How low is really low? Comparison of two C-peptide assays to establish residual C-peptide production in type 1 diabetes

Kitty de Leur, Charlotte Vollenbrock, Pim Dekker*, Martine M C de Vries-Velraeds, Erwin Birnie, Dick Mul, Bruce H R Wolffenbuttel, Joost Groen, Henk-Jan Aanstoot, Lianne Boesten

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

INTRODUCTION: C-peptide is an important marker to assess residual insulin production in individuals with type 1 diabetes (T1D). The accuracy and detection limits of C-peptide assays are important to detect C-peptide microsecretion and to reliably observe changes over time in these people. We compared and verified two commercially available assays able to measure C-peptide in the picomolar range.

METHODS: The ultrasensitive Mercodia enzyme-linked immunosorbent C-peptide assay (ELISA) was compared with the Beckman immunoradiometric assay (IRMA) for C-peptide, assessing reproducibility (coefficient of variation [CV]), limit of blank (LoB), limit of detection (LoD) and limit of quantitation (LoQ).

RESULTS: For both assays within-run and between-run variation were high at the low (around the detection limit) C-peptide concentration range, with CVs of around 40%. LoB values for the ultrasensitive ELISA and the IRMA were 1.3 and 0.16 pmol/L respectively. LoD values were 2.4 and 0.54 pmol/L respectively. LoQ values were 9.7 and 3.8 pmol/L respectively. Only the IRMA met the specifications claimed by the manufacturer.

CONCLUSIONS: The IRMA provided the lowest threshold for quantification of serum C-peptide. LoQ of commercially available assays should be established in-house before applying them in research studies and clinical trials in which low C-peptide levels have clinical or scientific relevance.

Original languageEnglish
Article numbere14785
Number of pages6
JournalDiabetic Medicine
Volume39
Issue number5
Early online date6-Jan-2022
DOIs
Publication statusPublished - May-2022

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