定量检测猕猴血清中重组人源化抗狂犬病毒单克隆抗体间接ELISA法的建立  

Establishment of Indirect ELISA for Quantitative Measurement of Recombinant Human Rabies Monoclonal Antibody in Rhesus Serum

作　　者：刘晓雷[1] 侯禹男[1] 陈知航[1] 单成启[1] 车津晶[1] 刘运龙[1] 宋艳霞[1] 苗小红[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》2008年第3期407-409,共3页Letters in Biotechnology

摘　　要：目的:建立定量检测血清中重组人源化抗狂犬病毒单克隆抗体(HuMabs)NM57的间接ELISA法,为药代动力学研究提供一种简单快速的方法。方法:采用狂犬病毒糖蛋白包被酶标板、HRP标记的IgG-Fc段为标记抗体,建立定量检测HuMabs NM57的间接ELISA法,并对其特异性、灵敏度、精密度及准确度进行检测。结果:间接ELISA法检测HuMabs NM57的灵敏度为5ng/mL,组内及组间精密度分别为2.6%～6.0%、8.5%～11.3%。结论:建立了灵敏度高、特异性强的检测HuMabs NM57的间接ELISA法,精密度及准确度均符合药代动力学要求,可用于猕猴及人血清中HuMabs NM57的检测。Objective： To establish indirect ELISA for quantitative measurement of recombinant human rabies monoclonal antibody（HuMabs）NM57 and provide a new convenient method for the investigation of pharmacokinetics. Methods： The microplate was coated with glycoprotein of rabies. HRP labeled IgG-Fc was used as labelled antibody. The established ELISA would be evaluated by the specificity, sensitivity, precision and accuracy. Results： The lower limit of sensitivity of the assay was 5 ng/mL. Intra-assay and inter-assay variability were 2.6%-6.0% and 8.5%-1.3%, respectively. Conclusion： The results showed that the established indirect ELISA was a sensitive and specific method and could be used for quantitative measurement of HuMabs NM57 in rhesus serum samples.

关 键 词：重组人源化抗狂犬病毒单克隆抗体 间接ELISA法 定量检测 

分 类 号：R392.1[医药卫生—免疫学]