Diazyme Laboratories, Inc., a Life Science Affiliate of General Atomics, announces the availability of two serological tests for the novel coronavirus (SARS-CoV-2), namely the Diazyme DZ-Lite SARS-CoV-2 IgG and SARS-CoV-2 IgM CLIA test kits.
The Diazyme IgG and IgM tests are run on the fully automated Diazyme DZ-Lite 3000 Plus chemiluminescence analyzer. The Diazyme serological test notification is now listed on FDA’s EUA website under “FAQs on Diagnostic Testing for SARS-CoV-2”.
“To make the tests available, Diazyme followed the FDA’s Emergency Use Notification process as provided in the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (March 16, 2020). We thank the FDA for its prompt response to our requests and its guidance in making additional tests available to combat the current novel coronavirus outbreak. 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 Dr. Chong Yuan, Managing Director of Diazyme Laboratories.