Anti-human hemoglobin monoclonal antibody or antibody kit, insoluble carrier particle to which Anti-human hemoglobin monoclonal antibody is immobilized, and measurement reagent and measurement method using same

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Solution Overview

Problem

Current methods for detecting hemoglobin-haptoglobin complex in feces are inefficient for screening digestive organ diseases due to decomposition by bacterial factors and difficulty in differentiating between complex and free hemoglobin/haptoglobin, leading to inaccurate measurements and prolonged processing times.

Innovation Solution

Development of an anti-human hemoglobin monoclonal antibody immobilized on insoluble carrier particles that specifically reacts with the hemoglobin-haptoglobin complex, allowing for its accurate detection and measurement using an agglutination method, while avoiding reactions with free hemoglobin and haptoglobin.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a sandwich immunoassay is used to detect hemoglobin-haptoglobin complex, then measurement specificity is improved, but measurement time is extended due to washing steps

Engineering Contradiction:
Improvemeasurement specificityVSAvoidmeasurement time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The invention extracts and eliminates the washing step from the sandwich immunoassay process by using an agglutination method where the hemoglobin-haptoglobin complex directly causes visible agglutination of antibody-coated particles, allowing detection without time-consuming washing operations

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention replaces the mechanical washing process with an optical detection method, where the agglutination reaction produces visible turbidity or color change that can be detected directly, eliminating the need for physical washing steps

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Productivity

If conventional antibodies are used in agglutination method, then productivity is improved by rapid measurement, but measurement precision deteriorates due to reaction with free hemoglobin and haptoglobin

Engineering Contradiction:
Improvemeasurement speedVSAvoidmeasurement specificity
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The invention applies local quality by designing antibodies with specific binding characteristics - one antibody specifically binds to hemoglobin only when it is in complex form with haptoglobin, while another antibody binds to haptoglobin, creating a localized specificity that distinguishes complexed from free forms

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The invention changes the binding parameter of the antibodies through selective immunization procedures, where antibodies are raised against the hemoglobin-haptoglobin complex rather than against free hemoglobin, fundamentally altering their binding specificity to recognize only the complexed state

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If hemoglobin is detected directly in feces, then detection simplicity is improved, but reliability deteriorates due to decomposition by bacterial factors

Engineering Contradiction:
Improvedetection simplicityVSAvoiddetection accuracy
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The invention introduces haptoglobin as an intermediary protective protein that binds to hemoglobin in the digestive tract, forming a complex that is resistant to bacterial decomposition, thereby preserving the hemoglobin signal for reliable detection while maintaining operational simplicity

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

Enables rapid and accurate measurement of the hemoglobin-haptoglobin complex in large samples, improving the efficiency of screening for digestive organ diseases by stabilizing the detection process and reducing interference from non-complex hemoglobin and haptoglobin.

Implementation Method 1

causing an agglutination reaction specifically with a hemoglobin-haptoglobin complex in a test specimen containing the hemoglobin-haptoglobin complex when the antibody or the kit is immobilized to an insoluble carrier particle

Methodology Applied
Scientific EffectAgglutination reaction: Coagulation

Data Source

PatentEP3467498B1Anti-human hemoglobin monoclonal antibody or antibody kit, insoluble carrier particle to which Anti-human hemoglobin monoclonal antibody is immobilized, and measurement reagent and measurement method using same
Publication Date: 2024.07.03 EIKEN KAGAKU
  • EP3467498B1 patent drawingFigure 1

AI summary

The present invention has an object to provide an anti-human hemoglobin monoclonal antibody or an antibody kit for specifically detecting and measuring a hemoglobin-haptoglobin complex in a sample with ease, and an insoluble carrier particle to which the monoclonal antibody is immobilized, and a measurement reagent and a measurement method for specifically detecting and measuring a hemoglobin-haptoglobin complex in a sample using the same. The anti-human hemoglobin monoclonal antibody of the present invention does not react to free hemoglobin or free haptoglobin which is not forming a complex but specifically reacts to a hemoglobin-haptoglobin complex, when the antibody is immobilized to the insoluble carrier particle and used.