FDA Authorizes 1st Antibody Test That Looks for Past Coronavirus Infections

Berlin Doctor Offers Covid-19 Testing

The U.S. Food and Drug Administration authorized a new type of blood test that would look for coronavirus antibodies in the blood, the agency announced this week. Known as a serology test, the kit is manufactured by a company called Cellex Inc. and requires blood collected from a person's vein with the test conducted in a certified lab.

While the FDA has previously warned against doctors using antibody tests to diagnose someone with COVID-19, the Emergency Use Authorization by the agency is an endorsement of using the new blood test outweighing the risks.

In a letter sent to the company authorizing it to begin selling the tests, the FDA said that based on the totality of scientific evidence available, "it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product."

Because COVID-19 is a respiratory illness, the simplest way for doctors to check if you have it is by swabbing inside a person's nose. But the FDA said in its letter that the initial antibodies against coronavirus are "generally detectable in blood several days after initial infection."

The agency did caution that antibody levels over the course of an infection are "not well characterized."

The U.S. Centers for Disease Control and Prevention is also working on its own serology test that would look for antibodies in people who experience mild, or no symptoms.

Photo: Getty Images


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