Comparison of the ePlex® Respiratory Pathogen Panel with Laboratory Developed Real-Time PCR for the 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 based assay, developed by GenMark Diagnostics Inc. (Carlsbad, California), 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 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 Ct-value <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, either in a laboratory or a decentralized setting.