Diazyme Laboratories receives second FDA EUA for COVID-19 antibody test

Aug. 19, 2020

Diazyme has received a second FDA Emergency Use Authorization (EUA) letter for the Diazyme DZ-Lite SARS-CoV-2 IgM CLIA test, the company announced. The Diazyme IgM test runs on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer.

"Diazyme continues to serve during the public health emergency with innovative products in COVID-19 serology (antibody) testing. The IgM test is typically used together with the IgG test for a more complete serology profile. The Diazyme DZ-Lite SARS-CoV-2 IgM test is highly sensitive and specific and does not cross-react when tested with an extensive list of interferents, including no cross reactivity to the common HKU1, OC43, NL63, 229E coronavirus strains. Recent independent performance studies in peer-reviewed journals cite excellent results with Diazyme serology tests", said Dr. Chong Yuan, Managing Director of Diazyme Laboratories.

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