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Xpert® Xpress CoV-2/Flu/RSV plus
Actionable rapid respiratory results to meet the challenges of co-circulating respiratory viruses
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10 Tests
XP3COV2/FLU/RSV-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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Collection Device (Pack of 50)
900-0370
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Swab Specimen Collection Kit (Pack of 50)
SWAB/G-50-US
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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
- Rapid testing to facilitate early diagnosis of high-risk patient populations and adoption of respiratory multiplexed tests with the integration of SARS-CoV-2 testing are required.5
- Ensure the accuracy of test performance despite new SARS-CoV-2 variants4 and influenza A mutations.3
- Rapid testing results to facilitate early diagnosis for effective patient management.5
- Multiplexing ability for the most prevalent and actionable pathogens (SARS-CoV-2, influenza A, influenza B, RSV) to simplify the diagnosis process.
1 Tam JS, Shu Y. Public Health Control Measures for the Co-circulation of Influenza and SARS-CoV-2 During Influenza Seasons. China CDC Wkly. 2022 Jan 14;4(2):22-26. doi: 10.46234/ccdcw2021.228. PMID: 35586519; PMCID: PMC8796727.
2 https://www.ecdc.europa.eu/en/publications-data/intensified-circulation-respiratory-syncytial-virus-rsv-and-associated-hospital
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 https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests|
5 Strategic preparedness and response plan: April ‘23 –’25
2 https://www.ecdc.europa.eu/en/publications-data/intensified-circulation-respiratory-syncytial-virus-rsv-and-associated-hospital
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 https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests|
5 Strategic preparedness and response plan: April ‘23 –’25
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.
- 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 positive results.
The Impact
- Xpert Xpress CoV-2/Flu/RSV plus allows for accurate and rapid results, optimizing diagnostic efficiency and improving the provision of appropriate treatment6
- 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 ventilations, and deaths compared to antigen and send-out PCR testing strategies6
- Gives the right result first time, reducing the need for reflex and/or confirmatory testing7
6 Davies, E. Boller, A. Beaubrun, C. Miller, I. Jensen. (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
7 K. Stockl, J. Tucker, J. Certa, A. Beaubrun, K. Schwebke. (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
This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. Xpert Xpress CoV-2/Flu/RSV plus 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. 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.
7 K. Stockl, J. Tucker, J. Certa, A. Beaubrun, K. Schwebke. (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
This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. Xpert Xpress CoV-2/Flu/RSV plus 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. 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.
Product Resources
Product Information
Package Inserts & MSDS
Technical Documentation
ADF Files
Video
The Answer is Simpler: The real cost of change
Understanding the total impact to workflow and improved efficiencies. Discover how it’s Simpler with Cepheid.
Video
The Answer is Simpler: The real cost of change
Understanding the total impact to workflow and improved efficiencies. Discover how it’s Simpler with Cepheid.
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: