For Immediate Release:

Today, the U.S. Food and Drug Administration licensed the first 2 COVID-19 serology tests that display an approximated quantity of antibodies present in the person’s blood. Both tests from Siemens, the ADVIA Centaur COV2G and Attelica COV2G, are what are called “semi-quantitative” tests, indicating that they do not display an accurate measurement, however estimate the amount of a patient’s antibodies produced versus infection with the infection that causes COVID-19

” Being able to measure a patient’s relative level of antibodies in action to a previous SARS-CoV-2 infection might be helpful as we continue to learn more about the infection and what the existence of antibodies may suggest,” stated Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Gadgets and Radiological Health. “There are still many unknowns about what the existence of SARS-CoV-2 antibodies might tell us about prospective resistance, but today’s authorizations give us extra tools to evaluate those antibodies as we continue to research study and research study this virus.

Due to these unknowns, the FDA warns patients against using the results from these tests, or any serology test, as an indicator that they can stop taking actions to safeguard themselves and others, such as stopping social distancing, stopping using masks or returning to work. The FDA likewise wants to advise patients that serology tests must not be utilized to detect an active infection, as they just find antibodies the body immune system develops in response to the infection– not the virus itself.

The FDA, an agency within the U.S. Department of Health and Person Solutions, safeguards the general public health by guaranteeing the security, effectiveness, and security of human and veterinary drugs, vaccines and other biological items for human usage, and medical gadgets. The firm also is responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for controling tobacco products.

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