摘要
目的:研发一种S100B蛋白新型检测试剂及仪器,为颅脑创伤疾病的诊疗提供参考。方法:将S100B蛋白单克隆抗体与生物素(Biotin)、S100B蛋白抗体与辣根过氧化物酶(HRP)、链霉亲和素与羧基磁珠分别按照一定比例进行交联并稀释,制备R1、R2、R0试剂,再用校准品稀释液稀释S100B蛋白抗原制备校准品。S100B蛋白新型检测仪器由试剂模块、反应模块、清洗模块、检测模块4个部分组成,具体由试剂盘、样本盘、磁微粒盘、装载台、反应盘、清洗盘和检测盘构成。结果:成功制备了用于颅脑创伤患者S100B蛋白检测的新型试剂,研发了配套的化学发光免疫分析仪器,实现了加样、反应、清洗、检测的模块化和自动化。经过临床测试,该试剂和仪器可以准确获得S100B蛋白的浓度。结论:S100B蛋白新型检测试剂和仪器可以提供S100B蛋白的快速批量检测,将为颅脑创伤病情的判断提供重要保证。
Objective To develop a new type of reagent and instrument for S100B protein detection to facilitate the diagnosis and treatment of traumatic brain injury(TBI).Methods R1,R2 and R0 reagents were prepared by crosslinking and diluting S100B protein monoclonal antibody with Biotin,S100B protein with horseradish peroxidase(HRP)and streptavidin with carboxyl magnetic beads in a certain proportion,then the calibrator was made by diluting S100B protein antigen with the dilutor.S100B protein detecting instrument fell into four modules for reagent,reaction,cleaning and detection,which was composed of the reagent disk,sample disk,magnetic beads disk,loading table,reaction disk,cleaning disk and detection disk.Results A new reagent for the detection of S100B protein in TBI patients was successfully prepared,and a complete set of chemiluminescent immunoassay instrument was developed to realize modularization and automation of sample addition,reaction,cleaning and detection.Clinical trial showed the reagent and instrument could accurately obtain the concentration of S100B protein.Conclusion The reagent and instrument developed can be used for rapid batch S100B protein detection,and thus can facilitate the diagnosis of traumatic brain injury.[Chinese Medical Equipment Journal,2019,40(3):15-18,22]
作者
代晨
王琦
江继鹏
杜振华
汪云峰
陈凯歌
陈旭义
战丽
张赛
靳颖
DAI Chen;WANG Qi;JIANG Ji-peng;DU Zhen-hua;WANG Yun-feng;CHEN Kai-ge;CHEN Xu-yi;ZHAN Li;ZHANG Sai;JIN Ying(Key laboratory of Neurotrauma Repair of Tianjin,Institute of Brain Trauma and Neurology Disease,Cerebral Surgery Center of Affiliated Hospital of Logistics University of the Chinese People's Armed Police Force,Tianjin 300162,China;Medical Unit of the Twelfth Division,Beijing Corps of the Chinese People's Armed Police Force,Tianjin 300481,China;Clinical Laboratory,Affiliated Hospital of Logistics University of the Chinese People's Armed Police Force,Tianjin 300162,China;Bioscience(TianJin)Diagnostic Technology Company Limited,Tianjin 300300,China;Teaching Evaluation Center,Logistics University of the Chinese People's Armed Police Force,Tianjin 300162,China)
出处
《医疗卫生装备》
CAS
2019年第3期15-18,22,共5页
Chinese Medical Equipment Journal
基金
天津市救援医学临床中心基金(15ZXLCSY00040)
国家科技重点研发计划(2016YFC1101500)
国家自然科学基金面上项目(11672332)
天津市科技支撑计划重点项目(17YFZCSY00620)
天津市应用基础与前沿技术研究计划(15JCYBJC28600)
关键词
纳米磁微粒
化学发光
S100B蛋白
颅脑创伤
试剂
检测仪
nano-magnetic particle
chemiluminescence
S100B protein
traumatic brain injury
reagent
detecting instrument