FDA authorizes new type of COVID-19 antibody test

The FDA has authorized a new type of antibody test that detects antibodies that have been shown to decrease the viral infection of COVID-19. 

The agency said Nov. 6 that it granted emergency use authorization to GenScript, a New Jersey-based biotechnology company, for a COVID-19 antibody test that detects what are called neutralizing antibodies. Neutralization makes an infectious particle no longer contagious, according to the FDA. Previously authorized COVID-19 antibody tests detected what is called binding antibodies, which don’t necessarily decrease the infection of cells. 

“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 FDA’s Office of In Vitro Diagnostics 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 emphasized that if the test shows someone has neutralizing antibodies, that doesn’t mean they should stop taking steps to protect themselves and others from COVID-19. It also can’t be used to diagnose active infection. 

Read the FDA’s full news release here

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