FDA Authorizes Emergency Use of Dr. Florian Krammer’s COVID-19 Antibody Test

Last week, the FDA issued their authorization for emergency use of a SARS-CoV-2 antibody test developed by Dr. Florian Krammer’s microbiology lab for in vitro diagnosis of COVID-19 cases. Dr. Krammer, an investigator at CEIRS Center for Research on Influenza Pathogenesis (CRIP), started developing the test in January 2020. The ELISA test detects the presence of SARS-CoV-2 IgG antibodies using an altered, more stable version of the SARS-CoV-2 spike protein and the receptor-binding domain of the spike protein. The highly specific and sensitive test can determine if a person has been infected with and recovered from SARS-CoV-2 infection. It could also be used in the future to identify persons with high antibody titers who may have developed immunity to the virus.

The test was validated by the Mount Sinai Hospital’s Clinical Laboratories. The FDA’s emergency use authorization allows the serological test to be distributed to and used by authorized laboratories to diagnose COVID-19 cases. Widespread use of this test could help to answer questions regarding potential immunity to COVID-19.

A detailed description of Dr. Krammer’s SARS-CoV-2 antibody test has been published in Current Protocols in Microbiology.