摘要
目的验证化学发光法定量检测抗线粒体M2体(AMA-M2)、抗肝细胞浆Ⅰ型抗原抗体(LC-1)、抗肝肾微粒体抗体Ⅰ型(LKM-1)及抗可溶性肝抗原/抗胰抗原抗体(SLA/LP)的分析性能。方法保证室内质控在控的情况下,参考美国临床和实验室标准协会(CLSI)的相关文件参考相关文件,对AMA-M2、LC-1、LKM-1及SLA/LP的精密度、线性范围和生物参考区间进行试验分析,同时比较免疫印迹法(LIA)和化学发光法(CLIA)结果的一致性,差异样本则用欧蒙酶联免疫吸附法(ELISA)进行复测,其结果与厂家或公认质量目标进行比较。结果批内精密度的变异系数(CV)和批间的精密度变异系数(CV)均小于厂家声称的值:≤15%;线性回归方程的相关系数r2处于0.9878~0.9966,b在(1±0.05)范围内;方法学对比结果显示化学发光法(CLIA)与免疫印迹法(LIA)结果差异无统计学意义(P>0.05);参考区间符合率≥95%,以上结果均符合厂家声称指标或质量要求。结论化学发光检测平台检测AMA-M2、LC-1、LKM-1及SLA/LP的分析性能符合实验室的质量管理要求,结果可靠,能满足临床的应用需求,相对于传统印记法具有自动、全定量和检测时间短等优势。
Objective To verify the analytical properties of anti-mitochondrial M2 antibody(AMA-M2),anti-hepatocyte plasma type I antigen antibody(LC-1),anti-liver and kidney microsomal antibody type I(LKM-1)and anti-soluble liver antigen/anti-pancreatic antigen antibody(SLA/LP).Methods Refer to the American Society of Clinical and laboratory standards(CLSI)for documentation to ensure internal quality control,the precision,linear range and biological reference interval of AMA-M2,LC-1,LKM-1 and SLA/LP were analyzed.The results of immunoblotting(LIA)and chemiluminescence(CLIA)were compared,the difference samples were retested with ELISA,and the results were compared with the manufacturer or recognized quality objective.Results The coefficient of variation(CV)of intra-and inter-lot precision were less than the manufacturer claimed:≤15%;The correlation coefficient R2 of linear regression equation is in the range of 0.9878-0.9966,b is in the range of 1±0.05.The results showed that there was no significant difference between CLIA and LIA,and the difference was not statistically significant(P>0.05);the coincidence rate of reference interval was more than 95%,and the above results were in accordance with the claims of manufacturers.Conclusion The analytical performance of chemiluminescence detection platform for AMA-M2,LC-1,LKM-1 and SLA/LP meet the requirements of quality management in the laboratory,the results are reliable and can meet the needs of clinical application,compared with the traditional imprinting method,it has the advantages of automatic,quantitative and short detection time.
作者
侯倩倩
李冠武
陈皓
黄良
付燕
徐文强
宗鸣
王瑛
HOU Qianqian;LI Guanwu;CHEN Hao;HUANG Liang;FU Yan;XU Wenqiang;ZONG Ming;WANG Ying(Jiangsu Haooubo Biomedical Co.,Ltd.,Shanghai 200335,China;Department of Radiology,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China;Department of Laboratory Medicine,The Fourth People's Hospital,Tongji University,Shanghai 200434,China)
出处
《国际检验医学杂志》
CAS
2021年第S02期105-109,共5页
International Journal of Laboratory Medicine
关键词
化学发光
自身免疫性肝病
性能评估
chemiluminescence
Autoimmune liver disease
quantitative detection
作者简介
通信作者:王瑛,E-mail:gongzhuying@126.com。
