Impedance-Based IgE Quantification for Rapid Allergy Diagnosis

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Solution Overview

Problem

Current methods for detecting and quantifying specific immunoglobulins E (IgE) in serum samples for allergic disease diagnosis are time-consuming, costly, and require extensive reagents and instrumentation, while they do not accurately predict the severity of allergic reactions.

Innovation Solution

A method and device that measure impedance changes in serum samples after contact with allergens, using a device with noble metal electrodes and a processing unit to quantify IgE levels based on impedance differences, allowing for rapid, accurate, and cost-effective quantification of IgE specific to allergens.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional RAST or ImmunoCAP methods are used for detecting specific IgE, then measurement precision is improved, but testing time increases significantly (3-6 hours) and device complexity increases

Engineering Contradiction:
Improvespecific IgE quantification accuracyVSAvoidtesting time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent replaces complex mechanical/chemical assay systems (RAST, ImmunoCAP) with an electrical impedance measurement system. Instead of using radioisotopes, enzymes, or fluorescent labels that require multiple incubation and washing steps, the invention directly measures electrical impedance changes caused by IgE-allergen binding, reducing test time from hours to minutes while maintaining diagnostic capability

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The invention changes the detection parameter from optical/chemical signals (requiring complex reagents and long incubation) to electrical impedance signals. By measuring impedance changes directly in real-time, the system achieves rapid IgE quantification without the time-consuming steps of traditional immunoassays, resolving the contradiction between speed and accuracy

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If traditional immunoassay methods are used, then measurement precision is improved, but device complexity and reagent requirements increase

Engineering Contradiction:
Improvespecific IgE detection accuracyVSAvoidinstrumentation complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent substitutes complex immunoassay instrumentation (automated analyzers, temperature control, multiple wash stations) with a simple electrical impedance measurement device. The core measurement unit requires only electrodes and an impedance meter, eliminating the need for complex mechanical systems while maintaining diagnostic accuracy through direct electrical measurement of IgE-allergen complexes

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The invention extracts and isolates the essential detection function from the complex immunoassay system. By focusing solely on measuring electrical impedance changes caused by IgE binding, the patent removes unnecessary complexity (reagent preparation, multiple incubation steps, washing protocols) while retaining the core diagnostic capability

Inventive Principle:
Principle #2Taking out (Extraction)

3Adaptability or versatility

If traditional RAST method is used with paper allergosorbent discs, then allergen detection capability is achieved, but testing time increases and automation becomes more difficult

Engineering Contradiction:
Improveallergen detection capabilityVSAvoidtesting throughput
Core Design Contradiction:
Adaptability or versatilityVSProductivity

Solution Approach 1:

The patent replaces the paper-based allergosorbent disc system with an electrical impedance measurement platform. This substitution enables real-time, automated detection of IgE-allergen interactions without the time-consuming manual steps of paper-based assays, significantly increasing testing throughput while maintaining the ability to detect multiple allergens

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The invention enables continuous real-time measurement of impedance changes as IgE binds to allergens. Unlike discrete step-wise paper-based methods requiring incubation and washing cycles, the electrical impedance system provides continuous monitoring, allowing multiple samples to be processed in sequence without idle time, thereby increasing productivity

Inventive Principle:
Principle #20Continuity of useful action

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 approach enables quick, reproducible, and cost-effective quantification of IgE levels, providing insights into allergic reactivity and reaction kinetics, and predicting the likelihood of severe allergic reactions, such as anaphylaxis, with minimal equipment and reagents, and in just 5 minutes.

Implementation Method 1

measuring an impedance value of the allergen-containing solution; adding a serum sample to the allergen-containing solution onto the support; measuring an impedance value of the serum sample added to the allergen-containing solution

Methodology Applied
Scientific EffectElectrical impedance measurement: Electrical Resistance

Data Source

PatentEP3283888B1A method for in vitro diagnosis of allergy and related device
Publication Date: 2020.06.10 AZIENDA OSPEDALIERO UNIVRIA MEYER
  • EP3283888B1 patent drawingFigure 1
  • EP3283888B1 patent drawingFigure 2
  • EP3283888B1 patent drawingFigure 3a

AI summary

The present invention refers to a method for the detection and quantification of specific immunoglobulins E (IgE) for an allergen of interest in a patient's serum sample, and to a device for achieving this method.