摘要
目的评价磁珠法核酸提取的HBV-DNA定量试剂(以下简称“磁珠法”)性能是否符合ISO15189实验室认可及临床诊断要求。方法使用高敏乙型肝炎病毒脱氧核糖核酸定量检测试剂盒(湖南圣湘生物科技有限公司),采用磁珠法提取核酸进行正确度、精密度、线性范围、可报告范围、抗干扰能力等的检测性能评价。结果磁珠法定量检测HBV-DNA项目重复性精密度<3/5TEa,中间精密度<4/5TEa(以室间质评评价界限靶值对数值±0.4作为允许总误差(TEa)),正确度与室间质评结果靶值偏倚的绝对值<7.5%;线性范围a值在1±0.05范围内,相关系数r^(2)≥0.95;可报告范围偏倚的绝对值≤20%,抗干扰实验结果与正常标本的检测结果在±0.4 Log内。结论高敏乙型肝炎病毒脱氧核糖核酸定量检测符合临床的检测需求。
Objective To evaluate whether the performance of HBV DNA quantitative reagent extracted by magnetic bead method(the magnetic beads method)meets the requirements of the ISO15189 quality certification and clinical applications.Methods The nucleic acid was extracted by magnetic beads with highly sensitive hepatitis B virus DNA quantitative detection kit.The accuracy,precision,linear range,reportable range and anti-interference ability were evaluated.Results The repeatability precision of magnetic bead method for quantitative detection of HBV-DNA was less than 3/5 TEa.and the intermediate precision was less than 4/5 TEa(0.4log Kow of the target value of external quality assessment as total allowable error,TEa).The absolute value of accuracy and the bias of external quality assessment was less than 7.5%.The a value of linear range was in the range of 1±0.05,The correlation coefficient r^(2) was greater than or equal to 0.95.The bias of reporting range was less than 20%.The results of the anti-interference experiment and the normal specimens were within±0.4 Log.Conclusion The quantitative detection of highly sensitve hepatitis B virus DNA meets the needs of clinical detection.
作者
梁小燕
何学虎
张玉英
师志云
赵倩颖
韩朝阳
郭雅琪
马婷婷
董洁
赵玥
赵志军
LIANG Xiaoyan;HE Xuehu;ZHANG Yuying;SHI Zhiyun;ZHAO Qianying;HAN Chaoyang;GUO Yaqi;MA Tingting;DONG Jie;ZHAO Yue;ZHAO Zhijun(Medical Experimental Center,General Hospital of Ningxia Medical University,Yinchuan 750004,China;Key Laboratory of Clinical Pathogenic Microbiology of Ningxia,Yinchuan 750004,China)
出处
《宁夏医学杂志》
CAS
2022年第2期133-135,共3页
Ningxia Medical Journal
关键词
乙肝病毒
磁珠法
临床检测
HBV-DNA
Method of magnetic beads
Clinical-test
