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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 develop anti-Brucella serum national standards. Methods The bovine serum of brucellosis was used as raw material to prepare anti-Brucella serum standard, and the quality standard was established. The content of IgG antibody to the anti-Brucella pure protein derivative in the sample was determined by ELISA and the uniformity of the standard was analyzed. The freeze-dried anti-Brucella serum standard samples were stored at -20 ° C, 4 ° C and 37 ° C, respectively. Sampling activity was measured at different time points to evaluate the stability of freeze-dried standard. Three laboratories were organized to collaborate on the standard. Results The anti-brucellosis serum national standard was prepared and all the tests met the requirements. The standard has good uniformity. The standard has good stability at -20 ° C and no decrease in agglutination activity within 12 months. Traceability to international standards, the standard agglutination activity of 500 IU / support. Conclusion The national standard of anti-Brucella serum was established, which could be used for the standardization of antigens for Brucella antibody detection and the identification of live Brucella vaccine.