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.
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.
Cohen DM
，Kline J
，May LS
，Harnett GE
，Gibson J
，Liang SY
，Rafique Z
，Rodriguez CA
，McGann KM Sr
，Gaydos CA
，Mayne D
，Phillips D
，Cohen J
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Comparison of Six Sample-to-Answer Influenza A/B and Respiratory Syncytial Virus Nucleic Acid Amplification Assays Using Respiratory Specimens from Children.
The rapid and accurate detection of influenza A virus (FluA), influenza B virus (FluB), and respiratory syncytial virus (RSV) improves patient care. Sample-to-answer (STA) platforms based on nucleic acid amplification and detection of these viruses are simple, automated, and accurate. We compared six such platforms for the detection of FluA, FluB, and RSV: Cepheid GeneXpert Xpress Flu/RSV (Xpert), Hologic Panther Fusion Flu A/B/RSV (Fusion), Cobas influenza A/B & RSV (Liat), Luminex Aries Flu A/B & RSV (Aries), BioFire FilmArray respiratory panel (RP), and Diasorin Simplexa Flu A/B & RSV (Simplexa). Nasopharyngeal (NP) swab specimens (n = 225) from children previously tested by RP were assessed on these platforms. The results were compared to those of the Centers for Disease Control and Prevention (CDC)-developed real-time reverse transcription-PCR (rRT-PCR) assay for influenza A/B viruses and RSV. Subtyping for FluA and FluB was performed for discrepant analysis where applicable. The percent sensitivities/specificities for FluA detection were 100/100 (Fusion), 98.6/99.3 (Xpert), 100/100 (Liat), 98.6/100 (Aries), 98.6/100 (Simplexa), and 100/100 (RP). The percent sensitivities/specificities for FluB detection were 100/100 (Fusion), 97.9/99.4 (Xpert), 97.9/98.3 (Liat), 93.7/99.4 (Aries), 85.4/99.4 (Simplexa), and 95.8/97.7 (RP); and those for RSV detection were 98.1/99.4 (Xpert), 98.1/99.4 (Liat), 96.3/100 (Fusion), 94.4/100 (Aries), 87/94.4 (Simplexa), and 94.4/100 (RP). The 75 strains confirmed to be FluA included 29 pH1N1, 39 H3N2, 4 sH1N1, and 3 untyped strains. The 48 strains confirmed to be FluB included 33 strains of the Yamagata lineage, 13 of the Victoria lineage, 1 of both the Yamagata and Victoria lineages, and 1 of an unknown lineage. All six STA platforms demonstrated >95% sensitivity for FluA detection, while three platforms (Fusion, Xpert, and Liat) demonstrated >95% sensitivity for FluB and RSV detection.
Banerjee D
，Kanwar N
，Hassan F
，Essmyer C
，Selvarangan R
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The performance of Luminex ARIES(®) Flu A/B & RSV and Cepheid Xpert(®) Flu/RSV XC for the detection of influenza A, influenza B, and respiratory syncytial virus in prospective patient samples.
The demand for rapid, accurate viral testing has increased the number of assays available for the detection of viral pathogens. One of the newest FDA cleared platforms is the Luminex ARIES® Flu A/B & RSV, which is a fully automated, real-time PCR-based assay used for detection of influenza A, influenza B, and respiratory syncytial virus (RSV).
We sought to compare the performance of Luminex ARIES® Flu A/B & RSV assay to the Cepheid Xpert® Flu/RSV XC assay for rapid Flu and RSV testing.
A series of consecutive nasopharyngeal specimens received in the clinical microbiology laboratory during peak influenza season at a major academic center in Chicago, IL, were prospectively tested, using both the ARIES® Flu A/B & RSV and Xpert® Flu/RSV XC assays, side by side. Discrepant results were tested on the BioFire FilmArray® Respiratory Panel for resolution.
A total of 143 consecutive nasopharyngeal specimens, obtained from patients ranging from six months to ninety-three years in age were received between January 1st, 2017 and March 21st, 2017. There was 96.6% agreement between the two assays for detection influenza A, 100% agreement for detection influenza B and RSV, and 98.9% agreement for negative results. The Xpert® Flu/RSV XC performed with an average turn-around time of approximately 60min, compared to the ARIES® Flu A/B & RSV of approximately 120min. Both assays were equally easy to perform, with a similar amount of hands-on technologist time for each platform.
Overall, these results indicate that both tests are comparable in terms of result agreement and technical ease-of-use. The Xpert® Flu/RSV XC assay did produce results with less turn-around-time, approximately 60min quicker than the ARIES® Flu A/B & RSV.
McMullen P
，Boonlayangoor S
，Charnot-Katsikas A
，Beavis KG
，Tesic V
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