Organic Colored Microparticles for Immunochromatography

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Solution Overview

Problem

Existing immunochromatographic assays face challenges in achieving favorable background and test result reproducibility while maintaining high detection sensitivity, primarily due to issues with particle clogging in the nitrocellulose membrane and poor contrast.

Innovation Solution

The development of organic colored microparticles with controlled sphericity and reduced coarse particles, specifically designed to prevent clogging and enhance contrast, is achieved by using reactive dyes with pyrimidine or triazine structures and precise control over particle diameter and hydrophilicity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If colored particles are used in immunochromatographic assays to enable detection, then detection sensitivity is improved, but particle clogging in the nitrocellulose membrane occurs resulting in poor background clarity

Engineering Contradiction:
Improvedetection sensitivityVSAvoidparticle clogging
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by precisely controlling the particle diameter within 100-650 nm and regulating the prevalence of coarse particles (700 nm or more) to 5% or less. This parameter optimization allows particles to be large enough for high detection sensitivity while small enough to prevent membrane clogging, resolving the contradiction between detection sensitivity and particle clogging.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If particle size is increased to enhance signal intensity, then detection sensitivity improves, but coarse particles cause membrane clogging and poor background

Engineering Contradiction:
Improvedetection sensitivityVSAvoidparticle size distribution
Core Design Contradiction:
Measurement precisionVSManufacturing precision

Solution Approach 1:

The patent implements parameter changes by establishing specific particle diameter ranges (100-650 nm average, with coarse particles ≤5%) and controlling sphericity (1.0-2.5). This precise parameter control ensures particles provide sufficient signal intensity while maintaining uniform size distribution that prevents membrane clogging and achieves favorable background clarity.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent applies local quality by differentiating particle characteristics - requiring high sphericity (1.0-2.5) for particles that will traverse the membrane smoothly while maintaining adequate coloring intensity. This localized optimization of particle morphology and size distribution resolves the contradiction between signal intensity and manufacturing precision.

Inventive Principle:
Principle #3Local quality

3Ease of operation

If antibody loading method is changed from chemical bonding to physical adsorption, then ease of operation improves, but analytical sensitivity may be compromised

Engineering Contradiction:
Improvehandling simplicityVSAvoidanalytical sensitivity
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent applies parameter changes by optimizing the particle surface properties through controlled sphericity (1.0-2.5) and size distribution, which enhance the efficiency of physical adsorption. These parameter optimizations ensure that physical adsorption achieves adequate analytical sensitivity while maintaining ease of operation, resolving the contradiction between handling simplicity and measurement precision.

Inventive Principle:
Principle #35Parameter changes

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 results in immunochromatographic assays with improved background clarity, enhanced test result reproducibility, and maintained high detection sensitivity, effectively addressing the limitations of previous technologies.

Implementation Method 1

The methods used to load antibody onto a labeling substance can be broadly divided into two methods. The first method involves loading antibody by chemical bonding while the other method consists of loading by physically adsorbing onto the surface of the labeling substance.

Methodology Applied
Scientific EffectPhysical adsorption: Adsorption

Data Source

PatentUS12203931B2Organic colored microparticles, diagnostic reagent kit, and in vitro diagnosis method
Publication Date: 2025.01.21 ASAHI KASEI KOGYO KABUSHIKI KAISHA
  • US12203931B2 patent drawing
  • US12203931B2 patent drawing

AI summary

The present invention provides organic colored microparticles used in an immunochromatography diagnostic kit, the microparticles having good background and test result reproducibility and sufficient detection sensitivity. These organic colored microparticles are characterized in that the average particle diameter is 100 to 650 nm; coloration intensity is 1.0 to 10.0; when a total of 100,000 particles are detected within a particle diameter range of 400 to 12000 nm, the percentage of coarse particles having a particle diameter of 700 nm or greater is 5% or less; and the sphericity represented by the major axis (L)/minor axis (D) is 1.0 to 2.5.