根据ISO15189《医学实验室—质量和能力的要求》，评估实时荧光定量PCR 检测HBV DNA和HCV RNA引入测量不确定度的应用。

采用室内质控数据计算HBV DNA 和HCV RNA测量复现性引入的不确定度，采用国家卫生健康委员会临床检验中心能力验证结果计算HBV DNA和HCV RNA偏倚引入的不确定度，将二者合成计算出合成标准不确定度和扩展不确定度。

HBV DNA测定低浓度相对合成标准不确定度为5.21%，高浓度为3.47%；低浓度相对扩展不确定度为10.42%，高浓度为6.94%（k=2）。HCV RNA测定低浓度相对合成标准不确定度为6.43%，高浓度为5.18%；低浓度相对扩展不确定度为12.86%，高浓度为10.36%（k=2）。HBV DNA低浓度（=3.45）扩展不确定度为0.36，小于目标不确定度（0.40），但高浓度（=6.38）扩展不确定度为0.44，高于目标不确定度（0.40）；HCV RNA低浓度（=3.23）和高浓度（=5.24）扩展不确定度分别为0.42和0.54，均高于目标不确定度（0.40）。

实时荧光定量PCR测定HBV DNA和HCV RNA引入不确定度使结果具有可比性，有助于检验报告的结果解释，并可作为检验质量持续改进的依据。

To evaluate the measurement uncertainty (MU) of real-time fluorescent quantitative PCR detection of HBV DNA and HCV RNA according to laboratory accreditation requirements of ISO15189.

The MU introduced by the reproducibility of HBV DNA and HCV RNA measurements was calculated using internal quality control. The MU introduced by the bias of HBV DNA and HCV RNA was calculated by using the proficiency testing results of National Center for Clinical Laboratories.

The relative synthesis standard uncertainty for HBV DNA determination at low concentrations was 5.21%, while at high concentrations it was 3.47%. The relative expanded uncertainty at low concentrations was 10.42%, while at high concentrations it was 6.94% (k=2). The relative synthesis standard uncertainty for HCV RNA determination at low concentrations was 6.43%, and at high concentrations it was 5.18%. The relative expanded uncertainty at low concentrations was 12.86%, while at high concentrations it was 10.36% (k=2). The expanded uncertainty of HBV DNA at low concentration (=3.45) was 0.36, which was less than the target uncertainty (0.40) , but at high concentration (=6.38) the expansion uncertainty was 0.44, higher than the target uncertainty (0.40). The expansion uncertainty of HCV RNA at low (=3.23) and high (=5.24) concentrations was 0.42 and 0.54, respectively, both higher than the target uncertainty (0.40).

The MU introduced by real-time fluorescent quantitative PCR determination of HBV DNA and HCV RNA makes the results comparable, which is helpful to the interpretation of the clinical results and can be used as the basis for the continuous improvement of the quality.