中国药物评价2025，Vol.42Issue(1)：42-48,7.
基于电化学发光免疫分析技术定量检测人血清中司美格鲁肽的含量
An Electrochemiluminescence Immunoassay for Quantitative Determination of Semaglutide in Human Serum
罗逸帆 1张贺峰 2梁宇 2邹灵龙3
作者信息
- 1. 温州医科大学,浙江温州 325035||国科温州研究院(温州生物材料与工程研究所),浙江温州 325024
- 2. 国科温州研究院(温州生物材料与工程研究所),浙江温州 325024||温州康瑞佰欧生物技术有限公司,浙江温州 325024
- 3. 温州医科大学,浙江温州 325035||国科温州研究院(温州生物材料与工程研究所),浙江温州 325024||温州康瑞佰欧生物技术有限公司,浙江温州 325024
- 折叠
摘要
Abstract
Objective:This study aimed to establish an electrochemiluminescence immunoassay for the quantitative determination of semaglutide in human serum,providing a novel analytical approach for the clinical quantification of this peptide-based drug.Methods:Anti-semaglutide monoclonal antibodies were prepared by mouse immunization and hybridoma technology,and the resulted mono-clonal antibody reagents were screened to obtain an optimal pair for this analytical method.The assay is based on the formation of a sandwich structure from the capture antibody,semaglutide,and the biotin-labeled detection antibody.Quantification is achieved by correlating the in-tensity of electrochemiluminescence signals with the concentration of the semaglutide.Key parameters such as assay sensitivity and specificity were established according to the intended use of the method,and validated per bioanalytical method validation guidance.Results:The assay sensitivity was determined to be 2.0 ng·mL-1 for clinical bioanalysis of semaglutide with a quantitative range of 2.0 to 240.0 ng·mL-1.The intra-and inter-assay precision(％CV)were both ≤17.1％,and intra-and inter-assay accuracy|％RE|were ≤17.3％,all meeting the pre-set requirement.Additionally,the method exhibited adequate specificity,as recombinant human GLP-1 up to 200.0 ng·mL-1 did not interfere with semaglutide quantification.The assay displayed good dilution linearity with dilution factors up to 200,and no hook effect was observed at an analyte concentration up to 2 400.0 ng·mL-1.Other validation parameters such as selectivity and sample stability were all within acceptable standards.Conclusion:In this study,an innovative electrochemiluminescence-based immunoassay was developed and validated for quantitative determination of semaglutide in human serum.Validation data demonstrate adequate sensitivity and specificity.As a novel method,it is suitable for pharmacokinetic study of semaglutide in a clinical trial.关键词
司美格鲁肽/电化学发光免疫分析/方法开发/生物分析Key words
Semaglutide/Electrochemiluminescence immunoassay/Method development/Biologlical analysis分类
药学引用本文复制引用
罗逸帆,张贺峰,梁宇,邹灵龙..基于电化学发光免疫分析技术定量检测人血清中司美格鲁肽的含量[J].中国药物评价,2025,42(1):42-48,7.
