Diazyme Laboratories, Inc. Announces Availability of COVID-19 Antibody Tests
SAN DIEGO, CA – (March 23, 2020)
Diazyme 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.
Diazyme Laboratories, Inc. is located in Poway, California. Diazyme uses its proprietary enzyme and immunoassay technologies to develop diagnostic reagents run on automated chemistry analyzers and chemiluminescence instruments in user-friendly formats. Diazyme is a cGMP and ISO 13485 certified medical device manufacturer. Information regarding Diazyme's technology and products can be found on its website at www.diazyme.com
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- For Rx use only.
- This test has not been reviewed by the FDA. For use in clinical laboratories by health care professionals following FDA guidance “Policy for Diagnostic Tests for Coronavirus Disease-2019 (COVID-19) during the Public Health Emergency”.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic assay should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
- Not for the screening of donated blood.