Universal Anticoagulant Activity Determination via Factor Xa Calibration
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Solution Overview
Problem
Current diagnostic procedures for anticoagulant activity in coagulation testing are inefficient and prone to errors due to the need for multiple calibrators and controls, leading to misinterpretation of results and increased complexity and cost in laboratory workflows.
Innovation Solution
A method that measures Factor Xa activity in a body fluid sample and calibrator samples, calculates a universal parameter for anticoagulation activity, and compares it to predefined ranges for multiple anticoagulants, using a computer program to assist in the process and simplify the calibration procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If multiple calibrators and controls are used for different anticoagulants, then measurement precision for specific anticoagulants is improved, but device complexity and ease of operation deteriorate
Solution Approach 1:
The patent implements a universal calibrator that can be used for determining anticoagulant activity of multiple different anticoagulants (direct Factor Xa inhibitors, indirect Factor Xa inhibitors, and Factor IIa inhibitors) with a single calibration curve. This eliminates the need for multiple anticoagulant-specific calibrators and controls, thereby reducing device complexity while maintaining measurement precision through the universal applicability of the calibration method
Solution Approach 2:
The patent merges the functionality of multiple separate calibrators into a single universal calibrator. By combining the calibration function for different anticoagulant types into one standardized system, the patent reduces the number of components needed and simplifies the overall testing procedure while preserving the ability to accurately measure various anticoagulants
2Measurement precision
If multiple calibrators and controls are used for different anticoagulants, then measurement precision is improved, but ease of operation deteriorates
Solution Approach 1:
The universal calibrator allows laboratory personnel to perform anticoagulant activity determination for multiple anticoagulant types using a single calibration curve and standardized procedure. This eliminates the need for operators to select and manage different calibrators based on the specific anticoagulant being tested, thereby improving ease of operation while maintaining measurement precision
Solution Approach 2:
The patent changes the calibration parameter from anticoagulant-specific concentrations to universal Factor Xa inhibition percentages. This parameter transformation allows a single calibration curve to accurately represent the anticoagulant activity of different drug types, simplifying the operational workflow while preserving measurement accuracy
3Reliability
If anticoagulant-specific testing procedures are used, then reliability for specific drug monitoring is improved, but adaptability deteriorates
Solution Approach 1:
The universal calibration method provides reliable anticoagulant activity determination for multiple anticoagulant types through a single standardized procedure. The method maintains reliability by accurately measuring Factor Xa inhibition percentages while adapting to different anticoagulant classes (direct and indirect Factor Xa inhibitors, Factor IIa inhibitors), thereby achieving both reliability and versatility
Solution Approach 2:
The patent implements a dynamic calibration system where the universal calibration curve can be applied flexibly to different anticoagulant types based on their mechanism of action. The system adapts to various clinical scenarios and anticoagulant regimens while maintaining consistent measurement principles, enabling both reliable specific monitoring and broad adaptability
4Manufacturing precision
If multiple calibrators are used, then manufacturing precision for specific assays is improved, but loss of time and productivity deteriorate
Solution Approach 1:
The patent merges multiple separate calibration procedures into a single universal calibration process. By consolidating the calibration function for different anticoagulants into one standardized method, the patent eliminates the time required to select, prepare, and validate multiple different calibrators, thereby reducing loss of time while maintaining manufacturing precision through the unified calibration approach
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 simplifies the workflow, reduces errors by providing a generic measurement of Factor Xa inhibition, and allows for standardized testing of various anticoagulant drugs, improving the accuracy and efficiency of anticoagulant monitoring.
Implementation Method 1
Factor Xa is inhibited by several different drugs... they all lead to the inhibition of Factor Xa and therefore to a reduction in thrombin generation
Data Source
AI summary
The present invention concerns diagnostic methods for coagulation testing involving determining anticoagulant activity elicited by a first anticoagulant in a sample comprising measuring a first Factor Xa activity in a body fluid test sample of said subject, measuring a second Factor Xa activity in at least one calibrator sample comprising a predefined anticoagulation activity for a second anticoagulant, calculating an universal parameter for the anticoagulation activity comprised in the test sample based on the first and the second measured Factor Xa activities and comparing the said parameter for the anticoagulation activity with predefined ranges of expected anticoagulation activity for at least three anticoagulants. Further provided is a computer program code assisting the method as well as a system for carrying out the said method as well as a kit.