单克隆抗体与多克隆抗体的混合在胱抑素C测定试剂盒(胶乳免疫比浊法)中的应用  

Application of the Mixture of Monoclonal Antibody and Polyclonal Antibody in Cystatin C Assay Kit(Latex Immunoturbidimetry)

作　　者：骆春梅 邱俊康 陈慧 杜萌泽 Luo Chunmei;Qiu Junkang;Chen Hui;Du Mengze(Health Medical Science and Technology College,Chengdu Neusoft University,Chengdu 611844,China;Guizhou Cormorant Biotechnology Co.,LTD.,Qiannanzhou 558000,China)

机构地区：[1]成都东软学院健康医疗科技学院,成都611844 [2]贵州鸬鹚生物技术有限公司,贵州黔南州558000

出　　处：《黑龙江科学》2024年第8期121-123,共3页Heilongjiang Science

基　　金：2023年度四川省自然科学基金项目(面上项目)“抗眼底新生血管性疾病新型肽体药物的理性设计与实验验证研究”(2023NSFSC0596)。

摘　　要：为优化兔抗人胱抑素C多克隆抗体和人胱抑素C单克隆抗体的混合比例,将不同比例混合的抗体制备成胱抑素C(胶乳免疫比浊法)测定试剂盒,对试剂盒的灵敏度进行测定,从而筛选出最适的混合比例,与进口抗体和市面上较为认可的试剂盒进行应用比较。结果表明,兔抗人胱抑素C多克隆抗体和人胱抑素C单克隆抗体最适的混合比例为70%:30%;将国产兔抗人胱抑素C多克隆抗体、进口胱抑素C多克隆抗体与最适混合比例的抗体相同质量投量料同时包被成试剂,分别命名为试剂1、试剂2、试剂3,三种试剂校准后同时进行临床样本测定及相关性分析、线性实验及抗原过剩测定,数据显示,试剂3与试剂1及试剂3与试剂2之间均具有很强的临床相关性,线性实验和抗原过剩测定数据无明显差异,都可以满足应用要求;将试剂3与市场上口碑较好的的胱抑素C试剂盒进行临床样本测定比对,实验数据显示,两者在临床应用上无明显差异;通过胱抑素C单克隆抗体和多克隆抗体混合,减少了交叉反应的可能性,实现了较好的批间和批内一致性,具备更广泛的识别范围,提供了更全面、准确的识别和检测结果。In order to optimize the mixing ratio of rabbit anti-human cystatin C polyclonal antibody and human cystatin C monoclonal antibody,the study prepares cystatin C(latex immunoturbidimetry)assay kit from different mixing ratios of antibodies,and determines the sensitivity of the kit,so as to screen out the most suitable mixing ratio,and compare the application with imported antibodies and more recognized kits on the market.The results show that the optimal mixing ratio of rabbit anti-cystatin C polyclonal antibody and human cystatin C monoclonal antibody is 70%:30%.The domestic rabbit anti-human cystatin C polyclonal antibody,the imported cystatin C polyclonal antibody and the antibody with the optimal mixing ratio are simultaneously packaged into reagents,which are named reagent 1,reagent 2 and reagent 3,respectively.After calibration,clinical sample determination,correlation analysis,linear experiment and antigen excess determination are conducted at the same time.The data show that reagent 3 and reagent 1,and reagent 3 and reagent 2 have strong clinical correlation,and there is no significant difference between linear experiment and antigen excess measurement data,which can meet the application requirements.Reagent 3 is compared with cystatin C kit with good reputation in the market.The experiment show that there is no significant difference in clinical application.By mixing cystatin C monoclonal antibody and polyclonal antibody,the possibility of cross-reaction is reduced,better inter-batch and intra-batch consistency is achieved with a wider recognition range,and more comprehensive and accurate recognition and detection results are provided.

关 键 词：兔抗人胱抑素C多克隆抗体 人胱抑素C单克隆抗体 单克隆抗体与多克隆抗体的混合 胶乳免疫比浊法 临床相关性 线性实验 抗原过剩 

分 类 号：R446.6[医药卫生—诊断学]