An Emergency Use Authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19 was issued by the U.S. Food and Drug Administration (FDA) on September 23, 2020.
 
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, according to the FDA.
 
The EUA is being reissued to authorize the test for POC use using fingerstick blood samples. With the authorization, fingerstick blood samples can be tested in POC settings like doctor’s offices, hospitals, urgent care centers and emergency rooms instead of a central lab for testing.
 
For more information on the serology (antibody) POC test for COVID19, visit: https://bit.ly/308rVnk.