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J Clin Microbiol. 2012 Oct 17. [Epub ahead of print]
Validation of a PLEX-ID Flu Device for Simultaneous Detection and Identification of Influenza Viruses A and B.
Tang YW, Lowery KS, Valsamakis A, Schaefer VC, Chappell JD, White-Abell J, Quinn CD, Li H, Washington CA, Cromwell J, Giamanco CM, Forman M, Holden J, Rothman RE, Parker ML, Ortenberg EV, Zhang L, Lin YL, Gaydos CA.
Source
Departments of Pathology, Microbiology, and Immunology.
Abstract
Background: 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 multi-locus 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 in nasopharyngeal swab (NPS) specimens.Methods: 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 May 28, 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. Specimens testing positive for influenza A by ProFLU+ were subtyped as H1N1-p, H1N1-s, or H3N2 using the ProFAST?+ Assay (Gen-Probe Prodesse, Inc.).Results: Reproducibility of the PLEX-ID Flu Assay ranged from 98.3-100.0% as determined by testing a nine-specimen panel at three clinical sites on each of five days. Positive percent agreements (PPA) and negative percent agreements (NPA) of the PLEX-ID Flu assay were 94.5% and 99.0% for Flu A and 96.0% and 99.9% for Flu B. For the Flu A subtyping characterization, the PLEX-ID Flu assay had PPA and NPA 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. The overall agreement between the PLEX-ID and Prodesse ProFLU?+/ProFAST+ assays were 97.1-100.0%. Bi-directional Sanger sequencing analysis revealed that 87.5% of 96 discrepant results between the PLEX-ID Flu and ProFLU?+/ProFAST+ assays were on Flu A detection and H1N1-p subtyping.Conclusions: The PLEX-ID Flu Assay demonstrated high accuracy for simultaneous detection and identification of influenza A and B in patient specimens, providing a new laboratory tool for rapid diagnosis and management of influenza A and B infections.
PMID:
23077123
[PubMed - as supplied by publisher]
Validation of a PLEX-ID Flu Device for Simultaneous Detection and Identification of Influenza Viruses A and B.
Tang YW, Lowery KS, Valsamakis A, Schaefer VC, Chappell JD, White-Abell J, Quinn CD, Li H, Washington CA, Cromwell J, Giamanco CM, Forman M, Holden J, Rothman RE, Parker ML, Ortenberg EV, Zhang L, Lin YL, Gaydos CA.
Source
Departments of Pathology, Microbiology, and Immunology.
Abstract
Background: 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 multi-locus 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 in nasopharyngeal swab (NPS) specimens.Methods: 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 May 28, 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. Specimens testing positive for influenza A by ProFLU+ were subtyped as H1N1-p, H1N1-s, or H3N2 using the ProFAST?+ Assay (Gen-Probe Prodesse, Inc.).Results: Reproducibility of the PLEX-ID Flu Assay ranged from 98.3-100.0% as determined by testing a nine-specimen panel at three clinical sites on each of five days. Positive percent agreements (PPA) and negative percent agreements (NPA) of the PLEX-ID Flu assay were 94.5% and 99.0% for Flu A and 96.0% and 99.9% for Flu B. For the Flu A subtyping characterization, the PLEX-ID Flu assay had PPA and NPA 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. The overall agreement between the PLEX-ID and Prodesse ProFLU?+/ProFAST+ assays were 97.1-100.0%. Bi-directional Sanger sequencing analysis revealed that 87.5% of 96 discrepant results between the PLEX-ID Flu and ProFLU?+/ProFAST+ assays were on Flu A detection and H1N1-p subtyping.Conclusions: The PLEX-ID Flu Assay demonstrated high accuracy for simultaneous detection and identification of influenza A and B in patient specimens, providing a new laboratory tool for rapid diagnosis and management of influenza A and B infections.
PMID:
23077123
[PubMed - as supplied by publisher]
