The U.S. Food and Drug Administration issued an emergency use authorization or EUA for the COVID-19 Self-Collected Antibody Test System developed by Symbiotica, Inc.
It is the first antibody test authorized for use with home collected dried blood spot samples. The collected samples will be sent to a Symbiotica laboratory for analysis.
A COVID-19 antibody test, also known as a serology test, is a blood test that can detect if a person has antibodies to SARS-CoV-2, the virus that causes COVID-19. The test helps identify people who may have had a prior infection or who may have recovered from COVID-19.
However, the antibody tests cannot detect the presence of the SARS-CoV-2 virus to diagnose COVID-19.
Symbiotica’s COVID-19 Self-Collected Antibody Test System is authorized 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 5 years of age and older.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said, “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.”
Many antibody tests are currently in development stage or available for use to detect antibodies to SARS-CoV-2.
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