Wednesday, April 08, 2020 1:50:00 PM
"To get [tests] out quickly means you don't have a clinical study," said Dr. Caliendo, who is also the secretary of the Infectious Diseases Society of America. "So the upside is we have the tests. The downside is we don't exactly know how well they're going to perform."
Adm. Giroir echoed that sentiment, noting that the volume of labs rolling out their own tests made it increasingly likely that some won't work.
"'Approved' is not a word we talk about," Giroir told reporters. "There is a test or two that has received emergency use authorization and many, many, many others out there that have not gone that way yet, and I want to take this opportunity to caution."
The FDA on Tuesday warned that some firms are "falsely claiming that their serological tests are FDA approved or authorized."
But will they work?
As for millions of faulty tests already on the market, Giroir said "we're not going to get in that situation."
Scott Becker, the CEO of the Association for Public Health Laboratories, said he has raised the concern of faulty tests with the federal officials – including Giroir. To their credit, Becker said, the FDA, CDC, and National Institutes of Health have responded well and indicated that they plan to roll out a government validation panel to review tests in the coming weeks.
"The last thing we need right now is bad tests on the market," Becker said. "You do not want to provide a bad result. We need to ensure that whatever tests Americans are going to get have a high degree of accuracy.
https://abcnews.go.com/Politics/simple-blood-test-covid-19-antibodies-reopen-economy/story?id=70024837
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