Blood Analyzer Fibrinogen Antigen Measurement via Coagulation Waveform
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Solution Overview
Problem
Current methods for measuring fibrinogen in blood specimens, such as the Clauss method, primarily assess active fibrinogen concentration, making it difficult to distinguish between fibrinogen deficiency and abnormal activity, as they do not directly provide information on the amount of fibrinogen antigen, which is crucial for accurate disease diagnosis.
Innovation Solution
A method involving mixing a blood specimen with a thrombin-containing reagent to generate a coagulation waveform, where parameters derived from the waveform, like differentiation parameters or total reaction time, are used to obtain information on the amount of fibrinogen antigen, allowing for differentiation between fibrinogen deficiency and abnormal activity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If the Clauss method is used to measure fibrinogen, then the active concentration of fibrinogen can be obtained, but it is difficult to distinguish between fibrinogen deficiency and abnormal activity
Solution Approach 1:
The invention segments the fibrinogen measurement into two distinct components: active concentration (functional activity) and antigen concentration (total amount). By introducing a second measurement dimension through immunological methods, the system can separately evaluate both aspects, enabling differentiation between fibrinogen deficiency (low antigen) and abnormal activity (normal antigen, low activity).
Solution Approach 2:
The invention adds a new measurement dimension by combining the traditional Clauss method (measuring activity) with immunological measurement (measuring antigen). This dimensional expansion from single-parameter to dual-parameter measurement allows comprehensive characterization of fibrinogen status, resolving the information loss about whether low activity stems from low amount or abnormal function.
2Loss of information
If immunological measurement is performed to obtain fibrinogen antigen amount, then information on antigen level is obtained, but it requires separate facilities and increases device complexity
Solution Approach 1:
The invention merges two previously separate measurement systems (coagulation time measurement and immunological measurement) into a single integrated blood specimen analyzer. The analyzer incorporates both the Clauss method measurement unit and the immunological measurement unit, allowing simultaneous or sequential execution of both measurements on the same sample within one device, thereby reducing facility requirements and operational complexity.
Solution Approach 2:
The blood specimen analyzer is designed as a universal platform capable of performing multiple functions: coagulation time measurement, antigen measurement, and automated differentiation of fibrinogen disorders. The device can handle different measurement modes and provide comprehensive diagnostic information, eliminating the need for separate dedicated facilities for each measurement type.
3Productivity
If only coagulation time measurement is performed, then the measurement process is simple and fast, but it cannot provide information on fibrinogen antigen amount
Solution Approach 1:
The system performs preliminary automated processing by automatically executing both coagulation time measurement and immunological measurement, then automatically comparing results and differentiating between fibrinogen deficiency and disorder. This preliminary automated action eliminates the need for manual intervention and provides complete diagnostic information efficiently.
Solution Approach 2:
The system uses feedback from both measurement methods to automatically determine the diagnosis. By comparing the active concentration from Clauss method with the antigen concentration from immunological measurement, the system receives feedback that enables automated differentiation of the underlying cause of abnormal fibrinogen levels, maintaining efficiency while improving information completeness.
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 the determination of fibrinogen antigen levels and functional activity, providing more comprehensive insights into fibrinogen-related diseases by correlating waveform parameters with immunological measurements, thus improving diagnostic accuracy.
Implementation Method 1
mixing a blood specimen and a thrombin-containing reagent to coagulate the blood specimen
Data Source
Figure 1
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Figure 3A~3B
AI summary
Disclosed is an analyzing method, for analyzing a blood specimen, which includes: mixing a blood specimen and a thrombin-containing reagent to coagulate the blood specimen, and obtaining a coagulation waveform; obtaining a value of a parameter concerning differentiation of the coagulation waveform, based on the coagulation waveform; and obtaining information concerning an amount of antigen of fibrinogen based on the obtained value of the parameter.