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Mount Sinai Coronavirus Antibody Test Gets NYSDOH Emergency Use Authorization for Quantitative Use

NEW YORK — Mount Sinai said on Thursday that it has received Emergency Use Authorization from the New York State Department of Health (NYSDOH) for the quantitative use of its SARS-CoV-2 antibody test.

The test, which received EUA from the US Food and Drug Administration and the NYSDOH for qualitative use in April, is designed to detect human IgG antibodies in serum and plasma. With the EUA from the NYSDOH, Mount Sinai said its clinical lab is the first in the US to run an authorized, fully quantitative antibody test that can deliver a precise numeric measurement of the level of SARS-CoV-2 antibodies in a patient's blood.

Mount Sinai said that being able to measure antibody levels in individual patients will help determine public health strategies and to accelerate both the development and evaluation of therapeutic treatments and vaccines.

"Our quantitative assay is being used to determine whether an individual has been exposed to SARS-CoV-2, to check their quantitative titers and eligibility for plasma donation, and to understand their antibody titers both in the initial response to SARS-CoV-2 and over time," Ania Wajnberg, director of the Antibody Donor Identification Program at Mount Sinai, said in a statement. "Eventually, this will help us link each individual's response to the immune correlate for COVID-19, which is a huge step forward in our fight against this virus."