The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System (Symbiotica, Inc), the first antibody test authorized for use with home collected dried blood spot samples.
The Symbiotica COVID-19 Self-Collected Antibody Test System is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The EUA allows for fingerstick dried blood samples to be self-collected at home by an individual 18 years of age and older or collected by an adult from an individual 5 years of age and older. The collected samples are then sent to a Symbiotica, Inc laboratory for analysis. The test is available only by prescription.
“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, MD, JD, director of the FDA’s Center for Devices and Radiological Health.
The Agency cautioned that the Symbiotica COVID-19 Self-Collected Antibody Test System should not be used to diagnose or exclude acute SARS-CoV-2 infection. It is unknown at this time if the presence of antibodies confers immunity and how long antibodies persist after an infection.
Coronavirus (COVID-19) update: FDA issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System. [press release]. Silver Spring, MD: US Food and Drug Administration; April 6, 2021.