CRP Quantification Kit with Integrated Hemolysis and Stabilization
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Solution Overview
Problem
Existing CRP quantitative analysis technologies require separate determination of hematocrit and are complex due to the absence of hemolysis, necessitating additional modifications to prevent red blood cell hemolysis, and lack sufficient investigation into stabilizers for reagent storage stability.
Innovation Solution
A kit and method utilizing a hemolytic reagent that does not affect CRP quantification, combined with a stabilizer like Trehalose and Sucrose, to enhance storage stability and simplify the analysis process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If hemolysis is performed to simplify CRP quantification, then measurement precision is improved, but red blood cell lysis may interfere with the analysis
Solution Approach 1:
The patent introduces a specific buffer system (containing glycine, sodium chloride, sodium azide, EDTA, and BSA) as an intermediary medium that facilitates hemolysis while protecting the CRP quantification process from interference. This buffer acts as a mediator between the hemolytic action and the subsequent immunological measurement, ensuring that red blood cell lysis occurs without compromising CRP detection accuracy.
Solution Approach 2:
The patent modifies the chemical parameters of the analysis system by adjusting pH, ionic strength, and buffer composition to optimize both hemolysis efficiency and CRP measurement accuracy. By controlling these parameters, the system achieves complete red blood cell lysis while maintaining conditions favorable for antigen-antibody reaction and CRP quantification.
2Reliability
If separate hematocrit determination is performed to prevent hemolysis, then red blood cell integrity is maintained, but device complexity and analysis time increase
Solution Approach 1:
The patent merges the hemolysis function with the CRP quantification process into a single integrated assay. By combining red blood cell lysis and CRP measurement in one test system, the patent eliminates the need for separate hematocrit determination and subsequent corrections, thereby reducing device complexity and analysis time while maintaining reliability.
Solution Approach 2:
The patent creates a universal reagent system that simultaneously performs multiple functions: hemolysis, CRP extraction, and immunological detection. This multi-functional approach replaces the traditional multi-step process of separate hematocrit measurement and CRP analysis, simplifying the overall device complexity while maintaining analytical reliability.
3Duration of action of stationary object
If stabilizer is added to enhance reagent storage stability, then reagent shelf life is extended, but reagent formulation complexity increases
Solution Approach 1:
The patent optimizes the concentration and composition of stabilizers in the reagent formulation to achieve maximum storage stability with minimal added complexity. By carefully adjusting stabilizer parameters (concentration, purity, and interaction with other reagents), the system extends shelf life without requiring complex formulation adjustments.
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
The solution enables precise CRP quantification over a wide range of concentrations with improved reagent stability and simplified usability, reducing complexity and enhancing storage stability.
Implementation Method 1
a first composition including a hemolytic reagent for hemolyzing at least a portion of blood cells in a blood sample
Implementation Method 2
a second composition including an anti-CRP antibody for antigen-antibody reaction of CRP contained in the hemolyzed sample
Implementation Method 3
the second composition further comprises a stabilizer for the stability of the anti-CRP antibody
Data Source
AI summary
The kit for quantitative analysis of C-Reactive Protein (CRP) according to an embodiment of the present application may comprises: a first composition including a hemolytic reagent for hemolyzing at least a portion of blood cells in a blood sample; and a second composition including an anti-CRP antibody for antigen-antibody reaction of CRP contained in the hemolyzed sample.