GenMark Dx ePlex 呼吸道病原体检测 panels 在上呼吸道和下呼吸道感染中的临床性能。
Clinical performance of the GenMark Dx ePlex respiratory pathogen panels for upper and lower respiratory tract infections.
机构信息
Johns Hopkins Hospital Medical Microbiology Laboratory, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD, 21287-7093, USA.
Johns Hopkins School of Medicine, Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD, 21287-7093, USA.
出版信息
J Clin Virol. 2021 Feb;135:104737. doi: 10.1016/j.jcv.2021.104737. Epub 2021 Jan 15.
The GenMark Dx ePlex Respiratory Pathogen Panel (RP) is a multiplexed nucleic acid test for the qualitative detection of common viral and a few bacterial causes of respiratory tract infections. The ePlex RP has received FDA clearance for nasopharyngeal swab (NPS) specimens collected in viral transport media. In this study, we evaluated the performance of the ePlex RP panel in comparison to the NxTAG Respiratory Pathogen Panel (NxTAG-RPP) from Luminex in use in our laboratory, not only for NPS but also for bronchoalveolar lavage specimens (BAL). We also evaluated the impact of implementing the ePlex RP on the test turn-around time (TAT). The newest panel from GenMark Dx, the ePlex Respiratory Pathogen Panel 2 (RP2), which added the SARS-CoV-2 target to the RP was also evaluated for NPS. Verification of the performance of the ePlex RP for both NPS and BAL showed 93.3 % and 84.9 % total agreement with the NxTAG-RPP respectively. An overall comparison of the TAT after implementing the ePlex RP as compared to the NxTAG-RPP assay showed an average decrease of almost seven-fold.
GenMark Dx ePlex 呼吸道病原体检测 panel（RP）是一种用于定性检测呼吸道感染常见病毒和少数细菌病原体的多重核酸检测方法。ePlex RP 已获得 FDA 批准，可用于采集于病毒运输介质中的鼻咽拭子（NPS）标本。在这项研究中，我们评估了 ePlex RP panel 与我们实验室中使用的 Luminex 的 NxTAG 呼吸道病原体检测 panel（NxTAG-RPP）的性能比较，不仅用于 NPS，还用于支气管肺泡灌洗液标本（BAL）。我们还评估了实施 ePlex RP 对检测周转时间（TAT）的影响。GenMark Dx 的最新面板 ePlex 呼吸道病原体检测 panel 2（RP2），在 RP 基础上增加了 SARS-CoV-2 靶点，也对 NPS 进行了评估。验证 ePlex RP 在 NPS 和 BAL 上的性能显示，与 NxTAG-RPP 的总符合率分别为 93.3%和 84.9%。与 NxTAG-RPP 检测相比，实施 ePlex RP 后的 TAT 总体比较显示，平均减少了近七倍。
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