For immediate release:


Today, the US Food and Drug Administration authorizes the first serological test to detect antibodies that are neutralized by recent or previous SARS-CoV-2 infection, which are binding antibodies. to a specific fraction of the pathogen and has been observed in the laboratory to reduce the SARS-CoV-2 virus infection of the cell. FDA has issued an Emergency Use License (EUA) to the SARS-CoV-2 cPass neutralizing antibody detector, which is used to specifically detect this antibody.

Although the FDA has previously issued the EUA for more than 50 antibody (serological) tests, those tests only detect the presence of binding antibodies. Antibodies bind to pathogens, such as viruses, but do not necessarily reduce infection and destroy cells. It is important to note the effect of the antibody that neutralizes SARS-CoV-2 in humans for which it is still being studied.

“The ability to detect neutralizing antibodies may help us understand more about the significance of the existence of antibodies to patients as we continue our fight against COVID-1

9,” Tim Stenzel, MD. , Ph.D., Director of the Office of In vitro Diagnosis and Radiation Health at FDA’s Center for Radioactive Health and Equipment. “There is still much unknown about the presence of SARS-CoV-2 antibodies that may tell us about potential immunity, but today’s permission gives us another tool to fight against. the prices of those antibodies as we continue to study and learn about this virus. Patients should not interpret the results as telling them they are immune, or have any degree of immunity from the virus.

The FDA warns patients not to use the results from this test, or any serological test, as an indication that they may stop taking steps to protect themselves and others. for example, stopping away from society, stopping wearing a mask or returning to work. The FDA also wants to remind patients that serological tests should not be used to diagnose an active infection, as they only detect antibodies that the immune system develops in response to the virus. must be the virus itself.

The EUA has been granted to GenScript USA Inc. for the SARS-CoV-2 cPass neutralizing antibody detector.

FDA, an agency under the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and security of veterinary and human drugs, vaccines, and products. other biology for human and medical devices. It is also responsible for the safety and security of food supplies, cosmetics, dietary supplements, and products that emit electronic radiation and regulates tobacco products in their respective countries. me.