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First Coronavirus Antibody Test Approved by FDA

a vile of blood markets coronavirus
(Ban Goland/Dreamstime)

By    |   Thursday, 02 April 2020 04:43 PM

The Food and Drug Administration has approved a method of testing for the coronavirus by looking for antibodies in the blood, making it the first such test to get approval, CNN reports.

Cellex Inc. created the serology test, the technical term for a blood test, which could identify past coronavirus infections but may be less reliable at identifying those currently infected. The test requires blood taken from a vein, and a certified lab to determine the results.

"Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19," the agency said after issuing an Emergency Use Authorization, according to CNN. It adds that "the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product."

The FDA said that antibodies are "generally detectable in blood several days after initial infection," but "levels over the course of infection are not well characterized."

The U.S. Centers for Disease Control and Prevention have also been working on a serology test, but it has not yet been approved. Earlier this week, a company called Bodysphere falsely claimed that the FDA issued an Emergency Use Authorization for its antibody test, but the agency later clarified that this was not true, and the company later acknowledged that they had not received approval.

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The Food and Drug Administration has approved a method of testing for the coronavirus by looking for antibodies in the blood, making it the first such test to get approval, CNN reports.
antibody, blood, test, fda, approval, rna, assay, testing, elisa
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2020-43-02
Thursday, 02 April 2020 04:43 PM
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