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

目的: 制备并标定抗A、抗B血型定型试剂(单克隆抗体)国家参考品。 方法: 按2010版年版中国药典三部和2000年版《中国生物制品规程》的有关要求,制备了抗A、抗B血型定型试剂(单克隆抗体),并分装冻干、进行质量检测,复溶后对效价开展协作标定,并进行稳定性检测。 结果: 抗A、抗B血型定型试剂的装量、外观、复溶时间、特异性、亲和力、效价、冷凝集素和不规则抗体检测、水分测定均符合2000年版《中国生物制品规程》中的规定。不同实验室的标定结果差异较大,计算效价的几何均数,抗A血型定型试剂结果为对A₁ 1:256~1:512之间,对A₂ 1:128~1:256之间,对A₂B 1:128~1:256之间;抗B试剂结果对B 1:256~1:512之间。稳定性检测符合要求。 结论: 该抗A、抗B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;经标准物质委员会讨论,将该参考品稀释1倍后可作为抗A、抗B血型定型试剂产品的最低效价标准。

Objective: To prepare and calibrate the national reference substances for anti-A and anti-B blood grouping reagents (monoclonal antibodies). Methods: According to the relevant requirements in Chinese Pharmacopoeia (2010 Edition) and China Biological Products Standards (2000 Edition),anti-A and anti-B blood grouping reagents (monoclonal antibodies) were prepared and calibrated in a collaborative study after dispersal,lyophilization,quality control,and reconstitution.Stability of the reagents was also examined. Results: The mean weight,appearance,reconstitute time,specificity,affinity,titer,cold agglutinin and irregular antibody,and moisture detection of these reagents conformed to the requirements of China Biological Products Standards (2000 Edition).The calibration results between laboratories showed large difference.The mean titers of anti-A blood grouping reagents were 1:256~1:512 to A₁,1:128~1:256 to A₂,and 1:128~1:256 to A₂B.The mean titer of anti-B was 1:256~1:512 to B.The stability test results conformed to the requirements. Conclusion: On the basis of these results,the anti-A and anti-B blood grouping reagents (monoclonal antibodies) could be used as national reference substances.The standard materials committee the reference substances (dilute 1 in 2) could be used as minimum potencies standards of anti-A and anti-B blood grouping reagents.

1 Yamanoto F.ABO blood group system-ABH oligosaccharide antigens,anti-A and anti-B,A and B glycosyltransferases,and ABO genes.Immunohematol,2004,20(1):3
2 ZHENG Lei(郑磊),ZHANG Peng(张鹏),WANG Qian(王前),et al.Present status and progression of ABO blood group detection (ABO血型实验室检测方法现状及进展).Chin J Blood Transfus(中国输血杂志),2006,19(1):80
3 Voak D,Lennox E,Sacks S,et al.Monoclonal anti-A and anti-B:development as cost-effective reagents.Med Lab Sci,1982,39(2):109
4 Voak D.Monoclonal antibodies as blood grouping reagents.Baillieres Clin Haematol,1990,3(2):219
5 China Biological Products Standards(中国生物制品规程).Beijing(北京):Chemical Industry Press(化学工业出版社),2000,601
6 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.Vox Sang,2006,91(4):336
7 ChP (中国药典).2005.Vol III (三部):4
8 Dunsford I,Bowley CC.Techniques in Blood Grouping.2nd Edition.Illinois:Springfield,1967.21
9 Stratton F,Renton PH.Practical Blood Grouping.Oxford:Blackwell,1958.47
10 Moore BPL,Humphreys P,Lovett-Moseley CA.Serological and Immunological Methods:Technical Manual of the Canadian Red Cross Blood Transfusion Service.6th Edition.Toronto:Canadian Red Cross Society,1968.64
11 MILES AA.International standards for anti-A and anti-B blood-grouping sera.Bull World Health Organ,1950,3(2):301
12 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.Vox Sang,2006,90:131