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

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

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。

Objective To compare the clinical feature of real-time PCR assay with COBAS Amplicor HBV Monitor test for quantitation of HBV DNA in serum samples.Methods One hundred and fifty-eight serum samples were chosen from the Chinese National Institute for the control of pharmaceutical and biological products and the National Center for clinical laboratories of China.The linearity,accuracy,reproducibility,assay time and costs of real-time PCR were evaluated and compared with those of the Cobas Amplicor test.Results The intra-assay and inter-assay variations of real-time PCR ranged from 0.3% to 3.8% and 1.4% to 8.1%,respectively.The HBV DNA levels measured by real-time PCR correlated very well with those obtained with COBAS Amplicor test (r=0.948).Real-time PCR HBV DNA kit was much cheaper and had a wider examination area.Conclusions Real-time PCR assay is an excellent tool for monitoring HBV DNA levels in patients with chronic hepatitis B.