FDA authorizes first COVID-19 point-of-care antibody test

September 24, 2020

The device is available by prescription only

The U.S. Food and Drug Administration (FDA) authorized an emergency use authorization (EUA) for the first point-of-care (POC) antibody test for COVID-19. Labs first authorized the Assure COVID-19 IgG/IgM Rapid Test Device in July 2020 to identify individuals with SARS-CoV-2 antibodies or indication of prior COVID-19 infection.

Today, the EUA was reissued and authorized for POC use using fingerstick blood samples. This approval allows doctor’s offices, hospitals, urgent care centers, and emergency rooms to test fingerstick blood samples directly, rather than sending samples to a 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,” said FDA Commissioner Stephen M. Hahn, MD, in a statement. “Until today, serology test samples were generally only able to be evaluated in a central lab, which can be time consuming and use additional resources to transport samples and run the test. As more and more point-of-care serology tests are authorized, they will help conserve those resources and may help reduce processing time for other types of COVID-19 tests, as less time is spent on serology tests.”

Since the start of the pandemic, some 50 serology tests have been granted EUA clearance. Unlike POC COVID-19 diagnostic tests, the Assure test is authorized for use with venous whole blood, serum, plasma, and fingerstick whole blood. It is a lateral flow immunoassay, or a diagnostic device used to confirm the presence of antibodies, in this case.

The FDA issued a statement reminding patients that the length of time COVID-19 antibodies persist following infection is currently unknown, so positive results obtained from a serology test should not be interpreted as immunity from the virus or a diagnosis of an active viral infection.

Similarly, the FDA cautions against lifestyle changes, like discontinuing wearing masks, returning to work, or ignoring social distancing regulations as a result of a serology test. False results are possible.

The Assure COVID-19 IgG/IgM Rapid Test Device is available by prescription only.

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