FDA Authorizes First Point-of-Care Antibody Test For COVID-19

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Azure Biotech Inc. for the Assure COVID-19 IgG/IgM Rapid Test Device. This is the first serology (antibody) point-of-care (POC) test for coronavirus disease 2019 (COVID-19) using fingerstick blood samples. This authorization means that fingerstick blood samples can now be tested in POC settings such as outpatient physician offices, hospitals, urgent care centers, and emergency rooms rather than having to be sent to a central lab for testing.

The Assure COVID-19 IgG/IgM Rapid Test Device is currently the only . . .