Pitfalls in Diagnosing Hypoglycemia Due to Exogenous Insulin: Validation and Utility of an Insulin Analog Assay.


Journal

Mayo Clinic proceedings
ISSN: 1942-5546
Titre abrégé: Mayo Clin Proc
Pays: England
ID NLM: 0405543

Informations de publication

Date de publication:
11 2022
Historique:
received: 01 04 2022
revised: 24 06 2022
accepted: 25 07 2022
pubmed: 10 10 2022
medline: 9 11 2022
entrez: 9 10 2022
Statut: ppublish

Résumé

To overcome the limitations of commercially available insulin immunoassays which have variable detection of analog insulin and can lead to clinically discordant results and misdiagnosis in the workup of factitious hypoglycemia. We performed analytical validation of a liquid chromatography high resolution accurate mass (LC-HRAM) immunoassay to detect insulin analogs. We completed clinical assessment using a large cohort of human serum samples from 78 unique individuals, and subsequently used the assay in the evaluation of eight individuals with high diagnostic suspicion for factitious hypoglycemia. The performance characteristics show that the LC-HRAM immunoassay can be applied to detect five commonly used synthetic insulin analogs (lispro, glulisine, aspart, glargine metabolite, and detemir) in human serum. Our clinical cases show that this assay could be used in the diagnosis of factitious hypoglycemia by identifying the analog insulin(s) in question. The LC-HRAM immunoassay reported here overcomes a gap in our diagnostic pathway for hypoglycemia. The results obtained from our studies suggest that this method is appropriate for use in clinical laboratories when factitious hypoglycemia is considered as a differential diagnosis.

Identifiants

pubmed: 36210202
pii: S0025-6196(22)00465-7
doi: 10.1016/j.mayocp.2022.07.021
pmc: PMC9996747
mid: NIHMS1879075
pii:
doi:

Substances chimiques

Insulin 0
Hypoglycemic Agents 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1994-2004

Subventions

Organisme : NIDDK NIH HHS
ID : R01 DK078646
Pays : United States

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2022 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

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Auteurs

Aoife M Egan (AM)

Division of Endocrinology, Diabetes, and Metabolism, Mayo Clinic, Rochester, MN, USA.

Kornelia D Galior (KD)

Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA; Department of Pathology and Laboratory Medicine, University of Wisconsin, Madison, WI, USA.

Anthony D Maus (AD)

Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.

Erica Fatica (E)

Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA; Department of Pathology and Laboratory Medicine, University of Cincinnati, Cincinnati, OH, USA.

Vinaya Simha (V)

Division of Endocrinology, Diabetes, and Metabolism, Mayo Clinic, Rochester, MN, USA.

Pankaj Shah (P)

Division of Endocrinology, Diabetes, and Metabolism, Mayo Clinic, Rochester, MN, USA.

Ravinder J Singh (RJ)

Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.

Adrian Vella (A)

Division of Endocrinology, Diabetes, and Metabolism, Mayo Clinic, Rochester, MN, USA. Electronic address: vella.adrian@mayo.edu.

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Classifications MeSH