细胞核染色法检测人免疫球蛋白类制品巨细胞病毒中和抗体效价  

Determination of neutralizing antibody titers against cytomegalovirus in human immunoglobulin products by staining of nuclei

作　　者：王敏力[1] 秦婷婷 刘波 杨春 刘兰军 侯继锋[1] 

机构地区：[1]中国食品药品检定研究院卫生部生物技术产品检定方法及标准化重点实验室,北京100050 [2]成都蓉生药业有限责任公司,四川成都610000

出　　处：《中国生物制品学杂志》2017年第7期718-722,共5页Chinese Journal of Biologicals

基　　金：国家"863"课题"血浆综合利用及特免球蛋白等新产品研发"项目(2012AA021903)

摘　　要：目的检测静注免疫球蛋白(intravenous immunoglobulin,IVIG)(p H 4)及巨细胞病毒(cytomegalovirus,CMV)免疫球蛋白(IG)中的CMV中和抗体效价。方法采用基于微量细胞病变的细胞核染色法检测39批国产IVIG、8批注册检验巨细胞病毒免疫球蛋白(CMV-IG)以及2批国外CMV-IG制品的CMV中和抗体效价。结果 39批IVIG的CMV中和抗体效价几何平均值为361 U/ml,最低效价为234 U/ml,最高效价为502 U/ml;8批注册检验CMV-IG的CMV中和抗体效价几何平均值为1 113 U/ml,最低效价为923 U/ml,最高效价为1 553 U/ml;2批国外CMVIG的CMV抗体效价分别为579 U/ml和163 U/m。8批注册检验CMV-IG的CMV中和抗体效价显著高于39批IVIG的CMV中和抗体效价(P<0.001)。结论国产39批IVIG的CMV中和抗体效价在234~502 U/ml之间,经血浆筛查后投浆制备的CMV-IG显著高于普通IVIG的CMV中和抗体效价。Objective To determine the neutralizing antibody titers against cytomegalovirus（CMV）in commercial human intravenous immunoglobulin（IVIG）（p H 4） and intravenous CMV immunoglobulin（CMV-IG） products. Methods The neutralizing antibody titers against CMV in 39 batches of domestic IVIG（p H 4）, 8 batches of experimental and 2 batches of imported CMV-IG were determined by staining of nuclei based on microcytopathic effect（micro-CPE）method. Results The neutralizing antibody titers against CMV were 234 - 502 U/ml in 39 batches of domestic IVIG, with a geometric mean of 361 U/ml, while were 923 - 1 553 U/ml in 8 batches of experimental CMV-IG, with a geometric mean of1 113 U/ml. However, the neutralizing antibody titers in 2 batches of imported CMV-IG were 579 and 163 U/ml respectively. The neutralizing antibody titers against CMV in 8 batches of experimental CMV-IG were significantly higher than those in 39 batches of IVIG（P 〈0. 001）. Conclusion The neutralizing antibody titers against CMV in 39 batches of domestic IVIG were 234 - 502 U/ml. However, the titer in CMV-IG with the screened plasma was significantly higher than that in IVIG.

关 键 词：免疫球蛋白 细胞核染色法 巨细胞病毒 中和抗体 

分 类 号：R373.9[医药卫生—病原生物学] R392-33[医药卫生—基础医学]