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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 detect the CMV neutralizing antibody titers in intravenous immunoglobulin (IVIG) (p H 4) and cytomegalovirus (CMV) immunoglobulins (IG). Methods Nineteen batches of domestic IVIG, eight batches of CMV-IG and two CMV-IG CMV neutralizing antibody titers were detected by the method of nucleus staining based on microcytopathology. Results The geometric mean of CMV neutralizing antibody titer of 39 batches of IVIG was 361 U / ml, the lowest titer was 234 U / ml and the highest titer was 502 U / ml. CMV-IG CMV neutralizing antibody The geometric mean titer was 1 113 U / ml, the lowest titer was 923 U / ml and the highest titer was 1 553 U / ml. The CMV antibody titers of two batches of CMVIG were 579 U / ml and 163 U / m. The CMV-IG CMV neutralizing antibody titers were significantly higher than CMV neutralizing antibody titers of 39 batches of IVIG (P <0.001) in 8 batches of registries. CONCLUSION: CMV-neutralizing antibody titers of 39 batches of IVIG made in China ranged from 234 to 502 U / ml. CMV-IG prepared by plasma screening was significantly higher than CMV neutralizing antibody titer of normal IVIG.