Skip to main content

Diazyme Receives Emergency Use Authorization for Coronavirus Antibody Test

NEW YORK — Diazyme Laboratories said on Wednesday that it has received Emergency Use Authorization from the US Food and Drug Administration for its Diazyme DZ-Lite SARS-CoV-2 IgG antibody test.

The test runs on the company's fully automated DZ-Lite 3000 Plus chemiluminescence analyzer and is designed to detect immunoglobulin G antibodies against SARS-CoV-2 using the virus' S and N proteins.

"The Diazyme DZ-Lite SARS-CoV-2 IgG test does not cross-react when tested with an extensive cross-reactivity profile list, including no cross reactivity to the common HKU1, OC43, NL63, 229E coronavirus strains," Chong Yuan, managing director of Poway, California-based Diazyme, said in a statement.