Accurate SARS-CoV-2 results in ~30 minutes
SARS-CoV-2 testing can seem like a choice between accuracy and rapid turnaround time. The rapid Accula SARS-CoV-2 Test uses proprietary Oscar™ PCR technology to shorten thermocycling times and provide a result in ~30 minutes. The Limit of Detection (LoD) is among the lowest measured for the FDA SARS-CoV-2 Reference Panel.
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.