吖啶酯标记建立血清透明质酸磁微粒化学发光检测方法  

The Establishment of a Serum Hyaluronic Acid Magnetic ParticleChemiluminescence Assay with Acridinium Ester Labeling

作　　者：吕东川 贺敏 李竹青 赵燕丽 LYU Dongchuan;HE Min;LI Zhuqing;ZHAO Yanli(Beijing North Institute of Biological Technology Co.,Ltd.,Beijing 100076,China)

机构地区：[1]北京北方生物技术研究所有限公司,北京100076

出　　处：《标记免疫分析与临床》2022年第3期478-482,500,共6页Labeled Immunoassays and Clinical Medicine

摘　　要：目的建立以吖啶酯为标记物检测透明质酸(HA)的磁微粒化学发光免疫分析方法。方法采用吖啶酰肼标记的HA作为示踪物,通过抗体将透明质酸结合蛋白固定在磁微粒上,建立了基于竞争法原理的免疫分析方法,研究了该方法的空白限、检出限、线性范围、重复性、批间差、回收率、和抗干扰能力,建立了正常人参考区间,并与放射免疫分析药盒的检测结果进行了比对。结果空白限为6.95ng/mL,检出限为16.97ng/mL,线性范围为25-1000ng/mL,重复性CV小于4%,批间差CV小于5%,平均回收率95.9%,血红蛋白浓度<2.5mg/mL、胆红素浓度<0.3mg/mL、中长链脂肪乳<10mg/mL时对血清样本测量无干扰,正常人参考区间为<106.6ng/mL。检测84例临床血清标本,与放射免疫分析药盒的相关性为0.972。结论成功建立了HA化学发光免疫分析法,可以满足临床诊断的要求。Objective To establish a magnetic particle chemiluminescence immunoassay method for the detection of hyaluronic acid(HA)using acridinium ester as a marker.Methods A competitive immunoassay procedure was established using acridine hydrazide labeled HA as a tracer and hyaluronic acid binding protein immobilized on magnetic particles by antibodies.LoB,LoD,linear range,repeatability,inter-batch difference,recovery,and anti-interference ability of the method were obtained,and the normal human reference interval was established and compared with the test results of the RIA kit.Results All evaluated parameters were as following:LoB was 6.95ng/mL,the LoD was 16.97ng/mL,the linear range was 25-1000ng/mL,the repeatability CV was less than 4%,the inter-batch variation CV was less than 5%,and the average recovery was 95.9%.The assay was unaffected by hemoglobin<2.5mg/mL,bilirubin<0.3mg/mL,medium and long-chain fat emulsion<10mg/mL.The reference interval for normal human was<106.6 ng/mL.84 clinical serum specimens were tested,and the correlation with the RIA kit was 0.972.Conclusion HA chemiluminescence immunoassay is successfully established,and can meet the requirements of the clinical diagnosis.

关 键 词：透明质酸 吖啶酯 全自动化学发光 

分 类 号：R-331[医药卫生]