February 3, 2026

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FDA approves first U.S. antibody test for COVID-19

April 3, 2020 at 12:06 pm sbracken
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The Food and Drug Administration (FDA) has approved the first test in the U.S. designed to detect coronavirus antibodies.   Cellex, a biotech firm located in Triangle Park, North Caroline,  applied for and got approval to use the test under the current Emergency Use Authorization that allow for use of medications or tests relative to COVID-19 without going through the usual approval process.

The tests being done currently are to detect the presence of COVID-19 in a person who currently has the disease.  The purpose of an antibody test is to determine whether  somebody has already had COVID-19, and has antibodies circulating in their blood which fight the disease.  If successful, widespread use of the blood tests could help inform decisions about people being able to return to work.

Various types of antibody tests  have been used in China and in  selected places  in the U.S., none of which have had FDA review and approval.   However, not enough is known about COVID-19 yet to know whether people really are immune to COVID-19, nor how long immunity might last.

Tags: COVID-19 antibody test
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