利用EP5-A2文件的方法评价实时荧光定量PCR检测HBV DNA的精密度  

Evaluation on the Precision of Real-time PCR for Detection of Hepatitis B virus DNA with EP5-A2 Proposal Document

作　　者：凡任芝[1] 沈佐君[1] 

机构地区：[1]安徽省立医院临床检验中心,合肥230001

出　　处：《临床输血与检验》2015年第2期139-141,共3页Journal of Clinical Transfusion and Laboratory Medicine

摘　　要：目的评价本实验室荧光定量PCR方法(Real-time PCR)测定HBV DNA结果的精密度。方法按照美国临床实验室标准化协会(CLSI)EP5-A2文件C1附录要求,对浓度约为107(copies/ml)(S7)、105(copies/ml)(S5)和103(copies/ml)(S3)样本,评价其精密度。结果 S7、S5、S3的批内精密度CV值分别为2.022%、3.682%、4.469%,总精密度的CV值分别为4.037%、4.452%、7.090%。结论本检测系统的精密度情况符合试剂厂商声明要求,可以满足临床需求。Objective To evaluate the precision of Real-time PCR for detection and quantification of hepatitis B virus（HBV）DNAs.Methods Clinical specimens containing 107（S7）,105（S5）,103（S3）copies per ml approximately were evaluated according to CLSI EP5-A2 Proposal document Appendix C1.Results The precision coefficients of variation for S7,S5,S3 samples were 2.022%,3.682%,and 4.469%,totally,4.037%,4.452%,and 7.090% respectively.Conclusion The precision is consistent with the reagent manufacturer declaration,and meets the requirements for clinical use.

关 键 词：EP5-A2 精密度 实时荧光定量PCR 

分 类 号：R392.11[医药卫生—免疫学] R512.63[医药卫生—基础医学]