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[Interference of Exogenous Insulin on Insulin Detection Test by Electrochemiluminescence Immunoassay]
Mei Zhang1, Jun Zhou1, Li-Dan Yang1
1Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu 610041, China.
Insights
Different exogenous insulins interfere with electrochemical luminescence immunoassay (ECLIA) insulin detection differently. Some cause positive or negative interference, while others do not, impacting accurate insulin level measurement.
Area of Science:
- Clinical Chemistry
- Immunoassay Technology
- Endocrinology
Context:
- Accurate insulin level measurement is crucial for managing diabetes and other metabolic disorders.
- Electrochemical luminescence immunoassay (ECLIA) is a common method for detecting insulin concentrations.
- Exogenous insulin therapy, widely used in diabetes management, may potentially interfere with these assays.
Purpose:
- To investigate the interference of various exogenous insulin formulations on insulin detection using ECLIA.
- To evaluate the impact of different exogenous insulin types and concentrations on assay results.
- To provide data for laboratory professionals and clinicians regarding potential interferences.
Summary:
- Eight types of exogenous insulin were tested for interference with ECLIA-based insulin detection according to EP7-A2 standards.
- Gansulin N®, Gansulin R®, Humulin R®, Novolin R®, and Lantus® showed linear positive interference at concentrations ≤250 μU/mL.
- Levemir® exhibited concentration-dependent interference (negative at high, none at low), while Humalog® and Novo Rapid® showed no interference.
Impact:
- Exogenous insulin therapy can significantly interfere with insulin measurements, leading to potential misdiagnosis.
- Understanding specific insulin interferences is essential for accurate clinical interpretation of insulin test results.
- This study highlights the need for awareness among laboratorians and physicians to ensure reliable patient care.
Objective:
To explore the interference of exogenous insulin therapy on insulin detection test by electrochemical luminescence immunoassay (ECLIA).
Methods:
Insulin level was determined by ECLIA. According to the requirements of EP7-A2 of American Society for Clinical Laboratory Standards Institute Standards, paired difference experiment was conducted to evaluate the interference of 8 kinds of exogenous insulin on insulin detection, dose effect experiment was conducted to determine the relationship between exogenous insulin concentration and interference degree.
Results:
When the interfering substance concentrations were ≤250 μU/mL, Gansulin NⓇ, Gansulin RⓇ, Humulin RⓇ,Novolin RⓇ and LantusⓇ all showed linear positive interference, while LevemirⓇ showed a linear negative interference in high concentrations insulin and non-interfering in low concentrations insulin, HumalogⓇ and Novo RapidⓇ showed non-interference in insulin detection.
Conclusions:
The use of different exogenous insulin may have different interference on insulin measurement, which need laboratorians and physicians notice to avoid misdiagnosis.
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