【摘要】 目的 评估抗-CD47单克隆抗体对输血相容性检测的干扰，研究去干扰方法，并对受试者输注效果进行评价。方法 收集本院参与接受天境和信达公司生产的抗-CD47单克隆抗体药物治疗的8名临床试验受试者标本，使用缺乏IgG4的抗人球蛋白试剂Gamma-clone、ZZAP试剂和药物独特型中和试剂等进行血型检测、意外抗体筛查、直接抗人球蛋白试验和交叉配血试验。结果 使用抗-CD47单抗治疗后，8名受试者中有5名ABO血型检定受到干扰；所有受试者直接抗人球蛋白凝集强度呈现2+～4+,且所有受试者意外抗体筛查结果都呈3+～4+。采用缺乏IgG4的抗人球蛋白试剂Gamma-clone的试管法进行意外抗体筛查试验，结果均呈现阴性，交叉配血试验均相合。采用药物独特型中和抗体进行意外抗体筛选，试验结果显示均为阴性，交叉配血试验均相合。使用CD47单抗药物导致贫血的患者均输注2U悬浮红细胞，评价经抗干扰处理后配血相合患者的输血效果，结果显示患者输血有效。结论 受试者使用CD47单抗药物后会干扰输血相容性检测，使用缺乏IgG4的抗人球蛋白试剂和药物独特型中和抗体可去除抗-CD47干扰，受试者输血效果良好。更多还原

【Abstract】 Objective To evaluate the interference of anti-CD47 monoclonal antibody on transfusion compatibility detection, in order to establish methods for removing interference and evaluate its efficacy. Methods Blood samples from 8 patients in our clinical trial who were treated with anti-CD47 monoclonal antibody from Tianjing and Xinda were collected. ABO and Rh blood group antigen identification, direct anti-human globulin test, unexpected antibody screening test and cross-matching test were performed by ZZAP, Gamma-clone(an anti-globulin reagent lacking IgG4) and Immucor Capture-R solid phase agglutination kit. Results ABO blood group identification of 5 subjects were interfered after treatment with anti-CD47 monoclonal antibody. All 8 subjects showed 2+ to 4+ agglutination intensity on direct anti-human globulin test and 3+ to 4+ on unexpected antibody screening. The results of unexpected antibody screening by Gamma-clone and Immucor Capture-R solid phase agglutination kit were all negative, while the cross-matching test were compatible. Patients with anemia caused by CD47 monoclonal antibody treatment were transfused with 2 U suspension red blood cells, and the evaluation showed that the transfusion was effective. Conclusion The CD47 monoclonal antibody can interfere with transfusion compatibility detection, and the use of antiglobulin reagents lacking IgG4 and Immucor Capture-R solid phase agglutination kit can remove the interference, with good transfusion efficacy in patients.更多还原