Diazyme Laboratories, Poway, Calif, has released two serological tests for the novel coronavirus SARS-CoV-2: 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 web page of ‘FAQs on Diagnostic Testing for SARS-CoV-2,’ under the heading of ‘What serology tests are being offered under the policy outlined in section IV.D of the policy for diagnostic tests for coronavirus disease-2019?’
“We thank FDA for its prompt response to our requests and its guidance in making additional tests available to combat the current novel coronavirus outbreak,” says Chong Yuan, PhD, managing director of Diazyme Laboratories. “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.”
For more information, visit Diazyme Laboratories.