NEW YORK — Diazyme Laboratories said on Tuesday that it has received the CE-IVD mark for its SARS-CoV-2 neutralizing antibody test.
According to Diazyme, the high-throughput chemiluminescent immunoassay is designed to measure the subset of neutralizing antibodies that block the interaction between the receptor binding domain of the SARS-CoV-2 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 Managing Director Chong Yuan said in a statement.
Diazyme said it intends to pursue US Food and Drug Administration Emergency Use Authorization for the test.
Last year, Poway, California-based Diazyme received separate EUAs from the FDA for its Diazyme DZ-Lite SARS-CoV-2 IgM and Diazyme DZ-Lite SARS-CoV-2 IgG antibody tests.