HBV DNA荧光定量检测方法的性能验证及评价  

Performance verification and evaluation of fluorescent quantitative detection method for HBV DNA

作　　者：陈梅莲[1] 谢丽珠 莫绮雯[1] 李柳燕[1] 谢岭平[1] 方秀珠 CHEN Mei-lian;XIE Li-zhu;MO Qi-wen;LI Liu-yan;XIE Ling-ping;FANG Xiu-zhu(Department of Medical Laboratory,the Affilated Houjie Hospital of Guangdong Medical College,Guandong Province,Dongguan 523945,China)

机构地区：[1]广东医学院附属厚街医院检验科,广东东莞523945

出　　处：《中国当代医药》2021年第22期28-31,共4页China Modern Medicine

摘　　要：目的对乙型肝炎病毒脱氧核糖核酸(HBV DNA)荧光定量检测方法进行性能验证及评价。方法参考《医学实验室质量和能力认可准则在分子诊断领域的应用说明(CNAS-CL36)》及美国临床和实验室标准化协会(CLSI)EP系列文件的相关要求对实验室HBV DNA荧光定量PCR检测方法的精密度、测量正确度、抗干扰能力、线性范围和检测下限等进行验证及评价。结果HBV DNA定量检测低值(1×10^(3) U/mL)、高值(1×10^(6) U/mL)标本的批内CV分别为0.07%和0.06%,批间CV分别为0.11%和0.08%;正确度误差在允许范围内;干扰物(三酰甘油、胆红素、血红蛋白)样本结果与对照样本的偏差≤±lg0.4;在1.45×10^(2)~1.45×10^(9)U/mL范围内线性关系良好(Y=1.042X-0.337,R^(2)=0.997);检测下限可以达到100 U/mL。结论HBV DNA荧光定量检测方法的各项性能指标与厂家声明相符,可用于临床常规检测。Objective To verify performance and evaluation of fluorescent quantitative detection method for hepatitis B virus deoxyribonucleic acid(HBV DNA).Methods According to the requirements of Application of accreditation criteria for quality and competence of medical laboratories in molecular diagnosis(CNAS-CL36)and EP series documents by the Clinical and Laboratory Standards Institute(CLSI),the precision,measurement accuracy,anti-interference ability,linear range and limit of detection of HBV DNA fluorescence quantitative PCR detection system were verified and evaluated.Results The intra assay CV of low(1×10^(3) U/mL)and high(1×10^(6) U/mL)value specimens were 0.07%and 0.06%,respectively,while the inter assay CV were 0.11% and 0.08%,respectively.Its accuracy was within acceptable range.The samples containing triglyceride,bilirubin,hemoglobin were detected,and the deviation between the measured value and the expected value was≤±lg0.4.It exhibited a benign linear relation from 1.45×10^(2)-1.45×10^(9)U/mL(Y=1.042X-0.337,R^(2)=0.997),and the limit of detection was 100 U/mL.Conclusion The performance indexes of the fluorescent quantitative detection method of HBV DNA are consistent with the manufacturer′s statement,which can be used for routine clinical detection.

关 键 词：乙型肝炎病毒 核酸定量 性能验证 荧光定量PCR 

分 类 号：R392.33[医药卫生—免疫学]