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首页> 外文期刊>Journal of Clinical Microbiology >Multicenter Evaluation of the ePlex Respiratory Pathogen Panel for the Detection of Viral and Bacterial Respiratory Tract Pathogens in Nasopharyngeal Swabs
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Multicenter Evaluation of the ePlex Respiratory Pathogen Panel for the Detection of Viral and Bacterial Respiratory Tract Pathogens in Nasopharyngeal Swabs

机译：ePlex呼吸道病原体检测试剂盒检测鼻咽拭子中病毒和细菌性呼吸道病原体的多中心评估

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ABSTRACT The performance of the new ePlex Respiratory Pathogen (RP) panel (GenMark Diagnostics) for the simultaneous detection of 19 viruses (influenza A virus; influenza A H1 virus; influenza A 2009 H1 virus; influenza A H3 virus; influenza B virus; adenovirus; coronaviruses [HKU1, OC43, NL63, and 229E]; human rhinovirus/enterovirus; human metapneumovirus; parainfluenza viruses 1, 2, 3, and 4; and respiratory syncytial virus [RSV] [RSV subtype A and RSV subtype B]) and 2 bacteria ( Mycoplasma pneumoniae and Chlamydia pneumoniae ) was evaluated. Prospectively and retrospectively collected nasopharyngeal swab (NPS) specimens ( n = 2,908) were evaluated by using the ePlex RP panel, with the bioMérieux/BioFire FilmArray Respiratory Panel (BioFire RP) as the comparator method. Discordance analysis was performed by using target-specific PCRs and bidirectional sequencing. The reproducibility of the assay was evaluated by using reproducibility panels comprised of 6 pathogens. The overall agreement between the ePlex RP and BioFire RP results was >95% for all targets. Positive percent agreement with the BioFire RP result for viruses ranged from 85.1% (95% confidence interval [CI], 80.2% to 88.9%) to 95.1% (95% CI, 89.0% to 97.9%), while negative percent agreement values ranged from 99.5% (95% CI, 99.1% to 99.7%) to 99.8% (95% CI, 99.5% to 99.9%). Additional testing of discordant targets (12%; 349/2,908) confirmed the results of ePlex RP for 38% (131/349) of samples tested. Reproducibility was 100% for all targets tested, with the exception of adenovirus, for which reproducibilities were 91.6% at low virus concentrations and 100% at moderate virus concentrations. The ePlex RP panel offers a new, rapid, and sensitive “sample-to-answer” multiplex panel for the detection of the most common viral and bacterial respiratory pathogens.
机译：摘要新型ePlex呼吸道病原体（RP）面板（GenMark Diagnostics）可同时检测19种病毒（甲型流感病毒;甲型H1流感病毒;甲型2009 H1流感病毒;甲型H3流感病毒;乙型流感病毒;腺病毒）的性能;冠状病毒[HKU1，OC43，NL63和229E];人鼻病毒/肠病毒;人间质肺病毒;副流感病毒1、2、3和4;以及呼吸道合胞病毒[RSV] [RSV亚型和RSV亚型B]）和评价了2种细菌（肺炎支原体和肺炎衣原体）。前瞻性和回顾性收集的鼻咽拭子（NPS）标本（n = 2,908）通过使用ePlex RP面板进行评估，并以bioMérieux/ BioFire FilmArray呼吸道面板（BioFire RP）作为比较方法。通过使用靶标特异性PCR和双向测序进行不一致分析。通过使用由6种病原体组成的重现性评估板评估了测定的重现性。对于所有目标而言，ePlex RP和BioFire RP结果之间的总体一致性> 95％。病毒与BioFire RP结果的正百分比一致性介于85.1％（95％置信区间[CI]，80.2％至88.9％）至95.1％（95％CI，89.0％至97.9％）之间，而负百分比一致性值介于从99.5％（95％CI，99.1％至99.7％）到99.8％（95％CI，99.5％至99.9％）。对不一致目标（12％; 349 / 2,908）的其他测试确认了38％（131/349）的测试样本的ePlex RP结果。除腺病毒外，所有测试目标的重现性均为100％，低病毒浓度下的重现性为91.6％，中病毒浓度下的重现性为100％。 ePlex RP面板提供了一个新的，快速且灵敏的“从样品到答案”的多重面板，用于检测最常见的病毒和细菌呼吸道病原体。

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