Accurate PCR Detection of Influenza A/B and Respiratory Syncytial Viruses by Use of Cepheid Xpert Flu+RSV Xpress Assay in Point-of-Care Settings: Comparison to Prodesse ProFlu

Daniel M. Cohen, Jennifer Kline, Larissa S. May, Glenn Eric Harnett, Jane Gibson, Stephen Y. Liang, Zubaid Rafique, Carina A. Rodriguez, Kevin M. McGann, Charlotte A. Gaydos, Donna Mayne, David Phillips, Jason Cohen

Research output: Contribution to journalArticle

21 Scopus citations

Abstract

The Xpert Flu+RSV Xpress Assay is a fast, automated in vitro diagnostic test for qualitative detection and differentiation of influenza A and B viruses and respiratory syncytial virus (RSV) performed on the Cepheid GeneXpert Xpress System. The objective of this study was to establish performance characteristics of the Xpert Flu+RSV Xpress Assay compared to those of the Prodesse ProFlu+ real-time reverse transcription-PCR (RT-PCR) assay (ProFlu+) for the detection of influenza A and B viruses as well as RSV in a Clinical Laboratory Improvement Amendments (CLIA)-waived (CW) setting. Overall, the assay, using fresh and frozen nasopharyngeal (NP) swabs, demonstrated high concordance with results of the ProFlu+ assay in the combined CW and non-CW settings with positive percent agreements (PPA) (100%, 100%, and 97.1%) and negative percent agreements (NPA) (95.2%, 99.5%, and 99.6%) for influenza A and B viruses and RSV, respectively. In conclusion, this multicenter study using the Cepheid Xpert Flu+RSV Xpress Assay demonstrated high sensitivities and specificities for influenza A and B viruses and RSV in ∼60 min for use at the point-of-care in the CW setting.

Original languageEnglish (US)
JournalJournal of clinical microbiology
Volume56
Issue number2
DOIs
StatePublished - Feb 1 2018

Keywords

  • CLIA-waived
  • DNA polymerase
  • influenza
  • respiratory syncytial virus

ASJC Scopus subject areas

  • Microbiology (medical)

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    Cohen, D. M., Kline, J., May, L. S., Harnett, G. E., Gibson, J., Liang, S. Y., Rafique, Z., Rodriguez, C. A., McGann, K. M., Gaydos, C. A., Mayne, D., Phillips, D., & Cohen, J. (2018). Accurate PCR Detection of Influenza A/B and Respiratory Syncytial Viruses by Use of Cepheid Xpert Flu+RSV Xpress Assay in Point-of-Care Settings: Comparison to Prodesse ProFlu. Journal of clinical microbiology, 56(2). https://doi.org/10.1128/JCM.01237-17