Molecular model of antibodies that are part of the body’s immune response.
Since the start of the pandemic in 2019, COVID-19 has claimed over 7 million lives worldwide, making it the deadliest infectious disease of our generation. When the pandemic began, testing for active infections was not widely available. Thus, it was impossible to know how many people had been infected.
NIAID provided support for one of the first serologic tests for COVID-19, a two-step Enzyme-Linked ImmunoSorbent Assay (ELISA) which was developed by researchers at the Icahn School of Medicine at Mount Sinai. Serologic tests can determine if someone was previously infected by testing for the presence of antibodies in a blood serum sample using an antigen, which is the part of the virus to which the antibody binds. In the case of SARS-CoV-2, the antigen is the spike protein. The Mount Sinai ELISA is highly specific and sensitive, making it an ideal research and public health tool.
Using this tool, Mount Sinai researchers were able to understand when local COVID-19 outbreaks started and how widespread they became. The test has also been used to study how long neutralizing antibodies to SARS-CoV-2 persist after infection, and to provide population-level data on how many people might have some immunity. More recent studies have used the test to characterize people’s antibody responses to vaccination, and to assess whether vaccine-induced immunity can protect against emerging variants. The protocol for the ELISA was shared openly with over 200 labs worldwide so that they can use the test in their own research.
The Mount Sinai ELISA received FDA Emergency Use Authorization in April 2020. It has since been developed as the commercial product ‘COVID-SeroKlir’ by the spin-out company Kantaro Biosciences, a joint venture between Mount Sinai and RenalytixAI.