FDA issues emergency authorization for first antigen test to rapidly detect coronavirus

A health care professional swab tests a patient for coronavirus at drive-through testing outside the Emergency Room entrance at Beth Israel Deaconess Hospital in Milton, MA on March 30, 2020.

Matthew J. Lee | The Boston Globe via Getty Images

The U.S. Food and Drug Administration has issued the first emergency use authorization for a new category of tests to help rapidly detect coronavirus. 

These diagnostic tests quickly detect fragments of proteins known as antigens found on or within the virus by testing samples collected from the nasal cavity using swabs. 

The main advantage of the antigen test is that it can provide results in minutes. However, it can’t detect all active infections, unlike polymerase chain reaction tests which are much more accurate but take longer to show results. 

There is a higher chance of false negatives with an antigen test and a negative result may need to be confirmed with an additional PCR test prior to further treatments. However, positive results from antigen tests are highly accurate. 

The emergency use authorization was issued on May 8 to Quidel Corporation for the Sofia 2 SARS Antigen FIA. The test was certified by the Clinical Laboratory Improvement Amendments. 

Once manufacturers start producing these antigen tests, it can test millions of Americans per day. The antigen tests have a simpler design and can be produced at a lower cost than PCR tests.  

The coronavirus has infected more than 1.2 million in the U.S., and 3.9 million worldwide, according to data compiled by Johns Hopkins University. The virus has killed at least 275, 397 globally and there at least 77,280 fatalities in the U.S. 

Widespread testing is important in assessing the problem and quickly identifying those who may need to be quarantined to reduce the risk of infecting others. 

There have been a total of 8,408,788 coronavirus tests with 1,275,916 positive cases in the U.S. so far, according to the COVID Tracking Project

Leading figures in the tech and corporate world such as Amazon CEO Jeff Bezos and Bill Gates have urged for more widespread testing before safely reopening the economy.  

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