Hemoglobin Measurement Correction for Carbamylation Errors

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Conventional methods for measuring stable hemoglobin Alc (HbAlc) in blood samples, particularly in patients with renal failure or high aldehyde concentrations, face inaccuracies due to chemical modifications like carbamylation and aldehydation, which affect the separation and measurement of stable Alc, leading to fluctuations and overestimation of its values.

Innovation Solution

A method that involves obtaining a correction factor based on peak areas from capillary electrophoresis to distinguish and correct for chemically modified HbA0, allowing for the accurate measurement of both chemically modified and unmodified stable Alc, by considering the time distribution of optical measured values and molecular surface charges of hemoglobin.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional separation analysis is used to separate stable Alc from chemically modified hemoglobin, then the separation of stable Alc from unmodified hemoglobin is achieved, but the measurement accuracy of stable Alc is deteriorated due to co-elution of chemically modified hemoglobin fractions

Engineering Contradiction:
Improvemeasurement accuracy of stable AlcVSAvoidco-elution of chemically modified hemoglobin
Core Design Contradiction:
Measurement precisionVSQuantity of substance

Solution Approach 1:

The patent segments the hemoglobin analysis into multiple distinct fractions based on their electrophoretic mobility. By dividing the total hemoglobin into unmodified HbA0, carbamylated HbA0, aldehydated HbA0, and stable Alc fractions, the method enables separate quantification of each component, preventing the measurement errors caused by co-elution in conventional single-peak analysis

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces a new dimension of analysis by using capillary electrophoresis with detection of time distribution of optical measured values, which separates hemoglobin components based on their electrophoretic mobility through an electric field. This adds a temporal and spatial dimension to the analysis, allowing resolution of components that co-elute in conventional HPLC methods

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Measurement precision

If capillary electrophoresis is used to separate stable Alc from chemically modified hemoglobin by changing coating or migration conditions, then the separation resolution is improved, but the measurement accuracy of stable Alc is still deteriorated due to exclusion of chemically modified stable Alc from measurement

Engineering Contradiction:
Improveseparation resolutionVSAvoidexclusion of chemically modified stable Alc
Core Design Contradiction:
Measurement precisionVSLoss of information

Solution Approach 1:

The patent employs feedback by using the detected peak areas of chemically modified HbA0 fractions (carbamylated and aldehydated) to calculate a correction factor. This correction factor is then applied to the measured stable Alc peak area to compensate for the chemically modified stable Alc that would otherwise be excluded, creating a closed-loop correction system that improves measurement accuracy

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent introduces chemically modified HbA0 fractions as intermediary components in the analysis. By measuring these intermediate fractions and using them to calculate correction factors, the method indirectly accounts for the chemically modified stable Alc, serving as a mediator to recover information that would otherwise be lost

Inventive Principle:
Principle #24Intermediary (Mediator)

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 enables more precise measurement of stable Alc, reflecting the average blood sugar level over one to two months, even in samples with chemical modifications, thereby improving diabetes management accuracy.

Implementation Method 1

A method of analyzing hemoglobin by capillary electrophoresis is disclosed in Japanese Patent Application Reissue No. 2008-139866

Methodology Applied
Scientific EffectCapillary electrophoresis: Capillary Electrophoresis

Implementation Method 2

the hemoglobin is subjected to chemical modification by carbamylation in which cyanate generated from urea binds with hemoglobin

Methodology Applied
Scientific EffectElectrophoresis: Electrophoresis

Implementation Method 3

a time distribution of an optical measured value of hemoglobin at a flow path which separates hemoglobin in the blood sample

Methodology Applied
Scientific EffectOptical absorption: Absorption (EM radiation)

Data Source

PatentEP3754338A1Method of measuring stable a1c
Publication Date: 2020.12.23 ARKRAY INC
  • EP3754338A1 patent drawingFigure 1
  • EP3754338A1 patent drawingFigure 2
  • EP3754338A1 patent drawingFigure 3

AI summary

A method of measuring stable Alc in a blood sample based on a time distribution of an optical measured value of hemoglobin at a flow path which separates hemoglobin in the blood sample on a basis of amounts of the charges of hemoglobin, the method comprising: a step of obtaining a correction factor, based on a peak area (A) of a fraction including HbA0 and either a peak area (G) of a first fraction including chemically-modified HbA0, or a peak area (D) of a second fraction including a component having a smaller amount of positive charge than HbAO adjacent to a fraction identified as HbAO, in the time distribution; and a step of correcting, based on the correction factor a peak area of a fraction including stable Alc in the time distribution.