title: Comparison of ePlex Respiratory Pathogen Panel with Laboratory-Developed Real-Time PCR Assays for Detection of Respiratory Pathogens.
abstract: Infections of the respiratory tract can be caused by a diversity of pathogens, both viral and bacterial. Rapid microbiological diagnosis ensures appropriate antimicrobial therapy as well as effective implementation of isolation precautions. The ePlex respiratory pathogen panel (RP panel) is a novel molecular biology-based assay, developed by GenMark Diagnostics, Inc. (Carlsbad, CA), to be performed within a single cartridge for the diagnosis of 25 respiratory pathogens (viral and bacterial). The objective of this study was to compare the performance of the RP panel with those of laboratory-developed real-time PCR assays, using a variety of previously collected clinical respiratory specimens. A total of 343 clinical specimens as well as 29 external quality assessment (EQA) specimens and 2 different Middle East respiratory syndrome coronavirus isolates have been assessed in this study. The RP panel showed an agreement of 97.4% with the real-time PCR assay regarding 464 pathogens found in the clinical specimens. All pathogens present in clinical samples and EQA samples with a threshold cycle (CT) value of <30 were detected correctly using the RP panel. The RP panel detected 17 additional pathogens, 7 of which could be confirmed by discrepant testing. In conclusion, this study shows excellent performance of the RP panel in comparison to real-time PCR assays for the detection of respiratory pathogens. The ePlex system provided a large amount of useful diagnostic data within a short time frame, with minimal hands-on time, and can therefore potentially be used for rapid diagnostic sample-to-answer testing, in either a laboratory or a decentralized setting.
authors.affiliation: Department of Medical Microbiology, Leiden University Medical Center, Leiden, The Netherlands r.h.t.nijhuis@lumc.nl.
authors.forename: R H T
authors.initials: RHT
authors.lastname: Nijhuis
authors.affiliation: Specialist Virology Center, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.
authors.forename: D
authors.initials: D
authors.lastname: Guerendiain
authors.affiliation: Department of Medical Microbiology, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: E C J
authors.initials: ECJ
authors.lastname: Claas
authors.affiliation: Specialist Virology Center, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.
authors.forename: K E
authors.initials: KE
authors.lastname: Templeton
mesh_terms: D001424:Bacterial Infections / Q000175:diagnosis*; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D011446:Prospective Studies; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D012141:Respiratory Tract Infections / Q000175:diagnosis*; D014777:Virus Diseases / Q000175:diagnosis*
keywords: influenza; point-of-care testing; rapid diagnostics; respiratory pathogens; sample-to-answer