Agglutinating Reagent for Rapid Hemoglobin Derivative Measurement

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Solution Overview

Problem

Current methods for measuring hemoglobin derivatives, such as hemoglobin A1c, are slow and require harsh reagents that can damage antibodies, and existing agglutinating reagents have low reaction rates and unstable storage properties.

Innovation Solution

A method using a nonionic surfactant, oxidizing agent, and metal salt to quickly and reliably denature hemoglobin, combined with an agglutinating reagent formed by binding ligands to a protein with a high-order structure, enhancing the agglutination reaction rate and storage stability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If harsh reagents are used to denature hemoglobin quickly, then measurement speed is improved, but antibody damage occurs

Engineering Contradiction:

Improvemeasurement speedVSAvoidantibody damage

Core Design Contradiction:

SpeedVSObject-affected harmful factors

Solution Approach 1:

The patent changes the chemical parameters of the denaturation reagent by using nonionic surfactants with specific HLB values (13-18) and controlled concentrations (0.1-5% w/v), combined with oxidizing agents and metal salts at optimized ratios. This parameter optimization enables rapid hemoglobin denaturation while maintaining antibody integrity, resolving the contradiction between measurement speed and antibody protection.

Inventive Principle:

Principle #35Parameter changes

2Ease of manufacture

If conventional agglutinating reagents are used, then manufacturing is simple, but reaction rate is low and storage stability is poor

Engineering Contradiction:

Improvemanufacturing simplicityVSAvoidreaction rate

Core Design Contradiction:

Ease of manufactureVSProductivity

Solution Approach 1:

The patent creates a composite agglutinating reagent system combining protein carriers with multiple ligands (including denatured hemoglobin derivatives) bound through specific chemical linkers. This composite structure maintains manufacturing feasibility while dramatically improving reaction rate and storage stability, as the multi-component system provides both high affinity binding and enhanced structural stability.

Inventive Principle:

Principle #40Composite materials

3Ease of manufacture

If conventional agglutinating reagents are used, then manufacturing is simple, but storage stability is unstable

Engineering Contradiction:

Improvemanufacturing simplicityVSAvoidstorage stability

Core Design Contradiction:

Ease of manufactureVSStability of the object's composition

Solution Approach 1:

The patent introduces stable metal salt complexes (such as ferricyanide or other oxidizing agents) as intermediaries that form stable cross-links between ligands and protein carriers. These intermediary compounds act as structural stabilizers that maintain reagent composition integrity during storage, while allowing simple manufacturing procedures to be maintained.

Inventive Principle:

Principle #24Intermediary (Mediator)

4Loss of time

If rapid denaturation is achieved, then measurement time is reduced, but immune reaction interference increases

Engineering Contradiction:

Improvemeasurement timeVSAvoidimmune reaction interference

Core Design Contradiction:

Loss of timeVSObject-generated harmful factors

Solution Approach 1:

The patent applies local quality control by using nonionic surfactants that selectively denature hemoglobin in specific local regions (red blood cells) while leaving the antibody environment unaffected. The surfactant's amphiphilic structure enables localized action at the cell membrane level, achieving rapid denaturation without generating harmful immune reactions in the bulk solution.

Inventive Principle:

Principle #3Local quality

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 allows for rapid and accurate measurement of hemoglobin derivatives with minimal immune reaction interference, reducing measurement time and improving storage stability of reagents, enabling room temperature storage.

Implementation Method 1

treating a sample containing a blood component with a nonionic surfactant, an oxidizing agent and a metal salt to denature hemoglobin in the sample

Methodology Applied

Scientific EffectDenaturation:

Implementation Method 2

a specific component in a biological sample is qualitatively and quantitatively measured and determined based on the presence or absence of agglutination of a free anti-analyte antibody or an anti-analyte antibody bound to a water suspensible particle

Methodology Applied

Scientific EffectAgglutination:

Implementation Method 3

treating a sample containing a blood component with a nonionic surfactant, an oxidizing agent and a metal salt to denature hemoglobin in the sample

Methodology Applied

Scientific EffectOxidation: Oxidation

Data Source

PatentUS9151765B2Method for producing agglutinating reagent, agglutinating reagent or product produced thereby, and method for measuring analysis object using the same, and test kit and analysis device

Publication Date: 2015.10.06 PHC HLDG CORP

AI summary

Hemoglobin in a sample solution is quickly and reliably denatured; at the same time, quick and accurate measurement of hemoglobin and a hemoglobin derivative is realized. In a method for measuring hemoglobin and a hemoglobin derivative, and a reagent composition, a measurement kit, an analysis device, and an analysis system used in the method, a sample solution containing a blood component is treated with a nonionic surfactant, an oxidizing agent, and a metal salt to denature hemoglobin in the sample solution to measure the hemoglobin, and thereafter the amount of a hemoglobin derivative in the sample is measured by an immunological method using an antibody specifically binding to a denatured site of the denatured hemoglobin derivative.