On Sept. 23, 2020, the FDA 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 Jul. 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection.

That EUA has been 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ﾒs offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing.