Factor Xa Inhibitor Detection in Serum and Urine
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Solution Overview
Problem
Current methods for detecting factor Xa inhibitors in clinical settings require separate blood withdrawals for plasma samples, which are prone to errors and side effects, and cannot analyze these inhibitors in serum or other matrices without cofactors.
Innovation Solution
A method involving mixing a sample containing a direct factor Xa inhibitor with a composition containing factor Xa and a chromogenic substrate, allowing the factor Xa to release a detectable substance, which is then measured, without the need for citrated plasma, enabling detection in serum, urine, and other samples.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If citrate plasma is used for detecting factor Xa inhibitors, then the detection can be performed with cofactors present, but separate blood withdrawal is required which increases patient risk and procedural complexity
Solution Approach 1:
The invention makes the detection method universal by enabling it to work with both plasma and serum samples. The method achieves this by using exogenous factor Xa and chromogenic substrate that do not require cofactors, allowing the same procedure to reliably detect factor Xa inhibitors in different sample types without requiring separate blood withdrawals for different test types.
Solution Approach 2:
The invention extracts the essential detection function from the plasma-specific cofactor system. By removing the requirement for plasma-derived cofactors and using only exogenous factor Xa and chromogenic substrate, the method can operate in serum (which lacks these cofactors) while maintaining detection capability, thereby eliminating the need for separate plasma sampling.
2Measurement precision
If separate blood withdrawal for plasma samples is performed, then factor Xa inhibitor detection is possible, but the procedure becomes more complex and time-consuming
Solution Approach 1:
The invention merges the detection of factor Xa inhibitors with routine serum chemistry tests. By making the coagulation inhibitor detection work in serum samples, the method allows clinicians to obtain both chemistry parameters and inhibitor levels from a single blood draw and processing workflow, eliminating the need for separate plasma sampling and reducing overall procedural time.
Solution Approach 2:
The invention performs preliminary preparation of exogenous factor Xa and chromogenic substrate that can be added to any serum sample. This pre-prepared reagent system allows rapid detection without requiring complex plasma preparation steps, thereby reducing the time needed for sample processing while maintaining detection accuracy.
3Reliability
If cofactors are required for inhibitor activity, then physiological relevance is maintained, but the sample must be plasma which limits testing options
Solution Approach 1:
The invention introduces exogenous factor Xa as an intermediary that mediates the detection process without requiring endogenous cofactors. This intermediary enzyme system allows the detection to proceed in serum by providing all necessary catalytic activity externally, thereby maintaining the ability to detect inhibitor activity while adapting to different sample types including serum and urine.
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 reduces the risks associated with blood withdrawals and allows for the detection of factor Xa inhibitors like rivaroxaban in serum and urine without additional blood sampling, providing a more reliable and safer analysis.
Implementation Method 1
the colorant para-nitroaniline is released by an exogenously added coagulation enzyme (e.g. factor Xa) from a chromogenic substrate (N-benzoyl-L-isoleucyl-L-glutamyl-L-glycyl-L-arginine-para-nitroaniline hydrochloride)
Data Source
AI summary
The present invention relates to a method for detecting at least one direct factor Xa inhibitor in a sample other than citrate plasma, comprising the step of mixing a sample containing a factor Xa inhibitor with a composition containing factor Xa under conditions which allow the factor Xa to release a detectable substance from a chromogenic substrate.