Glycated Hemoglobin Measurement Correction for Abnormal Hemoglobin Interference
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Cation exchange chromatography methods for measuring glycated hemoglobin A1c (sA1c) yield low values when blood samples contain abnormal hemoglobin components like D, S, or C, as these components elute with non-glycated hemoglobin A, leading to inaccurate diabetes diagnosis.
Innovation Solution
A method and device that perform cation exchange chromatography to identify and correct the sA1c percentage by estimating the glycated peak areas of abnormal hemoglobin components, using specific formulas to account for overlapping peaks, ensuring accurate measurement reflection of diabetes symptoms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If cation exchange chromatography is used to measure sA1c, then the measurement method is simple and widely applicable, but the measurement accuracy deteriorates when abnormal hemoglobin components (D, S, or C) are present in the blood sample
Solution Approach 1:
The invention segments the total hemoglobin peak into multiple components including normal hemoglobin A (A0, A1a, A1b, A1c, sA1c) and abnormal hemoglobin components (H-V0, H-V1, H-V2). By identifying and separately calculating the area of abnormal hemoglobin peaks, the method accurately determines sA1c even when abnormal hemoglobin is present, resolving the accuracy issue while maintaining the simplicity of cation exchange chromatography.
2Device complexity
If abnormal hemoglobin peaks are excluded from calculation, then the calculation is simpler, but the sA1c measurement value becomes inaccurate and low
Solution Approach 1:
The invention uses the abnormal hemoglobin non-glycated peaks (H-V0, H-V1, H-V2) as intermediary references to identify and quantify the corresponding glycated abnormal hemoglobin peaks that overlap with the normal hemoglobin A region. By using these identifiable abnormal peaks as mediators, the method can accurately separate and calculate sA1c without requiring complex additional separation techniques.
3Measurement precision
If affinity chromatography is used instead of cation exchange chromatography, then measurement accuracy is maintained with abnormal hemoglobin, but the measurement method becomes more complex and less widely applicable
Solution Approach 1:
The invention changes the analytical parameter from direct peak area calculation to a corrected calculation method that accounts for abnormal hemoglobin. By introducing correction formulas that use the ratio of glycated to non-glycated abnormal hemoglobin peaks, the method achieves affinity chromatography-level accuracy while maintaining the operational simplicity and widespread applicability of cation exchange chromatography.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The method corrects sA1c percentage measurements to accurately reflect diabetes symptoms, correlating well with affinity chromatography results, even in the presence of abnormal hemoglobin components, thereby improving diagnostic accuracy.
Implementation Method 1
Measurement of glycated hemoglobin by liquid chromatography is roughly classified into measurement by cation exchange chromatography by which hemoglobin is separated into various hemoglobin components utilizing a difference in charge of them using a packing material to which an ion exchange substance is fixed
Implementation Method 2
measurement by affinity chromatography using a packing material to which aminophenylboronic acid groups having high affinity for sugar are fixed. By affinity chromatography, which utilizes affinity for the sugar chain moiety, various glycated hemoglobin components including sA1c are to be measured
Data Source
AI summary
A method for measuring a proportion of sA1c (%), which includes, when a peak derived from abnormal hemoglobin D, abnormal hemoglobin S or abnormal hemoglobin C is identified, calculation of the peak area, and measurement of the proportion of sA1c (%) corrected by using the calculation results. Results of measurement are obtained, by cation exchange chromatography, of sA1c (%) with a subject who provided a blood sample containing abnormal hemoglobin D, abnormal hemoglobin S or abnormal hemoglobin C by eliminating influences by such abnormal hemoglobin.