FDA Grants Emergency Use Authorization to First Coronavirus Antigen Test

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Posted: May 09, 2020 1:45 PM
FDA Grants Emergency Use Authorization to First Coronavirus Antigen Test

Source: AP Photo/Andrew Harnik

The Food and Drug Administration (FDA) has issued the first emergency use authorization to a coronavirus antigen test. The Trump administration has been working to quickly expand testing abilities, and the antigen test represents a new category of testing that can rapidly detect infections of the Wuhan coronavirus. 

Public health experts have said widespread testing is paramount to safely reopening the country, and the FDA's emergency use authorization to diagnostic health care manufacturer Quidel's new coronavirus antigen test is part of that effort. 

Antigen tests have the potential to test millions of Americans per day and are cheaper to produce than polymerase chain reaction (PCR) tests. Expanded testing will allow infected individuals to be quickly identified and quarantined to help stop the virus from spreading.

According to CNBC, the new tests can quickly detect protein fragments belonging on or within the virus by testing samples collected through naval cavity swabs. The test results are returned in minutes, and while the new tests can't detect all active infections, the positive test results are highly accurate. Negative test results may require additional PCR tests to confirm the subject is negative for the virus. PCR tests are more accurate but take longer to analyze. 

More than 1.2 million coronavirus cases have been confirmed in the U.S. and more than 75,000 people have reportedly died from the disease, according to data from the Centers for Disease Control and Prevention. 

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