FcμR-Based Immune Complex ELISA for IgM Detection

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Solution Overview

Problem

Current methods for detecting IgM and IgA antibodies are not sufficiently effective for early diagnosis of infections, particularly as they often require complex procedures and may not accurately differentiate between specific and non-specific antibody binding.

Innovation Solution

Utilization of immobilized FcµR, specifically Faim 3/Toso or CD351, to quantify IgM or IgA antibodies in the form of immune complexes formed by mixing an antigen with a sample, enhancing sensitivity and specificity through the Ig-like domain's binding capabilities.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional IgM antibody-capture ELISA is used, then IgM antibodies can be detected, but the method lacks sensitivity and specificity for early infection diagnosis

Engineering Contradiction:
Improvedetection sensitivityVSAvoidprocedure complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent introduces FcμR as an intermediary component that specifically binds to the Fc region of IgM antibodies. This mediator enables indirect detection of IgM through immune complex formation, significantly improving detection sensitivity while maintaining procedural simplicity through the single-step ELISA format

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention changes the detection parameter from direct antigen-antibody binding to Fc region binding via FcμR. This parameter change allows detection of both free and complexed IgM antibodies, enhancing sensitivity for early infection diagnosis while preserving the ease of ELISA procedure

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If FcμR is used to detect immune complexes, then detection sensitivity improves, but the method requires specific receptor immobilization

Engineering Contradiction:
Improvequantification accuracyVSAvoidreceptor immobilization
Core Design Contradiction:
Measurement precisionVSEase of manufacture

Solution Approach 1:

FcμR serves multiple functions: it acts as a capture reagent for IgM antibodies, provides specific binding to the Fc region for quantitative measurement, and enables differentiation between IgM and other immunoglobulin classes. This multi-functionality achieves accurate quantification while simplifying the overall assay design

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

3Reliability

If IgM antibodies are detected using conventional methods, then general detection is possible, but early infection diagnosis is not sufficiently effective

Engineering Contradiction:
Improvediagnosis accuracyVSAvoiddiagnosis timing
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The method enables preliminary detection of IgM antibodies at very early stages of infection by capturing immune complexes before they are cleared from circulation. The FcμR-based ELISA detects IgM antibodies during the acute phase, allowing earlier diagnosis and intervention compared to conventional methods

Inventive Principle:
Principle #10Preliminary 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 allows for improved detection and quantification of IgM and IgA antibodies, enabling earlier diagnosis of infections by forming immune complexes in the presence of FcµR, which improves test sensitivity and reduces procedural complexity, facilitating acute diagnostic capabilities.

Implementation Method 1

an Fc receptor for IgM heavy chains (FcμR), in particular, Faim 3/Toso and also CD351 (Fcμ/αK), or a functional fragment thereof, which preferably comprises the Ig-like domain of Faim 3/Toso, may be used for in vitro quantification of IgM or IgA antibodies, preferably, IgM, in the form of immune complexes

Methodology Applied
Scientific EffectAntibody-antigen binding:

Data Source

PatentEP3207375B1Detection of igm antibodies using an immune complex (IC) elisa
Publication Date: 2020.01.08 BERNHARD NOCHT INST FUR TROPENMEDIZIN
  • EP3207375B1 patent drawingFigure 1
  • EP3207375B1 patent drawingFigure 2
  • EP3207375B1 patent drawingFigure 3A~3B

AI summary

The present invention relates to the field of diagnostic or analytic methods. In particular, the inventors teach that an Fc receptor for IgM heavy chains (FcμR), in particular, Faim 3/Toso or CD351, or a functional fragment thereof, which preferably comprises the Ig-like domain of Faim 3/Toso, may be used for in vitro quantification of IgM or IgA antibodies, preferably, IgM, in the form of immune complexes, i.e., complexes formed by antigen and specific antibody. These immune complexes may be formed by mixing an antigen with a sample comprising antibodies. A method for detection and quantification of IgA or IgM antibodies in the form of immune complexes is also provided. This can be useful for diagnosis of infections, e.g., with a virus.