New York State Department of Health Grants Emergency Use Authorization to Mount Sinai for Quantitative COVID-19 Antibody Test
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 is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report's "Honor Roll" of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians in the top 1% of all physicians nationally by U.S. News & World Report.