抗乙型脑炎病毒阳性血清抗体效价参考品的制备  

Preparation of Reference for Antibody Potency of Japanese Encephalitis Virus Positive Serum

作　　者：魏宪义[1] 陈光清[1] 魏红[1] 王海燕[1] 干科[1] 

机构地区：[1]四川远大蜀阳药业股份有限公司,成都610214

出　　处：《中国生物制品学杂志》2010年第2期176-178,共3页Chinese Journal of Biologicals

摘　　要：目的制备抗乙型脑炎病毒阳性血清抗体效价参考品。方法评估乙脑病毒IgG酶联免疫试剂盒定量检测不同浓度阳性血清抗体的线性范围、准确性、精密性及特异性,并以正常血清及其他免疫球蛋白产品为对照,对该参考品抗体效价定位进行适用性比较。结果不同浓度阳性血清的线性范围为0.625～10IU/ml,抗体效价回收率为91.2%～112.8%,试验内变异系数≤7.8%,正常血清与阳性血清的乙脑抗体效价相差15倍。试验用的阳性血清乙脑病毒抗体效价设为10U/ml时,在特定的疫苗免疫程序下,效价峰值期能够实现合格血浆≥50%的收获率。结论兼顾原料血浆的可获取性与产品临床效果的难以替代性,特定阳性血清定位为10U/ml。Objective To prepare the reference for antibody potency of Japanese encephalitis virus （JEV）positive serum Methods The linear range, accuracy, precision and specificity of ELISA kit for quantitative determination of JEV IgG in positive serum samples at various concentrations were evaluated, based on which the defined antibody potency of developed reference was eval uated for applicability using normal serum and other immunoglobulin products as controls. Results The linear range of ELISA ki positive serum samples at various concentrations was 0. 625 ～ 10 IU / ml, the recovery rate of antibody potency was 91. 2% ～ 112. 8%, and the inter-coefficient of variation of test results was not more than 7.8%. The JEV antibody potency of positive serum was 15 times higher than that of normal serum. By a specified immune schedule, if the antibody potency of positive serum for test was defined as 10 U / ml, the harvest rate of qualified plasma was not less than 50% when the peotency reached the maximum. Conclusion Taking account of the limited source of raw plasma and the clinical effect of immunoglobulin which could not be substituted with other drugs, the antibody potency of specified positive serum was defined as 10 U / ml.

关 键 词：乙型脑炎病毒 免疫球蛋白 参考品 

分 类 号：R392-33[医药卫生—免疫学] R512.62[医药卫生—基础医学]