Diazyme announced the availability of two serological tests for the novel coronavirus (SARS-CoV-2) – the Diazyme DZ-Lite SARS-CoV-2 IgG and the SARS-CoV-2 IgM CLIA test kits.
The Diazyme IgG and IgM tests run on the fully automated Diazyme DZ-Lite 3000 Plus chemiluminescence analyzer.
The Food and Drug Administration (FDA) recently issued a guidance, allowing commercial manufacturers to begin distributing tests for detecting SARS-CoV-2 before those products receive an emergency use authorization (EUA) from the FDA.
“Research has shown that after infection with SARS-CoV-2, viral antigens stimulate the body’s immune system to produce antibodies that can be detected with our IgM and IgG tests. The fully automated serological tests that we provide have high specificity, sensitivity and clinical agreement with samples confirmed with the standard nucleic acid testing method (RT-qPCR)" said Chong Yuan, PhD, managing director of Diazyme Laboratories, a Poway, CA-based life science affiliate of General Atomics.
