
There is also no explanation of why a German designed test was not used once the CDC test failed on Feb. 9, which would be a proper way for action considering that this pandemic had already shutdown parts of China by this time.
Alarming also is the mention in this report that on Feb. 22 a FDA official in charge of lab diagnostics flies to Atlanta where the CDC Respiratory Diagnostic lab which developed the test is located. His boss FDA medical device center director is cited from later information as describing the lab as "filthy" meaning the lab had the potential to contaminate, and going so far as saying that if it had been any other lab it would have been shut down.
Considering that investment in public health has deteriorated over the last two decades and that there has been a massive misallocation of capital in the country away from public infrastructure this is appalling. The thought of critical labs for emergency health needs as not being up to high quality standards in the U.S. as a result of two decades of misspending, that this shows, is very disturbing.
This WSJ report is based on interviews with people who know about the testing crisis, and undisclosed emails, correspondence on the issues involved.
Community transmission began in January 2020 in the U.S. These delays were costly in February and could have been prevented either by going with the German design on Feb 10 or asking labs across the U.S. to develop their own test, and letting other labs immediately use the modified 2 component test of CDC that worked instead of doing this action weeks later.
Mardi Gras on Feb 25 and other places where large crowds gathered in sports stadiums could have been stopped had testing gone forward and shown the true extent of the community transmission in these critical weeks.
First China delayed a U.S. team of experts coming into the country for weeks, and then the CDC, FDA, HHS, failed to get testing started, creating a false sense of complacency. Two crucial errors outside and inside the country that caused so much damage to America and the world.
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