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SARS-CoV-2

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

Xpert® Xpress CoV-2/Flu/RSV plus

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

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Xpert<sup>®&nbsp;</sup>Xpress CoV-2/Flu/RSV <em>plus</em>

The Need

  • Rapidly detect SARS-CoV-2, including emerging variants, to provide timely, effective triage.
  • Accurately diagnose respiratory tract infections to ensure appropriate treatment.
  • Rapidly differentiate flu, RSV, and SARS-CoV-2 and potential co-infections during respiratory season.

The Solution

  • Robust design with three distinct gene targets for SARS-CoV-2: N2, E, RdRP.
  • Accurate detection and differentiation of SARS-CoV-2, Flu A, Flu B, and RSV. Results for SARS-CoV-2 in as little as 25 minutes.^
  • Actionable results from a single sample with less than one minute of hands-on time.
  • Standardization of results between the central lab and near-patient testing sites.

The Impact

  • 3-gene design supports clinicians with broader coverage for SARS-CoV-2 variants.
  • Ensures that patients receive appropriate treatment in a timely manner.
  • Single cartridge with an easy-to-use workflow, enabling effective management of limited resources.

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.

Full test runtime is 36 minutes. SARS-CoV-2 positive results available in as soon as 25 minutes with early assay termination.

Ordering Info

Xpert® Xpress CoV-2/Flu/RSV plus

Number of Tests: 10  

Catalog #: XP3COV2/FLU/RSV-10

Product Resources

Product Information

Xpert Xpress CoV-2/Flu/RSV plus flyer

Datasheet (EUA)

Respiratory Product Comparison

Package Inserts & MSDS

Package Inserts*

Safety Data Sheets

Technical Documentation

Xpert Xpress CoV-2-Flu-Rsv Plus Quick Reference (Hub)

Xpert Xpress CoV-2 Flu RSV Plus Quick Reference (Tablet)

Xpert Xpress CoV-2-Flu-RSV Plus Test verification protocol

Xpert Xpress CoV-2-Flu-RSV Plus Verification Chart 1

Xpert Xpress CoV-2 Flu RSV Plus Verification Chart 2

Xpert Xpress CoV-2-Flu-RSV Plus_Reimbursement Info.

Xpert Xpress CoV-2-Flu-RSV Plus LIS Guidance

Xpert Xpress CoV-2 Flu-RSV plus Patient Fact Sheet

Xpert Xpress CoV-2 Flu-RSV plus Provider Fact Sheet

Assay Definition Files

ADF – Xpert Xpress CoV-2/Flu/RSV plus

Download ADF
View all self-service support and training materials

CD ADF Request Form

Frequently Asked Questions

How is the Xpert Xpress CoV-2/Flu/RSV plus product different from the existing Xpert Xpress SARS-CoV-2/Flu/RSV product?

Cepheid proactively developed Xpert Xpress CoV-2/Flu/RSV plus with several enhancements compared to Xpert Xpress SARS-CoV-2/Flu/RSV.  Key enhancements include the addition of a 3rd gene target for SARS-CoV-2 (RdRP now included in addition to E and N2), to be more robust against mutations, to include the addition of eNAT for Anterior Nasal and Nasopharyngeal Swabs.

What sample types and collection devices can be used with Xpert Xpress CoV-2/Flu/RSV plus?

Sample Types:

Nasopharyngeal swab, anterior nasal swab and nasal/wash aspirate specimens in 3mL of viral transport media (UTM/VTM) or saline, or in 2mL of eNAT. 

GeneXpert Xpress systems (Hub and Tablet): Nasopharyngeal swab and anterior nasal swab specimens in 3mL of viral transport media (UTM/VTM) or saline, or in 2mL of eNAT. 

What are my options for Viral Transport Media for Xpert Xpress CoV-2/Flu/RSV plus?

Viral transport media are available from several commercial vendors who may use the terminology VTM (Viral Transport Medium) or UTM (Universal Transport Medium).  UTM, VTM, and Saline are on label.  eNAT is on label for use with Nasopharyngeal and anterior nasal swab samples.

 

For additional questions regarding SARS-CoV-2 Transport Media options, please refer to the FDA webpage "FAQS on Viral Transport Media During COVID-19"

What external quality control (QC) material options are available for Xpert Xpress CoV-2/Flu/RSV plus?

The listed external controls are Zeptometrix Flu/RSV/SARS-CoV-2 Positive Control (PN: NATFRC-6C) and Negative Control (PN: NATCV9-6C). These are described in the “materials available but not provided section”. Please consult with Cepheid’s Technical Support team to inquire about additional commercial options for QC material.  

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

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

Why isn’t there a CD with the ADF nor a Package Insert in my Xpert Xpress CoV-2/Flu/RSV plus test kit?

In an effort to reduce our environmental footprint, Cepheid is moving towards CD-less products. The Package Inserts, ADFs and ADF import instructions for Xpert Xpress CoV-2/Flu/RSV plus are available for download on this website (see above). For customers who prefer to obtain the ADFs in a CD, please fill out the CD ADF request using the following link. USA requests USA CD ADF REQUEST FORM.

*For use under an Emergency Use Authorization in the United States

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