Immunochromatography Surfactant and Fast Membrane for Prozone Exclusion

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Solution Overview

Problem

Immunochromatography methods face challenges in accurately detecting substances present in large excess amounts due to the prozone phenomenon, leading to false-negative results and reduced test efficiency and accuracy.

Innovation Solution

Incorporating a nonionic and hydrophilic surfactant with an HLB value of 13 to 18 in the sample addition part and using a membrane with a fast flow speed as the chromatography medium, along with gold nanoparticles, to enhance the immunochromatographic kit and method, preventing the prozone phenomenon and ensuring accurate detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a sandwich method is used to detect a substance in large excess amount, then the detection sensitivity is improved, but a prozone phenomenon occurs causing false-negative results

Engineering Contradiction:
Improvedetection sensitivityVSAvoidtest accuracy
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent introduces free antibodies as an intermediary component to prevent the prozone phenomenon. These free antibodies act as mediators that compete with the excess antigen for binding sites on the detection antibodies, ensuring that the sandwich complex can still form even when antigen is in large excess. This resolves the contradiction by maintaining both detection sensitivity and test accuracy through the mediating作用 of free antibodies.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the parameter of antibody concentration by incorporating free antibodies at specific concentrations (0.1-10 μg/mL) into the reagent composition. This parameter change allows the system to handle a wider range of antigen concentrations without prozone effect, thereby maintaining both detection sensitivity and reliability across different sample conditions.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If free antibodies are added to exclude prozone phenomenon, then test accuracy is improved, but reagent composition complexity increases

Engineering Contradiction:
Improvetest accuracyVSAvoidreagent composition complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges the free antibodies with the detection antibody in a single reagent composition. Instead of using separate steps or components, the free antibodies are combined with the detection antibody to form an integrated reagent that can be applied in one step. This merging approach improves test accuracy while minimizing the increase in complexity by consolidating multiple functions into a unified reagent system.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The reagent composition is designed to be universal by incorporating free antibodies that serve multiple functions: they prevent prozone phenomenon, enhance detection sensitivity, and maintain reliability across a wide range of antigen concentrations. This multi-functionality reduces the need for separate reagents or complex procedural steps, thereby limiting the increase in overall system complexity.

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

3Reliability

If multiple detection regions are provided to exclude prozone phenomenon, then detection reliability is improved, but device complexity and determination criteria complexity increase

Engineering Contradiction:
Improvedetection reliabilityVSAvoidstructure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent extracts the prozone prevention function from the structural complexity of multiple detection regions and implements it through the chemical/biological mechanism of free antibodies in the reagent composition. Instead of adding physical detection regions, the solution is extracted into the reagent formulation itself, thereby improving reliability without increasing device structural complexity or determination criteria complexity.

Inventive Principle:
Principle #2Taking out (Extraction)

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 solution effectively suppresses the prozone phenomenon, allowing for rapid, simple, and sensitive detection of antigens in large excess amounts, maintaining high test accuracy and sensitivity without requiring dilution or complex determination criteria.

Implementation Method 1

a nonionic and hydrophilic surfactant having an HLB value of 13 to 18 is retained at least in a sample addition part

Methodology Applied
Scientific EffectSurfactant: Surfactant

Implementation Method 2

a nonionic and hydrophilic surfactant having an HLB value of 13 to 18 is retained at least in a sample addition part

Methodology Applied
Scientific EffectHydrophile: Hydrophile

Implementation Method 3

a membrane having a fast flow speed is used as a membrane to be used for a chromatography medium

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 4

colloidal gold having a relatively small particle diameter of 20 to 60 nm is used as colloidal gold to be used as a labeling substance

Methodology Applied
Scientific EffectLight scattering: Scattering

Data Source

PatentUS10466237B2Method for excluding prozone phenomenon in immunological measurement reagent
Publication Date: 2019.11.05 TANAKA KIKINZOKU KOGYO KK
  • US10466237B2 patent drawing

AI summary

An object is to provide an immunochromatography detection method and an immunochromatography kit in which a prozone phenomenon occurring in a sandwich method when using an analyte in which an antigen is present in a large excess amount is suppressed/excluded. The object was achieved by retaining a nonionic and hydrophilic surfactant having an HLB value of 13 to 18 in a sample addition part of an immunochromatography device, and also using a membrane having a fast flow speed as a membrane to be used for a chromatograph medium.