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外源性胰岛素对电化学发光免疫分析法检测胰岛素的影响
Interference of Exogenous Insulin on Insulin Detection Test by Electrochemiluminescence Immunoassay
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摘要: 目的 探讨外源性胰岛素对电化学发光免疫分析法检测胰岛素的影响。方法 采用电化学发光免疫分析法测定血清胰岛素水平，根据美国临床实验室标准化协会标准文件EP7-A2的要求，采用配对差异实验分别评价8种外源性胰岛素对高、低浓度血清胰岛素测定的影响。如具有显著影响，用剂量效应实验评价确定外源性胰岛素浓度与干扰程度间的关系。 结果 甘舒霖N?、甘舒霖R?、优泌林R?、诺和灵R?、来得时?在干扰浓度 ≤ 250 μU /mL时，对高、低浓度胰岛素测定的影响均为线性正干扰；诺和平?在干扰物浓度 ≤ 250 μU /mL时，对高浓度胰岛素的影响为线性负干扰，对低浓度胰岛素无干扰，优泌乐?和诺和锐?对胰岛素检测无干扰。 结论 不同外源性胰岛素对电化学发光免疫分析法检测血清胰岛素的影响不同，临床上应注意由此导致的检测误差。Abstract: Objective To explore the interference of exogenous insulin therapy on insulin detection test by electrochemical luminescence immunoassay (ECLIA). Methods Insulin level was determined by ECLIA. According to the requirements of EP7-A2 of American Society for Clinical Laboratory Standards Institute Standards, paired difference experiment was conducted to evaluate the interference of 8 kinds of exogenous insulin on insulin detection, dose effect experiment was conducted to determine the relationship between exogenous insulin concentration and interference degree. Results When the interfering substance concentrations were ≤250 μU/mL, Gansulin N?, Gansulin R?, Humulin R?，Novolin R? and Lantus? all showed linear positive interference, while Levemir? showed a linear negative interference in high concentrations insulin and non-interfering in low concentrations insulin, Humalog? and Novo Rapid? showed non-interference in insulin detection. Conclusion The use of different exogenous insulin may have different interference on insulin measurement, which need laboratorians and physicians notice to avoid misdiagnosis.
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期刊类型引用(5)
1. 康娟，朱晋升，李正，杨忠，王会如. 胰岛素化学发光免疫分析系统正确度和一致性评价的初步研究. 标记免疫分析与临床. 2024(05): 922-926+980 . 
百度学术
2. 康娟，李正，朱晋升，王会如. 内源性胰岛素检测的一致化进展. 医疗装备. 2024(17): 161-164 . 百度学术
3. 方福生，王宁，孙菁，刘星宇，王薇，孙般若，谷昭艳，傅晓敏，李红，闫双通. 成年人群血清C肽与胰岛素的相关性及对应值的分析. 中华医学杂志. 2023(15): 1127-1133 . 百度学术
4. 陈华玲. 分析电化学发光免疫分析法在糖尿病疾病临床检验中的应用效果. 当代临床医刊. 2021(02): 78-79 . 百度学术
5. 郑瑞娟，江道鸿，陈江海，林思伟，陈怀义. ZnO电致化学发光以及对尿酸的检测研究. 化学研究与应用. 2020(09): 1601-1607 . 百度学术
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