Diazyme receives FDA EUA for COVID-19 antibody test

July 10, 2020

Diazyme announced it received an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test, according to a company press release.

The Diazyme IgG test runs on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer.

Diazyme contends that the 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.

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