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Xpert® Xpress CoV-2/Flu/RSV plus (FDA cleared)
On-demand 4-in-1 PCR test delivering actionable results with less than 1 minute of hands-on time. FDA cleared: moderate complexity and CLIA waived
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10 Tests
XPRS4PLEX-10
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Collection devices
Copan 3C057N (Nasopharyngeal Swab) (Pack of 50)
3C057N
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Copan 3C064N (Nasal Swab) (Pack of 50)
3C064N
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The Need
Globally, co-circulation of SARS-CoV-2, influenza and respiratory syncytial virus (RSV) was observed during the 2022 respiratory season with the easing of COVID-19 measures. This led to increased burden on healthcare infrastructure and increased risk of severe illness for high-risk populations.1,2
- Fast results for symptomatic patients to facilitate early diagnosis, effective triage, and patient management.1
- Ensure the accuracy of test performance despite new SARS-CoV-2 variants2 and influenza A mutations.3
- Multiplexing ability for the most prevalent and actionable pathogens (SARS-CoV-2, influenza A, influenza B, RSV) to simplify the diagnosis process
- Multiplex testing that provides the right result first time, reducing costs associated with reflex and/or confirmatory testing4
1. Strategic preparedness and response plan: April ‘23 –’25 :https://iris.who.int/bitstream/handle/10665/372712/WHO-WHE-SPP-2023.2-eng.pdf?sequence=1
2. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests
3. Jørgensen, R. L. et al. Emergence of circulating influenza A H3N2 viruses with genetic drift in the matrix gene: be alert of false-negative test results. APMIS 130, 612–617 (2022).
4. Stockl et al. Use of Antigen and Molecular Testing for the Diagnosis of Coronavirus Disease 2019 (COVID-19) among Patients with Influenza-like Illness (ILI) in the Non-inpatient Setting. Association for Molecular Pathology 2023 Annual Meeting Abstracts. J Mol Diagn 2023, p 53 Abstract 006 https://www.jmdjournal.org/article/S1525-1578(23)00249-0/pdf
2. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests
3. Jørgensen, R. L. et al. Emergence of circulating influenza A H3N2 viruses with genetic drift in the matrix gene: be alert of false-negative test results. APMIS 130, 612–617 (2022).
4. Stockl et al. Use of Antigen and Molecular Testing for the Diagnosis of Coronavirus Disease 2019 (COVID-19) among Patients with Influenza-like Illness (ILI) in the Non-inpatient Setting. Association for Molecular Pathology 2023 Annual Meeting Abstracts. J Mol Diagn 2023, p 53 Abstract 006 https://www.jmdjournal.org/article/S1525-1578(23)00249-0/pdf
The Solution
The Xpert Xpress CoV-2/Flu/RSV plus test is a multiplexed real-time PCR test intended for the simultaneous in-vitro qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A, influenza B, and/or RSV in nasopharyngeal swab or anterior nasal swab specimens collected from individuals with signs and/or symptoms of respiratory viral infection.
The Xpert Xpress CoV-2/Flu/RSV plus test:
The Xpert Xpress CoV-2/Flu/RSV plus test:
- Provides fast and accurate results in as early as 25 minutes# for SARS-CoV-2 or Flu only results.
- Utilizes a multi-gene target approach for the detection of SARS-CoV-2 and influenza providing target redundancy to mitigate the potential impact of genetic shift and drift on strain detection.
- Detects SARS-CoV-2, influenza A, influenza B, and/or RSV simultaneously.
# With Early Assay Termination (EAT) for positives of SARS-CoV-2 only or Flu-only, otherwise full test runtime is 36 minutes
The Impact
- Xpert Xpress CoV-2/Flu/RSV plus allows for accurate and fast results, optimizing diagnostic efficiency and improving the provision of appropriate treatment5
- Testing with Xpert Xpress CoV-2/Flu/RSV plus may result in significant cost-savings compared to antigen and send-out PCR testing strategies and may result in fewer hospitalizations, ICU admissions, mechanical ventilation, and deaths5
- Gives the right result the first time, reducing the need for reflex and/or confirmatory testing6
5. Davies, E. et al (2023) A Cost-Consequence Analysis of Xpert Xpress CoV-2/Flu/RSV Plus for the Diagnosis of Viral Respiratory Infections from a US Health Plan Perspective. J Mol Diagn, 25(11) (S1-S186): S64. https://www.jmdjournal.org/article/S1525-1578%2823%2900249-0/pdf
6. K. Stockl, et al. (2023). Use of Antigen and Molecular Testing for Coronavirus 2019 (SARS-CoV-2) among Patients with Influenza-Like Illness (ILI) in the Non-inpatient Setting. J Mol Diagn, 25(11) (S1-S186): S53. https://www.jmdjournal.org/article/S1525-1578%2823%2900249-0/pdf
6. K. Stockl, et al. (2023). Use of Antigen and Molecular Testing for Coronavirus 2019 (SARS-CoV-2) among Patients with Influenza-Like Illness (ILI) in the Non-inpatient Setting. J Mol Diagn, 25(11) (S1-S186): S53. https://www.jmdjournal.org/article/S1525-1578%2823%2900249-0/pdf
Product Resources
Product Information
Package Inserts & MSDS
Technical Documentation
ADF Files
Frequently Asked Questions
Sample Types:
- Nasopharyngeal swab and anterior nasal swabs from 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)
- 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:
- External Positive Control – NATtrol Flu/RSV/SARS-CoV-2; Cat # NATFRC-6C-IVD
- External Negative Control – Coxsackievirus A9; Cat # NATCV9-6C-IVD
These are described in the “materials available but not provided” section of the package insert.
Yes. The FDA cleared product is for moderate complexity environment and 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 systems 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/Flu/RSV plus, FDA-cleared are available for download here.
A CD containing the ADF is also being provided with the first order place of XPRS4PLEX-10 or on the first order post ADF update for existing XPRS4PLEX-10 users. For customers who would like to order additional copies and/or misplaced the CD, please fill out the CD ADF request using the following link:
The FDA cleared and the EUA Xpert Xpress CoV-2/Flu/RSV plus products are technologically identical. There are no changes to the chemistry sample processing, consumables, procedures or analysis settings of the tests. They do, however, have different catalog numbers, unique ADFs and differ in intended use. Please see 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 product before transitioning to the FDA cleared version of 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 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 versions of the tests. There are some differences in the product claims compared to the EUA version:
Claims - Xpert Xpress CoV-2/Flu/RSV plus
Sample types
The following sample types are no longer supported: nasal aspirate/wash.
Nasopharyngeal and Anterior Nasal swabs 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 4Plex testing. All EUA (XP3COV2/FLU/RSV-10) customers in the USA will be expected to transition to the FDA cleared version (XPRS4PLEX-10) by 31st of December of 2025.
There are important changes included in the ADF of the FDA cleared version with CLIA waived claim (XPRS4PLEX-10) and all current users are required to perform and ADF update. The ADF changes do not affect the safety and effectiveness of the product.