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Xpert® Xpress CoV-2 plus (FDA cleared)
Designed with 3 gene targets for a rapid, robust detection of SARS-CoV-2. FDA cleared: moderate complexity and CLIA-Waived
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Copan 3C057N (Nasopharyngeal Swab) (Pack of 50)
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Copan 3C064N (Nasal Swab) (Pack of 50)
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The Need

  • SARS-CoV-2 infections are associated with increased morbidity, mortality, cost and pose an ever-present threat to public health globally.1,2
  • SARS-CoV-2 variants continue to emerge, resulting in the risk of new surge in cases and death.2
  • Accurate testing is required to identify the breakthrough infections and inform patient care, especially for the high risk population. 3
1. Silva S, Goosby E, Reid MJA. Assessing the impact of one million COVID-19 deaths in America: economic and life expectancy losses. Sci Rep. 2023 Feb 22;13(1):3065https://news.un.org/en/story/2023/05/1136367. Accessed Jan 2024.
2. Peeling RW, Heymann DL, Teo YY, Garcia PJ. Diagnostics for COVID-19: moving from pandemic response to control. Lancet. 2022 Feb 19;399(10326):757-768. doi: 10.1016/S0140-6736(21)02346-1. Epub 2021 Dec 20. PMID: 34942102; PMCID: PMC8687671
3.Shah MM, Joyce B, Plumb ID, et al. Paxlovid Associated with Decreased Hospitalization Rate Among Adults with COVID-19 — United States, April–September 2022. MMWR Morb Mortal Wkly Rep 2022;71:1531–1537.

The Solution

  • The Xpert Xpress CoV-2 plus test is a fast, real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and anterior nasal swab specimens collected from individuals with signs and symptoms of respiratory tract infection by their healthcare provider.
  • The test provides actionable results in as early as 19 minutes.* It was designed with three gene targets for the detection of SARS-CoV-2, providing target redundancy that mitigates impact of genetic mutations.
* With early assay termination for positives, otherwise, the full test runtime is 30 minutes

The Impact

  • Support clinicians with broader coverage for SARS-CoV-2 variants with a three-gene target design, minimizing the possibility of false negatives and the need for re-testing.
  • Significant reduction in time-to-results reduces isolation time and total costs while optimizing capacity.4
  • Rapid decision-making for cost-effective patient management and isolation practices.5
4. Fistera D, Kikull K, Risse J, Herrmann A, Brachmann M, Kill C. Point-of-care PCR testing of SARS-CoV-2 in the emergency department: Influence on workflow and efficiency. PLoS One. 2023 Aug 3;18(8) https://pubmed.ncbi.nlm.nih.gov/37535577/
5. Fenstermacher K et al. Pre- and Post-implementation Comparison of the Impact of Emergency Department (ED)-Based COVID-19 Point-of-Care Testing on ED Patient Metrics. Annals of Emergency Medicine. Vol 82, Issue 4, S172, October 2023. doi: 10.1016/j.annemergmed.2023.08.422

Product Resources

Product Information

Xpert® Xpress CoV-2 plus EUA and 510(k)

Product Comparison
Xpert Xpress CoV-2 plus Reference Sheet FDA-Cleared (English) (Product Reference Sheet 510K)

Datasheet

Package Inserts & MSDS

Xpert Xpress CoV-2 plus IFU FDA-Cleared (English)

Package Insert

Technical Documentation

Xpert® Xpress CoV-2 plus Verification Guide

Verification Guide
Xpert Xpress CoV-2 plus FDA-cleared Med/Sci Equivalency Letter

User Documentation
Xpert Xpress CoV-2 plus US-IVD Med/Sci Equivalency Letter for Moderate Complexity Users

User Documentation
Xpert Xpress CoV-2 plus Quick Reference Guide FDA-cleared (LIS Guidance)

Quick Reference Guide

ADF Files

Xpert Xpress CoV-2 plus FDA-cleared US-IVD ADF and Technical Documentation English (US)

Software

CD ADF Request Form

Frequently Asked Questions

Sample Types:

  • Nasopharyngeal swabs and anterior nasal swabs individuals suspected of COVID-19.

 

Collection Devices:

  • Nasopharyngeal Sample Collection Kit for Viruses
    • Copan, Flexible Minitip Flocked Swab with UTM® Medium w/o Beads, P/N: 3C057N or equivalent
    • BD Becton Dickinson, Flexible Minitip Flocked Swab with UVT Medium, Universal Viral Transport Kit P/N 220531 (Flexible Minitip Flocked Swab with UVT Medium) or equivalent
    • Copan, Flexible Minitip Flocked Swab with eNAT® Medium P/N: 6U074S01
  • Nasal Sample Collection Kit for Viruses
    • Copan UTM® 3C064N (Regular Flocked Swab with UTM® Medium) or equivalent
    • Copan eNAT® Molecular Collection and Preservation Medium P/N 6U073S01 (Regular Flocked Swab with eNAT® Medium)

 

Collection Media:

  • 3mL of viral transport media (UTM/VTM)
  • 2mL of eNAT

The listed external controls are Zeptometrix External Controls:

  • SARS Associated Coronavirus 2 (SARS-CoV-2) Positive 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. 

Yes. The FDA cleared product is also CLIA Waived for use on GeneXpert® Xpress systems.

Before going live with a new test, a verification study may be necessary.  Please refer to your relevant laboratory accreditation regulations for verification requirements.  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.  

 The decision to perform verification studies and the level of verification required is at the discretion of the laboratory director and should be conducted according to applicable regulations.   

 

Please Note: For GeneXpert Dx, GeneXpert Xpress,Infinity and GeneXpert with Touchscreen customers transitioning from EUA to FDA cleared, please contact your FAS representative for additional support. 

In an effort to reduce waste, Cepheid will provide electronic copies of Instructions for Use (IFU) and Assay Definition Files (ADF). The IFUs, ADFs, and ADF import instructions for Xpert Xpress CoV-2 plus, are available for download here. A CD containing the ADF is also being provided with the first order of XPRS-COV2-10 or on their first order post ADF update for existing XPRS-COV2-10 users.  For customers who would like to order additional copies, please fill out the CD ADF request form on the Cepheid website. USA CD ADF REQUEST FORM

The FDA cleared product and the EUA Xpert Xpress CoV-2 plus products are technologically identical; that is, there are no changes to the chemistry, sample processing, consumables, procedures, or analysis settings of the tests. They do, however, have different catalog numbers, labels, unique ADFs, and differ in intended use. Please see the respective IFUs for intended use differences.

Both product versions cannot be used interchangeably, each has its unique catalog number, labels, and ADFs. Customers are recommended to utilize (finish) their existing inventory of EUA products before transitioning to the FDA cleared version of the product.

Yes.  For GeneXpert systems that are compatible with both the EUA and FDA-cleared products, the ADFs can be installed and used concurrently for both versions of the product, on the same computer.  

 

Please Note: The EUA version is not compatible with GeneXpert System with Touchscreen.

While there are no significant performance differences between both two versions of the tests. There are some differences in the product claims compared to the EUA version:

 

Claims - Xpert Xpress CoV-2 plus

 

Intended Populations

Populations are no longer supported or claimed: asymptomatic and those suspected of COVID-19 disease

Sample types

The following sample types are no longer supported: nasal aspirate/wash, mid-turbinate, and oropharyngeal. 

Nasopharyngeal and Anterior Nasal are still on-label

Collection media

The following collection media is no longer supported: saline.

Sample storage conditions

Now ON-LABEL: Frozen (-80ºC) NPS and NS specimens in VTM/UTM and eNAT that have undergone 1 freeze/thaw cycle are now on claim. See IFU for details.

The FDA cleared product is our long-term solution for SARS-CoV-2. All EUA (XP3SARS-COV2-10) customers in the USA will be expected to transition to FDA cleared (XPRS-COV2-10) by 31st of December 2025.

There are no design differences between the current Moderate Complexity version of ADF and new version of ADF with CLIA Waived extension. The new ADF allows the FDA cleared test to be run on our CLIA Waived systems. Therefore, the ADF update can be performed when customers are ready.