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比较 GenMark Diagnostics eSensor 呼吸道病毒检测试剂盒与实时 PCR 检测儿童呼吸道病毒的性能。

Comparison of the GenMark Diagnostics eSensor respiratory viral panel to real-time PCR for detection of respiratory viruses in children.

机构信息

Division of Infectious Diseases, Department of Pediatrics, Children’s Hospital of Philadelphia and Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.

出版信息

J Clin Microbiol. 2012 Nov;50(11):3458-65. doi: 10.1128/JCM.01384-12. Epub 2012 Aug 8.

Abstract

A novel eSensor respiratory viral panel (eSensor RVP) multiplexed nucleic acid amplification test (GenMark Diagnostics, Inc., Carlsbad, CA) was compared to laboratory-developed real-time PCR assays for the detection of various respiratory viruses. A total of 250 frozen archived pediatric respiratory specimens previously characterized as either negative or positive for one or more viruses by real-time PCR were examined using the eSensor RVP. Overall agreement between the eSensor RVP and corresponding real-time PCR assays for shared analytes was 99.2% (kappa = 0.96 [95% confidence interval {CI}, 0.94 to 0.98]). The combined positive percent agreement was 95.4% (95% CI, 92.5 to 97.3); the negative percent agreement was 99.7% (95% CI, 99.4 to 99.8). The mean real-time PCR threshold cycle (C(T)) value for specimens with discordant results was 39.73 (95% CI, 38.03 to 41.43). Detection of coinfections and correct identification of influenza A virus subtypes were comparable between methods. Of note, the eSensor RVP rhinovirus assay was found to be more sensitive and specific than the corresponding rhinovirus real-time PCR. In contrast, the eSensor RVP adenovirus B, C, and E assays demonstrated some cross-reactivity when tested against known adenovirus serotypes representing groups A through F. The eSensor RVP is robust and relatively easy to perform, it involves a unique biosensor technology for target detection, and its multiplexed design allows for efficient and simultaneous interrogation of a single specimen for multiple viruses. Potential drawbacks include a slower turnaround time and the need to manipulate amplified product during the protocol, increasing the possibility of contamination.

摘要

一种新型的 eSensor 呼吸道病毒组合核酸扩增检测试剂盒(GenMark Diagnostics,Inc.,加利福尼亚州卡尔斯巴德)与实验室开发的实时 PCR 检测方法进行了比较,用于检测各种呼吸道病毒。共检测了 250 份先前通过实时 PCR 鉴定为阴性或阳性的冷冻存档儿科呼吸道标本,这些标本为一个或多个病毒所共有。eSensor RVP 与相应的实时 PCR 检测方法对共享分析物的总体一致性为 99.2%(kappa = 0.96[95%置信区间{CI},0.94 至 0.98])。联合阳性百分比一致率为 95.4%(95%CI,92.5 至 97.3);阴性百分比一致率为 99.7%(95%CI,99.4 至 99.8)。具有不一致结果的标本的实时 PCR 阈值循环(C(T))值平均值为 39.73(95%CI,38.03 至 41.43)。两种方法对合并感染的检测和甲型流感病毒亚型的正确鉴定相当。值得注意的是,eSensor RVP 鼻病毒检测比相应的鼻病毒实时 PCR 更敏感和特异。相比之下,当针对代表 A 至 F 组的已知腺病毒血清型检测时,eSensor RVP 腺病毒 B、C 和 E 检测显示出一些交叉反应性。eSensor RVP 坚固且相对易于操作,它涉及用于目标检测的独特生物传感器技术,其多重设计允许对单个标本进行高效且同时检测多种病毒。潜在的缺点包括周转时间较慢,以及在方案中需要处理扩增产物,从而增加污染的可能性。

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