磁敏免疫法与化学发光法检测心肌肌钙蛋白I方法与性能比较  

A Comparison of the Methods and Properties of Magnetic-Sensitive Immunoassay and Chemiluminescence in the Detection of Cardiac Troponin I

作　　者：侯立安[1] 夏良裕[1] 嵇巍[1] 徐二木[1] 刘茜[1] 刘荔[1] HOU Li′an;XIA Liangyu;JI Wei;XU Ermu;LIU Qian;LIU Li(Department of Clinical Laboratory,Peking Union Medical College Hospital,Chinese Academy of Mdeical Sciences & Peking Union Medical College,Beijing 100730,China)

机构地区：[1]中国医学科学院北京协和医院检验科,北京100730

出　　处：《标记免疫分析与临床》2020年第10期1745-1749,共5页Labeled Immunoassays and Clinical Medicine

基　　金：国家高技术研究发展计划(863计划)子课题(编号:2011AA02A111)。

摘　　要：目的评价磁敏免疫法检测cTnI的分析性能以及与化学发光法检测结果的可比性。方法选择cTnI水平在参考区间上限附近、低、中和高水平的4类样本,用理邦m16磁敏免疫分析仪进行连续测定,评价检测系统参考范围处精密度、不同批号测试卡精密度和不同仪器的精密度。检测20例表观健康人进行参考区间验证。收集西门子Dimension EXL分析系统检测cTnI后患者剩余肝素锂抗凝血浆102例,用理邦m16进行检测,比较两个检测系统结果的相关性和一致性。结果参考范围上限精密度CV在5.7%~8.0%之间。不同批号测试卡在三个水平cTnI检测中不精密度CV在3.4%~9.7%之间,低水平不精密度高于其他两个水平。测试卡在高、中、低三个水平的总不精密度分别为9.3%、4.1%和4.8%。两台不同仪器的低、中、高三水平的平均不精密度为8.6%、3.9%和4.6%。磁敏免疫分析法与化学发光法结果的相关系数r为0.9959。磁敏免疫分析临床诊断的阳性和阴性符合率均为100%。结论磁敏免疫法检测cTnI的分析精密度符合要求,临床诊断性能与本实验室当前在用的化学发光法一致。Objective To evaluate the performance of magnetic sensitive immunoassays to detect cTnI,and to analyze the relevance and consistency of the results between magnetic sensitive immunoassays and chemiluminescence assays.Methods Four classes of cTnI samples were selected,with concentrations including:near the upper limit of the reference interval,low,mediate and high levels.The samples were measured continuously by m16 magnetic sensitive immunoanalyzer to evaluate the precision at the reference range of the test system,the precision of different batch number test cards and the precision of different instruments.The serum of 20 healthy individuals was selected to verify the reference range of magnetic sensitive immunoassay.The remaining lithium heparin anticoagulant plasma of 102 patients after the detection of cTnI by Siemens Dimension EXL analysis system were collected.The samples were detected by m16 magnetic sensitive immunoanalyzer.We then compared the correlation and consistency of the results of the two detection systems.Results The CV of the upper limit of the reference range was between 5.7%and 8.0%.The inter-run CV of the test card in three levels was between 3.4%and 9.7%,and the low level of imprecision was higher than the other two levels.The total CV of the test card were 9.3%,4.1%and 4.8%at the three levels of high,medium and low.For low,medium and high levels,total CV of two different instruments were 8.6%,3.9%and 4.6%.The correlation coefficient r of the results of magnetic sensitivity immunoassay and chemiluminescence assay was 0.9959.The positive and negative coincidence rate of the clinical diagnosis of magnetic sensitivity immunoassay was 100%.Conclusion The precision of magnetic sensitive immunoassay for cTnI detection meets the requirements,and the clinical diagnostic performance is consistent with the chemiluminescence method,which is currently used in our laboratory.

关 键 词：磁敏免疫分析 心肌肌钙蛋白I 化学发光法 床旁快速检测 

分 类 号：R446.1[医药卫生—诊断学]