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Revogene® SARS-CoV-2

A real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene® instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swab specimens.

Catalog Number: 410700

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Why Revogene 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.

Revogene's fully automated molecular platform can help optimize the laboratory’s COVID-19 testing capacity with its time-saving, press-and-walk-away efficiencies in just 2 steps. This test can provide final results in as early as 47 minutes for positive specimens.*

*E-PRO: Early Positive Result Outcome. Positive results in ~47 minutes for highly positive specimens and negative results in 85 minutes.

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    Automated, streamlined workflow – sample to result in 2 easy steps
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    Time-saving, walk-away efficiencies with little hands-on-time
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    Advanced molecular diagnostic accuracy – 97.7% PPA , 97.7% NPA
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    Platform for growth – Single analyte and multiplex testing capability

CDC recommends that anyone with any signs or symptoms of COVID-19 get tested, regardless of vaccination status or prior infection.

Reference: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html

Definitive answers, confidence in results

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Definitive answers, confidence in results

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FAQs

CPT Code 87635 

Nasopharyngeal, anterior nasal, mid-turbinate nasal, or oropharyngeal swab specimens collected according to standard technique and placed in 3 mL of transport media according to manufacturer’s instructions.  

Swab specimens collected in VTM/UTM can be stored at 2-8 C for up to seven (7) days before being tested with the Revogene SARS-CoV-2 assay.  Specimens collected in CDC media, MicroTest M4RT® (Remel), or saline may be stored up to 72 hours at 2-8 C before use. 

The Revogene SARS-CoV-2 kit can be stored at 2-8 C.  The expiration date is indicated on the kit box label. For more information, please refer to the Revogene SARS-CoV-2 package insert. 

 

  • This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; 
  • This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and 
  • The emergency use of this product 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.

 

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