Multilaboratory Evaluation of Real-Time PCR Tests for Hepatitis B Virus DNA Quantification
Multilaboratory Evaluation of Real-Time PCR Tests for Hepatitis B Virus DNA Quantification
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DOI：
10.1128/jcm.00471-11
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发表时间：
2011-08-01
影响因子：
9.4
通讯作者：
Lurain, Nell S.
中科院分区：
文献类型：
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作者：
Caliendo, Angela M.;Valsamakis, Alexander;Lurain, Nell S.
对四种不同的乙肝病毒定量检测方法：雅培实时HBVIUO、罗氏Cobas AmpliPrep/Cobas TaqMan乙肝病毒检测方法、采用HighPure系统的罗氏Cobas TaqMan乙肝病毒检测方法和Qiagen Artus HBVTM ASR检测方法的性能特点进行了评价。检测限(LOD)、线性范围、重复性和一致性使用来自单个慢性感染受试者的连续稀释的血浆样本来确定。每种化验方法都要经过至少三个实验室的检测。实时和两次TaqMan检测的LOD约为1.0log(10)IU/ml；对于Artus乙肝病毒(使用最低体积的提取DNA)，其LOD约为1.5log(10)IU/ml，所有检测的线性范围均为1.0至至少7.0log(10)IU/ml。Artus乙肝病毒的中位数一直最低，而眼镜蛇AmpliPrep/Cobas TaqMan乙肝病毒的中位数最高。结合自动核酸提取的分析是最具重复性的；然而，总体变异性很小，因为所有测试浓度的平均值的标准偏差是
The performance characteristics of four different assays for hepatitis B virus (HBV) quantification were assessed: the Abbott RealTime HBV IUO, the Roche Cobas AmpliPrep/Cobas TaqMan HBV test, the Roche Cobas TaqMan HBV test with HighPure system, and the Qiagen artus HBV TM ASR. Limit of detection (LOD), linear range, reproducibility, and agreement were determined using a serially diluted plasma sample from a single chronically infected subject. Each assay was tested by at least three laboratories. The LOD of the RealTime and two TaqMan assays was approximately 1.0 log(10) IU/ml; for artus HBV (which used the lowest volume of extracted DNA), it was approximately 1.5 log(10) IU/ml. The linear range spanned 1.0 to at least 7.0 log(10) IU/ml for all assays. Median values were consistently lowest for artus HBV and highest for Cobas AmpliPrep/Cobas TaqMan HBV. Assays incorporating automated nucleic acid extraction were the most reproducible; however, the overall variability was minor since the standard deviations for the means of all tested concentrations were