Aug. 24, 2020—Diazyme Laboratories announced receiving FDA emergency use authorization for the Diazyme DZ-Lite SARS-CoV-2 IgM CLIA test. The test is highly sensitive and specific and does not cross-react with the HKU1, OC43, NL63, and 229E coronavirus strains.
The IgM test is typically used together with the IgG test for a more complete serology profile, the company says, and it runs on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer.