Ann Lab Med.  2018 Nov;38(6):530-537. 10.3343/alm.2018.38.6.530.

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

• Oh J
• Kim JH
• Park HD

• KMID: 2429118
• DOI: http://doi.org/10.3343/alm.2018.38.6.530

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 R2=0.9997, and that of the C-peptide assay in the range of 0-10 nmol/L was R2=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.

Keyword

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

MeSH Terms

C-Peptide*
Diabetes Mellitus
Humans
Insulin*
Methods
Proinsulin
C-Peptide
Insulin
Proinsulin

Figure

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  Fig. 1 Linearity of insulin and C-peptide in the Lumipulse G1200 system.

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  Fig. 2 Method comparison of the Lumipulse G1200 and Roche E170 systems. (A) Correlations between insulin and C-peptide results. (B) Bland–Altman plot showing differences between insulin and C-peptide results.

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  Fig. 3 Bland–Altman plot showing differences between Lumipulse G1200 and Roche E170 insulin results for 29 patients treated with insulin glargine.

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