均相酶免疫技术检测血清利奈唑胺浓度的方法学建立  

The Establishment of Homogeneous Enzyme Immunoassay Method for Serum Linezolid Measurement

作　　者：王坤[1] 燕文敬 冯杰[2] 李玉茹[1] 陆丽华 高艳红[2] 颜光涛[2] WANG Kun;YAN Wenjing;FENG Jie;LI Yuru;LU Lihua;GAO Yanhong;YAN Guangtao(Department of Clinical Laboratory Center,the Second Medical Center&National Clinical Research Center for Geriatric Diseases,Chinese PLA General Hospital,Beijing 100853,China;Department of Clinical Laboratory Center,the First Medical Center ofthe PLA General Hospital,Beijing 100853,China;Suzhou Evermed Biomedical Co.,Ltd,Suzhou 215163,China)

机构地区：[1]解放军总医院第二医学中心国家老年疾病临床研究中心,北京100853 [2]解放军总医院第一医学中心,北京100853 [3]苏州博源医疗科技有限公司,江苏苏州215163

出　　处：《标记免疫分析与临床》2022年第4期682-686,共5页Labeled Immunoassays and Clinical Medicine

基　　金：国家重点研发计划课题子课题(编号:2017YFF0205401)。

摘　　要：目的基于均相酶免疫技术检测血清利奈唑胺的浓度。方法收集2021年6月至10月于解放军总医院第一医学中心服用利奈唑胺药物患者的血清标本,用本研究建立的均相免疫方法检测标本中利奈唑胺浓度,参照CLSI EP文件对该方法进行正确度、精密度、线性范围、可报告范围的验证,同时与厂家声明的性能标准作比较;将质谱仪检测与本方法进行方法学比对。结果正确度验证方面,5份参考物偏倚百分比均小于12.5%,验证通过;精密度验证方面,高、低水平标本检测结果批内CV≤6.25%,批间CV≤8.33%,验证通过;检测线性范围为1.2~22.0μg/mL,厂家声明的线性范围为1.2~20.0μg/mL;临床可报告范围上限为60.0μg/mL;携带污染率小于1%;与质谱仪检测结果的相关系数为0.984。结论该检测方法适用于临床血清利奈唑胺浓度的检测。Objective To detect the concentration of serum linezolid by homogeneous enzyme immunoassay.Methods Serum samples of patients taking linezolid in the First Medical Center of the PLA General Hospital from June,2021 to October,2021 were collected for the study.The concentration of linezolid in these samples was detected by the homogeneous immune method established in this study.The correctness,precision,linear range and reportable range of the method were verified with reference to CLSI EP documents,and compared with the performance indexes declared by the manufacturer;And we also compared the mass spectrometer detection with this method.Results In terms of accuracy verification,the bias percentage of the five references was less than 12.5%;In terms of precision verification,the test results of high-level and low-level samples showed an intra batch CV≤6.25%and an inter batch CV≤8.33%;The detection linear range was 1.2-22.0μg/mL,and the linear range declared by the manufacturer was 1.2-20.0μg/mL;The upper limit of clinical reportable range was 60.0μg/mL;The carrying pollution rate was less than 1%;The correlation coefficient with the results of mass spectrometer was 0.984.Conclusion The developed method in the current study is suitable for the serum linezolid measurement in clinical serum samples.

关 键 词：利奈唑胺 均相酶免疫技术 药物浓度监测 

分 类 号：R-331[医药卫生]