Lupus Anticoagulant Detection via Coagulation Factor Buffer
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Solution Overview
Problem
Current methods for detecting lupus anticoagulant positivity are cumbersome, prone to false positives and negatives, especially in patients receiving anticoagulant therapy, and require stable and uniform healthy plasma, which is difficult to obtain and prepare.
Innovation Solution
A method involving the addition of a buffer solution containing blood coagulation factors to both a blood sample and its diluted version before measurement, allowing for comparison of coagulation times to enhance sensitivity and specificity of lupus anticoagulant detection, independent of anticoagulant therapy effects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple LA detection methods are combined to improve detection accuracy, then reliability improves, but device complexity and ease of operation worsen
Solution Approach 1:
The invention combines multiple detection functions into a single examination system that simultaneously performs screening and confirmation of lupus anticoagulant positivity, eliminating the need for separate multiple examinations while maintaining high detection accuracy
Solution Approach 2:
The examination system is designed to perform multiple functions including screening for LA positivity, confirmation of positivity, and differentiation from coagulation factor deficiencies, all within a single test protocol
2Reliability
If multiple LA detection methods are combined to improve detection accuracy, then reliability improves, but ease of operation worsens
Solution Approach 1:
Multiple detection functions are merged into one automated examination process that requires minimal manual intervention and interpretation, making it as easy to operate as a single test while providing comprehensive diagnostic information
Solution Approach 2:
The system automatically performs differentiation between LA positivity and coagulation factor deficiencies without requiring external healthy plasma or complex manual procedures, making the operation self-contained and simple
3Measurement precision
If healthy plasma is used for coagulation time measurement, then measurement precision improves, but ease of manufacture worsens
Solution Approach 1:
The invention replaces the need for stable, long-term storage of healthy plasma with a system that uses commercially available reagents and test plasma, eliminating the complex preparation and storage requirements while maintaining measurement precision
Solution Approach 2:
The system uses the patient's own test plasma combined with commercially available reagents to perform measurements, eliminating the need for external healthy plasma donation, processing, and quality control
4Reliability
If anticoagulant therapy is administered to patients, then therapeutic effect improves, but measurement precision of coagulation time worsens
Solution Approach 1:
The invention segments the measurement process into distinct phases (screening and confirmation) that can differentiate between anticoagulant effects and true LA positivity, allowing accurate measurement even in patients receiving anticoagulant therapy
Solution Approach 2:
Instead of trying to eliminate anticoagulant effects, the system inverts the approach by using the anticoagulated state itself as the basis for detection, comparing coagulation times in a way that reveals LA positivity despite the presence of anticoagulants
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 enables more accurate and sensitive detection of lupus anticoagulants in patients on anticoagulant therapy, reducing the need for healthy plasma and minimizing false results, thereby improving diagnostic reliability.
Implementation Method 1
adding a buffer solution containing blood coagulation factors to each of a blood sample and a diluted sample of the blood sample before measurement or at the time of measurement of blood coagulation time
Implementation Method 2
When LA is contained in a specimen, LA binds with phospholipids in the reagent. Therefore, phospholipids required to advance the coagulation reaction in vitro become insufficient, and the blood coagulation time is prolonged
Data Source
AI summary
Provided is the development of a convenient LA detection method in which even a sample derived from a patient who receives anticoagulant therapy of warfarin, heparin or the like, is not affected by the anticoagulant therapy, discrimination from the deficiency of blood coagulation factors is enabled, and healthy person's plasma is not used. The method for detecting lupus anticoagulant includes the following steps (A), (B) and (C): (A) a step of adding a buffer solution composition containing blood coagulation factors to each of a blood sample and a diluted sample of the blood sample before measurement or at the time of measurement of the blood coagulation time; (B) a step of measuring the blood coagulation times for the various samples of step (A); and (C) a step of comparing the blood coagulation times for the various samples obtained in step (B).