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Immunoassay quantification of human insulin added to ternary parenteral nutrition containers: comparison of two methods

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Abstract

Adding insulin directly into infusion bags seems to be a useful method for controlling hyperglycemia in patients under ternary parenteral nutrition (TPN). Its efficacy is assessed by glycemic monitoring but few data are available on insulin stability in this situation. Among the various methods for quantifying insulin levels in human serum, the immunoassay ones seemed potentially appropriate for a TPN admixture containing high lipid concentrations. We sought to identify and validate which of two immunoassay methods was the better to quantify human insulin and consequently be adapted to studying its stability in a TPN admixture. Two immunoassay methods to quantify recombinant human insulin were assessed in industrial TPN: an immunoradiometric assay (IRMA) and an immunoelectrochemiluminometric assay (IECMA). Validation trials for both methods were based on the accuracy profile method. Interference with immunometric assays due to the high lipidic content of TPN was eliminated through an improved preparation protocol using a bovine serum albumin (BSA) diluted in phosphate buffer saline (PBS). The relative total error of IECMA varied from 1.74 to 4.52% while it varied from −0.32 to 8.37% with IRMA. Only IECMA provided an accuracy profile with a 95% confidence interval of calculated-tolerance limits falling between the chosen acceptance limits (i.e., total error ≤±10%). IECMA combined with a BSA dilution is a simple and semi-automatic method that provides an accurate quantification of human insulin in a TPN admixture without any interference from lipids.

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Acknowledgements

The authors wish to thank Mrs. Alexandra Tavernier, M.A. University of Glasgow, U.K.; Professeur Agrégée, University of Lille, for her extensive revision of the final manuscript.

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Authors and Affiliations

  1. Univ. Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000, Lille, France

    Héloïse Henry, Damien Lannoy, Nicolas Simon, Christine Barthélémy, Bertrand Décaudin, Thierry Dine & Pascal Odou

  2. Institut de Pharmacie, CHU Lille, F-59000, Lille, France

    Héloïse Henry, Damien Lannoy, Nicolas Simon, Bertrand Décaudin & Pascal Odou

  3. Univ. Lille, U995 – LIRIC – Lille Inflammation Research International Center, F-59000, Lille, France

    David Seguy

  4. Department of Nutrition, CHU Lille, F-59000, Lille, France

    David Seguy

  5. Immunoanalysis Center, Biology and Pathology Center, CHU Lille, F-59000, Lille, France

    Michèle D’Herbomez

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  1. Héloïse Henry
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  2. Damien Lannoy
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  3. Nicolas Simon
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  4. David Seguy
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  5. Michèle D’Herbomez
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  7. Bertrand Décaudin
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  9. Pascal Odou
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Correspondence to Damien Lannoy.

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Henry, H., Lannoy, D., Simon, N. et al. Immunoassay quantification of human insulin added to ternary parenteral nutrition containers: comparison of two methods. Anal Bioanal Chem 409, 3677–3684 (2017). https://doi.org/10.1007/s00216-017-0311-0

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  • DOI: https://doi.org/10.1007/s00216-017-0311-0

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