重组抗CD20单克隆抗体ELISA检测新方法的建立  

Development of Original Enzyme Linked Immunosorbent Assay Method for Detection of rh-anti-CD20ximab

作　　者：刘若瑞[1] 陈知航[1] 许先兴[1] 孙丽丽[1] 刘运龙[1] 程远国[1] 

机构地区：[1]军事医学科学院微生物流行病研究所,北京100071

出　　处：《生物技术通讯》2011年第2期220-224,共5页Letters in Biotechnology

摘　　要：目的:建立一种检测重组抗CD20单克隆抗体的新的ELISA方法,以便快捷、简便、灵敏地检测生物体液中的重组抗CD20单抗。方法:采用双抗夹心ELISA法对重组抗CD20单克隆抗体进行定量检测,包被抗体用猴血清吸附的羊抗人IgG,检测抗体用猴血清吸附的羊抗人IgG-HRP,最后加底物显色剂,终止后在酶标仪450 nm下读数。结果:按照新药临床前药代动力学中方法学确认的要求进行验证,获得了检测重组抗CD20单克隆抗体的高灵敏度和稳定的ELISA方法。结论:该ELISA方法简便、稳定、灵敏度高,可用于重组抗CD20单克隆抗体的检测。Objective：To establish a rapid,sensitive and specific enzyme linked immunosorbent assay（ELISA） method for detection of rh-anti-CD20ximab.Methods：This assay employed the quantitative sandwich enzyme immunoassay technique.The assay method utilized sheep anti-human IgG that had been adsorbed against cynomolgus monkey serum for capture as well as detection of rh-anti-CD20ximab.Finally,a substrate solution was added to the wells and color develops in proportion to the amount of rh-anti-CD20ximab.The color development was stopped with stop solution,then read at 450 nm using a microplate reader.Results：A rapid,sensitive and specific ELISA method for detection of rh-anti-CD20ximab was established according to requirement of method validation in new drugs preclinical pharmacokinetics.Conclusion：The ELISA method is rapid,stable and high sensitivity for the detection of rh-anti-CD20ximab.

关 键 词：酶联免疫吸附测定 重组抗CD20单克隆抗体 药代动力学 

分 类 号：R392.1[医药卫生—免疫学]