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Xpert® Xpress CoV-2/Flu/RSV plus

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CoV-2/Flu/RSV virus computer generated depiction.

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

The Need

an ill woman listens to a physician
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

The Solution

a male and a female researchers scanning cepheid test cartridges
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:
  • 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

a smiling female doctor attends an elderly woman
  • Xpert Xpress CoV-2/Flu/RSV plus allows for accurate and fast results, optimizing diagnostic efficiency and supporting informed clinical assessment5
  • 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 be associated with fewer hospitalizations, ICU admissions, mechanical ventilation, and deaths as described in published health‑economic analyses5
  • Results that may reduce 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

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