FDA clears Mount Sinai’s COVID-19 antibody test

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The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to Mount Sinai Laboratory in New York City for a blood test that detects the presence of antibodies to the virus that causes COVID-19.

The test can detect response to infection as early as three days after the onset of symptoms, the Mount Sinai Health System said in a statement. It may also be used to identify positive specimens with an antibody titer level up to a dilution of 1:2880 for the identification of individuals with higher antibody titers.

Researchers at the Icahn School of Medicine at Mount Sinai used animal cells to produce copies of the spike protein that is present on the surface of SARS-CoV-2. The test involves exposing a sample of blood to the spike protein. If the test lights up, it means that person is positive for the antibodies.

A toolkit enabling test setup has been shared with more than 200 research laboratories globally, the health system said.

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