Hemoglobin A1c Measurement Correction for Abnormal Variant Interference

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Solution Overview

Problem

Conventional methods for measuring stable hemoglobin A1c in blood specimens, particularly those containing abnormal hemoglobin variants, often result in inaccurate values due to interference from these variants, leading to underestimation of stable hemoglobin A1c levels.

Innovation Solution

A method using a hemoglobin separation analysis based on cation exchange, which involves determining peak values from analysis signals, applying a correction arithmetic expression to reduce the measured value of stable hemoglobin A1c, accounting for the influence of specific peaks appearing between the stable hemoglobin A1c and hemoglobin A0 peaks, to obtain a more accurate result.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If a hemoglobin separation analysis method based on cation exchange is used to measure stable hemoglobin A1c, then the measurement process is simple and fast, but the measured value becomes higher than the true value when time-degraded specimens are used

Engineering Contradiction:
Improvemeasurement speedVSAvoidaccuracy of stable hemoglobin A1c value
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The invention performs preliminary identification of peak patterns and detection of specific peaks (such as hemoglobin E peaks) before final quantification. By analyzing the peak pattern in advance and identifying characteristic peaks that indicate specimen degradation or abnormal hemoglobin presence, the system can apply appropriate correction algorithms to obtain accurate stable hemoglobin A1c values from time-degraded specimens without sacrificing measurement speed

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The invention implements a feedback mechanism where the measured peak values and patterns are used to determine correction factors. The system calculates the stable hemoglobin A1c value based on the measured peaks, then uses the presence and characteristics of specific peaks (like hemoglobin E peaks between HbA1c and HbA0) as feedback to apply corrections that compensate for degradation effects, thereby improving measurement accuracy while maintaining the rapid cation exchange methodology

Inventive Principle:
Principle #23Feedback

2Measurement precision

If correction is performed to increase the hemoglobin A1c value to compensate for abnormal hemoglobin interference, then the accuracy for specimens with abnormal hemoglobin improves, but the complexity of the measurement process increases

Engineering Contradiction:
Improveaccuracy of stable hemoglobin A1c valueVSAvoidcomplexity of correction process
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The invention enables the measurement system to automatically detect the presence of abnormal hemoglobin variants and apply appropriate corrections without requiring external intervention or complex manual procedures. The system self-identifies peak patterns characteristic of abnormal hemoglobin (such as hemoglobin E, C, D, or S variants), automatically calculates correction factors based on the measured peak areas, and adjusts the stable hemoglobin A1c value accordingly, thereby improving accuracy while keeping the process simple and automated

Inventive Principle:
Principle #25Self-service

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

This approach effectively corrects for the increase in stable hemoglobin A1c values, providing measurements closer to true values, even in time-degraded specimens, by subtracting the influence of specific peaks, thereby improving the accuracy of hemoglobin A1c measurement.

Implementation Method 1

a hemoglobin separation analysis method based on cation exchange as a principle

Methodology Applied
Scientific EffectCation exchange: Ion Exchange

Data Source

PatentUS20240036028A1METHOD OF MEASURING STABLE HEMOGLOBIN A1c AND MEASUREMENT DEVICE THEREFOR
Publication Date: 2024.02.01 ARKRAY INC
  • US20240036028A1 patent drawing
  • US20240036028A1 patent drawing
  • US20240036028A1 patent drawing

AI summary

A method of measuring stable hemoglobin A1c by a hemoglobin separation analysis method based on cation exchange, the method comprising: obtaining an analysis signal from a blood specimen to be measured by the separation analysis method; determining a C value, which is a peak value of a stable hemoglobin A1c peak, and an X value, which is a peak value of a specific peak appearing between the stable hemoglobin A1c peak and a hemoglobin A0 peak, from the analysis signal; and correcting the C value by applying the C value and the X value to a predetermined arithmetic expression to obtain a C′ value that is a reduced value from the C value, wherein the arithmetic expression is determined based on a correlation between a C value and an X value obtained from a blood specimen in which a stable hemoglobin A1c value is known by the separation analysis method.