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SARS-CoV-2 Antibody Test


• Identify a recent or prior SARS-CoV-2 infection in 11 minutes from sample application


• Authorized for use in CLIA-waived POC settings with fingerstick capillary blood


• 100% sensitivity and specificity in an independent* clinical agreement validation study


LumiraDx SARS-CoV-2 Ab Test has not been FDA cleared or approved but has been authorized for by FDA under an EUA for use by authorized laboratories.The LumiraDx SARS-CoV-2 Ab Test has been authorized for use only for detecting the presence of total antibodies to 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 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. *Frederick National Laboratory for Cancer Research (FNLCR), sponsored by the National Cancer Institute (NCI) , see LumiraDx SARS- CoV-2 Ab Test Product Insert for additional study details.


S-COM-ART-01638 R1 2021-09


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