Blood Sample Analyzer Clot Waveform Differentiation
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Solution Overview
Problem
Current coagulation tests face difficulties in distinguishing between blood samples containing lupus anticoagulant (LA) and coagulation factor inhibitors, as both types of samples exhibit prolonged clotting times, necessitating additional tests and expert interpretation.
Innovation Solution
A method involving the emission of light to a mixture of a blood sample and a clotting time measuring reagent to obtain optical information, which is used to calculate parameters such as maximum coagulation velocity, acceleration, and deceleration, allowing for determination of whether the sample is derived from a subject with LA or a coagulation factor inhibitor based on predetermined thresholds.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If an ordinary coagulation test is conducted to measure clotting time, then the clotting time can be obtained, but it is difficult to distinguish between blood samples containing lupus anticoagulant (LA) and coagulation factor inhibitors
Solution Approach 1:
The patent transitions from one-dimensional clotting time measurement to multi-dimensional analysis by introducing clot waveform parameters (maximum coagulation velocity, maximum coagulation acceleration, maximum coagulation deceleration) derived from optical density changes over time. This dimensional expansion enables differentiation between LA and coagulation factor inhibitor samples that cannot be distinguished by clotting time alone.
Solution Approach 2:
The patent changes the measurement parameters from simple clotting time to derivative parameters of the clot waveform (first derivative for velocity, second derivative for acceleration and deceleration). These parameter transformations reveal subtle differences in coagulation dynamics that allow accurate identification of sample types while using常规 clotting time measuring reagents.
2Measurement precision
If additional tests are conducted to distinguish LA from coagulation factor inhibitors, then accurate identification can be achieved, but the testing time and complexity increase
Solution Approach 1:
The patent makes the常规 clotting time measuring reagent and instrument perform multiple functions by analyzing not only clotting time but also clot waveform characteristics. The same equipment and reagents used for routine coagulation testing can now differentiate between LA and coagulation factor inhibitors through waveform parameter analysis, eliminating the need for separate specialized tests.
Solution Approach 2:
The patent combines the differentiation function into the routine coagulation testing process itself. By analyzing clot waveform parameters during the standard clotting time measurement, the system simultaneously achieves both clotting time determination and sample type identification in a single test, rather than requiring separate additional tests.
3Measurement precision
If clot waveform analysis is performed to distinguish LA from coagulation factor inhibitors, then differentiation is possible, but expert interpretation is required which reduces ease of operation
Solution Approach 1:
The patent implements an automated determination system that performs sample type identification without requiring expert interpretation. The control unit automatically calculates clot waveform parameters, compares them against reference values, and provides automated differentiation between LA and coagulation factor inhibitor samples, making the process accessible to routine laboratory personnel.
Solution Approach 2:
The patent incorporates automated feedback mechanisms where the control unit continuously monitors clot waveform parameters during coagulation and provides real-time or post-test automated interpretation. This feedback system eliminates the need for expert subjective assessment by objectively comparing measured parameters against established criteria for sample type identification.
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 simple and accurate differentiation between blood samples suspected to contain LA or coagulation factor inhibitors using commonly available clotting time measuring reagents, reducing the need for additional tests and requiring minimal expert interpretation.
Implementation Method 1
emitting light to a measurement specimen prepared by mixing a clotting time measuring reagent and a blood sample suspected to be derived from a subject having LA or a coagulation factor inhibitor, to obtain optical information about an amount of light from the measurement specimen
Data Source
AI summary
Disclosed is a blood sample determination method including: emitting light to a measurement specimen prepared by mixing a clotting time measuring reagent and a blood sample suspected to be derived from a subject having lupus anticoagulant or a coagulation factor inhibitor, to obtain optical information about an amount of light from the measurement specimen; obtaining at least one parameter regarding derivative of clot waveform, based on the obtained optical information; and determining, based on a value of the obtained parameter, whether the blood sample is suspected to be a sample derived from a subject having lupus anticoagulant or is suspected to be a sample derived from a subject having a coagulation factor inhibitor.