Blood Sample Analyzer Coagulation Discrimination
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Solution Overview
Problem
Current methods struggle to accurately distinguish between blood samples containing direct anticoagulants (DAC) and those containing lupus anticoagulant (LA), leading to potential misclassification and excessive anticoagulation therapy risks, especially since conventional methods require specialized reagents and are costly.
Innovation Solution
A method involving the measurement of coagulation times using two types of reagents with different phospholipid concentrations to calculate index values, allowing discrimination between DAC, LA, and coagulation factor-deficient samples using a blood sample analyzer, without the need for additional reagents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If conventional coagulation time measurement methods are used, then the testing cost is reduced, but the measurement precision for discriminating between DAC and LA samples deteriorates
Solution Approach 1:
The invention changes the parameter of phospholipid concentration in coagulation time measurement reagents by using two different concentrations (first reagent with lower concentration and second reagent with higher concentration). This allows discrimination between DAC and LA samples through comparative analysis of coagulation times, achieving accurate identification using conventional reagents without requiring specialized expensive reagents.
Solution Approach 2:
The invention segments the coagulation time measurement process into multiple stages by performing measurements with two different reagents having different phospholipid concentrations. The first measurement with the first reagent and the second measurement with the second reagent are conducted separately, and their results are综合分析 to determine whether the sample contains DAC or LA, thereby improving discrimination accuracy.
2Measurement precision
If mixing test and confirmation test are conducted, then the measurement precision for detecting LA is improved, but the device complexity increases
Solution Approach 1:
The invention merges the mixing test and confirmation test into a single integrated process. By performing coagulation time measurements with two reagents of different phospholipid concentrations on both mixed samples (patient plasma + normal plasma) and control samples, the invention simultaneously achieves LA detection and DAC differentiation without requiring separate testing procedures, thereby reducing operational complexity.
Solution Approach 2:
The invention gives multi-functionality to the coagulation time measurement system by using the same measurement apparatus and reagents for both LA detection and DAC differentiation. The system can identify three conditions (LA-positive, DAC-positive, and normal) through a unified testing protocol, eliminating the need for specialized equipment or procedures for each test type.
3Measurement precision
If two types of coagulation time measurement reagents with different phospholipid concentrations are used, then the measurement precision for discriminating DAC and LA is improved, but the loss of time increases
Solution Approach 1:
The invention maintains continuous useful action by performing both coagulation time measurements in sequence without interruption. The first measurement with the first reagent and the second measurement with the second reagent are conducted continuously, and the results are analyzed together to achieve accurate discrimination, minimizing idle time while maintaining high measurement precision.
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
Enables accurate discrimination between DAC and LA samples, reducing the risk of excessive anticoagulation therapy by using conventional coagulation time measurement reagents, thereby improving clinical outcomes and reducing testing costs.
Implementation Method 1
Lupus anticoagulant (LA) is an autoantibody that inhibits a phospholipid-dependent coagulation reaction... The LA inhibits phospholipids necessary for phospholipid-dependent coagulation reactions, and a coagulation time is prolonged
Data Source
AI summary
A determination method of a blood sample may include: measuring, with a first coagulation time measurement reagent and a second coagulation time measurement reagent which contain phospholipids at different concentrations, coagulation times of a blood sample of a subject, coagulation times of a normal blood sample, and coagulation times of a mixed sample including the blood sample of the subject and the normal blood sample; acquiring a first index value and a second index value based on the coagulation times; and determining whether the blood sample of the subject is a blood sample containing a direct anticoagulant based on the first index value and the second index value.