FDA greenlights point-of-care coronavirus antibody test that uses blood samples

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The Food and Drug Administration (FDA) granted Assure Tech emergency use authorization for a point-of-care test capable of detecting past COVID-19 infections through blood samples.

In July, the Assure COVID-19 IgG/IgM Rapid Test Device was first authorized for emergency use by some labs to identify individuals with antibodies to SARS-CoV-2, indicating a recent or prior infection to COVID-19.

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As of Wednesday, the test is now authorized for point-of-care use using a blood sample from the fingertip. This means it can be tested in settings like “doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing,” the FDA announced.

FDA Commissioner Stephen Hahn said the point-of-care serology tests “will enable more timely and convenient results” for people who want to know if they have previously been infected with the virus.

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Until Wednesday, serology test samples were generally evaluated in a central lab, which Hahn noted can be “time consuming and use additional resources to transport samples and run the test.”

With more point-of-care serology tests authorized, Hahn says health care workers will be able to better conserve those resources. It may also “help reduce processing time for other types of COVID-19 tests, as less time is spent on serology tests,” he added.

Since the onset of the pandemic, nearly 50 serology tests have been granted emergency use authorization.

However, it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity, the FDA says. The agency said patients should not consider themselves “immune, or have any level of immunity, from the virus” based on the results.

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