The ASSURE-100 Rapid COVID-19 Test has been authorized by the U.S. FDA under an emergency use authorization for use by CLIA and CLIA waived laboratories in Point of Care settings. The ASSURE-100 Rapid COVID-19 Test is for use by authorized laboratories for the detection of proteins from 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 authorization is terminated or revoked sooner. The ASSURE-100 Rapid COVID-19 Test has not been FDA approved.