COVID-19 Antibody Test from Mount Sinai Gets an Emergency Use Authorization from the FDA
A new blood test that detects antibodies to coronavirus disease 2019 (COVID-19) has received an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA). The test, developed by Mount Sinai Health System, detects the presence or absence of antibodies to SARS-CoV-2, the virus that causes COVID-19.
With COVID-19 cases seemingly plateauing in several hotspots, officials have been mulling how a controlled relax of stay-at-home orders may eventually lead to a reopening of cities and states. With those discussions largely centering around the issue of earlier and more accurate testing, the antibody blood test developed at Mount Sinai could play a crucial role in minimizing the longer-term impact of the coronavirus pandemic.
"Our test can pick up the body's response to infection, in some cases as early as three days post-symptom onset, and is highly specific and sensitive," says Florian Krammer, PhD, Professor of Microbiology at Mount Sinai's Icahn School of Medicine, who has led the research team behind the serology test since January 2020.