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

摘要

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 similar to 60 min for use at the point-of-care in the CW setting.