Clinical accuracy of a PLEX-ID flu device for simultaneous detection and identification of influenza viruses A and B.
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.
Department of Pathology, Vanderbilt University Medical Center, Nashville, Tennessee, USA. tangy@MSKCC.org
Yi-Wei
YW
Tang
Kristin S
KS
Lowery
Alexandra
A
Valsamakis
Virginia C
VC
Schaefer
James D
JD
Chappell
Jill
J
White-Abell
Criziel D
CD
Quinn
Haijing
H
Li
Cicely A
CA
Washington
Jenna
J
Cromwell
Chantel M
CM
Giamanco
Michael
M
Forman
Jeffery
J
Holden
Richard E
RE
Rothman
Michelle L
ML
Parker
Elaine V
EV
Ortenberg
Lei
L
Zhang
Yea-Lin
YL
Lin
Charlotte A
CA
Gaydos
D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D019411:Clinical Laboratory Techniques / Q000379:methods*; D005260:Female; D006801:Humans; D009980:Influenza A virus / Q000145:classification / Q000302:isolation & purification*; D009981:Influenza B virus / Q000302:isolation & purification*; D007251:Influenza, Human / Q000175:diagnosis* / Q000821:virology*; D008297:Male; D008875:Middle Aged; D009305:Nasopharynx / Q000821:virology; D011446:Prospective Studies; D015203:Reproducibility of Results; D012189:Retrospective Studies; D014773:Virology / Q000379:methods*; D055815:Young Adult