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The events industry faced many challenges due to the COVID-19 pandemic, including canceling, postponing, and transitioning to hybrid events. The return of live events means that we need to continue to be proactive by working toward safeguarding attendee health. Integrating safety measures throughout the planning process can help set expectations and reduce risks of attending a live event.
This guide is designed to be an informative resource for event managers and leaders who are involved in coordinating tradeshows, corporate events, and live entertainment. It includes key considerations for decisions around pre-event and/or on-site testing, as well as the different approaches and technologies available.
The Accula SARS-CoV-2 test has not been FDA cleared or approved but has been authorized for emergency use by the FDA for use by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests. 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. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of 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.
For Emergency Use Authorization (EUA) Only. For prescription use only. For in vitro diagnostic use.