qa:qa_dcx-login
Xpert® Xpress CoV-2/Flu/RSV plus (US-IVD Moderately Complex)
On-demand 4-in-1 PCR test delivering actionable results with less than 1 minute of hands-on time
Sign in or create a MyCepheid account to add items to cart
Test pack size(s)
10 Tests
XPRS4PLEX-10
Qty
Unit price
Subtotal
USD
Product is not available for purchase in your region.
Collection devices
Copan 3C057N (Nasopharyngeal Swab) (Pack of 50)
3C057N
Qty
Unit price
Subtotal
USD
Product is not available for purchase in your region.
Copan 3C064N (Nasal Swab) (Pack of 50)
3C064N
Qty
Unit price
Subtotal
USD
Product is not available for purchase in your region.
Total
{{currency}}
0
Error adding items to cart. If this error persists, please contact Digital Support
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
US-IVD. For In Vitro Diagnostic Use in laboratories that are CLIA certified to perform moderate or high complexity tests.
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
US-IVD. For In Vitro Diagnostic Use in laboratories that are CLIA certified to perform moderate or high complexity tests.
Product Resources
Product Information
Package Inserts & MSDS
ADF Files
Frequently Asked Questions
The 510(k) cleared product and the EUA Xpert Xpress CoV-2/Flu/RSV plus products are technologically the same; that is, there are no changes to the chemistry 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.
When compared to the Xpert Xpress SARS-CoV-2/Flu/RSV (version 1) test, there are several enhancements with the Xpert® Xpress CoV-2/Flu/RSV plus (version 2) test. 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.
- Expansion of on-label transport media options to include the addition of eNAT® (Copan).
No. The 510(k) product does not yet have a CLIA Waived version. The EUA version of the Xpert Xpress CoV-2/Flu/RSV plus product is included for use at Point of Care (POC) and can be used in CLIA Waived settings. Cepheid is submitting for CLIA Waived status 510(k) version and expects that process to be completed by Q3 2024. Until CLIA Waiver is obtained, the EUA and US-IVD versions of the product will both remain in the market to be used in POC settings and Moderate Complexity settings, respectively.
Though the cartridge design and contents are the same, the EUA and US-IVD versions of the product are different; each has its unique catalog number, labels, and ADFs. Thus, they cannot be used interchangeably. GeneXpert® Dx and Infinity customers should utilize (finish) their existing inventory of EUA products before transitioning to the US-IVD version of the product.
GeneXpert Dx and Infinity Systems:
Sample Types:
- Nasopharyngeal swabs and anterior nasal swabs collected from individuals with signs and symptoms of respiratory tract infection.
Collection Devices:
Nylon flocked swabs, viral transport medium (VTM), Universal Transport Medium (UTM) and eNAT® Molecular Transport Medium are compatible for use with the Xpert Xpress CoV-2/Flu/RSV plus, US-IVD test.
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.
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.
For GeneXpert Dx and Infinity customers transitioning from EUA to US-IVD, please contact your FAS representative for additional support
In an effort to reduce our environmental footprint, 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 are available for download here. A CD containing the ADF is also being provided to customers on their first order of this product (Xpert Xpress CoV-2/Flu/RSV plus, US-IVD). For customers who would like to order additional copies, please fill out the CD ADF request using the following link: