WASHINGTON — A home antibody test for Covid-19 received an emergency use authorization (EUA) from the FDA. The Symbiotica Covid-19 Self-Collected Antibody Test System is the first such test to garner FDA approval.
The test, which requires a physician’s prescription, uses a dried blood sample from a fingerstick, which is then sent to Symbiotica for analysis. Individuals 18 years or older can self-administer the test, and an adult is allowed to gather the sample for children age 5 years or older.
“The test is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection,” the FDA noted in a statement. The agency also provided a caveat: “The Covid-19 Self-Collected Antibody Test System should not be used to diagnose or exclude acute SARS-CoV-2 infection. At this time, it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity.”
Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, wrote: “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.”
Candace Hoffmann, Managing Editor, BreakingMED™
Cat ID: 190
Topic ID: 79,190,730,933,190,926,192,927,725,928,925,934