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

Heloise Henry 1 Damien Lannoy Nicolas Simon 1 David Seguy 2 Michele d'Herbomez Christine Barthelemy 1 Bertrand Decaudin 1 Thierry Dine 1 Pascal Odou 1
1 GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA)-EA 7365
2 LIRIC - Lille Inflammation Research International Center
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.
Mots-clés : Parenteral nutrition solutions Accuracy profile Mesh:Humans Mesh:Electrochemical Techniques/methods Mesh:Hyperglycemia/blood Mesh:Limit of Detection Mesh:Radioimmunoassay/methods Mesh:Recombinant Proteins/administration & dosage Mesh:Parenteral Nutrition*/methods Mesh:Recombinant Proteins/blood Mesh:Insulin/blood* Mesh:Immunoassay/methods* Mesh:Insulin/administration & dosage Mesh:Hypoglycemic Agents/administration & dosage Mesh:Hypoglycemic Agents/blood* Mesh:Hyperglycemia/therapy Validation Immunoassay Human insulin
Type de document :
Article dans une revue
Liste complète des métadonnées
https://hal.univ-lille.fr/hal-02149403
Contributeur : Lilloa Université de Lille <>
Soumis le : jeudi 6 juin 2019 - 13:35:44
Dernière modification le : samedi 8 juin 2019 - 01:02:45

Fichier

manuscript submitted post prin...
Fichiers produits par l'(les) auteur(s)

Identifiants

Collections

UNIV-LILLE | RIIP | RIIP_LILLE

Citation

Heloise Henry, Damien Lannoy, Nicolas Simon, David Seguy, Michele d'Herbomez, et al.. Immunoassay quantification of human insulin added to ternary parenteral nutrition containers: comparison of two methods. Analytical and Bioanalytical Chemistry, Springer Verlag, 2017, Analytical and bioanalytical chemistry, 409, pp.3677-3684. ⟨10.1007/s00216-017-0311-0⟩. ⟨hal-02149403⟩

Exporter

BibTeX TEI DC DCterms EndNote

Partager

Métriques

Consultations de la notice

41

Téléchargements de fichiers

77

Contact

Informations

CCSD