首页|内源性胰岛素检测的一致化进展

内源性胰岛素检测的一致化进展

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内源性胰岛素(以下简称胰岛素)的可靠检测对于糖尿病的诊断和病情评估具有重要意义.目前,临床广泛应用的胰岛素检测方法为化学发光免疫分析法(CLIA),具有高通量、高灵敏度、强选择性、低成本等优点.但室间质量评价结果显示,目前CLIA的检测一致化较差.基于此,该研究首先介绍胰岛素的主要检测方法及优缺点,然后汇总国内现有注册胰岛素检测试剂盒的方法学分布情况,最后针对CLIA检测一致化差的问题,从标准物质和参考方法方面梳理了相关标准化情况,并提出改进建议,以期为相关产品的研发、监管、计量研究等提供参考,助力胰岛素检测质量的提升.
The Progress in Harmonisation of Endogenous Insulin Detection
The reliable detection of endogenous insulin(hereinafter referred to as insulin)is very important for the diagnosis and evaluation of diabetes.At present,with the advantages of high throughput,high sensitivity,strong selectivity,and low cost,chemiluminescent immunoassay(CLIA)is a widely used method for insulin detection in clinic.However,the results of the external quality assurance showed that the comparability of CLIA testing was currently poor.Based on this,the main detection methods of insulin and their advantages and disadvantages were first introduced,in this study.Then,the methodological distribution of insulin detection kits on sale in China was summarized.Finally,in response to the issue of poor comparability in CLIA testing,the relevant standardization status was summarized from the aspects of standard materials and reference methods.Improvement suggestions were proposed in order to provide reference for the research and development,supervision,and metrological research of related products,and to help improve the quality of insulin testing.

Endogenous insulinChemiluminescent immunoassay methodHarmonisationStandard substanceReference method

康娟、李正、朱晋升、王会如

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北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心)(北京 101111)

内源性胰岛素 化学发光免疫分析法 一致化 标准物质 参考方法

2024

医疗装备
国家食品药品监督管理局北京医疗器械质量监督检验中心 北京市医疗器械检验所

医疗装备

影响因子:0.339
ISSN:1002-2376
年,卷(期):2024.37(17)