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

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

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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, known as a covid-19 antigen test, to help rapidly detect coronavirus. 

These diagnostic tests quickly detect fragments of proteins 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. 

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.  

This is breaking news. Please check back for updates.

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