The Diazyme DZ-Lite SARS-CoV-2 IgM 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 IgM antibodies to SARS-CoV-2 in human serum and plasma (potassium EDTA, disodium EDTA and lithium heparin) to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
The DZ-Lite SARS-CoV-2 IgM CLIA kit runs on the fully automated DZ-Lite 3000 Plus Chemiluminescence Analyzer
The assay features:
- Specifically targets IgM antibodies to the N and S viral proteins
- No cross-reactivity to other coronaviruses (229E, HKU1, NL63, OC43), Influenza A and B viruses as well as an extensive list of other viruses and bacteria
- Overall Percent Positive Agreement (PPA) with RT-PCR at >15 days post symptom onset: 94.4%
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 IgM 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.