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Diazyme Gets Emergency Use Authorization for Second Coronavirus Antibody Test

NEW YORK — Diazyme Laboratories said on Tuesday that it has received Emergency Use Authorization from the US Food and Drug Administration for its Diazyme DZ-Lite SARS-CoV-2 IgM test.

The test is designed to detect immunoglobulin M antibodies against SARS-CoV-2 in human serum or plasma and runs on the Poway, California-based company's fully automated DZ-Lite 3000 Plus chemiluminescence analyzer.

The test "is highly sensitive and specific and does not cross-react when tested with an extensive list of interferents, including no cross reactivity to the common HKU1, OC43, NL63, 229E coronavirus strains," Diazyme Managing Director Chong Yuan said in a statement.

He added that the test can be used in conjunction with Diazyme's DZ-Lite SARS-CoV-2 IgG antibody test, which tests for immunoglobulin G antibodies and received EUA from the FDA last month, for a more complete serology profile.