In their private communications, scientists at academic, hospital and public health labs expressed alarm at the Trump administration’s failure to move quickly and at bureaucratic demands that delayed testing.
in the United States. At the time, Azar was the leader of the White House’s newly created coronavirus task force.
But once Azar announced a public health emergency, tests created in such laboratories had to receive an “emergency use authorization,” or EUA, from the FDA. The additional regulation is intended to ensure the efficacy of tests in public health crises in which inaccurate results could be damaging. Alex Greninger, an assistant director of the University of Washington’s clinical virology lab, said his efforts to develop a test for coronavirus were stalled by an FDA regulation.
The test kits contain compact collections of chemicals known as reagents. The chemicals help isolate viral genetic material and then amplify it so that it can be detected by probes that also came with the kit. New York State lab officials also passed on the news, according to documents and interviews. “There is a technical problem in one of the reagents which invalidates the assay and will not allow us to perform the assay,” the lab director of New York State’s Wadsworth Center, Jill Taylor, wrote to state health officials in an email that same night.Word that some labs were having problems with the test quickly made its way back to the CDC.
Scott Becker, chief executive of the Association for Public Health Laboratories, raised concerns to the CDC about issues with its test. The United States was clearly falling behind in the fight against covid-19. Other countries such as Singapore and Taiwan were ramping up testing quickly. In, 1,000 people were being tested each day by mid-February, a number that would increase more than tenfold by the end of the month.
The FDA’s confidence in the flawed test was based in part on assurances from the CDC that it could be fixed easily, according to officials familiar with the agency’s deliberations. “It’s unlike anything we’ve ever done before,” said Matt Binnicker, a director of clinical virology at Mayo.
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