Comparison of real-time polymerase chain reaction with the COBAS Amplicor test for quantitation of hepatitis B virus DNA in serum samples

AIM:To compare the clinical performance of a real-time PCR assay with the COBAS Amplicor Hepatitis B Virus (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 the COBAS Amplicor test (r = 0.948). The real-time PCR HBV DNA kit was much cheaper and had a wider dynamic range. CONCLUSION: The real-time PCR assay is an excellent tool for monitoring of HBV DNA levels in patients with chronic hepatitis B.

Meta分析评价AMPLICOR检测系统对结核病的诊断价值

目的用Meta分析综合评价AMPLICOR检测系统对结核病的诊断价值。方法搜索Medline数据库,检索用AMPLICROR检测系统诊断结核病的文献,摘录相关数据。数据分析用Sigmaplot软件绘制SROC曲线,用Cochrane工作组的Revman4．2软件进行Meta分析,用非参数检验比较不同金标准和不同标本类型对结果的影响。结果共获得到文献42篇,AMPLICOR检测系统诊断结核病敏感性81．2％,特异性96．0％,22篇文献分别分析了AMPLICOR检测系统对涂片阳性和阴性结果的差异,对涂片阳性病例敏感性97．0％,特异性76．6％,涂片阴性病例敏感性62．2％,特异性99．3％,采用不同金标准和不同标本类型DOR(Diagnostic Odd Ratio)有显著差异。结论AMPLICROR检测系统不仅对菌阳结核病,对菌阴结核病也具有一定诊断价值。影响试验结果的因素包括金标准的类型、菌阳标本所占比例、呼吸道标本所占比例等。

实时定量PCR与COBAS Amplicor定量检测血清HBV DNA的方法比较

目的比较实时定量PCR法与COBAS Amplicor法定量检测血清HBV DNA。方法自国家药品生物制品鉴定所与国家临检中心随机选取158例临床血清标本,比较了两种检测方法的线性范围、准确度、重复性、实验时间及成本。结果实时定量PCR的批内差和批间差分别为0.3%～3.8%和1.4%～8.1%。实时定量PCR法与COBAS AMPLICOR法具有良好的相关性(r=0.948),实时定量PCR法成本低且检测范围更宽。结论实时定量PCR是监测慢性乙型肝炎患者HBV DNA水平的有效方法。