单孔分析在ELISA法测定英夫利西单抗血浆浓度中的可行性评估  

Singlicate analysis for infliximab in therapeutic drug monitoring using enzyme-linked immunosorbent assay

作　　者：朱扣柱 周丹丽 李玉 洪远 林琼 王燕 ZHU Kouzhu;ZHOU Danli;LI Yu;HONG Yuan;LIN Qiong;WANG Yan(Department of Pharmacy,Affiliated Children's Hospital of Jiangnan University-Wuxi Children's Hospital,Wuxi 214023,China;Department of Gastroenterology,Affiliated Children's Hospital of Jiangnan University-Wuxi Children's Hospital,Wuxi 214023,China)

机构地区：[1]江南大学附属儿童医院-无锡市儿童医院药学部,无锡214023 [2]江南大学附属儿童医院-无锡市儿童医院消化内科,无锡214023

出　　处：《中国临床药学杂志》2025年第2期124-127,共4页Chinese Journal of Clinical Pharmacy

基　　金：无锡市市级临床重点专科项目(编号2023SZD-YXB);无锡市儿童医院博士科研启动基金(编号2023BSQD-ZKZ);无锡市卫生健康委员会青年项目(编号Q202162)。

摘　　要：目的评估单孔分析在酶联免疫吸附分析(ELISA)法测定英夫利西单抗(IFX)血浆浓度中的可行性。方法分别对校正标样和质控样品使用ELISA法进行复孔分析和单孔分析,比较2种分析方法的批内和批间相对偏差(RE)和变异系数(CV);通过检测110例临床样本评估2种方法所测得的IFX血浆浓度之间的相关性。结果复孔分析和单孔分析的校正标样批间RE和CV均<5%,质控样品批内和批间RE和CV均<20%。2种分析方法所测得的IFX血浆浓度之间的Pearson相关系数为0.99。结论基于校正标样和质控样品,ELISA法单孔分析所得结果符合精密度和准确度验证要求,临床样本的结果与复孔分析结果之间具有良好的一致性,单孔分析具有更高的效能和更低的成本。AIM To compare the efficiency and cost of duplicate analysis and singlicate analysis in the determination of infliximab(IFX)plasma concentration by enzyme-linked immunosorbent assay(ELISA).METHODS Duplicate and singlicate analyses were performed on calibration standards and quality control samples by ELISA respectively,the intra-batch and inter-batch relative error(RE)and coefficient of variation(CV)of the 2 analytical methods were compared,and the correlation between the IFX plasma concentrations measured by 2 methods was evaluated by testing 110 clinical samples.RESULTS The inter-batch RE and CV of the calibration standards for duplicate analysis and singlicate analysis were less than 5%,and the intra-batch and inter-batch RE and CV of the quality control samples were less than 20%.The Pearson correlation for the measured IFX concentrations from patient samples was 0.99.CONCLUSION The precision and accuracy of singlicate analysis of ELISA were consistent with the analysis requirement.Singlicate analysis demonstrates good consistency with duplicate analysis in the results of clinical samples,which indicates that singlicate analysis can be used for IFX therapeutic drug monitoring in clinical samples with higher efficiency and lower cost.

关 键 词：单孔分析 复孔分析 英夫利西单抗 治疗药物监测 酶联免疫吸附分析 

分 类 号：R917[医药卫生—药物分析学]