FDA Authorized First Point-of-Care Antibody Test for COVID-19

fda.gov September 25, 2020

U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19. The Assure COVID-19 IgG/IgM Rapid Test Device was first authorized for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection.

EUA was being reissued to authorize the test for POC use using fingerstick blood samples.

This authorization means that fingerstick blood samples can now be tested in POC settings like doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing.

Authorizing point-of-care serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19.

That serology tests should not be used to diagnose an active infection, as they only detect antibodies the immune system develops in response to the virus, not the virus itself.