Diazyme Secures Second FDA Emergency Use Authorization for COVID-19 Antibody Test

(Poway, CA, USA) has received FDA Emergency Use Authorization (EUA) for the company’s DZ-Lite SARS-CoV-2 IgM CLIA test which runs on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer.

The test is for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum and plasma (potassium EDTA, disodium EDTA and lithium heparin) to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The assay specifically targets IgM antibodies to the N and S viral proteins, and has no cross-reactivity to other coronaviruses (229E, HKU1, NL63, OC43), Influenza A and B viruses as well as an extensive list of other viruses and bacteria. The DZ-Lite SARS-CoV-2 IgM CLIA test has an overall Percent Positive Agreement (PPA) of 94.4%with RT-PCR at >15 days post symptom onset.

"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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Diazyme Laboratories, Inc.