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FDA Issues First Authorization for Coronavirus Serology Test

Employees in protective clothing carry out tests for the coronavirus at a laboratory in Berlin, Germany, March 26, 2020. (Axel Schmidt/Reuters)

The Food and Drug Administration on Thursday announced it had issued an emergency use authorization for a serology test for Wuhan coronavirus, the first such test approved by the agency.

A serology test analyzes the level of antibodies in a patient’s blood sample, and can be used to detect past coronavirus infections. The approved test is produced by Cellex Inc., and will be performed at certified labs, although it is not clear exactly how widely the test will be available.

The FDA has cautioned that such tests may not be completely accurate because antibodies take time to develop. However, serology tests seem to offer the clearest path toward detecting coronavirus patients who have had asymptomatic cases.

“Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your [Cellex Inc.’s] product may be effective in diagnosing COVID-19,” the agency wrote in its authorization. “The known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product.”

The coronavirus is known to spread through asymptomatic hosts, which is one of the reasons the highly contagious infection has spread throughout large areas undetected.

However, if an asymptomatic host has already had an infection, it is possible that the patient will have immunity to the virus and thus can travel to work.

“It is reasonable to predict we will have some immunity,”  To say you will have lifelong immunity? We just don’t know yet,” Frances Lund, chair of the microbiology department at the University of Alabama at Birmingham, told NBC. “To say you will have lifelong immunity? We just don’t know yet….But I think it’s a reasonable conclusion that you will have immunity for the rest of this season.”

Among other U.S. officials, New York governor Andrew Cuomo has expressed a desire to bring healthy people back to work as hospitals become less overwhelmed with coronavirus patients.

“We’ll restart the economy with a smart public health strategy, because closing the door on everyone was only because we didn’t know better,” Cuomo said on CNN last week. “But now you can come up with a smarter public health strategy that actually protects older people, lets younger people get back to work, and that can start the economic recovery.”

Send a tip to the news team at NR.

Zachary Evans is a news writer for National Review Online. He is a veteran of the Israeli Defense Forces and a trained violist.

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