Fibrinogen Measurement Using Magnetic Particle Waveform Analysis
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Solution Overview
Problem
Current fibrinogen measurement methods are inadequate for urgent perioperative and perinatal situations due to requirements for sample dilution, reagent preparation, and calibration, which delay results and are not suitable for rapid, accurate fibrinogen concentration determination in critical bleeding scenarios.
Innovation Solution
A novel fibrinogen measurement method using a dry reagent containing magnetic particles, where the movement signal of magnetic particles is analyzed to determine the starting point of coagulation, allowing direct computation of fibrinogen concentration in whole blood without the need for additional hematocrit measurement, enabling rapid and accurate determination of fibrinogen concentration in plasma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If sample dilution is performed to enable fibrinogen measurement, then measurement accuracy is improved, but measurement time is extended and operational complexity increases
Solution Approach 1:
The measurement system is segmented into two modes: a rapid mode for urgent clinical situations that provides preliminary results, and a precise mode for routine laboratory work that performs full dilution and measurement. This segmentation allows the system to deliver fast results when time is critical while maintaining the option for accurate measurements when time permits.
Solution Approach 2:
The system performs partial dilution (e.g., 2-fold or 5-fold) instead of the conventional extensive dilution (7.5-fold to 15-fold), achieving sufficient measurement accuracy for urgent situations with significantly reduced processing time. This partial action provides a compromise between speed and accuracy appropriate for emergency settings.
2Measurement precision
If sample dilution is performed to enable fibrinogen measurement, then measurement accuracy is improved, but operational complexity increases
Solution Approach 1:
The system automatically selects the appropriate measurement mode (rapid or precise) based on the clinical situation and sample type, eliminating the need for operators to manually choose between different measurement protocols. The automated selection simplifies operation while maintaining measurement accuracy through appropriate dilution strategies.
Solution Approach 2:
The operational process is segmented into automated and manual components, where the automated system handles dilution calculations, reagent dispensing, and result computation, while minimal manual intervention is required for sample loading and result interpretation. This segmentation reduces operational complexity despite the underlying measurement complexity.
3Reliability
If conventional thrombin time method is used for fibrinogen determination, then established methodology is maintained, but measurement speed is reduced due to multiple preparation steps
Solution Approach 1:
Reagents are prepared in advance in concentrated forms and stored in the instrument, eliminating the need for laboratory personnel to perform time-consuming reagent preparation, mixing, and calibration steps before each measurement. The system automatically handles all preparation steps, maintaining methodological reliability while significantly improving measurement throughput.
Solution Approach 2:
The manual mechanical process of reagent preparation, sample dilution, and measurement setup is replaced by an automated robotic system that performs these functions rapidly and consistently. This substitution maintains the reliability of the established thrombin time methodology while dramatically increasing productivity through automation.
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 method enables rapid and accurate fibrinogen concentration determination in plasma without additional reagents or apparatus, improving promptness and accuracy in critical care situations by directly computing fibrinogen concentration in whole blood and correcting for hematocrit values based on magnetic particle waveform analysis.
Implementation Method 1
a combination of an oscillating magnetic field and a static permanent magnetic field is applied at a given interval, magnetic particles contained in the dry reagent are allowed to move, the movement signal of the magnetic particles is detected
Implementation Method 2
use of an excessive amount of thrombin, so as to convert all fibrinogens into fibrin monomers
Implementation Method 3
in order to suppress the polymerization reaction of the resulting fibrin monomers and prolong the clotting time
Data Source
AI summary
This invention provides a method that enables determining the fibrinogen concentration in plasma of a sample. The method comprises: computing the fibrinogen concentration in whole blood of the sample using magnetic particles; computing the waveform-based hematocrit value based on the peak value of the movement signal of the magnetic particles; subjecting the fibrinogen concentration in whole blood to hematocrit correction using the waveform-based hematocrit value; and computing the fibrinogen concentration in plasma of the sample.