14th July 2020 Product update: Diazyme
Fully-Automated COVID-19 Serology Test Gets FDA Green Light
Diazyme announces receiving FDA Emergency Use Authorization (EUA) letter for the Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test. The Diazyme IgG 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. The fully automated Diazyme DZ-Lite SARS-CoV-2 IgG test exceeds sensitivity and specificity requirements for laboratory run serology test”, said Dr. Chong Yuan, Managing Director of Diazyme Laboratories.
“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” he concluded.
Date Published: 14th July 2020
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