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Coronavirus (COVID-19) Update: FDA Authorizes First Tests That Estimate a Patient’s Antibodies From Previous SARS-CoV-2 Infection


For immediate release:

Today, the US Food and Drug Administration authorized the first two COVID-19 serological tests that show an estimated amount of antibodies present in the individual’s blood. Siemens’ two tests, ADVIA Centaur COV2G and Attelica COV2G, are what are known as “semi-quantitative” tests, that is, they do not display an accurate measurement, but assess the quantity of a patient’s antibodies produced against infection with the virus that causes COVID-19.

“Being able to measure a patient’s relative antibody level in response to a previous SARS-CoV-2 infection can be helpful as we continue to learn more about the virus and what antibodies exist. can mean, ”said Tim Stenzel, MD, Ph.D., director of the office of in vitro diagnostics and radiologic health at the FDA’s Center for Devices and Radiologic Health. “There are still many unknowns about what the presence of anti-SARS-CoV-2 antibodies can tell us about potential immunity, but current clearances give us additional tools to assess these antibodies as we continue to research. and study this virus. Patients should not interpret the results as indicating that they are immune or have any level of immunity to the virus. “

Because of these unknowns, the FDA is warning patients against using the results of these tests, or any serologic test, as an indication that they can stop taking measures to protect themselves and others, such as stop social distancing, stop wearing masks or go back to work. The FDA also wants to remind patients that serologic tests should not be used to diagnose an active infection because they only detect antibodies that the immune system develops in response to the virus – and not the virus itself.

The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biologicals for human use, and medical devices . The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, products emitting electronic radiation and the regulation of tobacco products.



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