July 10, 2020—Diazyme Laboratories received FDA emergency use authorization for the Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test.
“The fully automated Diazyme DZ-Lite SARS-CoV-2 IgG test exceeds sensitivity and specificity requirements for laboratory run serology tests,” Chong Yuan, PhD, managing director of Diazyme Laboratories, said in a press statement. “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. The assay uses both S and N proteins of SARS-CoV-2 virus to detect SARS-CoV-2 IgG. We are pleased that the Diazyme serology tests currently deployed meet real-world expectations from health care professionals.”
The Diazyme IgG test runs on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer.