Mount Sinai’s Blood Test to Detect Antibodies to COVID-19 Receives FDA EUA

Apr 22, 2020 | Coronavirus, COVID-19, Diagnostic, FDA, FDA Emergency Use Authorization, Mount Sinai, Testing

Mount Sinai’s Blood Test to Detect Antibodies to COVID-19 Receives FDA EUA

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Mount Sinai Laboratory (MSL), Center for Clinical Laboratories for an antibody test that was developed, validated, and launched at Mount Sinai by a team of internationally renowned researchers and clinicians of the Icahn School of Medicine at Mount Sinai. This test detects the presence or absence of antibodies to SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) and importantly, may also be used to identify positive specimens with an antibody tier (level) up to a dilution of 1:2880 for the identification of individuals with higher antibody titers.

The Research toward the Test

The research team, led by Florian Krammer, PhD, Professor of Microbiology at the Icahn School of Medicine at Mount Sinai, began working on the serologic test in January, 2020 before COVID-19 had been seen in the United States. 

The research team used animal cells to produce compies of the telltale “spike” protein that is present on the surface of SARS-CoV-2. That protein is highly immunogenic, meaning that people’s immune cells see it and start making antibodies that can lock onto it. The test involves exposing a sample of blood to bits of the spoke protein. If the test “lights up,” it means that person has the antibodies. Similar to the most commonly used tests for other viruses, such as hepatitis B, this test shows whether a person’s immune system has come into contact with SARS-CoV-2.

Dennis S. Charney, MD, Anne and Joel Ehrenkranz Dean of the Icahn School of Medicine at Mount Sinai, and President for Academic Affairs of the Mount Sinai Health System, noted, “This important regulatory authorization reflects the success of a truly translational medical effort by our basic scientists, pathologists, and clinicians who have risen to the occasion and combined their unparalleled expertise in a way that will help the community at large as we fight this terrible disease.”

Superior Test

Dr. Krammer reports that the test could be more responsive than others noting, “Our test can pick up from the body’s response to infection, in some cases as early as three days post-symptom onset, and is highly specific and sensitive.” He continued “We have shared the toolkit needed to set the test with more than 200 research laboratories worldwide to help mitigate this global crisis.

Erik Lium, PhD, Executive Vice President and Chief Commercial Innovation Officer of the Mount Sinai Health System. He noted, “We continue to broadly partner this technology with industry, recognizing the need to scale serologic testing effectively.”

Technology Transfer & Validation

One the research test was developed in Dr. Krammer’s microbiology lab, Mount Sinai’s pathology and laboratory medicine experts were able to quickly transfer the technology to the Mount Sinai Hospital’s Clinical Laboratories, which are certified by the Clinical Laboratory Improvement Amendments and accredited by the College of American Pathologists, signifying that the laboratory meets or exceeds industry standards for clinical laboratory testing. The test was then validated in this highly regulated laboratory environment under the guidance of Carlos Cordon-Cardo, MD, PhD, Irene Heinz Given and John LaPorte Given Professor and Chair of Pathology, Molecular and Cell-Based Medicine.

Mount Sinai Hospital one of the First

Mount Sinai make other news recently as under the leadership of David L. Reich, https://www.mountsinai.org/about/hospital-presidents/david-l-reich MD, President of the Mount Sinai Hospital, and Judith A. Aberg, MD, Chief of the Division of Infectious Diseases and Immunology in the Department of Medicine, the Mount Sinai Hospital became among the very first in the nation to initiate a convalescent plasma program this on Saturday, March 28.

Lead Research/Investigator

Florian Krammer, PhD, Professor of Microbiology at the Icahn School of Medicine at Mount Sinai

Source: Mount Sinai

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