Annals of Clinical Microbiology, The official Journal of the Korean Society of Clinical Microbiology

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pISSN 2288-0585 eISSN 2288-6850

Evaluation of the Xpert Flu for the Detection of Influenza A Virus and Influenza A/H1N1/2009 Strain

Original article

Annals of Clinical Microbiology (Ann Clin Microbiol) 2013 September, Volume 16, Issue 3, pages 140-144.

https://doi.org/10.5145/ACM.2013.16.3.140

Evaluation of the Xpert Flu for the Detection of Influenza A Virus and Influenza A/H1N1/2009 Strain

Ji Yeon Sohn1*, Kyung Sun Park1*, Ji-Youn Kim2, Chang-Seok Ki1, Nam Yong Lee1
1Department of Laboratory Medicine and Genetics, Sungkyunkwan University School of Medicine, 2Center for Clinical Medicine, Samsung Biomedical Research Institute, Samsung Medical Center, Seoul, Korea

Abstract

Background: Xpert Flu (Cepheid, USA) allows for fully automated real-time RT-PCR using a single-use disposable cartridge. The aim of this study was to evaluate Xpert Flu for the detection of influenza A virus and subtype A/H1N1/2009 pandemic virus.

Methods: We conducted a prospective comparison study for Xpert Flu with the RealTime ready Influenza A/H1N1 Detection Set (Roche Diagnostics, Germany). Analytical specificities of the assays were determined by testing commonly encountered respiratory viral pathogens, including parainfluenza virus type 1/2/3, rhinovirus A, rhinovirus B, metapneumovirus, adenovirus, and coronavirus. The analytical sensitivities and workflow of both methods were also assessed.

Results: A total of 102 consecutive clinical specimens were tested by both methods. Total agreement between the two methods was estimated to be 99.0% (101/102): 11 A/H1N1/2009 and 3 seasonal influenza A by the RealTime ready Influenza A/H1N1 Detection Set; 10 and 3 by Xpert Flu. No cross-reactivity was observed between influenza A/H1N1/2009 and other respiratory viral pathogens in either method. The limits of detection of the RealTime ready Influenza A/ H1N1 Detection Set and Xpert Flu were 500 TCID50/ mL and 20 TCID50/mL, respectively. Xpert Flu required 85 minutes (10 minutes of hands-on time) for processing, while RealTime ready Influenza A/ H1N1 Detection Set took 128 minutes (30 minutes of hands- on time).

Conclusion: The results of Xpert Flu were comparable to those of the RealTime ready Influenza A/H1N1 Detection Set. It is of note that the fully automated and closed system of Xpert Flu could be advantageous for reducing hands-on time and for preventing cross-contamination during the testing process. (Ann Clin Microbiol 2013;16:140-144)

Keywords

 Influenza A Virus, H1N1 Subtype; RealTime ready Influenza A/H1N1 Detection Set; Xpert Flu