Respiratory Test Kit Revogene® SARS-CoV-2 24 Test CLIA Waived

Features

• The Revogene® SARS-CoV-2 assay is for Emergency Use Authorization (EUA) Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
• The Revogene® SARS-CoV-2 assay is a real-time RT-PCR test intended for the qualitative detection of RNA from SARS-CoV-2 in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swab specimens from individuals suspected of COVID-19 by their healthcare provider
• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet requirements to perform high or moderate complexity tests
• Positive results are indicative of the presence of SARS CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
• Positive results do not rule out bacterial infection or co-infection with other viruses
• Laboratories within the United States and its territories are required to report all test results to the appropriate public health authorities
• Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions
• Negative results must be combined with clinical observations, patient history, and epidemiological information
• The Revogene SARS-CoV-2 assay is a single-use test intended for use by qualified laboratory personnel specifically instructed and who are proficient in performing testing using the Revogene instrument
• Revogene® is a flexible molecular platform that can help standardize testing throughout your health system
• Turnaround time: 85 minutes, with as early as 47 minutes for positive specimens with EPro - early call feature
• Nasopharyngeal, anterior nasal, mid-turbinate nasal, or oropharyngeal swab specimens should be collected according to standard technique and placed in 3 mL of transport media according to manufacturer’s instructions
• The Revogene SARS-CoV-2 assay can only be used on the Revogene instrument
• Revogene® Instrument and Revogene® System RNA Software Upgrade Kit are required but not provided materials

More Information

• Revogene SARS-CoV-2 Test FDA EUA Letter
• Revogene SARS-CoV-2 Test IFU
• Revogene SARS-CoV-2 Test Brochure
• Revogene SARS-CoV-2 Test Healthcare Provders Fact Sheet
• Revogene SARS-CoV-2 Test Patients Fact Sheet