[KSCI] Korea Science Citation Index Service

http://dx.doi.org/10.3343/alm.2018.38.6.530

Clinical Utility and Cross-Reactivity of Insulin and C-Peptide Assays by the Lumipulse G1200 System

Oh, Jongwon (Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine)
Kim, Jae Hyeon (Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine)
Park, Hyung-Doo (Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine)

Publication Information

Annals of Laboratory Medicine / v.38, no.6, 2018 , pp. 530-537 More about this Journal

Abstract

Background: Measurement of insulin and C-peptide concentrations is important for deciding whether insulin treatment is required in diabetic patients. We aimed to investigate the analytical performance of insulin and C-peptide assays using the Lumipulse G1200 system (Fujirebio Inc., Tokyo, Japan). Methods: We examined the precision, linearity, and cross-reactivity of insulin and C-peptide using five insulin analogues and purified proinsulin. A method comparison was conducted between the Lumipulse G1200 and Roche E170 (Roche Diagnostics, Mannheim, Germany) systems in 200 diabetic patients on insulin treatment. Reference intervals for insulin and C-peptide concentrations were determined in 279 healthy individuals. Results: For insulin and C-peptide assays, within-laboratory precision (% CV) was 3.78-4.14 and 2.89-3.35%, respectively. The linearity of the insulin assay in the range of 0-2,778 pmol/L was $R^2=0.9997$ , and that of the C-peptide assay in the range of 0-10 nmol/L was $R^2=0.9996$ . The correlation coefficient (r) between the Roche E170 and Lumipulse G1200 results was 0.943 (P <0.001) for insulin and 0.996 (P <0.001) for C-peptide. The mean differences in insulin and C-peptide between Lumipulse G1200 and the Roche E170 were 19.4 pmol/L and 0.2 nmol/L, respectively. None of the insulin analogues or proinsulin showed significant cross-reactivity with the Lumipulse G1200. Reference intervals of insulin and C-peptide were 7.64-70.14 pmol/L and 0.17-0.85 nmol/L, respectively. Conclusions: Insulin and C-peptide tests on the Lumipulse G1200 show adequate analytical performance and are expected to be acceptable for use in clinical areas.

Keywords

C-peptide; Diabetes mellitus; Insulin; Lumipulse G1200; Performance;

Citations & Related Records

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