Description
The Diazyme DZ-Lite SARS-CoV-2 IgG CLIA kit 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 test runs on the fully automated DZ-Lite 3000 Plus Chemiluminescence Analyzer and is an Emergency Use Authorization (EUA) test authorized by the US FDA for use by authorized laboratories.
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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
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