First COVID-19 Antibody Test Receives FDA EUA for Use with Home Collected Dried Blood Spot Samples

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the first antibody test for use with home collected dried blood spot samples.

Symbiotica, Inc. (Vacaville, CA, USA) has received FDA EUA for its COVID-19 Self-Collected Antibody Test System for prescription use with a fingerstick dried blood sample that is self-collected by an individual age 18 years or older or collected by an adult from an individual five years of age and older. Samples collected at home are then sent to a Symbiotica laboratory for analysis.

The test is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The COVID-19 Self-Collected Antibody Test System is not meant to be used to diagnose or exclude acute SARS-CoV-2 infection.

“The authorization of the first prescription use, home collection antibody test will play an important role in helping health care professionals identify individuals who have developed an adaptive immune response from a recent or prior COVID-19 infection,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.”

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