emergency use authorization approved

FDA Grants Emergency Clearance for Symbiotica’s COVID-19 Antibody Test

April 7, 2021

The FDA has granted Emergency Use Authorization for Symbiotica’s COVID-19 antibody test, its first authorization for a test that uses self-collected dried blood samples.

The antibody test is now cleared for use with blood-spot samples collected by patients at home using a fingerstick and sent to a Symbiotica laboratory for analysis.

The test is meant to help identify patients who have generated an immune response to SARS-CoV-2, which indicates they have previously been infected. It should not be used to diagnose or exclude acute infection, the agency said.

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