Test Kit Revogene® Molecular Diagnostic / Real Time RT-PCR SARS-CoV-2 Nasopharyngeal / Oropharyngeal / Anterior Nasal / Mid-Turbinate Nasal Swab Sample 24 Test

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