Diazyme has received a reissued emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Semi-Quantitative DZ-Lite SARS-CoV-2 IgG CLIA test, which runs on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer, according to a company news release.
The FDA had already granted Diazyme an EUA for its qualitative DZ-Lite SARS-CoV-2 IgG CLIA test in July 2020. Upon reviewing additional data, the FDA has authorized the Diazyme IgG assay to be used as a semi-quantitative 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. The new semi-quantitative read-out adds additional meaning to the IgG test results for healthcare providers and recipients,” said Chong Yuan, PhD, Managing Director of Diazyme Laboratories.
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