Features & Benefits:

• • This test has not been FDA cleared or approved;
• • This test has been authorized by FDA under an EUA for use by authorized laboratories;
• • This test has been authorized only for the detection of proteins from SARS-CoV-2, and not for any other viruses or pathogens; and
• • 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 the virus that causes COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
• • The Sofia 2 SARS Antigen FIA is a lateral flow immunofluorescentassay used with the Sofia 2 instrument intended for the qualitative detection of the nucleocapsidprotein antigen from SARS-CoV-2in nasopharyngeal (NP) and nasal (NS) swab specimens directly or after the swabs have been added to viral transport media from individuals who are suspected of COVID-19 by their healthcare provider.
• • The test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
• • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests.
• • The United States (U.S.) FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA for this test is in effect for the duration of the COVID-19 emergency, unless terminated or revoked (after which the test may no longer be used). An FDA approved or cleared IVD should be used instead of an IVD under EUA, when applicable and available.