Colorimetric Peptide Screening for Skin Sensitization Risk

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Solution Overview

Problem

Current methods for assessing skin sensitization to topical substances, such as Human Repeat Insult Patch Testing (HRIPT) and Direct Peptide Reactivity Assay (DPRA), are time-consuming, resource-intensive, costly, and may produce unreliable results, raising ethical concerns and requiring expensive equipment and technical staff.

Innovation Solution

A diagnostic kit using synthetic peptides and colorimetric strips to detect covalent binding with test substances, indicating potential allergenicity through color changes, allowing for rapid and cost-effective identification of Type IV hypersensitivity risks without the need for HRIPT.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If HRIPT is used for skin sensitization assessment, then reliable results can be obtained, but the testing process becomes time-consuming and resource-intensive

Engineering Contradiction:

Improveaccuracy of skin sensitization assessmentVSAvoidtesting duration

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The invention extracts the essential function of HRIPT (detecting peptide depletion indicating allergenicity) and implements it through a simplified colorimetric assay that measures peptide depletion without requiring full HRIPT protocol, thereby reducing time while maintaining reliability

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The invention creates a simplified copy of the HRIPT assessment mechanism by using colorimetric strips that replicate the peptide depletion detection principle but with faster, more accessible methodology

Inventive Principle:

Principle #26Copying

2Loss of time

If DPRA is used for skin sensitization assessment, then testing time is reduced, but equipment cost and technical staff requirements increase

Engineering Contradiction:

Improvetesting durationVSAvoidequipment and technical staff requirements

Core Design Contradiction:

Loss of timeVSDevice complexity

Solution Approach 1:

The invention uses disposable colorimetric strips instead of expensive, complex mass spectrometry or HPLC equipment, making the test accessible without requiring sophisticated instrumentation or highly trained technical staff

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The invention replaces the complex mechanical and electronic systems of mass spectrometry/HPLC with a simple colorimetric chemical reaction system that can be performed with basic laboratory equipment

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If HRIPT is used for skin sensitization assessment, then comprehensive data can be collected, but ethical concerns arise due to potential skin tissue reaction

Engineering Contradiction:

Improvecomprehensive allergy dataVSAvoidskin tissue reaction

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention uses synthetic peptides as intermediaries that can bind to potential allergens in vitro, allowing assessment of allergenicity without requiring live human skin exposure and subsequent tissue reactions

Inventive Principle:

Principle #24Intermediary (Mediator)

4Reliability

If HRIPT is used for skin sensitization assessment, then accurate results can be obtained, but cost increases significantly

Engineering Contradiction:

Improveaccuracy of allergy assessmentVSAvoidtesting cost

Core Design Contradiction:

ReliabilityVSQuantity of substance

Solution Approach 1:

The invention employs inexpensive colorimetric strips and simple reagents instead of costly HRIPT procedures involving multiple patient enrollments and weeks of monitoring, dramatically reducing testing costs while maintaining reliability

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

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

Provides a reliable, low-cost, and efficient method for assessing skin sensitization risks, reducing the need for costly and time-consuming HRIPT, while offering objective and quantifiable results, potentially avoiding further testing and supporting regulatory compliance.

Implementation Method 1

a second container including a filter and a second synthetic peptide, the second container being configured to receive a substance to be tested with the filter being disposed between the substance to be tested and the second synthetic peptide

Methodology Applied

Scientific EffectFiltration: Filter (physical)

Implementation Method 2

a first well and a first testing strip including a first conjugated reagent, the first testing strip including the first conjugated reagent being configured to change color in response to being exposed to the first synthetic peptide

Methodology Applied

Scientific EffectColorimetric reaction:

Implementation Method 3

Nucleophile-containing synthetic peptides such as cysteine and lysine are combined with a test substance. Depletion of the peptide, through covalent binding of the test substance with the synthetic peptide, is then detected

Methodology Applied

Scientific EffectCovalent binding: Chemical Bonding

Data Source

PatentUS20250290858A1Rapid screening test for skin sensitization risk assessment

Publication Date: 2025.09.18 SALUJA RAMINDER

AI summary

Embodiments of the instant invention relate to compositions and methods for identifying and assessing risk for topical substances on the skin for eliciting a Type IV hypersensitivity reaction via a chemical colorimetric screening in a rapid diagnostic assay. In some embodiments, the methods comprise colorimetric chemical change with subsequent identification of the ability to elicit an allergic response.