Prozone Phenomenon Detection in Immunochromatography Tools

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Solution Overview

Problem

Existing specimen analysis tools using immunochromatography methods face inefficiencies in detecting the prozone phenomenon, leading to false-negative results due to the complex structure required and reduced examination efficiency.

Innovation Solution

A method employing a specimen analysis tool with a porous base material, a sample supplying portion, a reagent portion, and at least one detection portion, where the reagent portion contains labeled substances that bind to the target component, and the detection portion contains immobilized substances, allowing for the detection of prozone phenomena by analyzing peak shapes and magnitude relationships between detection results at different time points.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If plural types of antibodies with different affinities are used as immobilized antibodies in a specimen analysis tool, then the prozone phenomenon can be detected, but the device structure becomes complicated and examination efficiency is reduced

Engineering Contradiction:
Improveprozone phenomenon detection accuracyVSAvoidspecimen analysis tool structure
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The detection portion is divided into multiple detection portions (first detection portion and second detection portion) with different antibody concentrations. The first detection portion has a lower antibody concentration while the second detection portion has a higher antibody concentration, allowing the system to detect both normal samples and prozone phenomena without requiring multiple antibody types.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention changes the parameter of antibody concentration across different detection portions rather than changing the affinity of antibodies. By varying the concentration of the same antibody type in different regions, the system achieves prozone detection while maintaining a simple single-antibody structure.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If plural types of antibodies with different affinities are used, then prozone phenomenon can be detected, but examination efficiency is reduced due to complex structure

Engineering Contradiction:
Improveprozone phenomenon detectionVSAvoidexamination efficiency
Core Design Contradiction:
Measurement precisionVSProductivity

Solution Approach 1:

The detection portion is segmented into multiple regions with different antibody concentrations along the sample flow direction. This segmentation allows the system to handle both normal and prozone samples simultaneously in a single test, eliminating the need for separate testing procedures and maintaining high examination efficiency.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The specimen analysis tool achieves multi-functionality by incorporating detection portions with different antibody concentrations that can detect both normal samples and prozone phenomena using the same reagent system. This universal design allows a single test to serve multiple detection purposes without requiring different antibody types or complex procedures.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Measurement precision

If sample dilution is performed to detect prozone phenomenon, then accurate detection is achieved, but the process becomes complex and time-consuming

Engineering Contradiction:
Improvehigh concentration sample detection accuracyVSAvoiddetection process
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The detection portions are pre-configured with different antibody concentrations before the test is performed. The second detection portion is pre-loaded with higher antibody concentration to automatically capture prozone phenomena when they occur, eliminating the need for post-test dilution operations.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system performs self-service by automatically detecting prozone phenomena through the built-in high-concentration detection portion without requiring manual intervention for dilution. The detection process self-adjusts to handle both normal and high-concentration samples using the multi-concentration detection portion design.

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

Enables easy detection of prozone phenomena using conventional tools, enhancing examination efficiency and accuracy in clinical and biochemical fields by distinguishing false-negatives from actual negatives without the need for sample dilution and re-examination.

Implementation Method 1

The reagent portion contains a labeled substance that specifically binds to the target component

Methodology Applied
Scientific EffectSpecific binding:

Implementation Method 2

The detection portion contains an immobilized substance that specifically binds to the target component

Methodology Applied
Scientific EffectSpecific binding:

Implementation Method 3

a porous base material; a sample supplying portion; a reagent portion; and at least one detection portion. The sample supplying portion, the reagent portion, and the detection portion are arranged on the porous base material from upstream to downstream in a sample moving direction

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Data Source

PatentEP2423686B1Method for detecting prozone phenomenon and analysis method
Publication Date: 2015.09.02 ARKRAY INC
  • EP2423686B1 patent drawingFigure 1A~1B
  • EP2423686B1 patent drawingFigure 2
  • EP2423686B1 patent drawingFigure 3A~3B

AI summary

Provided is a prozone phenomenon detecting method, by which generation of a prozone phenomenon can be detected even when a conventional specimen analysis tool is used, and examinations using an immunochromatography method and the like can be performed efficiently. In the method, a specimen analysis tool containing substances that specifically bind to a target component contained in a sample is used. The specimen analysis tool is obtained by arranging a sample supplying portion, a reagent portion, and a detection portion on the porous base material from upstream to downstream in a sample moving direction in this order. The reagent portion contains a labeled substance that specifically binds to the target component. The detection portion contains an immobilized substance that specifically binds to the target component. The target component is detected by detecting a complex of the target component, the labeled substance, and the immobilized substance through detection of a label of the labeled substance in the detection portion. The method includes at least one of the following processes A and B: the process A: a process in which detection results obtained in the detection portion are plotted along the sample moving direction, and generation of a prozone phenomenon is detected on the basis of a position of a peak in plots thus obtained; and the process B: a process in which the label is detected at two or more different time points in the detection portion, and generation of a prozone phenomenon is detected on the basis of a magnitude relationship between two or more detection results thus obtained.