鼠疫、布氏菌、炭疽活疫苗浓度测定通用参考品的研制

摘要

Objective To establish a universal national reference materials for determining the concentrations of plague, brucellosis and anthrax vaccine. Methods Firstly, absorbance of universal national reference materials were established. Secondly, correlation between absorbance of universal national reference materials and concentrations ofthreekinds of vaccine was studied using respective national reference material. The universal references were prepared. The stability of the references was tested by measuring absorbance. Finally, the universal reference materials were compared with old reference materials by three professional laboratories. Results Absorbance of universal national reference materials were 0.350, 0.494 and 0.665. The relationship between absorbance of universal national reference materials and the concentrations ofthreekinds of vaccine was determined. Reference materials were successfully established. The reference materials stored at 4℃ were stable. By measuring three batches of each vaccine with two kinds of reference materials, the result errors were less than 2.0%. Conclusion A set of universal national reference materials for determining the concentrations of plague, brucellosis and anthrax vaccine is established.%目的将现用鼠疫、布氏菌、炭疽活疫苗3套浓度测定参考品整合成一套通用参考品。　　方法确定通用参考品吸光度值，从3套鼠疫、布氏菌及炭疽疫苗浓度测定用参考品共9个浓度中选取代表性3个浓度参考品；利用现用3种活疫苗浓度测定用参考品的线性方程，计算通用参考品所代表各种疫苗的浓度；制备参考品并进行质量控制；观察参考品的长期稳定性；组织3个实验室进行协作验证。　　结果确定通用参考品吸光度值为0.350、0.494、0.665；确定通用参考品所代表各种疫苗浓度；完成通用参考品的制备，各项检定符合规定；对4℃冷藏保存参考品进行稳定性研究，变异系数小于2.0%；经3个实验室协作验证，各实验室使用2种参考品的测定结果误差均小于2.0%。　　结论在现有参考品的基础上整合成一套鼠疫、布氏菌、炭疽活疫苗分光光度法浓度测定通用参考品，并为以后建立分光光度法细菌浓度测定通用参考品奠定基础。