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

doi:10.1128/JCM.01237-17

Comparative Study

. 2018 Jan 24;56(2):e01237-17.

doi: 10.1128/JCM.01237-17. Print 2018 Feb.

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

Affiliations

¹ Division of Emergency Medicine, Nationwide Children's Hospital and The Ohio State University, Columbus, Ohio, USA daniel.cohen@nationwidechildrens.org.
² Division of Emergency Medicine, Nationwide Children's Hospital and The Ohio State University, Columbus, Ohio, USA.
³ Department of Emergency Medicine, University of California-Davis, Sacramento, California, USA.
⁴ No-Resistance Consulting Group, Birmingham, Alabama, USA.
⁵ University of Central Florida College of Medicine, Orlando, Florida, USA.
⁶ Washington University School of Medicine, Saint Louis, Missouri, USA.
⁷ Baylor College of Medicine, Houston, Texas, USA.
⁸ University of South Florida, Tampa, Florida, USA.
⁹ Healthplex Family Clinic, LLC, Shreveport, Louisiana, USA.
¹⁰ Johns Hopkins University, Baltimore, Maryland, USA.
¹¹ Sacred Heart Hospital, Pensacola, Florida, USA.
¹² Pensacola Research Consultants, Inc., Pensacola, Florida, USA.
¹³ Albany Medical Center Hospital, Albany, New York, USA.

PMID: 29142048
PMCID: PMC5786727
DOI: 10.1128/JCM.01237-17

Comparative 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

Daniel M Cohen et al. J Clin Microbiol. 2018.

. 2018 Jan 24;56(2):e01237-17.

doi: 10.1128/JCM.01237-17. Print 2018 Feb.

Authors

Affiliations

¹ Division of Emergency Medicine, Nationwide Children's Hospital and The Ohio State University, Columbus, Ohio, USA daniel.cohen@nationwidechildrens.org.
² Division of Emergency Medicine, Nationwide Children's Hospital and The Ohio State University, Columbus, Ohio, USA.
³ Department of Emergency Medicine, University of California-Davis, Sacramento, California, USA.
⁴ No-Resistance Consulting Group, Birmingham, Alabama, USA.
⁵ University of Central Florida College of Medicine, Orlando, Florida, USA.
⁶ Washington University School of Medicine, Saint Louis, Missouri, USA.
⁷ Baylor College of Medicine, Houston, Texas, USA.
⁸ University of South Florida, Tampa, Florida, USA.
⁹ Healthplex Family Clinic, LLC, Shreveport, Louisiana, USA.
¹⁰ Johns Hopkins University, Baltimore, Maryland, USA.
¹¹ Sacred Heart Hospital, Pensacola, Florida, USA.
¹² Pensacola Research Consultants, Inc., Pensacola, Florida, USA.
¹³ Albany Medical Center Hospital, Albany, New York, USA.

PMID: 29142048
PMCID: PMC5786727
DOI: 10.1128/JCM.01237-17

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.

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References

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1. Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simoes EA, Rudan I, Weber MW, Campbell H. 2010. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet 375:1545–1555. doi:10.1016/S0140-6736(10)60206-1. - DOI - PMC - PubMed
1. Labella AM, Merel SE. 2013. Influenza. Med Clin North Am 97:621–645. doi:10.1016/j.mcna.2013.03.001. - DOI - PubMed
1. Brendish NJ, Schiff HF, Clark TW. 2015. Point-of-care testing for respiratory viruses in adults: the current landscape and future potential. J Infect 71:501–510. doi:10.1016/j.jinf.2015.07.008. - DOI - PMC - PubMed

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[1] Dalziel SR, Thompson JM, Macias CG, Fernandes RM, Johnson DW, Waisman Y, Cheng N, Acworth J, Chamberlain JM, Osmond MH, Plint A, Valerio P, Black KJ, Fitzpatrick E, Newton AS, Kuppermann N, Klassen TP, Pediatric Emergency Research Networks H1N1 Working Group. 2013. Predictors of severe H1N1 infection in children presenting within Pediatric Emergency Research Networks (PERN): retrospective case-control study. BMJ 347:f4836. doi:10.1136/bmj.f4836. - DOI - PMC - PubMed

[2] Dalziel SR, Thompson JM, Macias CG, Fernandes RM, Johnson DW, Waisman Y, Cheng N, Acworth J, Chamberlain JM, Osmond MH, Plint A, Valerio P, Black KJ, Fitzpatrick E, Newton AS, Kuppermann N, Klassen TP, Pediatric Emergency Research Networks H1N1 Working Group. 2013. Predictors of severe H1N1 infection in children presenting within Pediatric Emergency Research Networks (PERN): retrospective case-control study. BMJ 347:f4836. doi:10.1136/bmj.f4836. - DOI - PMC - PubMed

[3] Hall CB, Weinberg GA, Iwane MK, Blumkin AK, Edwards KM, Staat MA, Auinger P, Griffin MR, Poehling KA, Erdman D, Grijalva CG, Zhu Y, Szilagyi P. 2009. The burden of respiratory syncytial virus infection in young children. N Engl J Med 360:588–598. doi:10.1056/NEJMoa0804877. - DOI - PMC - PubMed

[4] Hall CB, Weinberg GA, Iwane MK, Blumkin AK, Edwards KM, Staat MA, Auinger P, Griffin MR, Poehling KA, Erdman D, Grijalva CG, Zhu Y, Szilagyi P. 2009. The burden of respiratory syncytial virus infection in young children. N Engl J Med 360:588–598. doi:10.1056/NEJMoa0804877. - DOI - PMC - PubMed

[5] Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simoes EA, Rudan I, Weber MW, Campbell H. 2010. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet 375:1545–1555. doi:10.1016/S0140-6736(10)60206-1. - DOI - PMC - PubMed

[6] Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simoes EA, Rudan I, Weber MW, Campbell H. 2010. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet 375:1545–1555. doi:10.1016/S0140-6736(10)60206-1. - DOI - PMC - PubMed

[7] Labella AM, Merel SE. 2013. Influenza. Med Clin North Am 97:621–645. doi:10.1016/j.mcna.2013.03.001. - DOI - PubMed

[8] Labella AM, Merel SE. 2013. Influenza. Med Clin North Am 97:621–645. doi:10.1016/j.mcna.2013.03.001. - DOI - PubMed

[9] Brendish NJ, Schiff HF, Clark TW. 2015. Point-of-care testing for respiratory viruses in adults: the current landscape and future potential. J Infect 71:501–510. doi:10.1016/j.jinf.2015.07.008. - DOI - PMC - PubMed

[10] Brendish NJ, Schiff HF, Clark TW. 2015. Point-of-care testing for respiratory viruses in adults: the current landscape and future potential. J Infect 71:501–510. doi:10.1016/j.jinf.2015.07.008. - DOI - PMC - PubMed

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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

Affiliations

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

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