A renowned team of virologists, pathologists, and clinicians at the Mount Sinai Health System developed, validated, and launched a blood test for COVID-19 antibodies that received the U.S. Food and Drug Administration’s (FDA) emergency use authorization late Wednesday.
The blood test determines whether individuals have antibodies to the SARS-CoV-2 virus that causes COVID-19. It is used for the qualitative detection of human IgG antibodies in serum and plasma that is collected from individuals suspected of having been infected with SARS-CoV-2.
Early development of the assay, led by Florian Krammer, PhD, Professor of Microbiology at the Icahn School of Medicine at Mount Sinai, enabled Mount Sinai to become the first health system in the nation to undertake a convalescent plasma program that transfers the antibody-rich plasma from recovered COVID-19 patients into those who are critically ill.
To date, Mount Sinai has identified more than 1,900 donors who are eligible to provide their antibodies. A total of 141 patients have received the protocol, and the results are being evaluated clinically.
Under the leadership of Peter Palese, PhD, Horace W. Goldsmith Professor and Chair of the Department of Microbiology, Mount Sinai has built one of the world’s leading academic institutions for the study of viruses and emerging pathogens. “The COVID-19 antibody test is not only helpful in identifying individuals who could be donors for the convalescent plasma program but also identifies persons who can safely go back to work now that they are immune to the virus,” Dr. Palese says. This important step would allow the nation to return to economic productivity.
“We are grateful to the FDA for granting this expanded authorization so that we can deploy this vital test to the community at large,” says Carlos Cordon-Cardo, MD, PhD, Irene Heinz Given and John LaPorte Given Professor and Chair of Pathology, Molecular and Cell-Based Medicine. Dr. Cordon-Cardo oversaw the validation of the test that is produced by the Mount Sinai Laboratory, Center for Clinical Laboratories. The Mount Sinai Hospital’s Clinical Laboratories are certified by the Clinical Laboratory Improvement Amendments and accredited by the College of American Pathologists.
According to Dr. Krammer, the antibody test can, in some cases, pick up the body’s response to infection as early as three days post-symptom onset and is highly specific and sensitive. “We have shared the toolkit needed to set up the test with more than 200 research laboratories worldwide to help mitigate this global crisis,” Dr. Krammer says.
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, have led Mount Sinai’s convalescent plasma program. “The exchange of ideas between clinicians and scientists and our intense drive to innovate is the catalyst that led to this achievement,” says Dr. Reich. “Mount Sinai will continue to advance the science and medicine in the fight against COVID-19.”