自制室内质控品在BK病毒DNA定量检测中的应用  

Clinical application of self-made internal quality control for BKV DNA quantitative detection

作　　者：应葳[1] 戎国栋 赵鸿 张洁心 黄珮珺 王芳[2] 徐婷 陈丹 

机构地区：[1]南京医科大学附属明德医院检验科,211000 [2]南京医科大学第一附属医院检验学部

出　　处：《中华实验和临床病毒学杂志》2015年第6期551-554,共4页Chinese Journal of Experimental and Clinical Virology

基　　金：国家自然科学基金（81371894,81272324,81000754,81101322,81201359）;国家临床重点专科建设项目;江苏高校优势学科建设工程基金项目;江苏省实验诊断学重点实验室基金（XK201114）;教育部博导基金（20113234110012）

摘　　要：目的探讨自制尿液和血清室内质控品用于BKVDNA定量检测室内质量控制的可行性。方法收集含有较高浓度BKVDNA（104-106拷贝／m1）的临床尿液和血清标本，分别充分混匀并分装数管，于-700C冻存。荧光定量PCR测定BKVDNA含量，连续检测20批次。采用“即刻法”、“学生化残差法”分析检测结果，并绘制Levey-Jennings质控图，进行室内质控动态监测。结果“即刻法”分析BKVDNA尿液和血清质控品，每批次检测值的SI上限和SI下限均在控；“学生化残差法”分析BKV尿液和血清质控品，每批次均无离群值。Levey—Jennings质控图显示BKV尿液质控品检测结果，除第四批次外均在警戒线面±2S内（i=6．06，S=0．33，CV=5．45％），血清质控品每批次检测结果均在警戒线x±2S内（x=4．35，S=0．36，CV=8．38％）。结论BKV尿液和血清室内质控品均匀稳定，制备简单，单次制备量大，适用于BKVDNA荧光定量PCR检测的室内质量控制。Objective To investigate the feasibility of the self-made quality control urine and serum as internal quality controls for BKV DNA quantitative detection. Methods Clinical samples of urine and serum with high level BKV DNA （ 104 - 106 copies/ml） were separately collected and uniformly mixed. The mixtures were subpackaged and kept in -70℃, and then 20 batches were tested in succession by fluorescence quantitative PCR. Instant Technique, Studentized Residual and Levey-Jennings quality control charts were used to monitor internal quality control. Results For each batch of BKV internal quality control urine and serum, the upper and lower limits of Separation Index （SI） were under control by Instant Technique,and which also had no outliers by Studentized Residual. Each batch of BKV control serum （x = 4.35, S = 0. 36, CV = 8.38% ） and urine（x = 6.06, S = 0.33, CV = 5.45% ） were below the warning line （ ＋ 2S）at Levey-Jennings quality control chart, except the forth batch of BKV urine control. Conclusions The self-made BKV internal quality control urine and serum samples were suitable for the clinical fluorescence quantitative PCR detection system, which were stable, massive and simple-produced.

关 键 词：BK病毒DNA 荧光定量PCR 室内质量控制 

分 类 号：R440[医药卫生—诊断学]