Research & Development
The US FDA announces EUA for first prescription use, home collection antibody test, the Symbiotica COVID-19
7 April 2021 -

Public health agency The US Food and Drug Administration on Tuesday issued its emergency use authorization (EUA) for the first antibody test authorized for use with home collected dried blood spot samples, the Symbiotica COVID-19 Self-Collected Antibody Test System.

The agency added that the samples collected at home are then sent to a Symbiotica Inc laboratory for analysis.

According to the agency, 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 five years of age and older.

This test is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. It is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity, said the agency.

COVID-19 antibody tests can help identify people who may have had a prior infection or who may have recovered from COVID-19. However, these tests cannot detect the presence of the SARS-CoV-2 virus to diagnose COVID-19, concluded the agency.

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