中国冶金工业医学杂志

乙肝患者158例血清HBV DNA含量变化对比分析

作者：崔万丰石铭石龙

单位：大连市第六人民医院

关键词：乙肝病毒 HBVDNA 实时PCR

分类号：R512.62;R450

出版年,卷(期):页码：2009,26(1):11-13

摘要：

目的:比较实时荧光PCR法与COBAS Amplicor法定量检测血清HBV DNA的准确性。方法:本研究参比血清来自国家药品生物制品鉴定所与国家临检中心,临床血清标本共158例。比较了两种方法的线性范围、准确度、重复性、实验时间及成本。结果:实时PCR的批内差和批间差分别为0.3%～3.8%和1.4%～8.1%。实时荧光PCR法与COBAS Amplicor法具有良好的相关性(r=0.948),实时荧光PCR法成本低且检测范围更宽。结论:实时PCR是监测慢性乙肝患者HBV DNA水平的有效方法。

Objective:To compare the clinical performance of a real-time PCR assay with the COBAS Amplicor HBV Monitor test for quantitation of HBV DNA in serum samples.Methods:The reference sera of the Chinese National Institute for the Control of Pharmaceutical and Biological Products and the National Center for Clinical Laboratories of China,and 158 clinical serum samples were used in this study.The linearity,accuracy,reproducibility,assay time,and costs of the real-time PCR were evaluated and compared with those of the Cobas Amplicor test.Results:The intra-assay and inter-assay variations of the real-time PCR ranged from 0.3% to 3.8% and 1.4% to 8.1%,respectively.The HBV DNA levels measured by the real-time PCR correlated very well with those obtained with COBAS Amplicor test(r=0.948).The real-time PCR HBV DNA kit was much cheaper and had a wider dynamic range.Conclusions:The real-time PCR assay is an excellenttool for monitoring of HBV DNA levels in patients with chronic hepatitis B.

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