Diazyme has received a reissued emergency use authorization (EUA) for its Semi-Quantitative DZ-Lite SARS-CoV-2 IgG CLIA test which is run on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer. The FDA has already granted Diazyme an EUA for its qualitative DZ-Lite SARS-CoV-2 IgG CLIA test (July 2020). Upon reviewing additional data, the FDA has authorized the Diazyme IgG assay to be used as a semi-quantitative test.
“Diazyme was one of the first companies to develop high-quality covid-19 serology (antibody) tests during the ongoing covid-19 public health emergency. The fully automated Diazyme DZ- Lite SARS-CoV-2 IgG test uses both S and N proteins of SARS-CoV-2 virus to detect SARS- CoV-2 IgG antibodies,” says Chong Yuan, PhD, managing director of Diazyme Laboratories. “The new semi-quantitative read-out adds additional meaning to the IgG test results for healthcare providers and recipients. We continue to value scientists who have independently performed studies with the Diazyme assay and have published their results in peer-reviewed journals.”
For more information, visit Diazyme.
Featured image: Diazyme’s Semi-Quantitative DZ-Lite SARS-CoV-2 IgG CLIA test is run on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer, pictured. (Courtesy: Diazyme)
