• Press Release

New York State Department of Health Grants Emergency Use Authorization to Mount Sinai for Quantitative COVID-19 Antibody Test

  • New York, NY
  • (September 17, 2020)

The Clinical Laboratories of The Mount Sinai Hospital has received emergency use authorization from the New York State Department of Health (NYSDOH) for quantitative use of Mount Sinai’s COVID-19 antibody test, making Mount Sinai’s lab the first in the country to run an authorized, fully quantitative antibody test that can deliver a precise numeric measurement of the level of antibodies in a patient’s blood. The value of an accurate, precise, and reliable antibody test that measures the level of antibodies an individual has cannot be underestimated. Such a test is urgently needed to help determine public health strategies and to accelerate both the development and evaluation of therapeutic treatments and vaccines.

“The Mount Sinai antibody test has been used on more than 68,000 patients, representing a highly diverse population due to the nature of our Health System, and gives us great confidence in the reliability and clinical relevance of the test,” said Carlos Cordon-Cardo, MD, PhD, Irene Heinz Given and John LaPorte Given Professor and Chair of the Lillian and Henry M. Stratton-Hans Popper Department of Pathology, Molecular and Cell-Based Medicine at the Icahn School of Medicine at Mount Sinai. “We have also used this testing with our essential workers to give insights into past infection rates and what levels of antibodies in people may ultimately be protective.”

In April 2020, the Mount Sinai antibody test was one of the first to receive emergency use authorization for qualitative use (detection of the presence or absence of antibodies) from both the U.S. Food and Drug Administration and the NYSDOH. The Mount Sinai antibody test detects the presence or absence of antibodies to SARS-CoV-2, the virus that causes COVID-19, in addition to measuring the titer (level) of antibodies a person has produced. It utilizes not one, but two virus antigens: the full-length spike protein and its receptor-binding domain (RBD), which is correlated with antibody neutralization, as described in a recent paper published in Nature Medicine. The test was used recently in a study by researchers at the Icahn School of Medicine at Mount Sinai that found most people with COVID-19 mount a robust antibody response that is stable for at least three months.

Created by a team of internationally renowned scientists and clinicians at the Icahn School of Medicine at Mount Sinai, the Mount Sinai antibody test is a serological enzyme-linked immunosorbent assay (ELISA) that was designed to measure the presence or absence of SARS-CoV-2 antibodies, in addition to measuring the titer (level) of antibodies a person has produced.

“One of the most important points is that what we measure in this assay correlates very well with virus neutralization. So, we can indirectly—and very easily—measure how well one person's serum can block and ultimately kill the virus without having to work with any infectious virus. That's amazing and allows us to measure thousands of samples per day,” said Florian Krammer, PhD, Mount Sinai Professor of Vaccinology at the Icahn School of Medicine at Mount Sinai, who led the team that developed the antibody test.

"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,” said Ania Wajnberg, MD, Director of the Antibody Donor Identification Program at Mount Sinai. “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."

About the Mount Sinai Health System

The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai advances medicine and health through unrivaled education and translational research and discovery to deliver care that is the safest, highest-quality, most accessible and equitable, and the best value of any health system in the nation. The Health System includes approximately 7,300 primary and specialty care physicians; 13 joint-venture ambulatory surgery centers; more than 415 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. The Mount Sinai Hospital is ranked on U.S. News & World Report's "Honor Roll" of the top 20 U.S. hospitals and is top in the nation by specialty: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. Mount Sinai Kravis Children's Hospital is ranked in U.S. News & World Report’s “Best Children’s Hospitals” among the country’s best in four out of 10 pediatric specialties. The Icahn School of Medicine is one of three medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report's "Best Medical Schools," aligned with a U.S. News & World Report "Honor Roll" Hospital, and No. 14 in the nation for National Institutes of Health funding. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

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