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FDA Coronavirus (COVID-19) Update: Emergency Use Authorization issued for Symbiotica COVID-19 Self-Collected Antibody Test System

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced it has issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples. Samples collected at home are then sent to a Symbiotica, Inc. laboratory for analysis.

COVID-19 Coronavirus

COVID-19 Coronavirus

“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.

“The FDA will continue to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options,” Shuren stated.

The 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.

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 should not be used to diagnose or exclude acute SARS-CoV-2 infection.

At this time, it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity.

Antibody tests, also known as serology tests, detect antibodies present in the blood when the body is responding to a specific infection, as with SARS-CoV-2. COVID-19 antibody tests can help identify people who may have had a prior infection or who may have recovered from COVID-19 Coronavirus.

However, these tests cannot detect the presence of the SARS-CoV-2 virus to diagnose COVID-19 Coronavirus.

About the U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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