The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for an 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. The test is now authorized for POC use using fingerstick blood samples. The Assure test is a lateral flow assay and is authorized for use with venous whole blood, serum, plasma and fingerstick whole blood.
The FDA notes that it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Patients should not interpret results from an antibody test as any level of immunity from the virus. The FDA also reminds the public 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.
Food and Drug Administration (FDA). Coronavirus (COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19 [news release]. September 23, 2020. Available at: click here. Accessed September 24, 2020.