血清胰岛素测量的现状和标准化的需要
Curt Rohlfing1, Gregory Petroski2, Maya Hatten-Beck3
1Department of Pathology & Anatomical Sciences, University of Missouri, Columbia, MO, USA.
Clinical chemistry and laboratory medicine
|August 13, 2025
概括
商业胰岛素测定显示出显著的变异性,阻碍了对胰岛素瘤等疾病的准确诊断. 对于这些重要测试的可靠临床和研究使用,迫切需要标准化.
科学领域:
- 临床化学 临床化学
- 内分泌学 在内分泌学.
- 测试开发 测试开发
背景情况:
- 胰岛素测试对于诊断胰岛素耐药性,胰岛素瘤和低血糖至关重要.
- 目前的商业胰岛素测定显示出显著的差异,限制了其临床和研究实用性.
研究的目的:
- 评估广泛使用的商业胰岛素免疫试验的可比性.
- 通过不同的测试来识别胰岛素测量的变化和潜在偏差.
主要方法:
- 分析了40个来自健康人和糖尿病患者的血清样本.
- 对比来自九家制造商的12个商业免疫试验与同位素稀释质谱法 (IDMS).
主要成果:
- 优异的试验内可重复性 (ICCs > 0.99),但在试验间的可变性很大.
- 相对于LC-MS的差异在 -298.2到+302.6 pmol/L之间.
- 测试显示在低胰岛素水平过高估计,在高水平低估;只有一个测试与IDMS一致.
结论:
- 尽管声称可追溯到世卫组织标准,但胰岛素检测仍然存在显著的变异性.
- 迫切需要对胰岛素测试进行标准化.
- 可交换的认证参考材料对于提高胰岛素测定精度至关重要.
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