目的 通过不同的检测平台和实验方法对9种抗人重组人促红细胞生成素(rhEPO)单克隆抗体的测试结果的比较,评价其在临床单纯红细胞再生障碍性贫血(pure red cell aplasia,PRCA)rhEPO免疫原性研究中应用的可行性。方法 中国食品药品检定研究院(中检院)和沈阳三生制药有限责任公司(三生制药)采用直接ELISA评价待测参考品的结合性抗体性质,厦门特宝生物工程股份有限公司(特宝生物)采用间接ELISA评价待测参考品的结合性抗体性质;3家单位均采用EPO依赖细胞株UT7/EPO细胞的增殖抑制法评价待测参考品的中和性抗体性质。结果 不同检测平台和检测技术均能对抗rhEPO单克隆抗体参考品的性质进行有效评价。结论 多种检测平台和检测方法的应用,对rhEPO在临床研究和上市后的免疫原性评价或PRCA的监测具有重要意义。
Abstract
OBJECTIVE To assess a panel of 9 human monoclonal antibodies against human erythropoietin (EPO) with defined characteristics (non-neutralizing, neutralizing, affinities) for suitability for EPO antibody assays. METHODS A multi-center collaborative study involving three different laboratories and different assay platforms was carried out. Direct ELISA was used to test the affinities of the samples by Shenyang Sunshine pharmaceutical Co., Ltd and National Institutes for Food and Drug control,while indirect ELISA was used by Xiamen amoytop biotech Co., Ltd. The neutralizing assays were performed using UT-7 cell line by all the three laboratories. RESULTS The properties of the 9 human monoclonal antibodies against human erythropoietin were assessed efficiently by all the three laboratories using different METHODS.CONCLUSION It is suggested that the EPO antibody panel is established to enable the evaluation of the performance of different EPO antibody assays and thus the selection of appropriate assay for clinical use.
关键词
抗人EPO抗体 /
直接ELISA /
间接ELISA /
中和性抗体 /
cut off值
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Key words
anti human EPO antibody /
direct ELISA /
indirect ELISA /
neutralizing antibody /
cut off value
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中图分类号：
R915
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参考文献
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