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Regulatory Focus™ > News Articles > 2020 > 8 > FDA authorizes first two semi-quantitative COVID-19 serology tests

FDA authorizes first two semi-quantitative COVID-19 serology tests

Posted 03 August 2020 | By Kari Oakes 

FDA authorizes first two semi-quantitative COVID-19 serology tests

The US Food and Drug Administration has authorized the first two serology tests that report semi-quantitative data about past infection with SARS-CoV-2, the virus that causes COVID-19 infection.
 
“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 Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, in announcing the emergency use authorizations (EUAs) on 31 July.
 
The two tests are both manufactured by Siemens. The ADVIA Centaur COV2G and the Atellica IM COV2G utilize SARS-CoV-2 recombinant antigens, which bind to a patient’s IgG antibody against SARS-CoV-2 during the testing process. Higher antibody levels in the patient’s serum results in higher Relative Light Unit (RLU) readings, a standard for the luminescence measurements used in this type of test. Siemens has used similar technology in previous serology tests, including a test for the hepatitis B virus antigen that garnered a 2011 FDA nod.
 
Both tests have unknown sensitivity to SARS-CoV-2 IgG antibody soon after COVID-19 infection, and are not meant to diagnose infection with the novel coronavirus.
 
“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,” said Stenzel, who also reminded the public that “Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus.”
 
FDA
 

Tags: coronavirus, FDA, US

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