Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Nov;97(11):1994-2004.
doi: 10.1016/j.mayocp.2022.07.021. Epub 2022 Oct 7.

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

Aoife M Egan  1 , Kornelia D Galior  2 , Anthony D Maus  3 , Erica Fatica  4 , Vinaya Simha  1 , Pankaj Shah  1 , Ravinder J Singh  3 , Adrian Vella  5
Affiliations

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

Aoife M Egan et al. Mayo Clin Proc. 2022 Nov.

Abstract

Objective: 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.

Patients and methods: 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.

Results: 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.

Conclusion: 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.

PubMed Disclaimer

Figures

Figure 1:
Figure 1:
Steps in a LC-HRAM immunoassay LC-HRAM: liquid chromatography-high resolution accurate mass
See this image and copyright information in PMC

Comment in

References

    1. Service FJ. Hypoglycemic disorders. N Engl J Med. 1995;332(17):1144–1152. - PubMed
    1. Whipple A The surgical therapy of hyperinsulinism. J Int Chir. 1938(3):237–276.
    1. Sheldon B, Russell-Jones D, Wright J. Insulin analogues: an example of applied medical science. Diabetes Obes Metab. 2009;11(1):5–19. - PubMed
    1. Owen WE, Roberts WL. Cross-reactivity of three recombinant insulin analogs with five commercial insulin immunoassays. Clin Chem. 2004;50(1):257–259. - PubMed
    1. Heald AH, Bhattacharya B, Cooper H, et al. Most commercial insulin assays fail to detect recombinant insulin analogues. Ann Clin Biochem. 2006;43(Pt 4): 306–308. - PubMed

Publication types