Binary Test Reagent System for Analyte Measurement
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Solution Overview
Problem
Existing test reagents using insoluble carrier particles for measuring analytes in biological samples face issues of self-agglutination during storage and non-specific agglutination during measurement, particularly due to variations in ionic strength and contamination.
Innovation Solution
A binary solution system is employed, where a buffer solution (Solution A) with an electric conductivity of at least 30 ms/cm is mixed with a particle suspension (Solution B) having an electric conductivity of no more than 6.5 ms/cm immediately before measurement, preventing self-agglutination during storage and non-specific agglutination during analysis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If insoluble carrier particles are suspended in a solvent with low ionic strength (low electric conductivity), then good dispensability and sensitivity are achieved, but non-specific agglutination occurs due to ion contamination from biological samples
Solution Approach 1:
The test reagent is divided into two separate solutions: Solution A (buffer solution with high electric conductivity ≥30 ms/cm) and Solution B (particle suspension with low electric conductivity ≤6.5 ms/cm). This segmentation allows each component to maintain its optimal properties independently, preventing non-specific agglutination while preserving sensitivity.
Solution Approach 2:
Solution A acts as an intermediary medium that modifies the ionic environment. By mixing Solution A with Solution B immediately before measurement, the buffer solution creates a controlled high-conductivity environment that prevents non-specific agglutination caused by ion contamination from biological samples.
2Reliability
If insoluble carrier particles are suspended in a solvent with high ionic strength (high electric conductivity), then self-agglutination is prevented during storage, but self-agglutination occurs during long-term storage for several days or months
Solution Approach 1:
The reagent system is segmented into two separate solutions stored independently. Solution B (particle suspension) is stored separately in a low-conductivity environment that prevents self-agglutination during long-term storage, while Solution A (buffer solution) is stored separately. This segmentation resolves the contradiction between storage stability and storage duration.
Solution Approach 2:
The two solutions are prepared and stored in advance in their respective optimal conditions (Solution B in low-conductivity medium for stability, Solution A in high-conductivity buffer), and then mixed immediately before measurement. This preliminary preparation allows long-term storage without self-agglutination while maintaining measurement performance.
3Measurement precision
If additives (polyethylene glycol or guanidine) are used to increase reagent sensitivity, then sensitivity is improved, but electric conductivity increases causing non-specific agglutination
Solution Approach 1:
The system separates the particle suspension (Solution B) from the buffer medium (Solution A), allowing sensitivity optimization in Solution B without adding conductive additives, while Solution A provides the necessary ionic environment. This segmentation eliminates the need to add sensitivity-enhancing additives that would increase conductivity and cause non-specific agglutination.
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 ensures accurate measurement of analytes by preventing self-agglutination during storage and minimizing non-specific agglutination during measurement, maintaining reagent stability and sensitivity.
Implementation Method 1
making the particle suspension with lower electric conductivity than a specific value, and making the buffer solution with higher electric conductivity than a specific value which is higher than the buffer solution normally employed in test reagents
Implementation Method 2
utilizing the level of agglutination by particle suspension which suspends insoluble carrier particles carrying a substance for capturing the analyte
Data Source
AI summary
Object: To provide a test reagent for the analyte in a test sample, utilizing the level of agglutination of a particle suspension which suspend insoluble carrier particles carrying a substance for capturing the analyte as an indicator, which reagent does not undergo self-agglutination during storage, and which non-specific agglutination rarely occurs during measurement, as well as to provide a method for the analyte to be measured in a test sample. Means for Solution: The test reagent for the analyte comprises at least a Solution A which is a buffer solution having an electric conductivity of not less than 30 ms/cm; and a Solution B having an electric conductivity of not more than 6.5 ms/cm, the Solution B being a particle suspension which suspends particles which are insoluble carrier particles carrying a substance for capturing the analyte.