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Updated: Aug 15, 2026
A Rapid and Chemical-free Hemoglobin Assay with Photothermal Angular Light Scattering
Published on: December 7, 2016
Quality control, quality assessment of laboratory tests, HbA1c
1Department of Clinical Pathology, Nihon University, Tokyo. Japan.
Insights
Hemoglobin A1c (HbA1c) testing is crucial for diabetes management. Standardizing measurement methods like HPLC has significantly reduced lab variations, improving patient care and diabetes complication risk assessment.
Area of Science:
- Clinical Chemistry
- Endocrinology
- Laboratory Medicine
Background:
- Hemoglobin A1c (HbA1c) is a reliable long-term blood glucose control index for diabetics.
- Reduced HbA1c levels significantly lower the risk of diabetic retinopathy progression.
- High precision and accuracy in HbA1c determination are vital for diabetes management.
Purpose of the Study:
- To assess the impact of standardization efforts on inter-laboratory HbA1c measurement variability.
- To highlight the importance of accurate HbA1c testing for predicting diabetic complications.
Main Methods:
- Comparison of various HbA1c measurement techniques, including High-Performance Liquid Chromatography (HPLC), immunoassay, and affinity chromatography.
- Evaluation of the influence of stable and labile HbA1c components on measurement results.
- Analysis of standardization initiatives by the Japan Diabetes Society.
Main Results:
- High-Performance Liquid Chromatography (HPLC) is the predominant method, effectively eliminating labile HbA1c components.
- Immunoassay use has increased, while other methods have declined.
- Standardization efforts, including reference methods and materials, have substantially reduced inter-laboratory measurement differences.
Conclusions:
- Standardization of HbA1c determination has led to smaller inter-laboratory variations, primarily due to adopted measurement methods.
- Continued efforts are necessary to further standardize HbA1c testing for optimal diabetes control.
Abstract:
HbA1c level is known to be highly correlated with blood sugar level for a while after the maximum blood sugar level was observed, and is now considered more reliable than blood sugar as a long-term index of blood sugar control in diabetic patients. The Diabetes Control and Complication Trial in United States of America reported that mean HbA1c was the dominant predictor of retinopathy progression and that 10% lower HbA1c (e.g., 8 vs. 7.2 %) is associated with a 43 % to 45 % lower risk of progression of retinopathy. This report indicated that only a 1% difference in HbA1c level has a critical effect on progression of diabetic retinopathy. It also indicates the need for high precision and accuracy of hemoglobin A1c determination for control of diabetes patients. There are various methods to measure HbA1c. but now most laboratories use the high-performance liquid chromatography (HPLC) method; immunoassay is the second most popular, followed by affinity chromatography. It has been reported that each of these methods has its own characteristics, and that their results can vary considerably. In addition, there are two types of HbA1c, one a stable component and the other a labile component, and the measured HbA1c values were influenced by the contents of labile component included in the sample. The Japan Diabetes Society took a leading role and organized a committee on inter-laboratory standardization of HbA1c Determination in 1994. The HPLC method, which eliminates labile components, is used in most laboratories. Also, the number of laboratories using the immunoassay has gradually increased, while use of the other methods has rapidly decreased. In conclusion, since the proposal of a reference method and initiation of supply of reference materials by the Japan Diabetes Society, inter-laboratory differences in measured values have become much smaller, mainly due to the methods used for measurements. We need to continue efforts toward further standardization of HbA1c determination.
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