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J Clin Microbiol. 2017 Nov 15. pii: JCM.01237-17. doi: 10.1128/JCM.01237-17. [Epub ahead of print]
Accurate PCR Detection of Influenza A/B and RSV Using the Cepheid Xpert Flu+RSV Xpress Assay in Point-of-Care Settings: Comparison to Prodesse ProFlu.
Cohen DM1, Kline J2, May LS3, Harnett GE4, Gibson J5, Liang SY6, Rafique Z7, Rodriguez CA8, McGann KM Sr9, Gaydos CA10, Mayne D11, Phillips D11, Cohen J12.
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Abstract
The Xpert Flu+RSV Xpress Assay is a fast, automated in vitro diagnostic test for qualitative detection and differentiation of influenza A, B, and 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 the Prodesse ProFlu+ real-time RT-PCR assay (ProFlu+) for the detection of influenza A and B as well as RSV in a CLIA-waived (CW) setting. Overall, the assay, using fresh and frozen nasopharyngeal (NP) swabs, demonstrated high concordance with ProFlu+ in the combined CW and non-CW settings with Positive Percent Agreements (PPA) (100%, 100%, 97.1%) and Negative Percent Agreements (NPA) (95.2%, 99.5%, 99.6%) for influenza A, B, and RSV, respectively. In conclusion, this multi-center study using the Cepheid Xpert Flu+RSV Xpress Assay demonstrated high sensitivities and specificities for Flu A, B, and RSV in ∼60 minutes for use at the point-of-care in the CW setting.
Copyright ? 2017 American Society for Microbiology.
PMID: 29142048 DOI: 10.1128/JCM.01237-17
Accurate PCR Detection of Influenza A/B and RSV Using the Cepheid Xpert Flu+RSV Xpress Assay in Point-of-Care Settings: Comparison to Prodesse ProFlu.
Cohen DM1, Kline J2, May LS3, Harnett GE4, Gibson J5, Liang SY6, Rafique Z7, Rodriguez CA8, McGann KM Sr9, Gaydos CA10, Mayne D11, Phillips D11, Cohen J12.
Author information
Abstract
The Xpert Flu+RSV Xpress Assay is a fast, automated in vitro diagnostic test for qualitative detection and differentiation of influenza A, B, and 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 the Prodesse ProFlu+ real-time RT-PCR assay (ProFlu+) for the detection of influenza A and B as well as RSV in a CLIA-waived (CW) setting. Overall, the assay, using fresh and frozen nasopharyngeal (NP) swabs, demonstrated high concordance with ProFlu+ in the combined CW and non-CW settings with Positive Percent Agreements (PPA) (100%, 100%, 97.1%) and Negative Percent Agreements (NPA) (95.2%, 99.5%, 99.6%) for influenza A, B, and RSV, respectively. In conclusion, this multi-center study using the Cepheid Xpert Flu+RSV Xpress Assay demonstrated high sensitivities and specificities for Flu A, B, and RSV in ∼60 minutes for use at the point-of-care in the CW setting.
Copyright ? 2017 American Society for Microbiology.
PMID: 29142048 DOI: 10.1128/JCM.01237-17