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

Xpert® Xpress CoV-2 plus

Designed with 3 gene targets for a rapid, robust detection of SARS-CoV-2.

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Xpert<sup>®</sup> Xpress CoV-2 <em>plus</em>

The Need

  • Rapidly detect SARS-CoV-2, including emerging variants, to provide timely, effective triage
  • Increase workflow efficiencies with minimal hands-on time

The Solution

The NEW Xpert Xpress CoV-2 plus test provides:

  • Fast and accurate results in as early as 20 minutes*
  • Three gene targets for SARS-CoV-2 as well as an optimization of N2 probes to enable more reliable virus detection
  • Rapid sample-to-answer testing with actionable results from a single sample

The Impact

  • Offers healthcare providers lab-quality results in a test that can be performed at the point of care
  • Supports clinicians with broader coverage for SARS-CoV-2 variants with a three-gene design
  • Enables hospitals to effectively manage limited resources with our single-cartridge technology and easy-to-use workflow

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 detection of nucleic acid from SARS-CoV-2, and not for any other viruses or pathogens. 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.

*With early assay termination for positives, otherwise, the full test runtime is 30 minutes.

Ordering Info

Xpert® Xpress CoV-2 plus

Number of Tests: 10  

Catalog #: XP3SARS-COV2-10

Frequently Asked Questions

1. How is the Xpert® Xpress CoV-2 plus product different from the existing Xpert® Xpress SARS-CoV-2 product?

Cepheid developed the Xpert® Xpress CoV-2 plus test with several enhancements compared to the Xpert® Xpress SARS-CoV-2.  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
  • Improved Time to Result (TTR) at about 30 minutes
  • Expansion of on-label transport media options to include the addition of eNAT®

2. What sample types and collection devices can be used with Xpert® Xpress CoV-2 plus?

Sample Types:

GeneXpert Dx and Infinity Systems:

  • From individuals suspected of COVID-19: Nasopharyngeal swab, anterior nasal swab, mid-turbinate swab, oropharyngeal swab or nasal wash/aspirate specimens
  • From any individual, including individuals without symptoms or other reasons to suspect COVID-19: anterior nasal swab specimens
  • In 3mL of viral transport media (UTM/VTM), 3mL of Saline, or 2mL of eNAT

GeneXpert Xpress systems (Hub and Tablet):

  • From individuals suspected of COVID-19: Nasopharyngeal swab, anterior nasal swab, or mid-turbinate swabs specimens
  • From any individual, including individuals without symptoms or other reasons to suspect COVID-19: anterior nasal swab specimens
  • In 3mL of viral transport media (UTM/VTM), 3mL of Saline, or 2mL of eNAT.

3. What are my options for Viral Transport Media for Xpert® Xpress CoV-2 plus?

Viral transport media are available from several commercial vendors who may use the terminology VTM (Viral Transport Medium) or UTM (Universal Transport Medium). Any brand meeting the guidelines for VTM/UTM can be used. UTM, VTM, Saline, and eNAT are on label.

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

4. What external quality control (QC) material options are available for Xpert® Xpress CoV-2 plus?

The listed external controls are Zeptometrix External Controls:

  • SARS-Related Coronavirus 2 (SARS-CoV-2) External Run Control, Catalog# NATSARS(COV2)-ERC
  • SARS Associated Coronavirus 2 (SARS-CoV-2) Negative Control, Catalog# NATSARS(COV2)-NEG

 

These are described in the “materials available but not provided” section of the package insert as the recommended source for external controls. Please consult with Cepheid’s Technical Support team to inquire about other commercial sources for QC material.

5. Do you have any guidelines for verification studies of the Xpert® Xpress CoV-2 plus test?

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 on the Cepheid website: Verification Guide.

6. What are my options for obtaining the ADF or the Package Insert for my Xpert® Xpress CoV-2 plus test?

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 plus are available for download here. For customers who prefer to obtain the ADFs in a CD, please fill out the CD ADF request using the following link:

USA CD ADF REQUEST FORM

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