FDA has issued an emergency use authorization (EUA) for the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection. These are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells.
The cPass SARS-CoV-2 Neutralization Antibody Detection Kit from GenScript Biotech, Piscataway, NJ,specifically detects this type of antibody. Although the FDA has previously issued EUAs to more than 50 antibody tests, those tests only detect the presence of binding antibodies. Binding antibodies bind to a pathogen, such as a virus, but do not necessarily decrease the infection and destruction of cells. It’s important to note that the effect of neutralizing antibodies for SARS-CoV-2 in humans is still being researched.
“The ability to detect neutralizing antibodies can help us gain additional insight into what the existence of antibodies may mean for patients as we continue the fight against covid-19,” says Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but today’s authorization gives us another tool to evaluate those antibodies as we continue to research and study this virus. Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus.”
The FDA cautions patients against using the results from this test, or any serology test, as an indication that they can stop taking steps to protect themselves and others, such as stopping social distancing, discontinuing wearing masks, or returning to work. The FDA also wants to remind patients that serology tests should not be used to diagnose an active infection, as they only detect antibodies that the immune system develops in response to the virus, not the virus itself.
Read more on the development of cPass from CLP.
For more information, visit GenScript Biotech.