Mayo Clinic has launched a new SARS-CoV-2 neutralizing antibody test in support of the national Expanded Access Program for Convalescent Plasma and other critical research efforts to establish effective therapies and vaccines for COVID-19. The test will be available through Mayo Clinic Laboratories to select labs, blood banks, and biopharma clients in late June.
The new test measures the level of neutralizing antibodies against SARS-CoV-2, the virus that causes COVID-19. Neutralizing antibodies are a subset of antibodies able to independently inactivate viruses, and are associated with protective immunity against re-infection for many infectious pathogens.
The neutralizing antibody test provides semi-quantitative detection of total neutralizing antibodies against the SARS-CoV-2 spike glycoprotein in human serum. The surface of the SARS-CoV-2 virus is coated with the spike glycoprotein, which binds to receptor proteins on the surface of healthy cells, leading to viral entry and infection throughout the body. Following infection, most individuals will develop an immune response to the virus, including the production of neutralizing antibodies against the SARS-CoV-2 spike glycoprotein. These antibodies can prevent future infection by blocking the binding activity of the spike glycoprotein. At this time, it is unknown for how long neutralizing antibodies persist following infection and what level of neutralizing antibodies are necessary to confer protective immunity.
This new test was developed and clinically-validated at Mayo Clinic with support of Vyriad, Inc., Regeneron, and Imanis Life Sciences. This was made possible through a significant COVID-19 innovation initiative of the Mayo Clinic Department of Laboratory Medicine and Pathology and the Mayo Clinic Center for Individualized Medicine.