高敏乙型肝炎病毒核酸定量检测系统的性能验证  

Performance verification of high-sensitivity hepatitis B virus nucleic acid quantitative detection system

作　　者：肇玉博 王大望 冯飞雪 王战争 周嘉迪 马艳侠 Zhao Yubo;Wang Dawang;Feng Feixue;Wang Zhanzheng;Zhou Jiadi;Ma Yanxia(Department of Laboratory Medicine,Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine,Xianyang 712000,China;不详)

机构地区：[1]陕西中医药大学附属医院检验科,咸阳712000 [2]陕西中医药大学医学技术学院

出　　处：《山西医药杂志》2020年第20期2727-2730,共4页Shanxi Medical Journal

基　　金：陕西省社会发展科技攻关项目(2017SF-230)。

摘　　要：目的验证DA3200-ABI7500全自动核酸检测平台高敏乙型肝炎病毒(HBV)-DNA定量检测性能。方法参考美国临床实验室标准化协会批准指南(CSLI-EP),通过定量检测HBV-DNA评价检测方法的精密度、正确度、线性范围、最低检出限、抗干扰能力和抗污染能力性能指标。结果精密度:高、低2个浓度样本的批间和批内精密度变异系数(CV)均≤5%;正确度:对5例国家卫健委临检中心室间质评样本和4例标准物质检测,实测值与靶值之间的偏差均≤±0.41 g;线性范围:对9个浓度的线性样本进行测定,线性范围为19.5^(1.95×109)U/mL,线性方程:Y=0.156 7+1.004 8 X(b=1.004 8,R2=0.999 6);检测能力方面,验证该系统的最低检出限为20 U/mL;抗干扰能力方面,对含20 g/L血红蛋白、300 mg/L胆红素、30 000 mg/L甘油三酯的样本进行检测,实测值与预期值之间的偏差≤±0.41 g;抗污染能力方面,高浓度阳性样本和阴性样本间隔放置,检测结果均符合预期。结论基于DA3200-ABI7500全自动核酸检测平台的高敏HBV-DNA定量检测各项分析性能指标均较好,可为临床提供更加可靠、准确的数据。Objective To verify the performance of DA3200-ABI7500 automatic nucleic acid testing platform for highly sensitive HBV-DNA quantitative detection.Method Referring to American standard CLSI-EP,the precision,accuracy,linear range,minimum detection limit,anti-interference ability and anti-pollution ability of the detection method were evaluated by quantitative detection of HBV-DNA.Results Precision:the CV of inter assay and intra assay precision of high and low concentration samples were less than or equal to 5%.Accuracy:the deviation between the measured value and the target value was less than±0.41 g for 5 cases of external quality assessment samples of National Health Commission clinical examination center and 4 cases of reference materials.Linear range:9 concentrations of linear samples were determined,the linear range was 19.5-1.95×109/U/mL,and the linear equation was Y=0.1567+1.0048 X(b=1.0048,R2=0.9996).In terms of detection ability,the minimum detection limit of the system is 20 U/ml;in terms of anti-interference ability,the samples containing 20 g/L hemoglobin,300 mg/L bilirubin and 30000 mg/L triglyceride were detected,and the deviation between the measured value and the expected value is less than±0.41 g.In terms of anti-pollution ability,the test results of high concentration positive samples and negative samples were all in line with the expectation.Conclusion High sensitivity HBV-DNA quantitative detection based on da3200-abi7500 automatic nucleic acid detection platform has good performance indicators,which can provide more reliable and accurate data for clinical application.

关 键 词：乙型肝炎病毒 检测限 

分 类 号：R512.62[医药卫生—内科学]