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
Engineering 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
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.
2Measurement precision
If particle size is increased to enhance signal intensity, then detection sensitivity improves, but coarse particles cause membrane clogging and poor background
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.
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.
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
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.
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.
Data Source
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.

