New Test to Detect COVID Antibodies Gets Green Light

FDA approves first test to detect neutralizing antibodies from COVID-19

(RxWiki News) The US Food and Drug Administration (FDA) approved a new test that can detect neutralizing antibodies from a past SARS-CoV-2 infection. It's the first test of its kind.

The FDA has granted more than 50 antibody (serology) tests an emergency use authorization (EUA). This newly approved test, called cPass SARS-CoV-2 Neutralization Antibody Detection Kit, was one of them. But this test is different.

This test can detect neutralizing antibodies, which are antibodies that bind to a certain part of a pathogen that has been shown to lower the SARS-CoV-2 viral infection of cells, according to the FDA.

An antibody test can't be used to diagnose an active COVID-19 infection. Antibody tests can't detect the virus but instead detect antibodies that the immune system developed in response to the virus.

More research is still needed to determine the effect of neutralizing antibodies for SARS-CoV-2 in humans, the FDA noted.

“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 Dr. Tim Stenzel, director of the FDA's Office of In Vitro Diagnostics and Radiological Health, in a press release. "Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus."

Even after getting results from this or any other serology test that shows the presence of antibodies, consumers should not stop taking measures to protect themselves and their families from COVID-19, the FDA said. Protective measures include wearing masks, social distancing and frequent hand-washing, among other measures.

The EUA for cPass SARS-CoV-2 Neutralization Antibody Detection Kit was issued to GenScript USA Inc.

Speak with your health care provider if you have any questions.

Last Updated:
November 13, 2020