Fecal IgA Autoantibody Detection for Lupus Diagnosis

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Solution Overview

Problem

Current methods lack effective, non-invasive systems for early detection and diagnosis of autoimmune diseases like systemic lupus erythematosus (SLE) due to the absence of reliable biomarkers for predicting disease progression and inadequate understanding of autoimmunity initiation in at-risk subjects.

Innovation Solution

A method involving the detection of IgA autoantibodies in fecal samples using capture molecules and detector molecules linked to detectable moieties, specifically targeting IgA anti-nuclear antigens, allowing for the identification of autoimmune disease risk or presence through fecal analysis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current diagnostic methods are used for autoimmune diseases, then disease detection can be performed, but the methods are invasive and lack reliable biomarkers for early detection

Engineering Contradiction:
Improvereliability of biomarkersVSAvoidinvasiveness of diagnostic method
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent extracts the diagnostic target (IgA autoantibodies) from the traditional serum sample and detects it in fecal samples instead. This extraction approach allows non-invasive collection of diagnostic material while maintaining the ability to detect specific autoimmune biomarkers, thereby resolving the contradiction between reliability and ease of operation.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent uses capture molecules (anti-IgA antibodies) as intermediaries to specifically bind and detect IgA autoantibodies in fecal samples. These capture molecules serve as mediators that enable specific detection of the biomarker of interest in the non-invasive fecal sample, resolving the contradiction by providing both reliability through specific binding and ease of operation through non-invasive sampling.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Loss of time

If early detection of autoimmune diseases is achieved, then preventive therapy can be initiated, but reliable biomarkers for predicting disease progression are currently unavailable

Engineering Contradiction:
Improvetime to disease detectionVSAvoidpredictive capability of biomarkers
Core Design Contradiction:
Loss of timeVSReliability

Solution Approach 1:

The patent enables preliminary detection of IgA autoantibodies in fecal samples before clinical disease manifestation. By detecting these biomarkers in advance, the system allows for early intervention and preventive therapy initiation, resolving the contradiction between early detection timing and biomarker reliability for prediction.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent replaces traditional serum-based detection mechanics with a fecal sample detection system using specific capture molecules. This substitution enables early detection in a non-invasive matrix while maintaining biomarker reliability through highly specific antibody-antigen binding, allowing time for early intervention without sacrificing predictive capability.

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

3Ease of operation

If fecal sample analysis is used for autoantibody detection, then non-invasive diagnosis is achieved, but the complexity of detecting specific IgA autoantibodies increases

Engineering Contradiction:
Improveinvasiveness of samplingVSAvoidcomplexity of detection system
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent segments the detection process into distinct functional components: capture molecules for specific binding, detector molecules for signal generation, and fecal sample preparation steps. This segmentation allows the complex detection task to be broken down into manageable steps, resolving the contradiction between non-invasive sampling and detection system complexity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs capture molecules as intermediaries that specifically bind IgA autoantibodies in the complex fecal matrix. These intermediaries simplify the detection process by selectively isolating the target analyte from the complex sample, thereby reducing the effective complexity while maintaining ease of operation through non-invasive sampling.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Measurement precision

If specific IgA autoantibodies are detected in fecal samples, then early diagnosis capability is improved, but the measurement precision requirements increase

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

Solution Approach 1:

The patent uses highly specific capture molecules (anti-IgA antibodies) as intermediaries to bind the target autoantibodies. This specific binding ensures that only the relevant biomarkers are detected, thereby maintaining high measurement precision and diagnostic accuracy simultaneously, resolving the contradiction between detection sensitivity and diagnostic reliability.

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

Enables early, non-invasive detection and diagnosis of autoimmune diseases by quantifying IgA autoantibodies in fecal samples, providing a biomarker for predicting disease progression and facilitating timely intervention.

Implementation Method 1

contacting a portion of the sample with a capture molecule which specifically binds to at least one IgA autoantibody

Methodology Applied
Scientific EffectAntigen-antibody binding:

Implementation Method 2

contacting the sample with a detector molecule, wherein the detector molecule is linked to a detectable moiety; and examining a detectable signal generated from the detectable moiety

Methodology Applied
Scientific EffectAntigen-antibody binding:

Data Source

PatentUS20210349094A1Detection of autoreactive fecal immunoglobulin a (IGA) for diagnosis of lupus
Publication Date: 2021.11.11 MUSC FOUNDATION FOR RESEARCH DEVELOPMENT(US)
  • US20210349094A1 patent drawing
  • US20210349094A1 patent drawing
  • US20210349094A1 patent drawing

AI summary

The invention provides a method for detecting an IgA anti-nuclear autoantibody in a fecal sample from a subject, wherein the presence of the IgA anti-nuclear autoantibody is an early indicator of the presence or increased risk of development of an autoimmune disease or disorder.