FDA clears Symbiotica COVID-19 self-collected antibody test system for use

The United States Food and Drug Administration today announced that it has issued an Emergency Use Authorization (EUA) for the Symbiotica COVID-19 Self-Adhesive Antibody Test System, the world’s first antibody test approved for use with dried blood samples collected at home. Samples collected at home are then sent to a Symbiotica, Inc. laboratory for analysis.

Authorization of the first, at-home, prescription antibody test will play an important role in helping healthcare professionals identify people who have developed an adaptive immune response from recent or previous COVID-19 infection . The FDA will continue to allow COVID-19 testing that will give more Americans access to greater flexibility and testing options.

Jeff Shuren, MD, JD, Director, FDA Center for Devices and Radiological Health

The COVID-19 Self-Collected Antibody Test System is cleared for prescription use with a finger-dried blood sample that is self-collected by a person 18 years of age or older or collected by an adult from a person ages 5 and over. The test is intended to help identify individuals with an adaptive immune response to SARS-CoV-2, indicating recent or previous infection. The COVID-19 Self-Collected Antibody Test System should not be used to diagnose or rule out acute SARS-CoV-2 infection. At present, it is not known how long antibodies persist after infection and whether the presence of antibodies confers protective immunity.

Antibody tests, also called serologic tests, detect antibodies in the blood when the body responds to a specific infection, such as with SARS-CoV-2. COVID-19 antibody tests can help identify people who may have previously had an infection or who have recovered from COVID-19. However, these tests cannot detect the presence of the SARS-CoV-2 virus to diagnose COVID-19.


US Food and Drug Administration