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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 accuracy of real-time fluorescence PCR and COBAS Amplicor in quantitative detection of serum HBV DNA. Methods: The reference serum in this study was from the National Institute of Pharmaceutical and Biological Products and the National Clinical Center, a total of 158 clinical serum samples. The linear range, accuracy, repeatability, experiment time and cost of the two methods are compared. Results: The intra-assay and inter-assay differences of real-time PCR were 0.3% -3.8% and 1.4% -8.1% respectively. Real-time fluorescent PCR method and COBAS Amplicor method has a good correlation (r = 0.948), real-time fluorescent PCR low cost and wider detection range. Conclusion: Real-time PCR is an effective method to monitor HBV DNA level in chronic hepatitis B patients.