Nijhuis R H T, Guerendiain D, Claas E C J, Templeton K E
Department of Medical Microbiology, Leiden University Medical Center, Leiden, The Netherlands
Specialist Virology Center, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.
J Clin Microbiol. 2017 Jun;55(6):1938-1945. doi: 10.1128/JCM.00221-17. Epub 2017 Apr 12.
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.
呼吸道感染可由多种病原体引起，包括病毒和细菌。快速微生物诊断可确保进行适当的抗菌治疗以及有效实施隔离预防措施。ePlex呼吸道病原体检测板（RP检测板）是由GenMark诊断公司（加利福尼亚州卡尔斯巴德）开发的一种基于分子生物学的新型检测方法，可在单个检测盒内进行，用于诊断25种呼吸道病原体（病毒和细菌）。本研究的目的是使用各种先前收集的临床呼吸道标本，比较RP检测板与实验室开发的实时PCR检测方法的性能。本研究共评估了343份临床标本、29份外部质量评估（EQA）标本以及2种不同的中东呼吸综合征冠状病毒分离株。RP检测板与实时PCR检测方法在临床标本中发现的464种病原体方面的一致性为97.4%。使用RP检测板可正确检测临床样本和EQA样本中所有阈值循环（ ）值<30的病原体。RP检测板还检测到另外17种病原体，其中7种可通过差异检测得到确认。总之，本研究表明，与实时PCR检测方法相比，RP检测板在检测呼吸道病原体方面表现出色。ePlex系统在短时间内提供了大量有用的诊断数据，动手时间最少，因此有可能用于实验室或分散式环境中的快速诊断样本到答案检测。
