Clinical accuracy of a PLEX-ID flu device for simultaneous detection and identification of influenza viruses A and B

Yi Wei Tang, Kristin S. Lowery, Alexandra Valsamakis, Virginia C. Schaefer, James D. Chappell, Jill White-Abell, Criziel D. Quinn, Haijing Li, Cicely A. Washington, Jenna Cromwell, Chantel M. Giamanco, Michael Forman, Jeffery Holden, Richard E. Rothman, Michelle L. Parker, Elaine V. Ortenberg, Lei Zhang, Yea Lin Lin, Charlotte A. Gaydos

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Abstract

Respiratory tract infections caused by influenza A and B viruses often present nonspecifically, and a rapid, high-throughput laboratory technique that can identify influenza viruses is clinically and epidemiologically desirable. The PLEX-ID Flu assay (Abbott Molecular Inc., Des Plaines, IL) incorporates multilocus PCR and electrospray ionization-mass spectrometry to detect and differentiate influenza A 2009 H1N1 (H1N1-p), seasonal H1N1 (H1N1-s), influenza A H3N2, and influenza B viruses in nasopharyngeal swab (NPS) specimens. The clinical performance characteristics of the PLEX-ID Flu assay in symptomatic patients were determined in this multicenter trial. A total of 2,617 prospectively and retrospectively collected NPS specimens from patients with influenza-like illness between February 2008 and 28 May 2010 were eligible for inclusion in the study. Each specimen was tested in parallel by the PLEX-ID Flu assay and by the Prodesse ProFLU+ assay (Prodesse Inc., Madison, WI), to detect influenza A and B viruses. Specimens testing positive for influenza A virus by ProFLU+ were subtyped as H1N1-p, H1N1-s, or H3N2 by using the ProFAST+ assay (Gen-Probe Prodesse Inc.). The reproducibility of the PLEX-ID Flu assay ranged from 98.3 to 100.0%, as determined by testing a nine-specimen panel at three clinical sites on each of 5 days. Positive percent agreements (PPAs) and negative percent agreements (NPAs) of the PLEX-ID Flu assay were 94.5% and 99.0% for influenza A virus and 96.0% and 99.9% for influenza B virus, respectively. For the influenza A virus subtyping characterization, the PLEX-ID Flu assay had PPAs and NPAs of 98.3% and 97.5% for H1N1-p, 88.6% and 100.0% for H1N1-s, and 98.0% and 99.9% for H3N2, respectively. The overall agreements between the PLEX-ID and Prodesse ProFLU+/ProFAST+ assays were 97.1 to 100.0%. Bidirectional Sanger sequencing analysis revealed that 87.5% of 96 discrepant results between the PLEX-ID Flu and ProFLU+/ProFAST+ assays were found upon influenza A virus detection and H1N1-p subtyping. The PLEX-ID Flu assay demonstrated a high level of accuracy for the simultaneous detection and identification of influenza A and B viruses in patient specimens, providing a new laboratory tool for the rapid diagnosis and management of influenza A and B virus infections.

Original languageEnglish (US)
Pages (from-to)40-45
Number of pages6
JournalJournal of clinical microbiology
Volume51
Issue number1
DOIs
StatePublished - Jan 1 2013

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ASJC Scopus subject areas

  • Microbiology (medical)

Cite this

Tang, Y. W., Lowery, K. S., Valsamakis, A., Schaefer, V. C., Chappell, J. D., White-Abell, J., Quinn, C. D., Li, H., Washington, C. A., Cromwell, J., Giamanco, C. M., Forman, M., Holden, J., Rothman, R. E., Parker, M. L., Ortenberg, E. V., Zhang, L., Lin, Y. L., & Gaydos, C. A. (2013). Clinical accuracy of a PLEX-ID flu device for simultaneous detection and identification of influenza viruses A and B. Journal of clinical microbiology, 51(1), 40-45. https://doi.org/10.1128/JCM.01978-12