Automated Analyzer Abnormality Detection via Reaction Curve Shape Analysis

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Solution Overview

Problem

Automated analyzers for clinical examinations face challenges in accurately detecting abnormalities in reaction processes due to vague evaluation of stirring quality and reagent degradation, leading to potential inaccuracies in measurement results.

Innovation Solution

The implementation of an automated analyzer that approximates time-series data using specific functions to calculate indices indicating shape features of absorbance changes, allowing for the detection of abnormalities by determining the presence or absence of deviations from a straight line, thereby evaluating the quality of stirring and reagent performance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional detection methods (linearity check, ABS limit) are used, then the analysis can be performed with simple procedures, but the detection accuracy of abnormality is insufficient

Engineering Contradiction:
Improveabnormality detection accuracyVSAvoidanalysis procedure complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The invention changes the parameter of abnormality detection from simple linearity checks and absorbance limits to shape feature quantities derived from approximation formulas. By calculating parameters such as curvature and inflection points from the reaction process curve, the system achieves more accurate abnormality detection while maintaining automated operation.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention replaces mechanical visual inspection methods with automated mathematical analysis. By using approximation formulas (such as polynomial fitting) to model the reaction curve and automatically calculating shape features, the system substitutes manual evaluation with computational analysis, improving both accuracy and automation.

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

2Reliability

If simple evaluation methods are used, then the operation is easy, but the stirring quality and reagent degradation cannot be accurately evaluated

Engineering Contradiction:
Improveevaluation reliabilityVSAvoidoperation simplicity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The system performs self-evaluation by automatically analyzing its own reaction process data. The automated analyzer calculates shape feature quantities from its measured reaction curves and compares them against reference values, enabling the system to self-diagnose stirring quality and reagent status without external intervention.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The invention implements feedback by comparing measured shape feature quantities against reference values stored in the system. When deviations exceed predetermined thresholds, the system provides feedback indicating abnormality, allowing operators to take corrective actions based on objective quantitative data rather than subjective judgment.

Inventive Principle:
Principle #23Feedback

3Measurement precision

If manual checking of reaction process data is performed, then the analysis procedure remains simple, but data reliability cannot be ensured

Engineering Contradiction:
Improvedata reliabilityVSAvoidautomatic abnormality detection
Core Design Contradiction:
Measurement precisionVSExtent of automation

Solution Approach 1:

The invention replaces manual data checking with automated computational analysis. The system automatically fits approximation formulas to reaction process data, calculates shape feature quantities, and compares them against reference values, substituting human evaluation with systematic mathematical analysis that eliminates subjective bias and fatigue.

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

Solution Approach 2:

The system creates a mathematical model (copy) of the normal reaction process through approximation formulas. By comparing actual reaction curves against this idealized model, the system can automatically identify deviations without requiring manual interpretation of each data point, thereby ensuring consistent and reliable evaluation.

Inventive Principle:
Principle #26Copying

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 reliable evaluation of both control and patient specimen measurements, ensuring accurate data reliability and proactive maintenance of the analyzer by quantifying stirring quality and detecting reagent degradation, thus preventing inaccurate results.

Implementation Method 1

The automated analyzer measures absorbance of a reaction solution throughout a certain time and calculates a concentration, an activity value, and the like of a measurement target substance based on a measurement result

Methodology Applied
Scientific EffectAbsorbance measurement: Absorption Spectroscopy

Data Source

PatentEP2434292B1Automatic analysis device and analysis method
Publication Date: 2019.12.25 HITACHI HIGH TECH CORP
  • EP2434292B1 patent drawingFigure 1
  • EP2434292B1 patent drawingFigure 2
  • EP2434292B1 patent drawingFigure 3

AI summary

Provided are an automated analyzer and an automatic analysis method for highly accurately determining presence or absence of abnormality based on reaction process data obtained when concentration of a chemical component or an activity level of an enzyme is measured. The reaction process data is approximated by a function, and shape feature quantities indicating features of a shape of a curve section at an early stage of reaction are calculated. The obtained shape feature quantities are used to determine the presence or absence of abnormality.