Urine Gluten Peptide Detection via Antibody Assays

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Solution Overview

Problem

Current methods for monitoring adherence to a gluten-free diet in coeliac patients are inadequate, as they lack sensitivity and reliability, particularly in detecting occasional dietary transgressions, and often require invasive procedures like intestinal biopsies, which are costly and risky.

Innovation Solution

A non-invasive process for detecting and quantifying immunogenic gluten peptides resistant to gastrointestinal digestion in urine using immunological assays, specifically through the use of antibodies like G12 and A1, which recognize gluten protein epitopes, allowing for the detection and quantification of gluten ingestion via immunochromatographic strips or other immunological techniques.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If intestinal biopsies are used to monitor gluten-free diet adherence, then measurement precision is improved, but object-affected harmful factors increase due to invasive procedures

Engineering Contradiction:
Improvedetection accuracyVSAvoidinvasive procedure risks
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent uses gluten-specific antibodies as intermediaries to detect gluten peptides in urine samples. These antibodies bind to target gluten peptides with high specificity, enabling accurate detection without direct intestinal sampling. The antibody-peptide interaction serves as a mediator that transfers detection capability from invasive biopsy to non-invasive urine analysis.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical invasive procedure of intestinal biopsy with an immunological chemical detection system. Instead of physically extracting tissue samples, the method uses antibody-antigen binding reactions in urine to infer gluten exposure, substituting mechanical invasion with biochemical detection.

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

2Measurement precision

If intestinal biopsies are performed frequently for monitoring, then measurement precision is improved, but loss of time and increased cost occur

Engineering Contradiction:
Improvedetection accuracyVSAvoidmonitoring time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent replaces time-consuming biopsy procedures with rapid immunological assays on urine samples. The antibody-based detection can be performed quickly without the need for surgical preparation, anesthesia, and post-procedure recovery time associated with biopsies.

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

Solution Approach 2:

Urine collection is a self-service procedure that patients can perform independently without medical personnel assistance. This eliminates the need for scheduled biopsy appointments and reduces the time burden on both patients and healthcare providers.

Inventive Principle:
Principle #25Self-service

3Ease of operation

If current monitoring methods are used, then ease of operation is maintained, but reliability of detection deteriorates due to insufficient sensitivity

Engineering Contradiction:
Improvemonitoring convenienceVSAvoiddetection reliability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent changes the detection parameter from general gluten markers to specific gluten peptide epitopes recognized by monoclonal antibodies. This parameter change increases detection sensitivity and reliability while maintaining ease of operation through urine-based sampling.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent introduces gluten-specific antibodies as intermediaries that enhance detection reliability. These antibodies specifically bind to gluten peptides, providing a reliable signal for gluten exposure that overcomes the insensitivity of current monitoring methods.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 method provides a sensitive and reliable means to monitor gluten ingestion, enabling early detection of dietary transgressions and adherence to a gluten-free diet, reducing the need for invasive procedures and improving patient monitoring and diagnosis of refractory coeliac disease.

Implementation Method 1

A non-invasive process for detecting and quantifying immunogenic gluten peptides resistant to gastrointestinal digestion in urine using immunological assays, specifically through the use of antibodies like G12 and A1, which recognize gluten protein epitopes

Methodology Applied
Scientific EffectAntibody-antigen recognition:

Data Source

PatentEP3168617B1Detecting gluten peptides in human fluids
Publication Date: 2019.12.04 BIOMEDAL SL
  • EP3168617B1 patent drawingFigure 1
  • EP3168617B1 patent drawingFigure 2A
  • EP3168617B1 patent drawingFigure 2B

AI summary

The invention relates to a method for detecting and quantifying gluten peptides, resistant to gastrointestinal digestion, in human fluids, preferably urine. The presence or absence of the gluten peptides is monitored by immunological tests based on specific antibodies against same.