HBV-DNA全自动检测系统的性能验证  

Verifying the performance of HBV-DNA automatic detection system

作　　者：张帅 黄静[1] 李俊如[1] 徐凤姣 Zhang Shuai;Huang Jing;Li Junru;Xu Fengjiao(Department of Clinical Laboratory,The First People's Hospital of Liangshan Yi Autonomous Prefecture,Xichang,Sichuan,615000,China;Department of Reporting Centre,Xichang People's Hospital,Xichang,Sichuan,615000,China)

机构地区：[1]凉山彝族自治州第一人民医院检验科,四川西昌615000 [2]西昌市人民医院报账中心,四川西昌615000

出　　处：《当代医学》2020年第11期13-16,共4页Contemporary Medicine

基　　金：四川省卫生和计划生育委员会科研课题(16PJ168);凉山州科学技术和知识产权局科研课题(16YYJS0019)。

摘　　要：目的对国产HBV-DNA全自动核酸提取仪及实时荧光定量PCR试剂(磁珠法)检测性能参数进行验证,评价其是否可应用于临床检测。方法依据CNAS《医学实验室质量和能力认可准则》相关文件对检测系统的精密度、线性范围、检测线、正确度、抗干扰能力、特异性进行性能验证。结果批间及中间精密度CV均<5%,标准差(s)分别<0.24、0.32。线性范围为1.03×102~2.71×107,检测线为100 IU/mL,正确度符合要求(<靶值对数值±0.4)。血红蛋白(≤2 g/dL)、胆红素(≤28 mg/dL)、甘油三脂(≤3000 mg/dL)对检测结果无影响,特异性符合要求。结论本实验室HBV-DNA全自动检测系统符合YY/T 1182—2010《核酸扩增检测用试剂(盒)》要求,可应用于临床检测工作。Objective To verify a domestic HBV-DNA automatic detection system whether it can be applied in clinical measures,based on the performance of the parameters on automatic nucleic acid extractor and real-time fluorescent quantitative reagent PCR(magnetic bead method).Methods According to the relevant document of CNAS"Quality and Capability Recognition Guidelines for Medical Laboratories",the performance of the detection system was empirically observed by the parameters of precision,linear,detection limit,accuracy,anti-interference ability and specificity.Results The within-batch and between-batch precision were both CV<5%,and the standard deviations were respectively less than 0.24 and 0.32;the linear range was from 1.03×102 to 2.71×107;the detection limit was 100 IU/mL;the accuracy value was consistent with the requirement(<target log value±0.4);the value of hemoglobin(≤2 g/dL),bilirubin(≤28 mg/dL),and triglyceride(≤3000 mg/dL)would not impact on the test results;the value of specificity also reached the requirements.Conclusion The performance of HBV-DNA automatic detection system conforms to the requirement of YY/T 1182—2010 Nucleic Acid Amplification test reagents,can be applied to clinical measures.

关 键 词：全自动核酸提取仪 实时荧光定量PCR 乙型肝炎病毒DNA 性能验证 

分 类 号：R512.62[医药卫生—内科学] R440[医药卫生—临床医学]