FDA issues emergency authorization for first coronavirus antigen test
The Food and Drug Administration has given diagnostic health care manufacturer Quidel Corp. emergency-use authorization for its COVID-19 antigen test, the first of its kind.
"The U.S. Food and Drug Administration has issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic," the agency said in a statement Saturday.
"These diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs," it added.
Health experts and lawmakers have said widespread testing is key to safely reopening the country but warn that current testing falls short. The administration has touted its efforts to quickly expand testing in the U.S.
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Experts have recommended that the U.S. do at least 4 million tests every week, The Wall Street Journal noted.
The Journal noted that Quidel has put roughly 36,000 test-analyzer instruments in hospital labs, emergency rooms and doctors' offices across the country.
“We are ramping up manufacturing to go from 200,000 tests next week [week of May 11] to more than a million a week within several weeks,” Douglas Bryant, Quidel’s CEO, told the newspaper.
