Automatic Analyzer Abnormality Detection via Multi-Function Reaction Approximation

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Solution Overview

Problem

Automatic analyzers for clinical tests face challenges in accurately detecting abnormalities in reaction processes due to the complexity of chemical reactions, particularly when multiple types of reactions occur simultaneously, leading to inaccurate approximation and vague evaluation of mixing process performance and reagent quality.

Innovation Solution

An automatic analyzer equipped with a storage mechanism for storing approximate expressions associated with test items, a parameter optimizing mechanism using algorithms like the least squares method, and a determining mechanism for detecting abnormalities through parameter optimization and multivariate analysis, allowing for precise evaluation of reaction abnormalities and reagent performance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If simple approximation functions are used for reaction process data, then the device complexity is reduced, but the measurement precision deteriorates due to inaccurate approximation when multiple reaction types occur simultaneously

Engineering Contradiction:
Improvecomplexity of approximation methodVSAvoidaccuracy of reaction process approximation
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The reaction process is segmented into multiple reaction types (e.g., enzyme-substrate reaction, color development reaction) and each segment is approximated by a separate function. This allows complex multi-type reactions to be accurately modeled without requiring a single complex function, thus maintaining measurement precision while avoiding excessive device complexity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The approximation function transitions from a static single-function model to a dynamic multi-function model that adapts to different reaction phases. The system dynamically selects and combines appropriate approximation functions based on the reaction progress, improving accuracy for complex reactions without permanently increasing system complexity.

Inventive Principle:
Principle #15Dynamics

2Reliability

If detailed monitoring of reaction process parameters is implemented, then the reliability of abnormality detection is improved, but the loss of information increases due to the difficulty of evaluating multiple simultaneous reactions

Engineering Contradiction:
Improveabnormality detection accuracyVSAvoidevaluation capability of reaction data
Core Design Contradiction:
ReliabilityVSLoss of information

Solution Approach 1:

The system implements feedback by comparing the measured reaction process data with the segmented approximation functions. Deviations between measured values and approximated values are calculated and used to detect abnormalities. This feedback mechanism maintains high reliability in abnormality detection while preventing information loss through systematic evaluation of multiple reaction parameters.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

An intermediary evaluation layer is introduced that processes complex multi-reaction data through standardized deviation calculations. This intermediary transforms difficult-to-evaluate multi-reaction information into comparable deviation metrics, maintaining information integrity while enabling reliable abnormality detection across different reaction types.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Manufacturing precision

If quantitative evaluation criteria for mixing process performance are established, then the manufacturing precision of reagent mixing is improved, but the device complexity increases due to the need for additional measurement and analysis mechanisms

Engineering Contradiction:
Improvemixing process consistencyVSAvoidevaluation system complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The system uses the reaction process data itself to evaluate mixing performance, rather than requiring separate dedicated measurement devices. The reaction kinetics serve as a self-indicating mechanism for mixing quality, allowing quantitative evaluation of mixing precision without adding complex external measurement systems.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system evaluates mixing precision by monitoring changes in reaction rate parameters and kinetic constants. By tracking how these parameters vary with mixing conditions, the system achieves quantitative assessment of mixing performance using existing reaction data, avoiding the need for additional complex evaluation hardware.

Inventive Principle:
Principle #35Parameter changes

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 solution enables accurate detection of abnormalities and performance evaluation of the mixing mechanism and reagents, reducing the risk of low-accuracy results and informing users of necessary maintenance or reagent recalibration, thereby enhancing the reliability of test data and reducing the need for re-tests.

Implementation Method 1

Absorbance of a reaction solution is then measured for a predetermined period of time and, based on measurements, concentration and activity values of substances to be measured are found.

Methodology Applied
Scientific EffectAbsorbance measurement: Absorption Spectroscopy

Data Source

PatentEP2428802B1Automatic analysis device and analysis method
Publication Date: 2019.01.30 HITACHI HIGH TECH CORP
  • EP2428802B1 patent drawingFigure 1
  • EP2428802B1 patent drawingFigure 2
  • EP2428802B1 patent drawingFigure 3

AI summary

In known automatic analyzers for detecting an abnormality by approximating reaction process data using a function, accuracy of detecting a reaction abnormality is degraded because of poor approximation accuracy depending on test items. Data processing means stores the absorbance and time of day at which the absorbance is measured as time-series data. Letting x denote absorbance, t denote time, and * denote a symbol representing multiplication, we have a function x = a0 + a1*exp(-k1*t) + a2*exp(-k2*t). Values of parameters a0, a1, a2, ai, k1, and k2 are calculated so that a difference between the absorbance at the measured time calculated using the above expression and the time-series data is minimal, and presence of an abnormality is determined based on the parameter values.