November 10, 2020

FDA issues EUA for first test to detect neutralizing antibodies after COVID-19

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA) on November 6 issued an emergency use authorization (EUA) for the first serology test (GenScript USA Inc) to identify patients with neutralizing antibodies after a COVID-19 infection.

Neutralizing antibodies have reduced the infection of cells in the laboratory, but their effects in humans are still being studied.

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The FDA has previously issued EUAs for antibody serology tests, but those detect the presence of binding antibodies, which do not necessarily decrease the infection and destruction of cells.


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