全量程C-反应蛋白定量检测试剂盒的研制  

On the Development of a Quantitative C-reactive Protein Test Kit

作　　者：谭有将 梁德智 陈静 戴尽波 陈耀 余一海 石星亮 TAN Youjiang;LIANG Dezhi;CHEN Jing;DAI Jinbo;CHEN Yao;YU Yihai;SHI Xingliang(Guangdong Shunde Innovative Design Institute,Foshan Guangdong 528311,China;Guangdong Shunde MorSci BioTech Co.,Ltd,Foshan Guangdong 528311,China;Guangdong Shunde Beijiao Hospital,Foshan Guangdong 528311,China)

机构地区：[1]广东顺德工业设计研究院,广东佛山528311 [2]广东顺德墨赛生物科技有限公司,广东佛山528311 [3]广东省佛山市顺德北滘医院,广东佛山528311

出　　处：《顺德职业技术学院学报》2018年第4期5-8,共4页Journal of Shunde Polytechnic

摘　　要：[目的]基于荧光定量免疫层析技术,开发一种全量程C-反应蛋白(C reactive protein,CRP)定量检测试剂盒。[方法]采用双抗体夹心法,检测人血中的CRP浓度水平。[结果]该方法的灵敏度为0.1 mg/L,线性范围为0.0～150 mg/L,批内变异系数为8.94%～13.39%,批间变异系数为10.0%～16.8%,相对偏差小于10%,40例临床标本的测试结果显示该试剂与国外试剂的测定结果具有良好的相关性,相关系数r>0.97.具有良好的相关性。[结论]建立一种操作简便,灵敏度高,有良好准确性和重复性,线性范围较宽,满足临床检验需求的全量程C-反应蛋白检测试剂盒。[Objective]Based on fluorescent quantitative lateral flow technology,a kind of quantitative C-reactive protein test kit was developed.[Methods]The test kit could quantitatively determine the concentration of CRP in human blood by using double antibody sandwich method.[Results]After the material optimization,the test kit was developed with remarkable performance.Its functional sensitivity is 0.1 mg/L,linear range is 0.0~150 mg/L,intraassay coefficient of variation is between 8.94% and 13.39%,interassay coefficient of variation is between 10.0% and 16.8%,relative standard deviation is less than 10% and correlation coefficient r is 0.97 with 40 clinical samples test,which suggests there are good correlation with test results of well-known test kit from foreign countries.[Conclusions]A quantitative C-reactive protein test kit was developed with high sensitivity,good accuracy and stability,and wide linear range which can satisfy perfectly with the need of clinical examination.

关 键 词：关键词C-反应蛋白 荧光定量 免疫层析技术 双抗夹心法 

分 类 号：R446.6[医药卫生—诊断学]