Solid Support Complex for Multi-Antigen Antibody Detection

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Solution Overview

Problem

Current multi-analyte assays for detecting antinuclear antibodies (ANAs) often lack sufficient antigens, leading to inefficient workflows and complex analysis, particularly when using multiple beads, which can be time-consuming and require skilled technicians.

Innovation Solution

A solid support complex with multiple antigens attached, including a carrier and linkers like PEG or biotin, allows for simultaneous detection of various antibodies, enhancing sensitivity and reducing analysis complexity by combining multiple antigens on a single solid support.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If multiple beads are used in multi-analyte assays to detect different antigens, then the detection capability is improved, but the workflow complexity and analysis time increase significantly

Engineering Contradiction:
Improvedetection capabilityVSAvoidworkflow complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent consolidates multiple antigens onto a single solid support, merging what would traditionally require multiple separate beads into one integrated platform. This allows simultaneous detection of multiple antibodies against different antigens (e.g., Scl-70, centromere, dsDNA, Ro52, Ro60, SS-B, Ribo-P, DFS-70, EJ, Sp100, Gp210, actin, AMA-M2, TIF1-γ, NXP-2, SAE, PL-7, PL-12, OJ, HMGCR, SRP, Mi-2, MDA-5, RNA Helicase, Ki/SL, Sm/RNP, SS-A, PM/Scl, RNA Pol III, Th/To, Fibrillarin, Sm, Ku, Jo-1, RNP, BICD2, HK, KL, LC1, LKM-1, SLA) while simplifying the workflow and reducing the need for complex computational analysis of multiple bead signals

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The solid support is designed with multi-functionality, serving as a universal platform that can detect multiple different antibodies simultaneously. The single solid support structure incorporates diverse antigen types (purified antigens and cellular extract components) that can capture various antibody specificities, making the assay universally applicable for comprehensive autoimmune disease screening without requiring multiple specialized beads

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

2Measurement precision

If multiple beads are used to capture sufficient antibodies, then the detection sensitivity is improved, but the calibration time and technician skill requirements increase

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

Solution Approach 1:

By merging multiple antigen-capturing functions into a single solid support, the patent eliminates the need for separate calibration procedures for each bead type. The unified structure allows for streamlined calibration and reduces the time required while maintaining high detection sensitivity through the combined antigen array that can capture sufficient antibodies across multiple specificities

Inventive Principle:
Principle #5Merging (Combining)

3Ease of operation

If a single antigen is immobilized on a single solid support, then the assay simplicity is improved, but the antibody capture capability is insufficient

Engineering Contradiction:
Improveassay simplicityVSAvoidantibody capture capability
Core Design Contradiction:
Ease of operationVSQuantity of substance

Solution Approach 1:

The single solid support is designed with universal multi-functionality, incorporating multiple different antigens (both purified antigens like Scl-70, centromere, dsDNA, Ro52, Ro60, SS-B, Ribo-P, DFS-70, EJ, Sp100, Gp210, actin, AMA-M2, TIF1-γ, NXP-2, SAE, PL-7, PL-12, OJ, HMGCR, SRP, Mi-2, MDA-5, RNA Helicase, Ki/SL, Sm/RNP, PM/Scl, RNA Pol III, Th/To, Fibrillarin, Sm, Ku, Jo-1, RNP, BICD2, HK, KL, LC1, LKM-1, SLA and cellular extract components) that work together to capture a broad range of antibodies. This maintains assay simplicity with a single solid support while dramatically enhancing antibody capture capability through the diverse antigen array

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

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 increases the sensitivity of ANA detection, simplifies workflows, and improves the accuracy of diagnosing autoimmune diseases by capturing a broader range of antibodies with fewer solid supports, comparable to the HEp-2 cell assay's sensitivity while reducing the need for multiple beads and complex computational analysis.

Implementation Method 1

An antibody in a sample binds to the antigen and the result is detected based, for example, on fluorescence of the bound antigen/antibody

Methodology Applied
Scientific EffectAntigen-antibody binding:

Implementation Method 2

The linker may include a polyethylene glycol (PEG) spacer or biotin

Methodology Applied
Scientific EffectChemical bonding: Chemical Bonding

Implementation Method 3

The carrier may include at least one of streptavidin, a polymerized protein, polymerized streptavidin with biotin, bovine serum albumin (BSA), human serum albumin (HSA)

Methodology Applied
Scientific EffectAdsorption: Adsorption

Data Source

PatentEP4524566A1Detecting antibodies using antigens
Publication Date: 2025.03.19 INOVA DIAGNOSTICS INC
  • EP4524566A1 patent drawingFigure 1A
  • EP4524566A1 patent drawingFigure 1B
  • EP4524566A1 patent drawingFigure 1C

AI summary

An example complex includes a solid support and at least two different types of antigens attached to the solid support. The complex includes a carrier protein attached to the solid support. At least one of the different types of antigens is attached to the carrier protein. The at least one of the different types of antigens is attached to the solid support through the carrier protein.