Lateral-Flow Test Strip Linkage for Ochratoxin Detection

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Solution Overview

Problem

Existing lateral-flow test strips for detecting antibiotics and toxins often face issues with weak or inconsistent binding between the binding substance and the signal component, leading to unreliable results, especially at safe levels determined by governments.

Innovation Solution

The method involves linking a binding substance, such as antibodies for ochratoxin or beta-lactam antibiotics, to a detectable signal component like gold particles using linkages that include antibody binding proteins and anti-species antibodies, ensuring strong affinity and specificity for analytes like ochratoxin and beta-lactams, thereby enhancing detection sensitivity and reliability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a binding substance is directly linked to a signal component, then the test strip structure is simple, but the binding affinity is weak or inconsistent leading to unreliable results

Engineering Contradiction:
Improvereliability of detection resultsVSAvoidcomplexity of linkage structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent introduces an intermediary linkage structure consisting of a binding substance, a linkage molecule, and a signal component. The linkage molecule acts as a mediator between the binding substance and signal component, providing consistent and reliable binding affinity. This intermediary approach resolves the contradiction by ensuring detection reliability while maintaining manageable structural complexity through standardized linkage chemistry.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If a strong linkage is used between binding substance and signal component, then detection sensitivity is improved, but the manufacturing process becomes more complex

Engineering Contradiction:
Improvedetection sensitivityVSAvoidease of manufacturing test strip
Core Design Contradiction:
Measurement precisionVSEase of manufacture

Solution Approach 1:

The patent applies preliminary action by pre-forming the linkage between the binding substance and signal component before final test strip assembly. The linkage is established under controlled conditions with optimized chemistry, ensuring strong and consistent binding affinity. This pre-formed linkage maintains high detection sensitivity while simplifying the overall manufacturing process by separating the linkage formation step from the test strip assembly steps.

Inventive Principle:
Principle #10Preliminary action

3Measurement precision

If a simple direct linkage is used, then the manufacturing process is easier, but the binding affinity becomes weak leading to inaccurate results at safe levels

Engineering Contradiction:
Improveaccuracy at safe levelsVSAvoidcomplexity of binding structure
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent employs parameter changes by optimizing the chemical parameters of the linkage molecule to achieve strong and consistent binding affinity. The linkage molecule is designed with specific chemical properties (such as affinity constants, steric characteristics, and chemical stability) that enhance binding strength. This parameter optimization ensures accurate detection at safe levels while maintaining a manageable binding structure through rational molecular design.

Inventive Principle:
Principle #35Parameter changes

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 improves the sensitivity and specificity of lateral-flow tests for detecting contaminants like ochratoxin and beta-lactam antibiotics, ensuring results are accurate at or below safe levels, as demonstrated by the test strip's ability to effectively detect these analytes in various samples.

Implementation Method 1

A binding substance (binder) with binding affinity for a substance that may be in a mobile phase of the test strip

Methodology Applied
Scientific EffectAffinity binding:

Implementation Method 2

Detection zones can include test zones and control zones... interpreted visually or using a reader, such as a spectrophotometer

Methodology Applied
Scientific EffectOptical detection:

Data Source

PatentUS9234889B1Method and test strip for detecting residues
Publication Date: 2016.01.12 CHARM SCIENCES INC
  • US9234889B1 patent drawing
  • US9234889B1 patent drawing

AI summary

A method and test strip for detecting one or more analytes in a test solution. The method and test strip include a detectable component, such as a gold particle, that is linked to a binder, such as an antibody, through a linkage. The linkage can include an antibody binding protein and an antispecies antibody.