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用于检测病毒和细菌呼吸道病原体的QIAstat-Dx呼吸检测板V2的多中心评估

Multicenter Evaluation of QIAstat-Dx Respiratory Panel V2 for Detection of Viral and Bacterial Respiratory Pathogens.

作者信息

Boers Stefan A, Melchers Willem J G, Peters Cas J A, Toonen Marga, McHugh Martin P, Templeton Kate E, Claas Eric C J

机构信息

Department of Medical Microbiology, Leiden University Medical Center, Leiden, The Netherlands.

Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, The Netherlands.

出版信息

J Clin Microbiol. 2020 May 26;58(6). doi: 10.1128/JCM.01793-19.

Abstract

QIAstat-Dx Respiratory Panel V2 (RP) is a novel molecular-method-based syndromic test for the simultaneous and rapid (∼70-min) detection of 18 viral and 3 bacterial pathogens causing respiratory infections. This report describes the first multicenter retrospective comparison of the performance of the QIAstat-Dx RP assay to the established ePlex Respiratory Pathogen Panel (RPP) assay, for which we used 287 respiratory samples from patients suspected with respiratory infections. The QIAstat-Dx RP assay detected 312 (92%) of the 338 respiratory targets that were detected by the ePlex RPP assay. Most of the discrepant results have been observed in the low-pathogen-load samples. In addition, the QIAstat-Dx RP assay detected 19 additional targets in 19 respiratory samples that were not detected by the ePlex RPP assay. Nine of these discordant targets were considered to represent true positives after discrepancy testing by a third method. The main advantage of the QIAstat-Dx system compared to other syndromic testing systems, including the ePlex RPP assay, is the ability to generate cycle threshold ( ) values, which could help with the interpretation of results. Taking the data together, this study showed good performance of the QIAstat-Dx RP assay in comparison to the ePlex RPP assay for the detection of respiratory pathogens. The QIAstat-Dx RP assay offers a new, rapid, and accurate sample-to-answer multiplex panel for the detection of the most common viral and bacterial respiratory pathogens and therefore has the potential to direct appropriate therapy and infection control precautions.

摘要

QIAstat-Dx呼吸道检测板V2(RP)是一种基于新型分子方法的综合征检测,可同时快速(约70分钟)检测18种引起呼吸道感染的病毒病原体和3种细菌病原体。本报告描述了QIAstat-Dx RP检测与既定的ePlex呼吸道病原体检测板(RPP)检测性能的首次多中心回顾性比较,我们使用了287份疑似呼吸道感染患者的呼吸道样本。QIAstat-Dx RP检测检测到了ePlex RPP检测所检测到的338个呼吸道目标中的312个(92%)。大多数差异结果出现在低病原体载量样本中。此外,QIAstat-Dx RP检测在19份呼吸道样本中检测到了ePlex RPP检测未检测到的19个额外目标。在通过第三种方法进行差异测试后,这些不一致目标中的9个被认为代表真阳性。与其他综合征检测系统(包括ePlex RPP检测)相比,QIAstat-Dx系统的主要优势在于能够生成循环阈值( )值,这有助于结果的解释。综合这些数据,本研究表明,与ePlex RPP检测相比,QIAstat-Dx RP检测在检测呼吸道病原体方面表现良好。QIAstat-Dx RP检测为检测最常见的病毒和细菌呼吸道病原体提供了一种新的、快速且准确的从样本到结果的多重检测板,因此有可能指导适当的治疗和感染控制预防措施。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/01f0/7269373/f58d5f1b602f/JCM.01793-19-f0001.jpg

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