RhD(IgM)血型定型试剂(单克隆抗体)国家参考品的协作标定

目的:标定RhD(IgM)血型定型试剂(单克隆抗体)国家参考品。方法:对RhD(IgM)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:RhD(IgM)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RhD(IgM)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 Ⅲ. 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.

[1] 李秋. Rh抗D血型检验是临床安全输血的关键[J]. 中外医疗, 2014, 1(1):186 LI Q. Rh blood group test is critical for clinical blood transfusion[J]. China Foreign Med Treat, 2014, 1(1):186
[2] 苑新,朱爱枝,邓婷. 血型鉴定在临床输血安全中的应用[J]. 医药论坛杂志, 2006, 27(12):106 YUAN X, ZHU AZ, DENG T. Application of blood grouping in clinical blood transfusion safety[J]. J Med Forum,2006,27(12):106
[3] 周华友,兰炯采. 人类Rh血型系统研究进展[J]. 中国输血杂志, 2004, 17(3):211 ZHOU HY, LAN JC. Research progress of human Rh blood group system[J]. Chin J Blood Transfus, 2004, 17(3):211
[4] 李勇,陈维佳. 单克隆抗体RhD血型定型试剂质量要求及临床应用要点[J]. 中国生物制品学杂志, 2005, 18(5):434 LI Y, CHEN WJ. Quality control of RhD blood grouping reagents(monoclonal antibodies)and key points of their clinical application[J]. Chin J Biol. 2005, 18(5):434
[5] THORPE SJ, FOX B, HEATH AB, et al. An international standard for specifying the minimum potency of anti-D blood grouping reagents:evaluation of a candidate preparation in an international collaborative study[J]. Vox Sang, 2006, 90(2):131
[6] 中国生物制品标准化委员会. 中国生物制品规程[M]. 北京:化学工业出版社, 2000:602 China Biological Products Standardization Committee. China Biological Products Standards[M]. Beijing:Chemical Industry Press, 2000:602
[7] 中国药典2010年版. 三部[S]. 2010:5 ChP 2010. Vol Ⅲ[S]. 2010:5
[8] REID ME, LOMAS-FRANCIS C, OLSSON ML. The Blood Group Antigen Facts Book[M]. 3rd Ed. Italy[:Printer Trento s.r.l],2012:192
[9] DANIELS G, BROMILOW I. Essential Guide to Blood Groups[M]. 3rd Ed. UK:John Wiley & Sons, Ltd., 2014:40
[10] 赵桐茂. 人类血型遗传学[M]. 北京:科学出版社, 1987:105 ZHAO TM. Human Blood Type Genetics[M]. Beijing:Science Press, 1987:105
[11] THORPE SJ, FOX B, HEATH AB, et al. International standards for minimum potency of anti-A and anti-B blood grouping reagents:evaluation of candidate preparations in an international collaborative study[J]. Vox Sang, 2006, 91(4):336
[12] 马秋平,吕秀华,侯继锋. 抗A、抗B血型定型试剂(单克隆抗体)国家参考品的制备与协作标定[J]. 药物分析杂志, 2012, 32(12):2270 MA QP, LÜ XH, HOU JF. Preparation and collaborative calibration of national reference substances for anti-A and anti-B blood grouping reagents(monoclonal antibodies)[J]. Chin J Pharm Anal, 2012, 32(12):2270