Diazyme Laboratories, Inc. Receives Reissued EUA for Semi-Quantitative SARS-CoV-2 IgG Test
SAN DIEGO, CA – (March 23, 2021)
Diazyme announces that it has received a reissued Emergency Use Authorization (EUA) for its Semi-Quantitative DZ-Lite SARS-CoV-2 IgG CLIA test which is run on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer. The FDA has already granted Diazyme an EUA for its qualitative DZ-Lite SARS-CoV-2 IgG CLIA test (July, 2020). Upon reviewing additional data, the FDA has authorized the Diazyme IgG assay to be used as a semi-quantitative test.
“Diazyme was one of the first companies to develop high quality COVID-19 serology (antibody) tests during the on-going COVID-19 public health emergency. The fully automated Diazyme DZ-Lite SARS-CoV-2 IgG test uses both S and N proteins of SARS-CoV-2 virus to detect SARS-CoV-2 IgG antibodies. The new semi-quantitative read-out adds additional meaning to the IgG test results for healthcare providers and recipients. We continue to value scientists who have independently performed studies with the Diazyme assay and have published their results in peer-reviewed journals", said Dr. Chong Yuan, Managing Director of Diazyme Laboratories.
Diazyme Laboratories, Inc., a Life Science Affiliate of General Atomics, is located in Poway, California. Diazyme uses its proprietary enzyme and immunoassay technologies to develop diagnostic test 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
- Raymond T. Suhandynata et al. Multi-Platform Comparison of SARS-CoV-2 Serology Assays for the Detection of COVID-19, JALM 05:06 1324-1336 (11.2020)
- Raymond T Suhandynata et al. Longitudinal Monitoring of SARS-CoV-2 IgM and IgG Seropositivity to Detect COVID-19, J Appl Lab Med. 2020 Sep 1; 5(5):908-920
- This test has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for detecting IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
- The emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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