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FDA Issues EUA for First COVID-19 Test That Detects Neutralizing Antibodies

FDA maze of regulations

With over 50 COVID-19 antibody tests authorized for use under FDA EUA, a milestone has been recognized with this announcement

The US Food and Drug Administration (FDA) announced today that it has issued an emergency use authorization (EUA) for the first SARS-CoV-2 antibody (serology) test that detects neutralizing antibodies for the virus. While the FDA has issued EUAs to over 50 antibody tests to date, these previous tests have only detected binding antibodies.

The EUA was issued to GenScript USA Inc. for its cPass SARS-CoV-2 Neutralization Antibody Detection Kit. While the development of a neutralizing antibody test for SARS-CoV-2 represents a significant milestone in antibody testing, the FDA does note that the effect of neutralizing antibodies for SARS-CoV-2 is still under research.

“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,” said 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 reminds the public in this announcement that this test and other antibody tests should not be used to diagnose an active SARS-CoV-2 infection, as they only detect antibodies that the immune system develops in response to the virus, not the virus itself.

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