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.
Abbreviations and Acronyms:
CMSL (Clinical Mass Spectrometry Laboratory), LC-HRAM (liquid chromatography high resolution accurate mass), MS (mass spectrometry)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: October 07, 2022
Footnotes
For editorial comment, see page 1966
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© 2022 Mayo Foundation for Medical Education and Research
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- Explaining Unexplained Hypoglycemia Due To Insulin AnalogsMayo Clinic ProceedingsVol. 97Issue 11
- PreviewHypoglycemia is a potentially life-threatening condition that requires urgent medical attention. Most hypoglycemia in patients with diabetes is related to medication use, and recent studies have indicated the contributions of insulin analogs in cases of hypoglycemia.1,2 Even in patients without diabetes, it is important to exclude insulin administration as a cause of hypoglycemia, yet detection of insulin analogs is not straightforward. The small structural changes that result in favorable pharmacokinetics of insulin analogs also affect the detection of analog insulin by immunoassays, culminating in varying results from different commercially available assays.
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