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TaqMan甲型流感检测试剂盒及快速自动化全核酸提取方法在鼻咽标本中检测甲型流感病毒的验证

Validation of the TaqMan Influenza A Detection Kit and a rapid automated total nucleic acid extraction method to detect influenza A virus in nasopharyngeal specimens.

作者信息

Bolotin Shelly, De Lima Cedric, Choi Kam-Wing, Lombos Ernesto, Burton Laura, Mazzulli Tony, Drews Steven J

机构信息

Ontario Public Health Laboratories, Molecular Diagnostics, Mount Sinai Hospital, 81 Resources Road, Etobiocoke, Ontario M9P 3T1, Canada.

出版信息

Ann Clin Lab Sci. 2009 Spring;39(2):155-9.

PMID:19429802
Abstract

This study describes the validation of the TaqMan Influenza A Detection Kit v2.0 combined with an automated nucleic acid extraction method. The limit of detection of this assay was determined by probit regression (95% confidence interval) to be 2 influenza A/PR/8/34 (H1N1) virus particles per microlitre. One hundred and eleven specimens previously tested using the Seeplex RV assay and viral culture methods were tested using the TaqMan Influenza A Detection Kit. Compared to the aggregate gold-standard, the sensitivity and specificity of the TaqMan Influenza A Detection Kit were 100% (35/35) and 97% (74/76), respectively. Because of its accuracy, quick turn-around-time and lyophilized bead form, the TaqMan Influenza A Detection Kit, combined with the NucliSense easyMAG automated extraction method, constitutes a reliable protocol for influenza A diagnosis.

摘要

本研究描述了TaqMan甲型流感检测试剂盒v2.0与自动化核酸提取方法相结合的验证情况。通过概率回归（95%置信区间）确定该检测方法的检测限为每微升2个甲型流感/PR/8/34（H1N1）病毒颗粒。使用TaqMan甲型流感检测试剂盒对111份先前采用Seeplex RV检测法和病毒培养法检测过的标本进行检测。与总体金标准相比，TaqMan甲型流感检测试剂盒的灵敏度和特异性分别为100%（35/35）和97%（74/76）。由于其准确性、快速周转时间和冻干珠形式，TaqMan甲型流感检测试剂盒与NucliSense easyMAG自动化提取方法相结合，构成了一种可靠的甲型流感诊断方案。

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