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PEG修饰长效干扰素血清定量检测方法的建立及评价
引用本文:陈曦,;盛艾娟,;贾敏,;王美霞,;茹莉莉,;李星,;牛春,;刘金毅. PEG修饰长效干扰素血清定量检测方法的建立及评价[J]. 中华实验和临床感染病杂志(电子版), 2014, 0(6): 1-4
作者姓名:陈曦,  盛艾娟,  贾敏,  王美霞,  茹莉莉,  李星,  牛春,  刘金毅
作者单位:[1]首都医科大学附属北京佑安医院,北京100069; [2]北京三元基因工程有限公司(北京市长效干扰素工程技术研究中心),北京100069;
基金项目:“十一五”重大新药创制专项课题(No.2008ZX09203-007); 北京市科委科技计划项目“创新药研究专项”课题(No.D08080200290808)
摘    要:目的建立PEG-IIFNm血清定量检测方法,用于人体药代动力学研究。方法采用鼠单抗为包被抗体,生物素标记兔多抗为捕获抗体,辣根酶标记亲和素显色,检测血清中不同浓度的PEGIIFNm,评价该方法的特异性、灵敏度、准确度和精密度。结果建立双抗体夹心定量检测方法,血清中药物浓度的定量检测范围为0.25~10 ng/ml,相关系数R2=0.999,检测准确度为80.0%~92.0%,批内和批间差均10%,与市售其他PEG修饰干扰素无交叉反应。结论已建立血清PEG-IIFNm药物浓度双抗体夹心定量检测方法,灵敏度、特异性、精密度以及准确性符合临床药代动力学研究要求。

关 键 词:PEG修饰  干扰素  药代动力学  双抗体夹心ELISA

Establishment and evaluation of quantitative detection method for long-acting pegylated interferon in serum
Affiliation:CHEN Xi,SHENG Aijuan,JIA Min,WANG Meixia,RU Lili,LI Xing,NIU Chun,LIU Jinyi(National Drug Clinical Trial Agency, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China)
Abstract:Objective To establish a quantitative detection method for PEG-IIFNm pharmacokinetic studies in human serum. Methods The different concentrations of PEG-IIFNm in serum were detected by murine monoclonal antibody as the coating antibody, biotin-labeled rabbit polyclonal antibody as the capturing antibody, horseradish peroxidase-labeled avidin to color, and the specificity, sensitivity, accuracy and precision of the method were evaluated, respectively. Results Double antibody sandwich ELISA for drug concentration in serum was established. The quantitation range was 0.25-10 ng/ml, the correlation coefficient R^2 = 0.999, detection accuracy was 80.0%-92.0%, intra-assay and inter-assay differences were less than 10%, and there was no cross-reaction with other pegylated-interferon on the market. Conclusions The doubleantibody sandwich ELISA for PEG-IIFNm concentration in serum was established. The sensitivity, specificity, precision and accuracy of the method could meet the requirements of clinical pharmacokinetic study.
Keywords:Pegylated  Interferon  Pharmacokinetic  Double-antibody sandwich ELISA
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