Fingerstick Coronavirus Test Now Authorized

The U.S. FDA issued an emergency use authorization (EUA) on September 23, 2020, for the first serology point-of-care (POC) test for COVID-19. The Assure COVID-19 IgG/IgM Rapid Test Device was authorized in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection.

Today, that EUA is being reissued to authorize the test for POC use using fingerstick blood samples.

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