Peptide-Based Rheumatoid Arthritis Diagnostic Test

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Solution Overview

Problem

Current diagnostic methods for rheumatoid arthritis, particularly serological tests using rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPA), suffer from low sensitivity and specificity, leading to missed diagnoses in approximately 30% of patients, and are confounded by similar symptoms with periodontal disease, necessitating a more accurate diagnostic approach.

Innovation Solution

A novel peptide fragment derived from the RgpA protein of Porphyromonas gingivalis, specifically binding to rheumatoid arthritis autoantibodies, is used in a serological test to increase diagnostic sensitivity and specificity, employing immunoassay methods such as ELISA or immunochromatography to detect antibodies in patient sera compared to healthy controls.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional serological tests using RF and ACPA are used for rheumatoid arthritis diagnosis, then the diagnostic process is simple and cost-effective, but the sensitivity and specificity are low leading to missed diagnoses in approximately 30% of patients

Engineering Contradiction:
Improvediagnostic sensitivity and specificityVSAvoidtest system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent introduces a peptide fragment derived from Porphyromonas gingivalis RgpA protein as an intermediary antigen that specifically binds to rheumatoid arthritis autoantibodies. This intermediary substance enables more specific detection of pathogenic autoantibodies while maintaining the simplicity of serological testing, thereby improving diagnostic sensitivity and specificity without significantly increasing system complexity

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the diagnostic parameter from detecting general rheumatoid factor or anti-citrullinated protein antibodies to detecting specific autoantibodies against the P. gingivalis RgpA peptide fragment. This parameter change targets the specific pathogenic mechanism involving molecular mimicry between bacterial and human proteins, thereby improving diagnostic accuracy while maintaining serological test simplicity

Inventive Principle:
Principle #35Parameter changes

2Reliability

If traditional RF and ACPA tests are used, then the testing procedure is straightforward, but the results are confounded by similar symptoms with periodontal disease leading to false positives and negatives

Engineering Contradiction:
Improvediagnostic reliabilityVSAvoidtesting procedure simplicity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent extracts and isolates the specific peptide fragment from the RgpA protein of Porphyromonas gingivalis that contains the epitope recognized by rheumatoid arthritis autoantibodies. By using this extracted specific antigen rather than whole-cell lysates or general citrullinated proteins, the test achieves higher reliability in distinguishing RA from periodontal disease while maintaining procedural simplicity through standardized peptide preparation

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

Instead of trying to differentiate RA from periodontal disease by comparing multiple general markers, the patent inverts the approach by using a specific P. gingivalis-derived peptide that is pathogenic to RA patients. This inversion allows the test to specifically detect the molecular mimicry mechanism unique to RA, thereby improving diagnostic reliability while keeping the procedure straightforward

Inventive Principle:
Principle #13The other way round (Inversion)

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

The peptide-based test significantly enhances the sensitivity and specificity of rheumatoid arthritis diagnosis, improving the detection of patients who test negative with traditional RF and ACPA tests, allowing for earlier intervention and reducing joint damage.

Implementation Method 1

a peptide fragment derived from an RgpA protein of Porphyromonas gingivalis and capable of binding to rheumatoid arthritis autoantibodies

Methodology Applied
Scientific EffectAntigen-antibody binding:

Implementation Method 2

employing immunoassay methods such as ELISA or immunochromatography to detect antibodies in patient sera compared to healthy controls

Methodology Applied
Scientific EffectImmunoassay detection:

Data Source

PatentUS12105097B2Rheumatoid arthritis auto-antibody-bound peptide and application thereof
Publication Date: 2024.10.01 CHINA MEDICAL UNIVERSITY(TW)
  • US12105097B2 patent drawing
  • US12105097B2 patent drawing
  • US12105097B2 patent drawing

AI summary

The present invention relates to a peptide capable of binding to rheumatoid arthritis autoantibodies, which is a consecutive 10-25 amino acid sequence of any one fragment of the group consisting of SEQ ID NO: 3-4, 7-13 or 16-19, wherein the peptide fragment has an epitope that binds to the rheumatoid arthritis autoantibodies. Furthermore, the peptide fragment bound to the rheumatoid arthritis autoantibodies is used for testing rheumatoid arthritis, and according to this use, the present invention provides a method for testing rheumatoid arthritis disease and a test reagent kit used for determining whether a subject to be tested suffers from rheumatoid arthritis disease.