Diazyme Announces Availability of COVID-19 Antibody Tests
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By LabMedica International staff writers Posted on 27 Mar 2020 |
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Diazyme Laboratories, Inc. (San Diego, CA, USA) has announced 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.
Diazyme uses its proprietary enzyme and immunoassay technologies to develop diagnostic reagents run on automated chemistry analyzers and chemiluminescence instruments in user-friendly formats.
“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.
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Diazyme Laboratories, Inc.
Diazyme uses its proprietary enzyme and immunoassay technologies to develop diagnostic reagents run on automated chemistry analyzers and chemiluminescence instruments in user-friendly formats.
“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.
Related Links:
Diazyme Laboratories, Inc.
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