Stabilizing Alpha-Thrombin in Fibrinogen Assay Reagents
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Solution Overview
Problem
Existing methods for stabilizing α-thrombin in thrombin-containing solutions for fibrinogen assays are inadequate, particularly for low-fibrinogen-concentration samples, leading to prolonged assay times and measurement issues, making them unsuitable for emergency medical tests.
Innovation Solution
Adjusting the percentage of α-thrombin to 70% or more within the thrombin-containing solution, while reducing β-thrombin and γ-thrombin content to less than 30%, effectively stabilizing α-thrombin and maintaining its activity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a thrombin antagonist is added to a thrombin-containing solution to stabilize thrombin, then the stability of thrombin is improved, but the clotting time of low-fibrinogen-concentration samples is considerably prolonged
Solution Approach 1:
The invention changes the chemical composition parameters of the thrombin-containing solution by adding specific stabilizing agents (polyols such as glycerol, mannitol, or sorbitol at concentrations of 1-20% by mass, and/or saccharides such as sucrose or lactose at concentrations of 1-20% by mass). This parameter change stabilizes the thrombin molecule structure without introducing antagonistic effects, thereby maintaining both stability and normal clotting time.
2Stability of the object's composition
If high-concentration glycerol and polyol are added to thrombin to stabilize it, then the storage stability is improved, but the assay performance on low-fibrinogen-concentration samples deteriorates
Solution Approach 1:
The invention optimizes the concentration parameters of stabilizing agents to achieve a balance between stability and assay performance. Specifically, polyols are added at 1-20% by mass and saccharides at 1-20% by mass, which provides sufficient stabilization while avoiding excessive viscosity or interference with the clotting reaction, thus maintaining accurate measurement of low-fibrinogen-concentration samples.
Solution Approach 2:
The invention uses a composite stabilization system combining multiple types of stabilizing agents (polyols and/or saccharides) rather than relying on a single agent. This composite approach provides synergistic stabilization effects while maintaining compatibility with the clotting assay, improving both storage stability and measurement accuracy.
3Duration of action of stationary object
If thrombin is stabilized in a liquid fibrinogen assay reagent using conventional methods, then the shelf life is extended, but the sample throughput is reduced due to prolonged clotting time
Solution Approach 1:
The invention modifies the compositional parameters of the liquid fibrinogen assay reagent by incorporating specific concentrations of polyols (1-20% by mass) and/or saccharides (1-20% by mass) as stabilizing agents. These parameter changes extend the shelf life of the reagent while maintaining normal clotting times, thereby preserving high sample throughput capability.
Data Source
AI summary
To provide a method for stabilizing unstable α-thrombin in a thrombin-containing solution, a solution containing stabilized α-thrombin, and a liquid fibrinogen assay reagent containing the solution. The method for stabilizing α-thrombin in a thrombin-containing solution, which includes adjusting the percentage of α-thrombin to 70% or more with respect to the amount of total thrombin in the thrombin-containing solution.