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

VSEngineering 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

Engineering Contradiction:
Improvemeasurement precisionVSAvoidinformation loss
Core Design Contradiction:
Measurement precisionVSLoss of information

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).

Inventive Principle:
Principle #1Segmentation

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.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

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

Engineering Contradiction:
Improveinformation completenessVSAvoiddevice complexity
Core Design Contradiction:
Loss of informationVSDevice 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.

Inventive Principle:
Principle #5Merging (Combining)

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.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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

Engineering Contradiction:
Improvemeasurement efficiencyVSAvoidinformation completeness
Core Design Contradiction:
ProductivityVSLoss of information

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.

Inventive Principle:
Principle #10Preliminary action

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.

Inventive Principle:
Principle #23Feedback

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

Methodology Applied
Scientific EffectCoagulation: Coagulation

Data Source

PatentEP3396384B1Method for analyzing blood specimen, and analyzer
Publication Date: 2020.11.18 SYSMEX CORP
  • EP3396384B1 patent drawingFigure 1
  • EP3396384B1 patent drawingFigure 2
  • EP3396384B1 patent drawingFigure 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.