Diazyme, Poway, Calif, has received FDA emergency use authorization (EUA) for the Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test. The test is run on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer.
“Diazyme has been at the forefront of the development effort to bring timely, high-quality covid-19 serology (antibody) tests during the public health emergency,” says Chong Yuan, PhD, managing director of Diazyme Laboratories. “The fully automated Diazyme DZ-Lite SARS-CoV-2 IgG test exceeds sensitivity and specificity requirements for laboratory run serology tests. 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 healthcare professionals. We value scientists who have independently performed studies and have published peer-reviewed data.”
For more information, visit Diazyme.