用于血型鉴定的国产微柱凝胶卡抗体试剂的选择  

Selection of antibody reagent of domestic microcolumn gel card for blood grouping

作　　者：吴涛[1] 周俊[1] 陈震[1] 张秋丽[1] 晋晶[1] 陈玉平 张永超 

机构地区：[1]北京军区总医院输血科,北京100700 [2]江阴力博医药生物技术有限公司,江苏江阴214431

出　　处：《中国生物制品学杂志》2016年第10期1064-1065,1068,共3页Chinese Journal of Biologicals

摘　　要：目的筛选特异性强、效价高、亲和力高的用于血型鉴定的国产微柱凝胶卡抗A、抗B及抗D抗体试剂。方法按《中国生物制品规程》2000版中《抗A、抗B血型定型试剂(单克隆抗体)制造及检定规程》的要求,对4家公司的抗A、抗B及抗D抗体试剂进行特异性、效价、亲和力检测。结果 3批抗A、抗B单克隆抗体试剂及3批抗D抗体试剂的特异性、效价和亲和力检测结果均符合《中国生物制品规程》2000版中《抗A、抗B血型定型试剂(单克隆抗体)制造及检定规程》的要求,选择成本相对较低的上海血液生物医药有限责任公司生产的抗A、抗B试剂和英国Millpore公司亲和力更好、效价更高的抗D抗体试剂,用于制备国产微柱凝胶卡。结论 3批抗A、抗B、抗D单克隆抗体试剂均合格,已选择更优的试剂用于制备国产微柱凝胶卡。Objective To screen anti-A, anti-B and anti-D antibody reagents with high specificity, titer and affinity.Methods The anti-A, anti-B and anti-D antibody reagents from four manufacturers were tested for specificity, titer and affinity according to the Chinese Requirements for Biologics（2000 edition）. Results All the specificities, titers and affinities of three batches of anti-A, anti-B monoclonal antibody reagents and three batches of anti-D antibody reagents met the Chinese Requirements for Biologics（2000 edition）. The anti-A, anti-B antibody reagent manufactured by Shanghai Hemo-pharmaceutical Biological Co., Ltd., with a low cost, and the anti-D antibody reagent manufactured by Millpore,with higher affinity and higher titer, were selected for preparation of domestic microcolumn gel card. Conclusion All the three batches of anti-A, anti-B and anti-D antibody reagents were qualified, from which the optimal ones were selected for preparation of domestic microcolumn gel card.

关 键 词：微柱凝胶卡 抗体试剂 血型 鉴定 

分 类 号：R457.11[医药卫生—治疗学]