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FDA Issues First EUAs for SARS-CoV-2 Serology Tests that Provide Quantitative Information About COVID-19 Antibodies

FDA maze of regulations

First EUAs of their kind make semi-quantitative measurement of SARS-CoV-2 antibodies possible.

The US Food and Drug Administration (FDA) issued two emergency use authorizations (EUAs) for COVID-19 serology tests that provide quantitative analysis of antibodies present in an individual’s blood. Both tests are semi-quantitative tests that do not provide a precise measurement of the quantity of antibodies but will provide an estimate of antibody concentrations. 

Both of the EUAs were announced by the FDA July 31, 2020, and were issued to Siemens. The EUAs are for theirADVIA Centaur COV2G and Atellica IM COV2G tests and open the opportunity for better understanding of immune response to COVID-19 and the duration of antibodies that could confer immunity for COVID-19.

“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 Timothy Stenzel, MD, PhD, Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, as part of the FDA’s announcement. 

“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,” Stenzel said. “Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus.”

Regulatory Resource:

FDA Press Release: FDA Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection