Abstract
Insulin testing is widely used in the diagnosis and assessment of the stage of glucose metabolism disorders. In this study, we evaluated the performance characteristics and clinical utility of “Norudia® Insulin”. The coefficients of variation (C.V.) for within-run and between-run precisions were 1.25–3.08% and 3.69–8.07%, respectively. Linearity was maintained up to 144.2 μU/mL, and the quantitation limit was 1.0 μU/mL. Prozone effects were observed at ≥ 202.5 μU/mL. There was significant interference by hemoglobin. Comparison with “ARCHITECT Insulin” showed good correlation with a regression equation of y = 0.96x + 1.0 and a correlation coefficient of r = 0.992 (samples from patients not receiving insulin analog formulations). In addition, the reagent was confirmed to not react with insulin analog formulations after analytical recovery testing. The results of a questionnaire survey targeting doctors at our hospital revealed that assays that can selectively measure endogenous insulin are highly desirable; in addition, they can reduced testing times and costs. As such, the assay should be a useful tool in clinical settings.
