Cepheid Xpert Flu+RSV Rapid PCR Assay Validated for CLIA-Waived Point-of-Care Settings
A multicenter study established the performance of the Cepheid Xpert Flu+RSV Xpress assay in CLIA-waived point-of-care settings, demonstrating 97-100% positive agreement and 95-99.6% negative agreement with the Prodesse ProFlu+ reference RT-PCR for influenza A, influenza B, and RSV. The fully automated cartridge-based system delivers results in approximately 60 minutes, enabling near-patient molecular respiratory virus detection without laboratory-grade infrastructure.
The original study
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.
- Authors
- Cohen DM, Kline J, May LS, Harnett GE, Gibson J, Liang SY, et al.
- Journal
- Journal of clinical microbiology
- Type
- Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't
- PMID
- 29142048
Original 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.