乙型肝炎病毒(hepatitis B virus，HBV)DNA定量检测对慢性HBV感染者的诊断和管理有重要意义。慢性乙型病毒性肝炎的临床治疗决策是根据HBV DNA的绝对或相对水平改变确定的。为获得高质量和可比较的HBV DNA结果，必须验证分析性能特征，并设计统计质量控制方法。本研究中我们确定了血浆HBV DNA检测的随机误差和系统误差，并通过标准化的操作过程规范(operational process specifications，OPSpecs)图验证检验方法性能。结果显示低和高控制物水平的系统误差分别为0.33和0.22 log(IU/ml)，而其检测标准差(s)均为0.17 log(IU/ml)。另外，将具有2个质控结果的单规则1_2.5s作为候选的质量控制方法。研究结果显示，HBV DNA检测方法性能良好，且临床应用是可接受的，并可通过自动化提纯法进一步改善。我们将完善的统计质量控制学用于实时定量聚合酶链反应检测研究，结果表明通过长期采用西格玛度量统计质量控制法，可发现检测系统中的关键变化。西格玛度量和OPSpecs图可为实验室确定所用方法性能及质量控制设计，同时这些技术为实验室选择正确的方法和选择正确的质量控制提供了一种实用方法。

Hepatitis B virus (HBV) DNA measurement plays an important role in the diagnosis and management of patients with chronic HBV infection, because the treatment strategy is formulated based on either the absolute HBV DNA level, or the relative change in HBV DNA level. To obtain the results with high quality, assay, performance characteristics must be verified and statistical quality control methods must be planned. In this study, systematic and random error values of plasma HBV DNA were determined. Performance of the method was examined by employing a normalized operational process specifications (OPSpecs) chart. The systematic error at low and high control levels were 0.33 and 0.22 log (IU/ml) respectively. At both levels, the standard deviations (SD) of the assay were 0.17 log (IU/ml). In addition, a single rule of 1_2.5s with 2 control measurements was selected as a candidate quality control method. Results showed that the assay performed well and was acceptable for clinical use. Further improvement might be attained by switching to automated purification methods. The well-established discipline of statistical quality control was applied to a real-time quantitative polymerase chain reaction (PCR). It was concluded that by employing sigma-metrics statistical quality control (QC) methods which utilized long-term controls, critical changes in the measurement system could be detected. Sigma metrics and OPSpecs chart could examine the performance of the method and whether the quality control scheme planed was appropriate. Therefore, these methods were practical for assisting laboratory choose the proper measurement method and select correct quality control scheme.