荧光定量PCR法检测HBV—DNA室内质控物的制备及质控图的应用

目的制备HBV—DNA荧光定量PCR检测室内质控物，建立室内质控管理体系，利用Excel表格进行质控图的绘制。方法取单一浓度HBV—DNA阳性血清，稀释至一定浓度后，分装数管，-70℃保存。连续检测20次，计算均值、标准差和变异系数，绘制质控图，进行室内质控动态监测。结果HBV—DNA室内质控均值的对数值为5．573，标准差为0．244，变异系数为4．4％，稳定性很好，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。结论荧光定量PCR方法进行HBV—DNA检测的质控物制备简单，稳定性良好，质控图操作方便，一目了然，适合临床实验室应用和推广。

Preparation and Application of Internal Quality Control Substance by Real-time PCR to Quantify Hepatitis B Virus DNA and Quality Control Chart

Objective To prepare an internal quality control substance of HBV-DNA used in real time quantitative PCR, and establish a statistics internal quality control system and plot quality control chart with Microsoft Office Excel. Methods HBV-DNA positive quality control serum was prepared and was subpackage several centrifuge tubes with 0. 5ml,and saved subzero 70 degree. After detected 20 runs repeatly,mean value,standard deviation （s） and coefficient of variability （CV） were calculated and quality control chart was plotted. Results The log of mean value of HBV-DNA internal quality control is 5. 573,standard deviation is 0. 244, coefficient of variability is 4. 4%. It is fit for dynamic state monitoring through be plotted warning line and out of control line with Excel. Conclusion Internal quality control substance of HBV DNA used in real-time quantitative PCR is very stable and applicable in clinical laboratory.