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AllplexTM 呼吸道复合检测 panel 1 与 SimplexaTM 流感 A/B 和 RSV 检测流感病毒和呼吸道合胞病毒感染(包括亚型)的临床性能比较。

Clinical Performance of the AllplexTM Respiratory Panel 1 Test Compared to SimplexaTM Flu A/B and RSV for Detection of Influenza Virus and Respiratory Syncytial Virus Infection Including Their Subtyping.

机构信息

Department of Laboratory Medicine, College of Medicine, Korea University Guro Hospital, Seoul, Republic of Korea.

Department of Laboratory Medicine, College of Medicine, Korea University Guro Hospital, Seoul, Republic of Korea,

出版信息

Med Princ Pract. 2019;28(4):380-386. doi: 10.1159/000499313. Epub 2019 Mar 4.

Abstract

OBJECTIVE

TheAllplexTM Respiratory Panel 1 (ARP) is a new assay based on a real-time polymerase chain reaction (RT-PCR) for the detection of influenza A (Flu A), influenza B virus (Flu B), and respiratory syncytial virus (RSV), including subtyping by multiple detection temperature (MuDT) technology. We evaluated the performance of the Allplex Respiratory Panel compared to the SimplexaTM Flu A/B & RSV assay (SP) and other diagnostic tools.

MATERIALS AND METHODS

A total of 372 samples were collected from patients at the Korea University Guro Hospital in Seoul, Korea. All samples were tested for influenza virus and RSV by ARP, SP, and an in-house RT-PCR.

RESULTS

The sensitivity of ARP was 95.56, 100, and 95.24% for Flu A, Flu B, and RSV, respectively. The specificity of ARP was 100, 100, and 100% for Flu A, Flu B, and RSV, respectively. SP had sensitivities and specificities of 98.89 and 100% for Flu A, 100 and 100% for Flu B, and 100 and 100% for RSV.

CONCLUSION

The Allplex panelshowed high sensitivity, specificity, positive predictive, and negative predictive values for the detection of Flu A, Flu B, and RSV. This assay is fast and easy to perform because it takes only about 150 min and there is no need for post-PCR electrophoresis. The ARP can be used as a reliable and convenient assay in clinical laboratories.

摘要

目的

AllplexTM 呼吸道Panel 1(ARP)是一种基于实时聚合酶链反应(RT-PCR)的新检测方法,用于检测甲型流感(Flu A)、乙型流感病毒(Flu B)和呼吸道合胞病毒(RSV),包括多重检测温度(MuDT)技术的亚型检测。我们评估了 Allplex 呼吸道Panel 与 SimplexaTM Flu A/B & RSV 检测试剂盒(SP)和其他诊断工具的性能。

材料与方法

总共从韩国首尔高丽大学古罗医院的患者中采集了 372 个样本。所有样本均通过 ARP、SP 和内部 RT-PCR 检测流感病毒和 RSV。

结果

ARP 的灵敏度分别为 95.56%、100%和 95.24%,用于检测 Flu A、Flu B 和 RSV。ARP 的特异性分别为 100%、100%和 100%,用于检测 Flu A、Flu B 和 RSV。SP 的灵敏度和特异性分别为 98.89%和 100%,用于检测 Flu A,100%和 100%,用于检测 Flu B,100%和 100%,用于检测 RSV。

结论

Allplex 试剂盒显示出对 Flu A、Flu B 和 RSV 的高灵敏度、特异性、阳性预测值和阴性预测值。该检测方法快速简便,因为仅需约 150 分钟,并且无需进行 PCR 后电泳。ARP 可作为临床实验室可靠且方便的检测方法。

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