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

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.

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.