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作 者:周齐洋 廉倩倩 梁辰[3] 冯杰[3] 颜光涛[3] ZHOU Qiyang;LIAN Qianqian;LIANG Chen;FENG Jie;YAN Guangtao(Jiangsu Institute of Medical Device Testing,Nanjing 210012,China;Suzhou Hybiome Biomedical Engineering Co.,LTD,Suzhou 215163,China;Department of Clinical Laboratory Medicine,The First Medical Center of the PLA General Hospital,Beijing 100853,China)
机构地区:[1]江苏省医疗器械检验所,江苏南京210012 [2]苏州长光华医生物医学工程有限公司,江苏苏州215163 [3]解放军总医院第一医学中心医学检验中心,北京100853
出 处:《标记免疫分析与临床》2020年第10期1756-1760,共5页Labeled Immunoassays and Clinical Medicine
基 金:国家科技支撑计划(编号:2015BAK45B01)。
摘 要:目的建立一种双抗体夹心法定量检测人尿液中中性粒细胞明胶酶相关脂质运载蛋白(neutrophil gelatinase associated lipocalin,NGAL)的化学发光免疫分析方法。方法以磁颗粒-链酶亲和素-生物素为固相分离系统,生物素标记1株鼠单抗-NGAL,吖啶酯标记另1株鼠单抗-NGAL,建立NGAL定量免疫分析方法。结果此分析方法功能灵敏度高于3ng/mL;批内不精密度不超过5%,批间不精密度不超过8%;线性范围为10~1500ng/mL;参考区间上限为130ng/mL;尿液样本中可能存在的干扰物如丙酮、白蛋白、胆红素等对结果的干扰不超过5%;尿液样本2~8℃常规储存1~3周检测水平变化幅度小于20%;与Abbott的NGAL免疫试剂相比,斜率达0.9611,相关系数0.9938。结论该NGAL化学发光定量检测方法,性能优良,适合临床推广使用。Objective To develop a double antibody sandwich chemiluminescence quantitative immunoassay for neutrophil gelatinase associated lipocalin in human urine samples.Methods Using magnetic particle-streptavidin-biotin as the solid-phase separation system,one mouse monoclonal antibody-NGAL was labeled with biotin,while another mouse monoclonal antibody-NGAL was labeled with acridine ester,and a quantitative immunoassay method for NGAL was established.Results The functional sensitivity of this assay was below 3 ng/mL,the intra-batch and total precision were less than 5%and 8%,the linear range was 10-1500 ng/mL,and the upper limit of reference interval was 128 ng/mL.Increased concentrations of other components(acetone,albumin,bilirubin,etc)in urine samples caused no more than 5%cross-interference.The range of the variation of urine samples detection concentration was less than 20%under the condition of 2-8℃for 1-3 weeks.When compared with the results of Abbott NGAL assay,the slope was 0.9611 and the correlation coefficient was over 0.9938.Conclusion The studied NGAL chemiluminescence quantitative detection method has an excellent performance and is suitable for clinical applications.
关 键 词:中性粒细胞明胶酶相关脂质运载蛋白 急性肾损伤 肌酐 尿样储存稳定性
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