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

J Clin Microbiol. 2018 Jan 24;56(2):e01237-17. doi: 10.1128/JCM.01237-17. Print 2018 Feb.

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.

Keywords: CLIA-waived; DNA polymerase; influenza; respiratory syncytial virus.

Publication types

  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Automation, Laboratory
  • DNA, Viral / genetics
  • Humans
  • Influenza A virus / genetics
  • Influenza A virus / isolation & purification*
  • Influenza B virus / genetics
  • Influenza B virus / isolation & purification*
  • Influenza, Human / diagnosis
  • Influenza, Human / virology
  • Molecular Diagnostic Techniques / methods*
  • Molecular Diagnostic Techniques / standards
  • Nasopharynx / virology
  • Point-of-Care Systems*
  • Real-Time Polymerase Chain Reaction*
  • Respiratory Syncytial Virus Infections / diagnosis
  • Respiratory Syncytial Virus Infections / virology
  • Respiratory Syncytial Virus, Human / genetics
  • Respiratory Syncytial Virus, Human / isolation & purification*
  • Sensitivity and Specificity
  • Time Factors

Substances

  • DNA, Viral