BACKGROUND Respiratory tract infections are among the most common infections during winter season. Rapid diagnostics is required for clinical decision making regarding isolation of patients and appropriate therapy. OBJECTIVES The aim of this study was to evaluate the analytical and clinical performance characteristics of the Panther Fusion® respiratory panel using published laboratory-developed real-time PCR assays (LDT). STUDY DESIGN Analytical sensitivity of Panther Fusion® Flu A/B/RSV was assessed by testing dilutions of cell culture isolates. Clinical performance assessment included the complete Panther Fusion® respiratory panel (Flu-A/B/RSV, PIV 1-4 and AdV/hMPV/RV) and consisted of a retrospective and a prospective study-arm. The retrospective evaluation included 201, stored (-80 °C) samples collected between February 2006 and January 2017. Prospective evaluation was performed on 1045 unselected pretreated respiratory tract samples from patients presented to our hospital between November 2017 and May 2018. RESULTS Analytical sensitivity was generally slightly lower for the Panther Fusion® assays. Clinical specificity and sensitivity was between 96 %-100 % and 71.9 %-100 %, respectively. Discrepant results were found in 146 samples of which 88 samples tested LDT positive / Panther Fusion® negative and 58 samples were LDT negative / Panther Fusion® positive. A total of ten discrepant samples with Ct-values <30 were sequenced to confirm the presence of 7 RV-C not-detected by LDT and 1 RV-A and 2 ADV-2 not detected by Panther Fusion®. CONCLUSIONS The Panther Fusion® provides a random-access system with continuous loading and much shorter sample-to-answer times compared to LDT, albeit with a slightly less clinical sensitivity compared to the LDT.

中文翻译：

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PantherFusion®呼吸道面板的性能评估。

背景技术呼吸道感染是冬季最常见的感染之一。有关患者隔离和适当治疗的临床决策需要快速诊断。目的本研究的目的是使用已发表的实验室开发的实时PCR分析（LDT）评估PantherFusion®呼吸板的分析和临床性能特征。研究设计PantherFusion®Flu A / B / RSV的分析敏感性通过测试细胞培养分离株的稀释度来评估。临床表现评估包括完整的PantherFusion®呼吸板（Flu-A / B / RSV，PIV 1-4和AdV / hMPV / RV），并包括回顾性研究和前瞻性研究组。回顾性评估包括2006年2月至2017年1月之间收集的201个储存的（-80°C）样品。在2017年11月至2018年5月之间，对1045份未选择的经过预处理的呼吸道样本进行了前瞻性评估，这些样本来自我们的医院。结果PantherFusion®分析的分析灵敏度通常略低。临床特异性和敏感性分别在96％-100％和71.9％-100％之间。在146个样品中发现了不一致的结果，其中88个样品的LDT阳性/ PantherFusion®阴性，58个样品的LDT阴性/ PantherFusion®阳性。总共对10个Ct值小于30的差异样本进行了测序，以确认存在7种RV-C未被LDT检测到，1 RV-A和2 ADV-2未被PantherFusion®检测到。结论PantherFusion®提供了一种随机访问系统，与LDT相比，该系统具有连续加载和更短的采样到应答时间，