荧光定量PCR检测巨细胞病毒DNA试剂盒的性能验证及评价  

Performance verification and evaluation of fluorescence quantitative PCR kit for detection of cytomegalovirus DNA

作　　者：朱舜华 李世宝 ZHU Shunhua;LI Shibao(Medical Technology Institute,Xuzhou Medical University,Xuzhou,Jiangsu 221000,China;Department of Clinical Laboratory,Affiliated Hospital of Xuzhou Medical University,Xuzhou,Jiangsu 221000,China)

机构地区：[1]徐州医科大学医学技术学院,江苏徐州221000 [2]徐州医科大学附属医院检验科,江苏徐州221000

出　　处：《检验医学与临床》2021年第16期2385-2388,共4页Laboratory Medicine and Clinic

基　　金：中国博士后科学基金项目(2020M670076ZX)。

摘　　要：目的对实验室新开展项目巨细胞病毒核酸(CMV-DNA)进行性能验证。方法采用荧光定量PCR仪检测CMV-DNA含量,对精密度、检出限、正确度、线性范围进行验证及评价。结果CMV的高浓度和低浓度样本批内与批间精密度的变异系数(CV)平均值均<5%,符合规定标准。检出限验证时,重复检测浓度为(1.00E+03)copy/mL,检出率为100%,符合要求。正确度线性R 2为0.9987,在(2.40E+03)~(2.26E+07)copy/mL范围内,线性关系良好,符合要求。结论CMV-DNA试剂盒的主要性能指标已达到相关标准的要求,可在临床上应用。Objective To verify the performance of cytomegalovirus nucleic acid(CMV-DNA),a new project of the laboratory.Methods The CMV-DNA content was detected by fluorescence quantitative PCR,and the precision,detection limit,accuracy and linear range were verified and evaluated.Results The average coefficient of variation(CV)of intra-batch and inter-batch precision of high-concentration and low-concentration CMV samples was less than 5%,which met the prescribed standards.When the detection limit was verified,the repeated detection concentration was(1.00E+03)copy/mL,and the detection rate was 100%,meeting the requirements.Accuracy linear correlation coefficient R 2=0.9987,The linear relationship between(2.40E+03)-(2.26E+07)copy/mL was good,meeting the requirements.Conclusion The main performance indexes of the CMV-DNA kit have reached the requirements of relevant standards,and can be applied in clinical practice.

关 键 词：巨细胞病毒DNA 精密度 检出限 正确度 线性范围 

分 类 号：R446[医药卫生—诊断学]