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FDA authorizes two tests that estimate patient's antibodies from past COVID-19 infection

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Posted at 9:58 PM, Jul 31, 2020
and last updated 2020-07-31 21:58:47-04

The U.S. Food and Drug Administration (FDA) authorized the first two COVID-19 serology tests that estimate a patient's antibodies from a previous COVID-19 infection on Friday.

FDA says both tests -- from Siemens, the ADVIA Centaur COV2G and Attelica COV2G -- "display an estimated quantity of antibodies present in the individual’s blood."

“Being able to measure a patient’s relative level of antibodies in response to a previous SARS-CoV-2 infection may be useful as we continue to learn more about the virus and what the existence of antibodies may mean,” said Dr. Tim Stenzel, from FDA, 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 authorizations give us additional tools to evaluate those antibodies as we continue to research and study this virus."

Dr. Stenzel said patients should not interpret results as telling them they are immune from the virus.

FDA is warning patients against using the results from these tests as a sign that they can stop social distancing and put an end to wearing masks. FDA also reminds patients that serology tests should not be used to diagnose an active infection. The agency explained in the press release that these tests only "detect antibodies the immune system develops in response to the virus – not the virus itself."