The FDA has granted emergency use authorization for the first COVID-19 antibody test that allows patients to collect blood at home.
The Symbiotica COVID-19 self-collected antibody test system enables adults to obtain a fingerstick dried blood sample at home from themselves or from a child age 5 or older and send it to a Symbiotica laboratory for analysis, according to the agency. The test is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating a prior infection.
“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, director of the FDA’s Center for Devices and Radiological Health, in a news release. “The FDA will continue to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options.”
Antibody tests cannot detect the presence of the SARS-CoV-2 virus to diagnose COVID-19 and it is not known how long antibodies to the virus last, the agency said.