Called the Assure test, it uses fingerstick blood samples to detect antibodies from the virus. Antibody tests, also called serology tests, can tell people if they’ve previously been infected with the virus but can’t detect an active infection.
The Assure test can be used in physician’s offices, hospitals, urgent care centers and emergency rooms, and it doesn’t need to be sent to a lab. It’s available by prescription only.
“Until today, serology test samples were generally only able to be evaluated in a central lab, which can be time-consuming and use additional resources to transport samples and run the test,” said FDA Commissioner Stephen Hahn, MD.
The FDA also said that the longevity of antibodies after infection is unknown, so people shouldn’t assume that having antibodies gives them any level of immunity to COVID-19.
Read the FDA’s full news release here.
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