New COVID Antibody Test: Approved

FDA approves Symbiotica COVID-19 Self-Collected Antibody Test System

(RxWiki News) The US Food and Drug Administration (FDA) has approved the first at-home COVID-19 antibody test to use dried blood spot samples.

Users send samples from this test, called the Symbiotica COVID-19 Self-Collected Antibody Test System, to a lab for analysis.

The FDA approved this test for prescription use in adults or with adult assistance for children older than 5.

“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 Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a press release. “The FDA will continue to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options.”

This test looks for COVID-19 antibodies. Antibodies indicate that the body has been infected with COVID-19 in the past. It is not meant to diagnose COVID-19 or clear someone from having the virus. That's because health officials do not yet know how long it takes the body to develop COVID-19 antibodies or how long those antibodies remain in the blood.

Antibody tests are also called serology tests. These tests identify COVID-19 antibodies in the blood to indicate whether someone has previously had COVID-19. The body produces antibodies when it fights off an infection.

Talk to your health care provider about the available COVID-19 infection tests, vaccines and antibody tests.

The FDA approved the Symbiotica COVID-19 Self-Collected Antibody Test System for Symbiotica, Inc. It did so via an emergency use authorization (EUA). Learn more about EUAs.

Review Date: 
April 11, 2021