Interference Assessment for High-Performance Liquid Chromatography HbA1c Assays
Linghao Zhao1, Wei Yang2, Shengjin Cui3
1Department of IVD Research and Development, Lirimax (Tianjin) Medical Technology Co. Ltd., Tianjin, China.
Biomedical Chromatography : BMC
|February 3, 2026
Summary
Laboratory interference can cause inaccurate hemoglobin A1c (HbA1c) results. This study identified specific substances like cholic acid, low pH, and ethanol that interfere with HbA1c measurements, providing thresholds for clinical interpretation.
Area of Science:
- Clinical Chemistry
- Analytical Chemistry
- Laboratory Medicine
Background:
- Laboratory errors, particularly interference, significantly impact measurement accuracy.
- Accurate clinical laboratory results are essential and must be free from interference.
Purpose of the Study:
- To evaluate the interference of endogenous and exogenous substances on hemoglobin A1c (HbA1c) measurements using ion exchange high-performance liquid chromatography.
- To determine interference concentration thresholds for various substances across different HbA1c analyzer brands.
Main Methods:
- Ion exchange high-performance liquid chromatography (HPLC) was used to analyze HbA1c.
- 12 endogenous and 24 exogenous substances were added to hemoglobin solutions at varying HbA1c levels to simulate clinical samples.
- Interference screening and dose-response experiments were conducted to identify and quantify interference effects.
Main Results:
- Endogenous cholic acid and low pH elevate HbA1c values above interference thresholds.
- Exogenous ethanol causes increased HbA1c in low-value samples and decreased values in high-value samples.
- While analyzer brands showed slight differences in interference thresholds, these were not statistically significant.
Conclusions:
- Established interference concentration thresholds and identified key interfering substances (cholic acid, low pH, ethanol).
- Provides crucial data for clinical laboratory experts to accurately interpret HbA1c testing results.
- Aids in mitigating laboratory errors caused by interference in HbA1c analysis.
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