第六批狂犬病免疫球蛋白国家标准品的协作标定

Collaborative calibration of the 6th national standard for rabies immunoglobulin

目的 对第六批狂犬病免疫球蛋白国家标准品开展赋值研究。方法 组织10个有资质的实验室,分别采用小鼠中和试验(mouse neutralization test,MNT)和快速荧光灶抑制试验(rapid fluorescence focus inhibition test,RFFIT),用第二批狂犬病免疫球蛋白国际标准品(RAI)对新标准品进行协作标定。随机抽取一定数量的新标准品,检测其pH值,方差分析检验标准品的均匀性;将新标准品分别在不同的温度(4、25和37℃)放置不同时间(1、2、3和4周),每个时间点取3支先于-20℃保存,待所有样本收集完成后采用RFFIT法检测抗体效价,方差分析检验标准品的稳定性。结果 协作标定的数据经统计学分析,MNT法的赋值为35.4 IU/mL,95%可信限为32.6~38.2 IU/mL;RFFIT法的赋值为38.7 IU/mL,95%可信限为36.8~40.6 IU/mL;将两种方法的赋值取几何均值(37.0 IU/mL)即为第六批狂犬病免疫球蛋白国家标准品的赋值,其均匀性和稳定性良好。结论 完成了第六批狂犬病免疫球蛋白国家标准品(批号:250011-201306)的赋值研究,其结果准确可靠、科学严谨,对狂犬病人免疫球蛋白类制品的质量控制具有重要意义。

Objective To carry out assignment research on the 6th national standard for rabies immunoglobulin. Methods Ten qualified laboratories were organized for collaborative calibration of a novel standard with the 2nd international standard for rabies immunoglobulin(RAI)by mouse neutralization test(MNT)and rapid fluorescence focus inhibition test(RFFIT)respectively. A certain number of novel standards were randomly selected and determined for the pH value,while the uniformity was analyzed by ANOVA. The standards were stored at various temperatures(4,25 and 37 ℃) for various time durations(1,2,3 and 4 weeks)separately,from which three containers were taken at each time point and stored at-20 ℃ provisionally,and determined for antibody titer by RFFIT and analyzed for stability by ANOVA after all the samples were collected. Results Statistical analysis showed that the assignment of antibody titer determined by MNT was 35. 4 IU/mL with a 95% confidence limit of 32. 6 ~ 38. 2 IU/mL,while that by RFFIT was 38. 7 IU/mL with a95% confidence limit of 36. 8 ~ 40. 6 IU/mL. The geometric mean(37. 0 IU/mL)of two assignments was served as the assignment of the 6th national standard for rabies immunoglobulin, which showed good uniformity and stability.Conclusion The assignment research of the 6th national standard for rabies immunoglobulin(Lot:250011-201306)has been completed with accurate,reliable,scientific and rigorous results,which is of a great significance in the quality control of rabies human immunoglobulin products.