F1+2 Peptide Assay for Simplified Blood Coagulation Diagnostics
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Solution Overview
Problem
Current blood coagulation diagnostic tests are complex and not suitable for automated determination in whole blood, limiting their ability to provide a simplified assessment of blood coagulation status, particularly in platelet-rich plasma and whole blood samples.
Innovation Solution
A method involving the activation of blood coagulation in vitro by adding a coagulation activator to a sample, followed by incubation and quantitative determination of F1+2 peptide levels, which are then compared to reference values to establish the blood coagulation system status, allowing for the detection of procoagulatory or anticoagulatory tendencies.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional ETP determination methods are used, then thrombin formation can be measured, but the test setup becomes extremely complex requiring multiple customizations
Solution Approach 1:
The patent extracts the measurement of thrombin formation from the complex conventional ETP determination process by specifically measuring F1+2 peptide levels instead. This extraction simplifies the test setup while maintaining the ability to assess thrombin generation, as F1+2 is a direct cleavage product of prothrombin activation and serves as a specific marker for thrombin formation without requiring the full complex ETP assay infrastructure
Solution Approach 2:
The patent changes the measurement parameter from monitoring thrombin substrate reaction kinetics (which requires complex setup with multiple reagents and algorithms) to directly quantifying F1+2 peptide concentration. This parameter change simplifies the assay by focusing on a single stable peptide marker that can be measured with standard immunoassay techniques, eliminating the need for complex test-specific algorithms and multiple customizations
2Measurement precision
If conventional ETP determination is performed, then thrombin activity can be assessed, but automated determination in whole blood is not possible
Solution Approach 1:
The patent uses F1+2 peptide as an intermediary marker that bridges the gap between thrombin activity assessment and automated whole blood testing. F1+2 serves as a stable, measurable intermediate that reflects thrombin generation without requiring the complex real-time kinetic monitoring needed for conventional ETP assays, thereby enabling automation in whole blood samples while maintaining assessment accuracy
Solution Approach 2:
The patent replaces the mechanical/chemical complexity of real-time thrombin substrate reaction monitoring with a simpler immunological detection system. By substituting the complex kinetic measurement mechanism with F1+2 peptide quantification using immunoassays, the system enables automated determination in whole blood samples, as the immunoassay approach is more amenable to automation and works effectively in the presence of blood cells
3Device complexity
If F1+2 determination method is used, then test setup is simplified, but information on blood coagulation cascade functionality must be equivalent to ETP
Solution Approach 1:
The patent establishes feedback validation by comparing F1+2 determination results with conventional ETP determination results across multiple sample types and conditions. This feedback mechanism confirms that F1+2 levels provide equivalent information about blood coagulation cascade functionality, as the correlation between F1+2 and ETP measurements validates that the simplified assay preserves the essential diagnostic information about coagulation status
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 simplifies the test setup and evaluation, enabling the assessment of blood coagulation status in whole blood and platelet-rich plasma, effectively detecting tendencies towards thrombosis or bleeding by measuring F1+2 levels, thus providing a more comprehensive and practical diagnostic tool.
Implementation Method 1
providing a reaction mixture by adding a coagulation activator to a sample from the individual and incubating the reaction mixture
Implementation Method 2
Thrombin, a serine protease, is the central enzyme of plasmatic blood coagulation, the main function of which is the induction of fibrin polymerization
Data Source
AI summary
Embodiments of the present invention are in the field of blood coagulation diagnostics and relate to a test for establishing an individual's blood coagulation system status based on the amount of in-vitro-generated F1+2 peptide, and to a test kit for use in such a method.