全自动核酸提取及荧光定量多聚酶链式反应分析系统对HBV-DNA试剂盒检测性能的验证及评价  

Verification and evaluation of detection performance of HBV-DNA kit by automatic nucleic acid extractor and fluorescence quantitative polymerase chain reaction analysis system

作　　者：史露宾 毛逸琪 李世宝 马萍 SHI Lubin;MAO Yiqi;LI Shibao;MA Ping(Medical Technology Institute,Xuzhou Medical University,Xuzhou Jiangsu 221000;Department of Laboratory Medicine,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：《临床与病理杂志》2022年第2期263-273,共11页Journal of Clinical and Pathological Research

基　　金：青苗人才(2019128014)。

摘　　要：目的:评估全自动核酸提取仪及荧光定量多聚酶链式反应(polymerase chain reaction,PCR)分析系统Anadas9850检测乙型肝炎病毒核酸(HBV-DNA)的性能。方法:根据美国临床实验室标准化协会(Clinical and Laboratory Standards Institution,CLSI)批准指南,对全自动核酸提取及荧光PCR分析系统Anadas9850检测HBV-DNA试剂盒进行性能评估实验,包括精密度、正确度、线性实验、最低检测限、抗干扰能力。结果:在精密度方面,批内精密度高值、低值CV分别是1.71%和2.64%,批间精密度高值、低值CV分别是2.40%和2.61%;在正确度方面,标本检测结果对数值与给定的质控品靶值的对数值差值在±0.4个log值;线性检测范围,在50~5.0×10^(8) U/mL的梯度范围具有良好的线性,线性回归方程为Y=0.9385X+0.2552,R^(2)=0.9986;在最低检出限方面,实验结果的检出率为100%,符合检出要求;在抗干扰能力方面,溶血、高血脂、高胆红素对检测结果无影响。结论:全自动核酸提取及荧光PCR分析系统Anadas9850检测HBV-DNA的各项性能参数均符合临床检测的要求,可以在临床检测中使用。Objective:To evaluate the performance of automatic nucleic acid extractor and fluorescence quantitative polymerase chain reaction(PCR)analysis system Anadas9850 for detection of hepatitis B virus nucleic acid(HBV-DNA).Methods:According to the guidelines approved by the Clinical and Laboratory Standards Institution(CLSI),the performance verification of the automatic nucleic acid extractor and fluorescence PCR analysis system Anadas9850 for detection of HBV-DNA kit was carried out,including precision,accuracy,linear test,minimum detection range and anti-interference ability.Results:In terms of precision,the coefficient of variations(CVs)of high and low intra-batch precision were 1.71%and 2.64%respectively.The high and low CVs of inter-batch precision were 2.40%and 2.61%,respectively.In terms of accuracy,the difference between the logarithmic value of the test result of the sample and the quality control target value was±0.4 in log value.It had good linearity in the gradient range of 50 to 5.0×10^(8) U/mL.The linear regression equation was Y=0.9385X±0.2552,R^(2)=0.9986.The minimum detection rate of the experimental results was 100%,which met the detection requirements.In terms of anti-interference ability,hemolysis,hyperlipidemia,and high bilirubin had no effect on the test results.Conclusion:The performance of automatic nucleic acid extractor and fluorescence PCR analysis system Anadas9850 for detection of hHBV-DNA meets the requirements of clinical detection and can be used in clinical detection.

关 键 词：乙型肝炎病毒 乙型肝炎病毒核酸 精密度 实时荧光定量多聚酶链式反应 性能验证 

分 类 号：R446.1[医药卫生—诊断学] R512.62[医药卫生—临床医学]