人ABO血型定型试剂(单克隆抗体)临床试验

Clinical Trial of the Grouping Reagents(Monoclonal Antibody)on Human ABO Blood Group System

通过与１１家单位协作，对中国药品生物制品检定所分发的ＡＢＯ血型单克隆抗体定型试剂进行临床考核，检测１～１２个月婴儿、５９岁以上老人、１～５９岁成人、健康献血员、癌症患者及其它疾病患者共计７０９６８例，单抗试剂检测结果与反定型结果完全相符，特别是对红细胞表面抗原位点少、亚型抗原性弱的新生儿和红细胞表面抗原成份可能发生变化的癌症患者，均呈现较好的凝集模式。

In cooperation with 11 research units, total 70968 blood samples including infants of 1 to 12 months,elder people of more than 59 years old,adults between 1 to 59 years old ,healthy blood donor,cancer patients and other patients have been tested by the monoclonal antibody grouping reagents on human ABO group system alloted by NICIBP.The clinical trial demenstrated that the result of the McAb reagent is perfectly consistent with those from the reverse typing for ABO group.Significantly better agglutinational model was also got in newborn with few erythrocyte surface antigenic sites and weak subgroup antigenicity.As well as cancer patients whose erythrocyte surface antigen components may change.