After loosening restrictions on antibody tests, the US FDA has decided government scientists will review data on lab tests that claim they can detect if someone has antibodies to Covid-19, according to the CEO of a lab association who spoke with officials
After loosening restrictions on antibody tests, the US Food and Drug Administration has decided government scientists will review data on lab tests that claim they can detect if someone has antibodies to Covid-19, according to the CEO of a lab association who was on a call with FDA officials Tuesday morning.
On March 16, the FDA loosened its standards and allowed companies to sell antibody tests without submitting any evidence that they worked. That led to"crappy" tests flooding the market, according to Scott Becker, CEO of the Association of Public Health Laboratories. 'Crappy' tests to check for past coronavirus infection are flooding the US, lab association says Dr.
"The floodgates were opened and now the consequences of that are becoming apparent," he said."Now they're putting in some flood control measures to verify accuracy. It would have been ideal if these measures were in place in the first place, but this is a good step given where we are in this pandemic." The FDA did not respond to questions for this story, referring CNN to the NCI. Minali Nigam contributed to this story.
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