We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
Abbott Diagnostics

Download Mobile App





FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection

By LabMedica International staff writers
Posted on 09 Nov 2020
Print article
Image: cPass SARS-CoV-2 Neutralization Antibody Detection Kit (Photo courtesy of GenScript USA Inc.)
Image: cPass SARS-CoV-2 Neutralization Antibody Detection Kit (Photo courtesy of GenScript USA Inc.)
The US Food and Drug Administration has authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection.

The FDA has issued an emergency use authorization (EUA) to GenScript USA Inc. (Piscataway, NJ, USA) for its cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which specifically detects antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells. Although the FDA has previously issued EUAs to more than 50 antibody (serology) tests, those tests only detect the presence of binding antibodies. Binding antibodies bind to a pathogen, such as a virus, but do not necessarily decrease the infection and destruction of cells. It is important to note that the effect of neutralizing antibodies for SARS-CoV-2 in humans it is still being researched.

“The ability to detect neutralizing antibodies can help us gain additional insight into what the existence of antibodies may mean for patients as we continue the fight against COVID-19,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but today’s authorization gives us another tool to evaluate those antibodies as we continue to research and study this virus. Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus.”

Related Links:
GenScript USA Inc.


Print article

Channels

Molecular Diagnostics

view channel
Image: Schematic representation of Chiari malformation type 1; it involves the lower part of the cerebellum known as tonsils, but not the brain stem (Photo courtesy of Healthline).

Common Brain Malformation Traced to Its Genetic Roots

About one in 100 children has a common brain disorder called Chiari 1 malformation, but most of the time such children grow up normally and no one suspects a problem. However about one in 10 of those children,... Read more

Industry

view channel
Image: uPath HER2 Dual ISH image analysis for breast cancer (Photo courtesy of Roche)

Roche Launches Digital Pathology Image Analysis Algorithms for Precision Patient Diagnosis in Breast Cancer

Roche (Basel, Switzerland) has announced the CE-IVD launch of its automated digital pathology algorithms, uPath HER2 (4B5) image analysis and uPath Dual ISH image analysis for breast cancer to help determine... Read more
Copyright © 2000-2021 Globetech Media. All rights reserved.