Automatic Analyzer Limit of Detection Evaluation Automation

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Solution Overview

Problem

The evaluation of the limit of detection/limit of quantification in automatic analyzers is typically conducted manually, requiring complex operations and is not performed regularly, leading to inadequate reflection of the current state of measurement reliability and accuracy.

Innovation Solution

An automatic analyzer is designed to automate the limit of detection/limit of quantification test, reducing operator operations and enabling the output of measurement results that reflect the most recent state of the apparatus or reagent, ensuring high reliability and adequacy of measurement results.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If manual evaluation of limit of detection/limit of quantification is performed, then measurement accuracy can be assessed, but operator workload increases and regular evaluation cannot be ensured

Engineering Contradiction:
Improvelimit of detection/limit of quantification evaluation accuracyVSAvoidoperator workload
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The automatic analyzer performs self-evaluation of its own measurement capabilities by automatically conducting limit of detection and limit of quantification tests using built-in standard solutions and automated evaluation algorithms, eliminating the need for manual operator intervention while ensuring regular assessment of measurement reliability

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system pre-programs evaluation protocols, standard solution concentrations, and acceptance criteria before operation, allowing the automatic analyzer to execute complete limit of detection/quantification assessments without real-time operator input, thus reducing workload while maintaining evaluation accuracy

Inventive Principle:
Principle #10Preliminary action

2Reliability

If manual evaluation is performed occasionally, then some measurement reliability data is obtained, but the current state of measurement reliability is not accurately reflected

Engineering Contradiction:
Improvemeasurement reliability data availabilityVSAvoidtime elapsed since last evaluation
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The automatic analyzer continuously evaluates measurement reliability by automatically performing limit of detection and limit of quantification tests at predetermined intervals using internal standard solutions, ensuring that measurement reliability data is always current and accurately reflects the present state of the apparatus or reagent

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The system implements scheduled periodic evaluation cycles where the automatic analyzer automatically conducts limit of detection/quantification assessments at predetermined time intervals, maintaining up-to-date reliability data without requiring manual initiation while preventing excessive time gaps between evaluations

Inventive Principle:
Principle #19Periodic action

3Measurement precision

If complex manual operations are required for limit of detection/limit of quantification test, then thorough evaluation can be performed, but the test is not performed regularly

Engineering Contradiction:
Improvelimit of detection/limit of quantification evaluation thoroughnessVSAvoidevaluation frequency
Core Design Contradiction:
Measurement precisionVSProductivity

Solution Approach 1:

The automatic analyzer replaces manual mechanical operations with automated liquid handling systems, robotic sample preparation, and computer-controlled measurement sequences, enabling thorough limit of detection/quantification evaluations to be performed automatically at high frequency without operator intervention

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

Solution Approach 2:

The system performs self-evaluation by automatically preparing test samples, conducting measurements, analyzing data, and determining limit of detection and limit of quantification values through built-in algorithms, enabling frequent thorough evaluations without manual operational complexity

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

The automatic analyzer reduces operator workload and ensures reliable measurement results by automating the limit of detection/limit of quantification test, allowing for timely determination of whether reexamination is necessary and providing data that accurately represents the current state of the apparatus or reagent.

Implementation Method 1

applies a light from a light source to a reaction solution obtained by mixing a biological sample, such as blood serum and urine, and a reagent, calculates the absorbance from the change of the amount of the transmitted light at a certain wavelength and determines the concentration of a substance measured according to the Lambert-Beer law

Methodology Applied
Scientific EffectAbsorbance measurement: Absorption Spectroscopy

Implementation Method 2

a light is applied to aggregates generated by the aggregation of the latex particles due to the substance to be measured, and the change of the amount of the light which has been transmitted without being scattered is measured

Methodology Applied
Scientific EffectLight transmission measurement: Absorption (EM radiation)

Implementation Method 3

measures the intensity of the scattered light by applying a light to aggregates generated by the reaction of an antigen contained in a sample and an antibody contained in a reagent

Methodology Applied
Scientific EffectLight scattering: Scattering

Data Source

PatentEP2878952B1Automatic analysis device
Publication Date: 2023.03.15 HITACHI HIGH TECH CORP
  • EP2878952B1 patent drawingFigure 1
  • EP2878952B1 patent drawingFigure 2
  • EP2878952B1 patent drawingFigure 3

AI summary

An automatic analyzer which can reduce the effort necessary for conducting a test of limit of detection/limit of quantification properties and managing the test results is provided. Operation condition-setting means for conducting an evaluation test for at least one of a limit of detection and a limit of quantification for each measurement item, determination condition-setting means for setting a determination condition of the evaluation test, and a calculation unit for obtaining a measurement result of a dilution series containing different dilution concentrations by controlling the sample-dispensing mechanism, the reagent-dispensing mechanism and the measurement unit based on the set operation condition, and calculating a test result of the evaluation test from the measurement result of the dilution series based on the set determination condition are disposed.