HBV-DNA质控物的制备及评价  

Preparation and Evaluation of the Quality Control Materials of HBV-DNA

作　　者：胥明勇[1] 胡冬[1] 朱华强[1] 

机构地区：[1]绵阳市中心医院,四川绵阳621000

出　　处：《四川医学》2015年第1期32-34,共3页Sichuan Medical Journal

摘　　要：目的制备HBV-DNA荧光定量PCR质控物,评价其均匀性及稳定性。方法利用混合血清样本制备质控物。依据《能力验证样品均匀性和稳定性评价指南》和ISO Guide 35标准随机抽取足够的样本,采用单因子方差分析评价质控物均匀性;用一元线性回归分析评价质控物的稳定性。结果均匀性评价结果显示样品内和样品间均匀性差异无统计学意义(P>0.05),稳定性评价线性回归分析结果显示,HBV-DNA质控物随时间变化无明显趋势变化(P>0.05)。结论 HBV-DNA质控物制备简单,其均匀性、稳定性符合标准。Objective To prepare quality control Materials of HBV-DNA used in real-time PCR,To evaluate the homoge-neity and stability of it. Methods The quality control materials which prepared with pooled serum. According to Guidance on E-valuating the Homogeneity and Stability of Samples Used for Proficiency Testing and ISO Guide 35,we selected adequate sample at random, then evaluated the homogeneity of the control material by a one-way analysis of variance. At last the stability of the control material was evaluated using a linear regression model. Results In the homogeneity evaluation the results show that there is insig-nificant difference of the within groups and bet ween groups（P〉0. 05）,A linear regression based on stability evaluation indicated that the linear trend was insignificant（P〉0. 05）. Conclusion Quality control materials of HBV-DNA have simple preparation,by us meet the needs of the homogeneity and stability of the control material.

关 键 词：HBV—DNA 质控物 均匀性 稳定性 

分 类 号：R943[医药卫生—药剂学]