Diazyme Obtains CE-IVD Marking for Its Semi-Quantitative SARS-CoV-2 Neutralizing Antibody Test

Diazyme Laboratories, Inc. (Poway, CA, USA) has obtained CE-IVD marking for its SARS-CoV-2 neutralizing antibody test, which is a high throughput chemiluminescent immunoassay with excellent correlation to a fluorescence based neutralization assay that has been used to evaluate the adaptive immune response in vaccine studies. Diazyme now plans to work with the US FDA for its EUA application.

“Unlike the widely available total SARS-CoV-2 IgG antibody tests, Diazyme’s neutralizing antibody test measures the subset of neutralizing antibodies that block the interaction between the receptor binding domain (RBD) of the viral spike glycoprotein and the human ACE2 cell surface receptor. The Diazyme neutralizing antibody test gives the scientific community and health authorities a valuable tool to evaluate the level of effective antibodies generated after infection or vaccination, and to assess adaptive immunity in studies going forward. Diazyme serology tests meet real world expectations from healthcare professionals and have been independently evaluated in several published studies2-4,” said Dr. Chong Yuan, Managing Director of Diazyme Laboratories, Inc.