COVID-19 Antibody Test Information and Resources

Thank you for your interest in Mount Sinai’s serologic test, a blood test which determines the presence of anti-COVID-19 antibodies. As of the last week of April, the Mount Sinai Laboratory (MSL) has completed many thousands of tests. We’ve made the underlying technology available to companies and are pursuing the development of testing kits for use by commercial laboratories. Please stay tuned for updates on these developments in the coming weeks.

We have received a large number of inquiries and have endeavored to address the most Frequently Asked Questions (FAQs) below.

Can you describe the test?

The COVID-19 ELISA IgG Antibody Test consists of two serial direct Enzyme-Linked Immunosorbent Assays (ELISA) for the qualitative detection of human IgG antibodies in serum and plasma specimens collected from individuals suspected of prior infection with the virus that causes COVID-19. The Mount Sinai Antibody Test received FDA emergency use authorization (EUA) for qualitative use on April 15, 2020 and the New York State Department of Health (NYSDOH) announced EUA for quantitative use on September 17, 2020, 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.

Learn more by reading the press release.

How can I get tested?

Currently, this test is only available at Mount Sinai for individuals volunteering to donate convalescent plasma, and for healthcare workers and first responders. If you are interested in donating plasma, please complete the pre-screening questionnaire. For information about availability of this test in the future, outside of Mount Sinai, please check this site for updates.

I am an academic, non-profit laboratory, how can I replicate the assay in my laboratory?

To request the assay for replication in your laboratory, please visit the Mount Sinai Innovation Partners website.

The protocol for this assay is available via medRxiv.

If you need additional information, please review the FDA Emergency Use Authorization (EUA).

Can I send samples to Mount Sinai for testing?

Currently, we’re unable to accept samples coming from outside our system. The information provided here relates to the Mount Sinai COVID-19 serology assay that received FDA emergency use authorization (EUA) on April 15, 2020, as well as EUA from the New York State Department of Health (NYSDOH) for quantitative use on September 17, 2020, for use in The Mount Sinai Hospital laboratory subject to the requirements of the EUA issued to Mount Sinai. If you are interested in information about the COVID-19 test kit currently under development by Kantaro Biosciences Inc., please visit Kantaro’s website at www.kantarobio.com.

I am a distributor, how can my company distribute this assay commercially?

The information provided here relates to the Mount Sinai COVID-19 serology assay that received FDA emergency use authorization (EUA) on April 15, 2020, as well as EUA from the New York State Department of Health (NYSDOH) for quantitative use on September 17, 2020, for use in The Mount Sinai Hospital laboratory subject to the requirements of the EUA issued to Mount Sinai. If you are interested in information about the COVID-19 test kit currently under development by Kantaro Biosciences Inc., please visit Kantaro’s website at www.kantarobio.com.