The test, made by Symbiotica, is prescription-only and can indicate recent or prior infection with COVID-19.
The test, authorized April 5, can be used in people as young as 5 years old as long as an adult is administering it, the FDA said.
“The authorization of the first prescription-use, home collection antibody test will play an important role in helping healthcare professionals identify individuals who have developed an adaptive immune response from a recent or prior COVID-19 infection,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a news release.
The FDA noted that it’s unknown how long antibodies last after infection with the virus or the level of protection the antibodies provide.
Read the full news release here.
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