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
Engineering 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
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
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
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
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
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
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
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
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
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
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
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
Data Source
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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.