中国临床药学杂志2025，Vol.34Issue(2)：124-127,4.DOI:10.19577/j.1007-4406.2025.02.008
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
摘要
Abstract
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Key words
singlicate analysis/duplicate analysis/infliximab/therapeutic drug monitoring/enzyme-linked immunosorbent assay分类
药学引用本文复制引用
朱扣柱,周丹丽,李玉,洪远,林琼,王燕..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[J].中国临床药学杂志,2025,34(2):124-127,4.基金项目
无锡市市级临床重点专科项目(编号2023SZD-YXB) （编号2023SZD-YXB）
无锡市儿童医院博士科研启动基金(编号2023BSQD-ZKZ) （编号2023BSQD-ZKZ）
无锡市卫生健康委员会青年项目(编号Q202162) （编号Q202162）
