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Diazyme Receives FDA Emergency Use Authorization for New COVID-19 Antibody Test

By LabMedica International staff writers
Posted on 13 Jul 2020
Diazyme Laboratories, Inc. More...
(San Diego, CA, USA) has received FDA Emergency Use Authorization (EUA) letter for the Diazyme DZ-Lite SARS-CoV-2 IgG CLIA test.

The Diazyme IgG test is an indirect chemiluminescence immunoassay and specifically detects the presence/absence of COVID-19-specific IgG antibodies in the blood of a patient. The test is run on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer and is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Using the fully automated chemiluminescence analyzer, the blood sample of a patient goes through a series of treatments with various reagents to generate a light signal that is proportional to the concentration of SARS-CoV-2 IgG antibodies.

"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," said Dr. Chong Yuan, Managing Director of Diazyme Laboratories. "The fully automated Diazyme DZ-Lite SARS-CoV-2 IgG test exceeds sensitivity and specificity requirements for laboratory run serology tests. 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."




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