Meridian Bioscience Revogene™ SARS-CoV-2

Description

Detects SARS-CoV-2 RNA from nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate swab samples.

• 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 for laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet requirements to perform moderate or high complexity tests
• The Revogene™ platform features a fully automated molecular workflow designed to optimize COVID-19 testing capacity
• With its intuitive, press-and-walk-away design, the system streamlines operations into just two easy steps and requires less than one minute of hands-on time
• The assay can deliver positive results as early as 47 min, with negative results available in 85 min

Specifications

• CE Marker: No
• Clia Complexity: Moderate Complexity
• Detectable Analytes: SARS-CoV-2
• Detection Method: RT-PCR
• DoA Calibrators: No
• Sample Type: Nasopharyngeal, Oropharyngeal. Anterior Nasal, Mid-Turbinate Nasal Swab Sample
• Type: COVID Test Kit
• Disposable: Single-use
• For Use With (Application): Nasopharyngeal, Oropharyngeal, Anterior Nasal, and Mid-Turbinate Nasal Swab Specimens
• For Use With (Equipment): Revogene Instrument (23-029-051)
• High-throughput Compatibility: 8 Samples/Run
• Includes: 24 Disposable Transfer Tools, 24 Individual Pouches, Each Containing Revogene SARS CoV-2 Microfluidic Cartridge (PIE)
• Quantity: 24 Tests/kit
• Sterility: Sterile
• Analysis Time: 47 min. early call feature/85 min. result
• Form: Ready-to-Use (RTU)

Safety and Handling

WARNING: Cancer and Reproductive Harm - www.P65Warnings.ca.gov