Blood Coagulation Analysis Early Reaction Error Detection

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Solution Overview

Problem

Current blood coagulation analysis methods face challenges in accurately determining the occurrence of early reaction errors (ERE) even when they are detected, which can lead to erroneous calculation of coagulation time, especially in cases where the early reaction does not significantly influence the coagulation time.

Innovation Solution

A method that calculates coagulation time based on optical detection values and determines the occurrence of early reaction errors by comparing index values related to derivatives of the coagulation curve to predetermined thresholds, allowing for accurate differentiation between genuine coagulation reactions and misrecognized early reactions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If early reaction detection is performed using conventional methods, then the occurrence of early reaction errors can be identified, but the accuracy in determining whether an ERE actually occurred even when early reaction is detected is insufficient

Engineering Contradiction:
Improveaccuracy of ERE determinationVSAvoidreliability of coagulation time calculation
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent applies parameter changes by introducing a new evaluation parameter (index value based on derivative characteristics) to distinguish between genuine ERE cases and false positives. By calculating derivatives of the coagulation curve and comparing index values against thresholds, the system transforms the detection approach from simple early reaction presence to quantitative assessment of ERE impact on coagulation time accuracy.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent replaces manual specialist review of coagulation curves with an automated computational system that calculates derivatives and compares index values. This substitution of mechanical/automated analysis for human expert judgment improves consistency and accuracy in determining whether ERE occurred while maintaining reliability of coagulation time calculations.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Productivity

If automated early reaction detection is implemented, then the detection process is streamlined, but false positives occur where genuine coagulation reactions are misidentified as ERE

Engineering Contradiction:
Improveautomation of detection processVSAvoidaccuracy of ERE identification
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent implements feedback by using derivative calculations and index value comparisons to provide additional verification beyond simple early reaction detection. The system feeds back the characteristics of the coagulation curve (through derivative analysis) to confirm or refute ERE status, reducing false positives while maintaining automation.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent applies preliminary action by performing derivative calculations and index value assessments before finalizing ERE determination. This preliminary analysis of the coagulation curve characteristics allows the system to pre-screen cases and avoid false positive identifications before committing to an ERE diagnosis.

Inventive Principle:
Principle #10Preliminary action

3Measurement precision

If specialist review of coagulation curves is required for every early reaction case, then accuracy of ERE determination improves, but the time and resource requirements increase significantly

Engineering Contradiction:
Improveaccuracy of ERE determinationVSAvoidtime for manual review and repreparation
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent replaces the mechanical process of manual specialist review with an automated computational system that performs derivative calculations and index value comparisons. This substitution maintains high accuracy in ERE determination while eliminating the time loss associated with manual review and potential repreparation of specimens.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent enables the system to self-evaluate ERE status through automated derivative analysis and threshold comparison, without requiring external specialist intervention for each case. The system serves itself by internally validating whether early reaction detection represents a genuine ERE or a false positive, significantly reducing time requirements.

Inventive Principle:
Principle #25Self-service

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 precise determination of whether an early reaction error has occurred, ensuring the reliability of calculated coagulation times and reducing false positives, thereby improving the accuracy of blood coagulation analysis.

Implementation Method 1

a coagulation curve obtained by optically detecting a turbidity change that occurs in a blood specimen

Methodology Applied
Scientific EffectTurbidity: Scattering

Data Source

PatentUS11747350B2Blood coagulation analyzing method, apparatus, and non-transitory computer-readable storage medium for determining occurence of an early reaction error
Publication Date: 2023.09.05 SYSMEX CORP
  • US11747350B2 patent drawing
  • US11747350B2 patent drawing
  • US11747350B2 patent drawing

AI summary

A blood coagulation analyzing method according to one or more aspects may include: calculating a coagulation time based on data representing a coagulation curve of a change in an optical detection value of a blood specimen added with a reagent for starting a coagulation reaction; calculating an index value related to derivatives calculated concerning the coagulation curve represented by the data used in the calculating the coagulation time; and determining whether an early reaction error has occurred based on a comparison result obtained by comparing the index value to a predetermined threshold.