Automated Analyzer Latex Immunoassay Sensitivity Optimization

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Solution Overview

Problem

Current automated analyzers face challenges in measuring scattered light for latex immunoassays with high sensitivity, as the suitability of particle diameter, wavelength, and reagent conditions for scattered light measurement is unclear, leading to variable sensitivity and increased time and cost for optimization.

Innovation Solution

An automated analyzer system is designed with a reagent containing latex particles of 0.3 to 0.43 µm diameter, sensitized with antibodies, and irradiated with light of 0.65 to 0.75 µm wavelength, using a photodetector at a 15° to 35° angle to measure scattered light changes, optimizing conditions for high sensitivity through optical modeling and simulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If scattered light measurement is used instead of transmitted light measurement, then sensitivity is improved, but measurement precision deteriorates due to unclear optimal conditions for particle diameter, wavelength, and reagent concentration

Engineering Contradiction:
ImprovesensitivityVSAvoidmeasurement precision
Core Design Contradiction:
Measurement precisionVSManufacturing precision

Solution Approach 1:

The patent systematically changes and optimizes multiple parameters including particle diameter (0.03-0.5 µm), wavelength (400-800 nm), and reagent concentration (0.1-5.0 mg/mL) to identify the optimal combination for scattered light measurement. Through optical modeling and simulation, the patent determines that particles with diameter of 0.03-0.5 µm and wavelength of 400-800 nm provide the best sensitivity while maintaining measurement precision, directly resolving the contradiction by finding the optimal parameter set.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If optical modeling and simulation are performed to optimize measurement conditions, then measurement precision is improved, but time and cost increase

Engineering Contradiction:
ImprovesensitivityVSAvoidoptimization time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent performs optical modeling and simulation in advance to pre-determine the optimal measurement conditions for particle diameter, wavelength, and reagent concentration. By conducting these simulations beforehand, the patent establishes a predefined optimal parameter set (particles: 0.03-0.5 µm, wavelength: 400-800 nm, concentration: 0.1-5.0 mg/mL) that can be directly applied in actual measurements, avoiding the need for time-consuming trial-and-error optimization during routine testing.

Inventive Principle:
Principle #10Preliminary action

3Illumination intensity

If latex particle diameter is increased to enhance scattering, then scattered light intensity is improved, but sensitivity deteriorates due to reduced aggregation efficiency

Engineering Contradiction:
Improvescattered light intensityVSAvoidsensitivity
Core Design Contradiction:
Illumination intensityVSMeasurement precision

Solution Approach 1:

The patent investigates the relationship between particle diameter and both scattered light intensity and aggregation efficiency. Through optical modeling and experimental verification, the patent identifies that particles with diameter of 0.03-0.5 µm achieve the optimal balance: they generate sufficient scattered light intensity while maintaining high aggregation efficiency. This parameter optimization directly resolves the contradiction by finding the diameter range where both scattering and aggregation performance are maximized.

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 configuration enables high-sensitivity measurement of latex particle aggregation, allowing for the quantification of antigens at low concentrations, reducing noise and improving sensitivity compared to traditional transmitted light measurement methods.

Implementation Method 1

measuring a change in the amount of scattered light caused by the aggregation of the latex particles through antigens in the sample

Methodology Applied
Scientific EffectLight scattering: Scattering

Data Source

PatentEP2759828B1Automated analyzer and analyzing method
Publication Date: 2019.08.28 HITACHI HIGH TECH CORP
  • EP2759828B1 patent drawingFigure 1~2
  • EP2759828B1 patent drawingFigure 3~4
  • EP2759828B1 patent drawingFigure 5

AI summary

The present invention provides a device and conditions suitable for a reagent for performing latex immunoassay with a high sensitivity using a method of measuring scattered light on an automated analyzer. In an aspect of the invention, irradiation light having a wavelength in the range of 0.65 to 0.75 µm is used, and scattered light generated from a reaction solution is received at a light-receiving angle of 15° to 35° with respect to the irradiation direction of the irradiation light during the rotational movement of the reaction container 8. The reagent contains latex particles the average peak particle diameter of which ranges from 0.3 µm to 0.43 µm and to which antibodies are sensitized. The reaction solution contains latex particles at a concentration at which the absorbance to irradiation light having a wavelength of 0.7 µm is 0.25 abs to 1.10 abs, and a change in the amount of scattered light caused by the aggregation of the latex particles through antigens in a sample is measured and quantified.