Porous Medium Agglutination Assay for Stable Dry Reagents
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Solution Overview
Problem
Existing dry analysis methods for detecting trace substances like antibodies or antigens face challenges with storage stability and sensitivity, particularly in the latex reagent system, and require cumbersome operations and large sample volumes, while the colloidal gold method lacks quantitative results and is time-consuming.
Innovation Solution
A dry analysis method using a porous medium layer where particles bearing anti-analytes agglutinate upon sample application, allowing for sensitive and quantitative detection by measuring optical changes, with the layer maintaining reagent stability in a dry state and enabling efficient use of small sample volumes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If latex reagent is used in liquid form for agglutination assay, then the assay can be performed with simple operation, but the storage stability becomes poor
Solution Approach 1:
The patent applies freeze-drying (lyophilization) to convert the liquid latex reagent into a solid powder form for storage. This phase transition preserves the reagent's stability during storage while allowing reconstitution to liquid form for assay performance, thus resolving the contradiction between storage stability and operational simplicity
Solution Approach 2:
The reagent is prepared in advance in dry powder form with all necessary components (latex particles, antibodies, buffers, preservatives) already combined. This preliminary preparation eliminates the need for complex mixing operations during actual use, maintaining operational simplicity while enabling long-term stable storage
2Stability of the object's composition
If colloidal gold-labeled reagent is used in lyophilized form, then storage stability is improved, but the operation becomes cumbersome requiring mixing with dedicated solution
Solution Approach 1:
The patent combines the latex particles, antibodies, buffers, and preservatives into a single integrated dry powder formulation. This merging eliminates the need for separate mixing steps with dedicated solutions, providing both storage stability and operational simplicity simultaneously
Solution Approach 2:
The dry powder reagent is designed to be self-sufficient, containing all necessary components for the assay. When reconstituted with sample or buffer, it automatically forms the functional agglutination system without requiring additional reagents or complex preparation procedures
3Measurement precision
If conventional agglutination assay is performed in liquid suspension, then quantitative analysis can be achieved, but the sample volume required becomes large
Solution Approach 1:
The patent employs a porous membrane support that concentrates the latex particle suspension in a defined area. This porous structure allows efficient light scattering measurement with concentrated samples, enabling accurate quantitative analysis with minimal sample volume (as low as 1-10 μL)
Solution Approach 2:
The patent replaces traditional nephelometric measurement of large volume suspensions with light scattering measurement through a porous membrane. This substitution enables precise quantification using much smaller sample volumes while maintaining measurement accuracy
4Stability of the object's composition
If dry analysis method is used with porous medium layer, then storage stability and operation convenience are improved, but the sensitivity for trace substance detection becomes insufficient
Solution Approach 1:
The patent creates a composite system combining dry powder reagent (for stability) with porous membrane support (for sensitivity). The latex particles are adsorbed onto the porous membrane, creating a structure that maintains reagent stability in dry form while enabling sensitive detection through light scattering enhancement in the porous matrix
Solution Approach 2:
The patent optimizes multiple parameters including particle size distribution of latex, antibody coating density, porous membrane pore size and thickness, and light scattering measurement conditions. These parameter optimizations collectively enhance detection sensitivity while maintaining the advantages of dry analysis format
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 method provides high sensitivity and convenience in analyzing trace substances with improved storage stability and rapid analysis, allowing for precise quantification of analytes with minimal sample disturbance and operation complexity.
Implementation Method 1
supplying said sample, together with said particles, to a porous medium layer to cause the agglutination of said particles in said porous medium layer
Implementation Method 2
measuring the extent of the agglutination of the particles in the porous medium layer
Data Source
AI summary
An agglutination assay method for quantitatively determination of an analyte in an aqueous liquid sample using particles bearing an anti-analyte. The agglutination is conducted in the porous medium layer of the analysis element A speedy quantitative analysis of the analyte can be conveniently attained with high sensitivity. When the particle-labeled anti-analyte is contained in the porous medium layer, the anti-analyte can be stored with higher stability in the dry state A dry analysis element for enabling such analysis method is also provided.