FDA authorizes first test to detect neutralizing antibodies from prior infection

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FDA authorizes first test to detect neutralizing antibodies from prior infection
tjordan_drupal
Nov 9, 2020

The Food and Drug Administration Friday issued an emergency use authorization for the first serology test to identify individuals with neutralizing antibodies from recent or prior infection with the virus that causes COVID-19. Neutralizing antibodies have reduced the infection of cells in a laboratory setting, but researchers are still studying their effect in humans. FDA previously has issued EUAs for serology tests that detect binding antibodies, which do not necessarily reduce cell infection.

“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,” said Tim Stenzel, M.D., director of the FDA’s Office of In Vitro Diagnostics and Radiological Health. “Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus.”

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FDA authorizes first test to detect neutralizing antibodies from prior infection
tjordan_drupal
Nov 9, 2020

The Food and Drug Administration Friday issued an emergency use authorization for the first serology test to identify individuals with neutralizing antibodies from recent or prior infection with the virus that causes COVID-19. Neutralizing antibodies have reduced the infection of cells in a laboratory setting, but researchers are still studying their effect in humans. FDA previously has issued EUAs for serology tests that detect binding antibodies, which do not necessarily reduce cell infection.

“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,” said Tim Stenzel, M.D., director of the FDA’s Office of In Vitro Diagnostics and Radiological Health. “Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus.”

Novel Coronavirus (COVID-19)
COVID-19: CDC, FDA and CMS Guidance

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