HBV-DNA荧光定量PCR检测的室内质控研究

目的研究HBV-DNA荧光定量PCR检测室内质控管理体系。方法自制HBV-DNA阳性质控血清,连续测量20次,计算均值、标准差和变异系数,从第3次开始利用即刻法进行质控,20次以后利用质控图法进行质控。结果自制阳性质控血清均一性和准确度均达到实验要求,用即刻法检测3～20次质控结果均小于N2S数值,在控制范围内,用质控图法检测HBV-DNA室内质控对数值的均值为5.54,标准差为0.22,CV为3.9%,稳定性好,有临床应用价值,质控图利用EXCEL表格标示出警告限和失控限,有利于动态监控质控结果。结论联合即刻法和质控图法对于应用荧光定量PCR的方法进行HBV-DNA检测的室内控制切实可行。

Laboratory quality control of detection of HBV -DNA by FQ -PCR

Objective To prepare an internal quality control substance of HBV - DNA used in real time quantitative PCR, and combine instant method with control chart to establish an internal quality control system. Methods HBV -DNA positive quality control serum was prepared and detected 20 runs repeafly. Mean value, standard deviation （SD） and coefficient of variability （CV） were calculated. The instant method and control chart method were used for quality control after 3, 20 runs respectively. Results The homogenicity of positive control serum and the accuracy of method could satisfy the request of test. The quality control results of instant method were lower than N2S. The log of mean value of HBV - DNA internal quality control was 5.54, the standard deviation was 0.22, and the coefficient of variability was 3.9%. Conclusion An internal quality control system used in real time quantitative PCRhas been established by combination of instant method with control chart. It is feasible for internal quality control in detection of HBV - DNA.