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Updated: Sep 21, 2025
Homogeneous Time-resolved Förster Resonance Energy Transfer-based Assay for Detection of Insulin Secretion
Published on: May 10, 2018
Measurement comparability of insulin assays using conventional immunoassay kits
Nordiana Rosli1,2,3, Ha-Jeong Kwon1, Jinsook Lim4
1Biometrology Group, Division of Chemical and Biological Metrology, Korea Research Institute of Standards and Science, Daejeon, South Korea.
Background:
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.
Methods:
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.
Results:
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.
Conclusions:
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.
