FDA OKs test that detects neutralizing antibodies from recent, prior SARS-CoV-2 infection
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The FDA approved the first test capable of detecting neutralizing SARS-CoV-2 antibodies from recent or prior infection.
The agency granted an emergency use authorization (EUA) to GenScript USA Inc. for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit.
The FDA has issued EUAs to more than 50 serology tests, but those tests only detect the presence of binding antibodies, which do not necessarily decrease infection or the destruction of cells. The role of neutralizing antibodies in SARS-CoV-2 infection is still being researched, the agency said.
“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,” 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, said in a press release. “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.”
According to the FDA, patients should not use results from any serology test as an excuse to stop mitigation efforts, including social distancing or face mask wearing, and noted that serology tests should not be used to diagnose active infection.
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