13价肺炎结合疫苗小鼠血清ELISA方法的建立与验证  

Establishment and validation of an ELISA method for quantitation of 13 serotype-specific anti-pneumococcal IgG antibodies in mouse serum

作　　者：刘佳[1] 王欣茹[1] 赵志强[1] 刘方蕾[1] 胡浩[1] 于旭博 毛睿[1] 罗树权[1] 谢贵林[1,2] 

机构地区：[1]兰州生物制品研究所有限责任公司甘肃省疫苗工程技术研究中心,兰州730046 [2]中国生物技术股份有限公司,北京100029

出　　处：《中国新药杂志》2014年第18期2144-2149,2160,共7页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2011ZX09401-403);国家高技术研究发展计划(863计划)(2012AA02A-401)

摘　　要：目的:建立检测小鼠血清中13型别肺炎球菌型特异IgG抗体的ELISA方法。方法:分别使用纯化的肺炎球菌荚膜多糖作为包被抗原,制备实验室小鼠的肺炎ELISA参考血清,从方法特异性,稳定性,精密度等方面对ELISA方法进行验证。结果:本实验室建立的检测免疫小鼠血清中肺炎荚膜多糖型特异IgG抗体的ELISA方法,特异性、稳定性、精密度、线性等均与文献一致。结论:建立的ELISA方法在实验室条件下,可以取得稳定的结果,适用于定量检测动物血清中肺炎型特异IgG抗体,在疫苗临床前研究的动物实验方面有一定意义。Objective： To establish and validate an EL1SA method to measure the concentrations of 13 serotype-specific anti-Pneumococcal IgG antibodies in mouse serum. Methods： Purified pneumococcal capsule poly- saccharide was used as coating antigen to prepare anti-pneumococcal reference serum for ELISA. Validation was carried out for the specificity, precision, linearity, etc. Results： An ELISA method has been established for deter- mination of serotype-specific anti-Pneumococcal IgG antibodies in mouse serum. And the s linearity of this assay complied with international criterion. Conclusion： This assay can be tion of serotype-specific anti-pneumococcal IgG antibodies in mouse serum, which will lay pecificity, precision and applied to the quantita- foundation for pre-clinical research of pneumococcal vaccines.

关 键 词：肺炎球菌 ELISA 小鼠血清 验证 

分 类 号：R979.5[医药卫生—药品]