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SARS-CoV-2

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Home / Tests / Critical Infectious Diseases / Xpert Xpress SARS-CoV-2/Flu/RSV

Xpert® Xpress SARS-CoV-2/Flu/RSV

Actionable rapid respiratory results to meet the challenges of the ongoing pandemic.

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VIDEO

Cepheid Receives Emergency Use Authorization for SARS-CoV-2, Flu A, Flu B and RSV Combination Test

Challenged by Similar Clinical Presentations, Accurate Detection & Differentiation of all 4 Viruses is Critical for Clinicians This Flu Season

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The Need

  • Detection and differentiation of flu, RSV, and COVID-19 which all present with similar symptoms
  • Insights for effective triage and patient management
  • Risk assessment for patients and staff while resuming traditional healthcare procedures
  • Identify potential cases of co-infections during respiratory season
  • Current flu and SARS-CoV-2 therapies need definitive diagnosis for each pathogen

The Solution

  • Actionable detection of SARS-CoV-2, Flu A, Flu B, and RSV in as little as 25 minutes^
  • Actionable on-demand results with 1 sample collection
  • Optimizes GeneXpert® System module capacity by combining 2 Xpress tests into 1
  • Standardization of results between the central lab and near patient testing sites

The Impact

  • Empower patients with rapid results to help keep their loved ones and the community safe
  • Assist hospitals to effectively manage limited resources
  • Provide labs with single-test confidence to accelerate workflows
  • Support clinicians with on-demand, timely, and accurate results

*For Use Under an Emergency Use Authorization (EUA) only. This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by authorized laboratories; this test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acids from SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV), and not for any other viruses or pathogens; and this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

^ For positives when running SARS-CoV-2 only on Xpress SARS-CoV-2/Flu/RSV; otherwise, the test will have a runtime of approximately 36 minutes.

Frequently Asked Questions

What are my options for Viral Transport Media for Xpert Xpress SARS-CoV-2/FLU/RSV

Viral transport media is available from several commercial vendors who may use the terminology VTM (Viral Transport Medium).  Alternate transport media, not identified in the package inserts (302-4421 Xpert Xpress SARS-CoV-2 Flu RSV EUA English Package Insert, 302-5159 Xpert Xpress SARS-CoV-2 Flu RSV CE IVD English Package Insert), should not be used with Xpert® Xpress SARS-CoV-2/Flu/RSV.  

Due to the limited supply of commercial collection devices and transport media, the FDA has posted some information on their website including the “COVID-19 Transport Media Policy” and “Testing Supply Substitution Strategies” slides, which can be accessed on their “FAQs on Testing for SARS-CoV-2” webpage: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2#testingsupply. For additional questions, please contact Cepheid’s Technical Support team.

All inquiries about off-label use, including those pertaining to transport media/transport media containing inactivation reagents, need to be addressed to Medical Affairs for support (MedSci.Affairs@cepheid.com).

What are the requirements for verification and what guidelines do you have for transitioning from my current Xpert Xpress SARS-CoV-2 and/or Xpert Xpress Flu/RSV tests to the Xpert Xpress

Before going live with a new test, a verification study may be necessary.  A verification guide that describes the preparation of contrived positive specimens (prepared by spiking commercial reference material into negative specimens) is available for download.  Alternatively, customers can also use previously tested patient specimens for a verification study. Please follow your laboratory and regulatory requirements when instituting a new test in your laboratory. 

What external quality control (QC) material options are available for SARS CoV-2/FLU/RSV?

The listed external controls are Zeptometrix SARS-COV2/FLU/RSV Positive Control (PN: NATFRC-6C) and Negative Control (PN: NATCV9-6C). These are described in the “materials available but not provided” section of the Package Insert. Please consult with Cepheid’s Technical Support team to inquire about additional commercial options. Customers may also elect to use other commercial sources or previous patient specimens.

What sample types and collection devices can be used with Xpert® Xpress SARS CoV-2-FLU-RSV?

Sample Types:
GeneXpert Dx and Infinity Systems: Nasopharyngeal swab, nasal swab and nasal/wash aspirate specimens in 3mL of VTM (EUA) or 3mL of VTM or saline (CE-IVD). 
GeneXpert Xpress Systems (Hub and Tablet): Nasopharyngeal swab and nasal swab specimens in 3mL of VTM (EUA) or 3mL of VTM or saline (CE-IVD). 

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