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Friday, May 7th, 2021

FDA authorizes first at home blood spot COVID-19 antibody test for emergency use

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The Symbiotica COVID-19 Self-Collected Antibody Test System gained emergency use authorization from the United States Food and Drug Administration (FDA) this week, making it the first antibody test authorized for use with self-collected dried blood spot samples.

The test allows those prescribed it to self-collect a fingerstick dried blood sample. Both adults and children at least five years old can utilize it, though the latter only if adults collect the samples for them. Like all antibody tests, it can help indicate recent or prior infection by SARS-CoV-2 and will 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 Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “The FDA will continue to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options.”

Once collected, samples taken for the at-home test can then be dispatched to a Symbiotica, Inc. lab for analysis.

Antibody tests are incapable of detecting current infection by SARS-CoV-2/COVID-19. They are for determining if one has had it in the past. Even then, scientists are uncertain how long antibodies persist following infection or the extent of protection against infection that antibodies provide.