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Xpert® Xpress CoV-2 plus
Designed with 3 gene targets for a rapid, robust detection of SARS-CoV-2
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Test pack size(s)
10 Tests
XP3SARS-COV2-10
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Collection devices
Copan 305CN (Nasopharyngeal Swab) (Pack of 50)
305C
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Copan 346N (Nasal Swab) (Pack of 50)
346C
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Nasopharyngeal Collection Kit (Pack of 100)
SWAB/B-100
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Nasal Collection Kit (Pack of 100)
SWAB/F-100
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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 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 SARS-CoV-2 probes to enable more realizable virus detection
- Rapid sample-to-answer testing with actionable results from a single sample
*With early assay termination for positives, otherwise, the full test runtime is 30 minutes.
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
In the United States: This product has not been FDA cleared or approved, but has been authorized 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.
CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries
CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries
Product Resources
Product Information
Package Inserts & MSDS
Technical Documentation
ADF Files
Frequently Asked Questions
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®
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.
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.
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.
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 this page.
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 on this page. For customers who prefer to obtain the ADFs in a CD, please fill out the CD ADF request using the following link: