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Gold-standard RT-PCR detection of SARS-CoV-2

Gold-standard RT-PCR detection of SARS-CoV-2 at rapid speed: a solution for asymptomatic screening.

Evidence to date strongly points to rapid RT-PCR tests as the optimal solution for asymptomatic screening, based on performance characteristics equivalent to gold-standard lab-based testing for SARS-CoV-2 and operational characteristics enabling rapid, decentralized deployment.

Comparison of rapid RT-LAMP and rapid RT-PCR methods

Comparison of rapid RT-LAMP and rapid RT-PCR methods for the detection of SARS-CoV-2 RNA

POC NAATs are a promising approach to achieve a massive expansion in testing, and a diverse range of POC tests based on RT-PCR and isothermal amplification such as RT-LAMP offer rapid, decentralized options. A rapid RT-PCR test such as the Accula SARS-CoV-2 Test is an ideal solution that addresses the requirements for timely results with best-in-class performance.

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This 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.