Blood Coagulation Analyzer Quantification Index for Inhibitor Differentiation

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Solution Overview

Problem

Current methods for differentiating between blood specimens containing coagulation factor inhibitors and those with lupus anticoagulant (LA) based on coagulation time prolongation are challenging due to the lack of a quantitative index for evaluating coagulation factor inhibitors.

Innovation Solution

A method involving the measurement of coagulation times for blood specimens, normal specimens, and mixed specimens under various conditions, followed by the calculation of quantification indices to determine the cause of coagulation time prolongation, utilizing a blood coagulation analyzer with optical information acquisition and processing to differentiate between coagulation factor inhibitors and LA.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If cross mixing test is performed to differentiate coagulation factor inhibitors from lupus anticoagulant, then the cause of coagulation time prolongation can be identified, but the differentiation requires experienced interpretation of pattern changes in graphs and is difficult for non-skilled persons

Engineering Contradiction:
Improvedifferentiation accuracyVSAvoidoperational simplicity
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent transforms the qualitative pattern recognition task into a quantitative measurement by introducing specific parameters: the ratio of coagulation times at different incubation temperatures (37°C and 20°C) and the degree of correction by normal plasma. These parameter changes enable automated calculation of an index value that objectively distinguishes between coagulation factor inhibitors and lupus anticoagulant, eliminating the need for experienced graphical interpretation.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If quantitative index for coagulation factor inhibitor evaluation is introduced, then diagnostic accuracy is improved, but the test complexity and calculation requirements increase

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidtest system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent segments the diagnostic process into distinct measurable components: (1) coagulation time measurement at standard temperature, (2) coagulation time measurement after incubation at different temperatures, (3) calculation of correction degree using normal plasma mixing, and (4) computation of the final index value. This segmentation allows each component to be measured and processed independently, reducing overall system complexity while maintaining high diagnostic accuracy.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces normal plasma as an intermediary substance to facilitate the quantification process. By mixing test plasma with normal plasma at specific ratios and measuring the correction of coagulation time, the system creates an intermediate measurement that enables calculation of the quantitative index. This intermediary approach transforms the direct differentiation task into a series of simpler measurable steps.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 quantitative evaluation of coagulation factor inhibitors in blood specimens, effectively differentiating between coagulation factor inhibitors and other causes of prolongation, such as LA, improving diagnostic accuracy.

Implementation Method 1

measuring coagulation time of blood, for grasping the state of hemostatic mechanism

Methodology Applied
Scientific EffectCoagulation: Coagulation

Implementation Method 2

an optical information acquiring unit for irradiating the prepared measurement sample with light and acquiring optical information on the light amount from the measurement sample

Methodology Applied
Scientific EffectOptical detection:

Data Source

PatentEP3264096B1Method for acquiring information on cause of prolongation of coagulation time and device for performing said method
Publication Date: 2023.09.06 SYSMEX CORP
  • EP3264096B1 patent drawingFigure 1
  • EP3264096B1 patent drawingFigure 2
  • EP3264096B1 patent drawingFigure 3

AI summary

The present invention relates to a method for acquiring information on a cause of prolongation of coagulation time. The present invention also relates to a device, a system and a computer program for analyzing blood coagulation.