高效价巨细胞病毒人免疫球蛋白原料血浆的筛查

Screening of source plasma for production of high titer human immunoglobulin against cytomegalovirus

目的分析普通健康供浆员中人巨细胞病毒humancytomegalovirus，HCMV）免疫球蛋白（IgG）抗体效价分布情况，筛查富含高效价HCMVIgG抗体的原料血浆。方法采用HCMVIgG定量检测试剂，检测本公司下属广西地区五个单采血浆站采集的血浆样本的HCMVIgG抗体效价，检测抗体效价〉15PEI-U／ml的血浆样本混合后的HCMVIgG抗体效价，并对血浆中富含HCMV抗体的供浆员血浆进行采集，分析效价分布变化情况。结果健康供浆员28607份血浆样本的HCMVIgG抗体阳性率为85．2％，其中效价分布在1-10、10-15、〉15PEI-U／ml的各占64．5％、8．7％和11．9％；1318名血浆中富含HCMV抗体的供浆员8426份血浆样本HCMVIgG抗体阳性率为98．1％，抗体效价〉15PEI-U／ml占43．8％，约为普通健康人血浆样本的3．7倍，3个月内平均抗体效价可维持在15PEI-U／ml以上的有586人，占44．5％；不同浆站抗体效价〉15PEI-U／ml的血浆样本混和后的平均效价为33．72PEI-U／ml。结论健康供浆员中高效价HCMVIgG抗体的比例较高，部分供浆员HCMVIgG抗体高效价水平可稳定维持3个月，从健康供浆员中采集含高效价HCMVIgG抗体的原料血浆，用于制备巨细胞病毒人免疫球蛋白具有可行性。

Objective To investigate the distribution of human cytomegalovirus （HCMV） IgG titer in healthy donors, and screen the source plasma with high HCMV IgG titer. Methods The plasma samples collected from five plasmapheresis centers under Shenzhen Weiguang Biological Products Co., Ltd. were determined for HCMV IgG titer by quantitative assay kit, of which those with IgG titers of more than 15 PEI-U / ml were mixed and determined for HCMV IgG titer. Plasma were collected from the donors with high HCMV IgG titers and analyzed for distribution of titer. Results The positive rate of HCMV IgG was 85.2% in 28 607 plasma samples from healthy donors. The proportions of samples with HCMV IgG titers of 1 ~ 10, 10 - 15 and more than 15 PEI-U/ml were 64. 5%, 8. 7% and ll. 9%, respectively. The positive rate of HCMV IgG in 8 426 plasma samples from 1 318 donors with high HCMV IgG titers was 98. 1%, and the titers of 43. 8% of samples was more than 15 PEI-U/ml, which was approximately 3. 7 times of those in healthy human plasma. The mean HCMV IgG titers of 586 （44. 5%） of the 1 318 donors were more than 15 PEI-U/ml within 3 months. However, the mean HCMV IgG titer of mixtures of plasma from various plasmapheresis centers, with titers of more than 15 PEI-U / ml, was 33. 72 PEI-U/ml. Conclusion The proportion of donors with high HCMV IgG titers was preferable, and the high HCMV IgG titers in partial donors lasted for 3 months. It is feasible to screen plasma with high HCMV IgG titer from healthy donors for manufacturing HCMV IgG.