Biometrology Group, Division of Chemical and Biological Metrology, Korea Research Institute of Standards and Science, Daejeon, South Korea.
Department of Bio-Analytical Science, University of Science and Technology, Daejeon, South Korea.
J Clin Lab Anal. 2022 Jul;36(7):e24521. doi: 10.1002/jcla.24521. Epub 2022 May 27.
The standardization of measurement aims to achieve comparability of results regardless of the analytical methods and the laboratory where analyses are carried out. In this paper, a comparison of results from several immunoassay-based insulin analysis kits is described, and the steps necessary to improve comparability are discussed.
Four manual enzyme-linked immunosorbent assay (ELISA) kits produced by Mercodia, Alpco, Epitope Diagnostics, and Abcam, and three automated chemiluminescent (CLIA) insulin assay kits (Siemens Centaur XP, Unicel Dxl800, Cobas e801) were compared by analyzing human serum samples and certified reference materials for human insulin.
The seven evaluated assay kits showed substantial discrepancies in the results, with relative standard deviation ranges between 1.7% and 23.2%. We find that the traceability chains and the unit conversion factors are not yet harmonized, and current reference materials for insulin are not applicable for immunoassay-based method validation due to the use of different matrices.
The findings suggest the need to fine tune insulin analysis methods, measurement traceability, and any conversion factor used in post-analysis steps in accordance with the necessity for standardization.
测量的标准化旨在实现无论分析方法和进行分析的实验室如何，结果都具有可比性。本文描述了对几种基于免疫测定的胰岛素分析试剂盒的结果进行比较，并讨论了提高可比性所需的步骤。
使用 Mercodia、Alpco、Epitope Diagnostics 和 Abcam 生产的四种手动酶联免疫吸附测定（ELISA）试剂盒，以及西门子 Centaur XP、Unicel Dxl800 和 Cobas e801 三种自动化化学发光（CLIA）胰岛素检测试剂盒，分析人血清样本和人胰岛素的认证参考物质。
这七种评估的检测试剂盒在结果上存在显著差异，相对标准偏差范围在 1.7%到 23.2%之间。我们发现，可追溯链和单位换算因子尚未协调，并且由于使用了不同的基质，当前的胰岛素参考物质不适用于基于免疫测定的方法验证。
研究结果表明，需要根据标准化的必要性，对胰岛素分析方法、测量可追溯性以及任何后分析步骤中的换算因子进行微调。
