The Diazyme DZ-Lite SARS-CoV-2 IgG CLIA kit is an Emergency Use Authorization (EUA) test authorized by the U.S. FDA for use by authorized laboratories. The test is for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma to aid identifying individuals with an adaptive immune response to SARS-CoV-2, indicating a recent or prior infection.
The DZ-Lite SARS-CoV-2 IgG CLIA kit runs on the fully automated DZ-Lite 3000 Plus Chemiluminescence Analyzer
The assay features:
- Specifically targets IgG antibodies to the N and S viral proteins
- No cross-reactivity to other coronaviruses (229E, HKU1, NL63, OC43), Influenza A and B viruses and an extensive cross-reactivity profile list
- Overall Percent Positive Agreement (PPA) with RT-PCR >7 days post symptom onset: 96.23% for IgG
- Percent Positive Agreement (PPA) with RT-PCR ≥15 days post symptom onset: 100% for IgG
100 tests/kit and is used in conjunction with the fully automated DZ-Lite 3000 Plus Chemiluminescence Analyzer
- For use under an Emergency Use Authorization Only.
- For in vitro Diagnostic Use Only.
- This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests.
- This test has been authorized only for the presence of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests 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 authorization is terminated or revoked sooner.