Comparison of ePlex Respiratory Pathogen Panel with Laboratory-Developed Real-Time PCR Assays for Detection of Respiratory Pathogens

• Published in: Journal of clinical microbiology Vol. 55; no. 6; pp. 1938 - 1945
• Main Authors: Nijhuis, R H T, Guerendiain, D, Claas, E C J, Templeton, K E
• Format: Journal Article
• Language: English
• Published: United States American Society for Microbiology 01.06.2017
• Subjects: Bacterial Infections - diagnosis; Humans; Molecular Diagnostic Techniques - methods; Prospective Studies; Real-Time Polymerase Chain Reaction - methods; Respiratory Tract Infections - diagnosis; Virology; Virus Diseases - diagnosis; influenza; point-of-care testing; rapid diagnostics; respiratory pathogens; sample-to-answer
• ISSN: 0095-1137; 1098-660X
• DOI: 10.1128/JCM.00221-17

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 ( ) 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.