March 26, 2021—Diazyme Laboratories received FDA emergency use authorization for its Semi-Quantitative DZ-Lite SARS-CoV-2 IgG CLIA test, which runs on the DZ-Lite 3000 Plus chemiluminescence analyzer. The FDA granted Diazyme an EUA for its qualitative DZ-Lite SARS-CoV-2 IgG CLIA test in July and has now authorized the assay to be used as a semiquantitative test.
“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,” Chong Yuan, PhD, managing director, Diazyme Laboratories, said in a press release. “The new semiquantitative readout adds additional meaning to the IgG test results for health care 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.”