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Xpert® Xpress CoV-2/Flu/RSV plus

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

Verwertbare schnelle Ergebnisse für Atemwegserkrankungen, um den Herausforderungen von kozirkulierenden Atemwegsviren gerecht zu werden.

Der Bedarf

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
  • 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

Die Lösung

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.
  • 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.

Der Vorteil

a smiling female doctor attends an elderly woman
  • Xpert Xpress CoV-2/Flu/RSV plus allows for accurate and rapid results, optimizing diagnostic efficiency and supporting informed clinical assessment.6
  • 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 ventilations, and deaths as described in published health-economic analyses.6
  • Results that may reduce the need for reflex and/or confirmatory testing.7
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
Dieser Test wurde noch nicht von der FDA freigegeben oder zugelassen. Dieser Test wurde von der FDA im Rahmen einer Notfallzulassung zur Verwendung durch autorisierte Labore zugelassen. Xpert Xpress CoV-2/Flu/RSV plus wurde nur für den gleichzeitigen qualitativen Nachweis und die Differenzierung von Nukleinsäuren von SARS-CoV-2, Influenza A, Influenza B und das Respiratorische Synzytial-Virus (RSV) zugelassen, nicht jedoch für andere Viren oder Krankheitserreger. Die Notfallverwendung dieses Produkts ist nur während der Erklärung der bestehenden Umstände zulässig, die diese Zulassung für die Notfallverwendung von In-vitro-Diagnostika zum Nachweis und/oder zur Diagnose von COVID-19 gemäß Abschnitt 564(b)(1) des Federal Food, Drug and Cosmetic Act, 21 U.S.C.
360bbb-3(b)(1) rechtfertigen, sofern die Zulassung nicht vorher beendet oder widerrufen wird.

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