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FDA Issues First EUA for COVID-19 Antibody Test Using Self-Collected Blood Samples

NEW YORK — The US Food and Drug Administration on Monday granted Emergency Use Authorization for Symbiotica's COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples.

The prescription-only test is designed to detect immunoglobulin G against SARS-CoV-2 in dried blood spots obtained via fingerstick. Samples may be self-collected by individuals aged 18 years and older or by adults from children as young as five years. Blood samples are obtained using lancets included in the kit and are mailed for analysis to Vacaville, California-based Symbiotica.

"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," Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. "The FDA will continue to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options."