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首页> 外文期刊>Journal of Clinical Microbiology >Multicenter Evaluation of BioFire FilmArray Respiratory Panel 2 for Detection of Viruses and Bacteria in Nasopharyngeal Swab Samples
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Multicenter Evaluation of BioFire FilmArray Respiratory Panel 2 for Detection of Viruses and Bacteria in Nasopharyngeal Swab Samples

机译：用于检测鼻咽拭子样本中病毒和细菌的BioFire FilmArray呼吸板2的多中心评估

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ABSTRACT The FilmArray Respiratory Panel 2 (RP2) is a multiplex in vitro diagnostic test for the simultaneous and rapid (～45-min) detection of 22 pathogens directly from nasopharyngeal swab (NPS) samples. It contains updated (and in some instances redesigned) assays that improve upon the FilmArray Respiratory Panel (RP; version 1.7), with a faster run time. The organisms identified are adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus NL63, coronavirus OC43, human metapneumovirus, human rhinovirus/enterovirus, influenza virus A, influenza virus A H1, influenza virus A H1-2009, influenza virus A H3, influenza virus B, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, respiratory syncytial virus, Bordetella pertussis , Chlamydia pneumoniae , and Mycoplasma pneumoniae . Two new targets are included in the FilmArray RP2: Middle East respiratory syndrome coronavirus and Bordetella parapertussis . This study provides data from a multicenter evaluation of 1,612 prospectively collected NPS samples, with performance compared to that of the FilmArray RP or PCR and sequencing. The overall percent agreement between the FilmArray RP2 and the comparator testing was 99.2%. The RP2 demonstrated a positive percent agreement of 91.7% or greater for detection of all but three analytes: coronavirus OC43, B. parapertussis , and B. pertussis . The FilmArray RP2 also demonstrated a negative percent agreement of ≥93.8% for all analytes. Of note, the adenovirus assay detects all genotypes, with a demonstrated increase in sensitivity. The FilmArray RP2 represents a significant improvement over the FilmArray RP, with a substantially shorter run time that could aid in the diagnosis of respiratory infections in a variety of clinical scenarios.
机译：摘要FilmArray呼吸板2（RP2）是一种多重体外诊断测试，用于直接从鼻咽拭子（NPS）样品中同时快速检测（约45分钟）22种病原体。它包含更新（并在某些情况下经过重新设计）的检测方法，这些检测方法在FilmArray呼吸面板（RP;版本1.7）上得到了改进，并且运行时间更快。鉴定出的生物是腺病毒，冠状病毒229E，冠状病毒HKU1，冠状病毒NL63，冠状病毒OC43，人类偏肺病毒，人类鼻病毒/肠病毒，甲型流感病毒，甲型流感H1，甲型流感H1-2009，甲型流感H3，乙型流感B ，副流感病毒1，副流感病毒2，副流感病毒3，副流感病毒4，呼吸道合胞病毒，百日咳博德特氏菌，肺炎衣原体和肺炎支原体。 FilmArray RP2中包括两个新的目标：中东呼吸综合征冠状病毒和副百日咳博德特氏菌。这项研究提供了来自1,612个预期收集的NPS样本的多中心评估数据，其性能与FilmArray RP或PCR和测序相比。 FilmArray RP2和比较器测试之间的总体一致性百分比为99.2％。 RP2的阳性百分比一致性达到91.7％或更高，可用于检测除三种分析物以外的所有分析物：冠状病毒OC43，副百日咳杆菌和百日咳博德特氏菌。 FilmArray RP2还显示出所有分析物的负百分比一致性≥93.8％。值得注意的是，腺病毒检测可检测到所有基因型，并显示出敏感性的提高。 FilmArray RP2代表了与FilmArray RP相比的重大改进，运行时间大大缩短，可以在各种临床情况下帮助诊断呼吸道感染。

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