乙型肝炎病毒DNA定量检测室内质控品的制备与评价

目的自制乙型肝炎病毒DNA(HBV-DNA)临界阳性、强阳性和阴性3个水平的室内质控品,对其临床检验实际应用价值进行初步评价。方法收集日常工作中HBV-DNA强阳性、临界阳性和阴性标本,分别混合后分装冷冻于-80℃,按方法学评价进行均一性、重复性、准确性和稳定性研究。结果自制HBV-DNA3个水平室内质控品的均一性、重复性、准确性均达到实验要求;15个月的自制质控品均数(x珋)、标准差(s)、变异系数(CV)差异无统计学意义,稳定性好,符合检测项目质控要求。结论自制HBV-DNA3个水平的质控品具有良好的均一性、重复性、准确性和稳定性,可用于HBV-DNA室内质控。

Preparation and evaluation on self-made internal quality control of HBV DNA

Objective To explore and prepare self-made internal quality control for clinical examination of HBV DNA.Methods The mixed plasma was collected from HBV patients with critical positive,strong positive and negative specimens,mixed packing and frozen at-80℃.The homogeneity,reproducibility,accuracy and stability were observed according to the methodology evaluation.Results The homogeneity,reproducibility,accuracy of the self-made internal quality control had reached the experimental requirements.Within 15 months,the mean(X),standard deviation(SD),coefficient of variation(CV) of the three level of self-made internal quality control for HBV DNA showed no significant difference.Conclusion Self-made internal quality control for HBV DNA has high homogeneity,reproducibility,accuracy and stability,and it can be used for internal quality control and meet with the requirements.