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

Diazyme Laboratories, Inc. (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."