Antigen Test*

• Low limit of SARS-CoV-2 detection
• 100% Specificity; 89.5% Sensitivity
• Qualified using nasal swabs

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IgG Antibody Test**

• Detects both S1 and nucleocapsid
• Quantifiable results with antibody level compared to cut-off value
• Qualified using serum, plasma and whole blood samples

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*This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and the emergency use of this product 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.
**These statements reflect the data submitted to the FDA under the EUA process. The Qorvo Biotechnologies IgG Antibody Test has not been reviewed by the FDA and is not available for sale. An application for Emergency Use Authorization (EUA) of this test has been submitted to the FDA and is pending. The application is for use of the test in CLIA laboratories certified to perform moderate- and high-complexity testing.