NYSDA Publications

FDA Issues EUA for First COVID-19 Point-Of-Care Antibody Test

The United States Food and Drug Administration (FDA) has issued the first Emergency Use Authorization (EUA) for a point-of-care antibody test for the novel coronavirus (COVID-19).  The FDA notes that this type of serology test should not be used to diagnose an active infection, as it only detects antibodies the immune system develops in response to the virus – not the virus itself.  To read the FDA announcement and summary of the issuance of an EUA for a COVID-19 antibody point-of-care test, use the link below.