Immunoassay Analysis Device with Blank Region Normalization

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Solution Overview

Problem

Existing immunoassay analysis methods are inaccurate when antibodies are non-uniformly fixed in reaction regions, leading to deteriorated relative count values and analysis accuracy.

Innovation Solution

An analysis device and method that includes a configuration with a turntable, optical pickup, and signal processing circuit to accurately analyze detection target substances by using relative count values, even if antibodies are non-uniformly fixed, by forming detection target substance capturing regions and blank regions on the analysis substrate and calculating relative count values based on these regions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If antibodies are fixed in reaction regions for immunoassay analysis, then the detection of detection target substances is enabled, but non-uniform fixation of antibodies causes deterioration of relative count value accuracy and analysis accuracy

Engineering Contradiction:
Improverelative count value accuracyVSAvoiduniformity of antibody fixation
Core Design Contradiction:
Measurement precisionVSStability of the object's composition

Solution Approach 1:

The patent changes the parameter of count value normalization by introducing a reference count value obtained from a blank region. Instead of using absolute count values which are affected by antibody fixation uniformity, the system normalizes measurement count values by dividing them by the reference count value, thereby compensating for variations in antibody fixation across different reaction regions.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent introduces a blank region as an intermediary reference element that does not contain antibodies. This blank region serves as a mediator to establish a reference count value that represents the background signal and fixation variations, which is then used to normalize the count values from regions containing antibodies, thereby eliminating the effect of non-uniform antibody fixation.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Adaptability or versatility

If multiple antibodies are fixed to different reaction regions for multiplexed detection, then the ability to detect multiple detection target substances is improved, but variations in antibody fixation across regions cause deterioration of quantitative accuracy

Engineering Contradiction:
Improvemultiplexed detection capabilityVSAvoidquantitative accuracy
Core Design Contradiction:
Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The patent segments the analysis substrate into multiple functional regions including blank regions and multiple detection target substance capturing regions. Each capturing region is assigned a specific antibody for detecting a particular detection target substance. This segmentation allows simultaneous multiplexed detection while the included blank regions provide reference values for normalizing quantitative measurements across all antibody-fixed regions.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent applies parameter transformation by converting absolute count values into relative count values through normalization using reference count values from blank regions. This parameter change enables accurate quantitative comparison across multiple antibody-fixed regions even when antibody fixation amounts vary, thereby maintaining measurement precision in multiplexed detection.

Inventive Principle:
Principle #35Parameter changes

3Device complexity

If relative count values are calculated based on assumption of uniform antibody fixation, then the analysis process is simplified, but the accuracy of analysis deteriorates when antibody fixation is non-uniform

Engineering Contradiction:
Improveanalysis process complexityVSAvoidanalysis accuracy
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The patent performs a preliminary action by measuring and storing reference count values from blank regions before conducting the actual analysis. These reference values are obtained in advance and used to normalize the count values from antibody-fixed regions during data processing, thereby compensating for non-uniform antibody fixation without adding significant complexity to the analysis workflow.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements a feedback mechanism where reference count values obtained from blank regions are used to adjust and normalize the count values from detection regions. This feedback loop allows the system to automatically compensate for variations in antibody fixation by using the measured reference values to calculate accurate relative count values, thereby maintaining high analysis accuracy.

Inventive Principle:
Principle #23Feedback

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 method enables accurate analysis by reducing the influence of in-plane distribution of count values in reaction regions, resulting in a uniform relative count value with less variation, ensuring high accuracy even if antibodies are fixed differently in each reaction region.

Implementation Method 1

an optical pickup 8, the optical pickup 8 irradiating the analysis substrate 30 with a laser beam 82

Methodology Applied
Scientific EffectLight scattering: Scattering

Implementation Method 2

a fluorescence detector in advance

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Data Source

PatentEP3951360B1Analysis device and analysis method
Publication Date: 2023.12.27 JVC KENWOOD CORP
  • EP3951360B1 patent drawingFigure 1
  • EP3951360B1 patent drawingFigure 2~3
  • EP3951360B1 patent drawingFigure 4

AI summary

An analysis device (1) includes an analysis substrate (30), an optical pickup (8), a signal processing circuit (10), and a control unit (20). The analysis substrate (30) includes a reaction region (40). The reaction region (40) includes a region (41) fixed with an antibody (A) bound with a detection target substance (43), and a region (42) other than the region (41) in the reaction region (40). The optical pickup (8) irradiates the analysis substrate (30) with a laser beam (82) and receives reflected light to generate a light reception level signal (JS). The signal processing circuit (10) has a computation unit (11) that calculates a count value (Ca) in the region (41) and a count value (Cb) in the region (42). The control unit (20) has a computation unit (21) which calculates a relative count value (Rc) in the reaction region (40) based on the count values (Ca, Cb).