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Xpert® Xpress CoV-2/Flu/RSV plus

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

Resultados respiratórios rápidos acionáveis para responder aos desafios dos vírus respiratórios cocirculantes

A necessidade

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

A solução

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.

O impacto

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. +() 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
Este teste não foi autorizado nem aprovado pela FDA. Este teste foi autorizado através da Autorização de Utilização de Emergência (EUA) da FDA em laboratórios autorizados. O Xpert Xpress CoV-2/Flu/RSV plus foi autorizado apenas para a deteção qualitativa e diferenciação simultâneas de ácidos nucleicos de SARS-CoV-2, gripe A, gripe B e do vírus sincicial respiratório (RSV), e não para outros vírus ou agentes patogénicos. A utilização de emergência deste produto só está autorizada durante a duração das circunstâncias que justificam a autorização de utilização de emergência de diagnóstico in vitro para deteção e/ou diagnóstico de COVID-19 ao abrigo da secção 564(b)(1) da Food and Drug Administration Act 21 U.S.C.
360bbb-3(b)(1), salvo se a declaração já tiver cessado ou a autorização tiver sido revogada.

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