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

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
Publication statusPublished - Feb 1 2018

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Keywords

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

ASJC Scopus subject areas

  • Microbiology (medical)

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