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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
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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
- 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.