抗布鲁菌血清标准品的研制  

Preparation for national standard material of anti-Brucella abortus serum

作　　者：魏东[1] 陈成[1] 李恪梅[1] 赵爱华[1] 王国治[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国卫生检验杂志》2017年第15期2129-2130,2134,共3页Chinese Journal of Health Laboratory Technology

基　　金："重大新药创制"国家科技重大专项(2014ZX09304311-002)

摘　　要：目的研制抗布鲁菌血清国家标准品。方法以感染布鲁菌的病牛血清为原料制备抗布鲁菌血清标准品,建立质量标准。通过ELISA方法测定样品中抗布鲁菌纯蛋白衍生物IgG抗体含量,对标准品进行均匀性分析。将冻干抗布鲁菌血清标准品分别置于-20℃、4℃及37℃保存,在不同时间点取样进行凝集活性测定,评估冻干标准品的稳定性。组织3个实验室对该标准品进行协作标定。结果制备了抗布鲁菌血清国家标准品,各项检定符合要求。该标准品具有较好的均匀性。该标准品在-20℃条件下具有较好的稳定性,12个月内凝集活性未见降低。以国际标准品溯源,该标准品的凝集活性为500 IU/支。结论建立了抗布鲁菌血清国家标准品,可用于布鲁菌抗体检测用抗原的标准化及布鲁菌活疫苗的鉴别试验。Objective To prepare national standard material of anti-Brucella abortus serum. Methods National standard material of anti-Brucella abortus serum was acquired from a cow which has been infected with Brucella abortus and the quality standard was estatlished. The content of Ig G antibody against Brucella abortus protein derivative was determined by ELISA method. Homogeneity of this standard material was analyzed. The freeze-dried and anti-Brucella abortus serum standard samples were stored at-20 ℃,4 ℃ and 37 ℃,respectively,and samples were collected at different time points to determine the stability of lyophilized standard. This standard was calibrated by three professional laboratories. Results National standard material of anti-Brucella abortus serum was prepared and quality control standards were established. Homogeneity of this standard material was proved to meet national standard. This standard material was stable stored at-20 ℃. The agglutination activity was not decreased within 12 months. Each ampoule was assigned a unitage of 500 international unit of agglutinating activity referring to the international standard. Conclusion National standard material of anti-Brucella abortus serum was established.It was intended for standardizing Brucella antigen and identifying brucellosis vaccine.

关 键 词：布鲁菌 均匀性 稳定性 质量控制 标准品 

分 类 号：R446.6[医药卫生—诊断学]