The Food and Drug Administration issued an emergency use authorization for the first coronavirus antigen test, which could be used to quickly detect cases in hospitals, doctors' offices or even some workplaces.
The test, which involves swabbing the inside of the nose, can produce results in minutes. Its manufacturer, Quidel, already uses antigen technology to market rapid tests for conditions such as strep and flu.
The FDA authorized the new test Friday for use in labs and "patient-care settings," such as hospitals and doctors' offices, but administration officials have suggested they could eventually be used to test people before they go to work or school.
Antigen tests deliver results faster than the majority of tests on the market, which rely on a technology called PCR. But the antigen tests produce more false negatives — prompting the FDA to warn that negative results from antigen tests "do not rule out infection."
The agency said that it expects other antigen tests to hit the market soon. Because they are cheaper and simpler to make than PCR tests, they could eventually be used to test millions of Americans per day, "helping our country better identify infection rates closer to real time," the FDA said.
Health experts say the United States needs to vastly expand its coronavirus testing capacity to safely reopen the country, although some governors have already moved to re-open their states.
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May 10, 2020 at 03:32AM
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FDA authorizes first coronavirus antigen test - POLITICO
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