Diazyme receives EUA for COVID-19 antibody test

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September 2020—Diazyme Laboratories received FDA emergency use authorization for the Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test.

The assay uses S and N proteins of SARS-CoV-2 virus to detect SARS-CoV-2 IgG and does not cross-react when tested with an extensive cross-reactivity profile list, including the HKU1, OC43, NL63, and 229E coronavirus strains. The test runs on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer.