RhD(IgM)血型定型试剂(单克隆抗体)国家参考品的协作标定

Collaborative calibration of national reference substances for Rh D(IgM)blood grouping reagents(monoclonal antibodies)

目的:标定Rh D(Ig M)血型定型试剂(单克隆抗体)国家参考品。方法:对Rh D(Ig M)血型定型试剂(单克隆抗体)原料进行分装冻干及复溶时间和水分检测,复溶后对效价开展协作标定,并进行了稳定性检测。结果:Rh D(Ig M)血型定型试剂参考品的复溶时间、水分均符合2010年版中国药典标准。标定效价为国际参考品的1.2倍。结论:该批Rh D(Ig M)血型定型试剂各项指标均符合要求,可作为国家参考品使用;将该参考品稀释至3.6倍可达到WHO推荐的最小效价要求。

Objective： To calibrate national reference substances for RhD （ IgM ） blood grouping reagents （ monoclonal antibodies ）. Methods ： RhD （ IgM ） blood grouping reagents （ monoclonal antibodies ） were calibrated in a collaborative study after dispersal, lyophilization, reconstitute time and moisture content testing. Stability of the reagents was also examined. Results： Reconstitute time and moisture content of these reagents conformed to the requirements of ChP 2010, Vol ]I[ Calibrated titer of the national reference substance was 1.2 times of the international reference substance. Conclusion： The RhD （ IgM ） blood grouping reagents （ monoclonal antibodies ） could be used as national reference substances. The reference substances of 3.6-fold dilution could meet the minimum potencies standards of RhD （ IgM ） blood grouping reagents recommended by WHO.