Lateral Flow Test Strip with Parallel Antigen Lanes for Parasitic Disease Detection

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Solution Overview

Problem

Current diagnostic tests for Chagas disease, Leishmaniasis, and Heartworm in veterinary medicine suffer from high false positive and false negative results, and lack a rapid and accurate detection method, particularly in dogs, where existing tests are limited by sensitivity and specificity issues.

Innovation Solution

A diagnostic test using specific antigen combinations and configurations in immunoassay formats that include multiple antigens from Trypanosoma cruzi, Leishmania species, and Dirofilaria immitis, applied in a rapid detection immunoassay method with parallel lanes on test strips, allowing for simultaneous detection of antibodies in biological samples.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a single antigen is used in the diagnostic test, then the test is simple and quick, but the sensitivity and specificity are insufficient leading to high false positive and false negative results

Engineering Contradiction:

Improvediagnostic accuracyVSAvoidtest structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent divides the diagnostic test into multiple parallel lanes, with each lane containing a different antigen (e.g., T. cruzi antigen, Leishmania antigen, Dirofilaria antigen). This segmentation allows simultaneous detection of multiple pathogens while maintaining a simple lateral flow format, resolving the contradiction between diagnostic accuracy and test complexity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The test strip functions as a composite diagnostic system integrating multiple antigens, detection antibodies, and control mechanisms in a single device. This composite structure enables multi-pathogen detection with high sensitivity and specificity without requiring multiple separate tests, thus improving reliability while managing complexity.

Inventive Principle:

Principle #40Composite materials

2Measurement precision

If multiple antigens are used in parallel lanes, then the sensitivity and specificity improve reducing false results, but the device complexity increases

Engineering Contradiction:

Improvedetection accuracyVSAvoidtest strip structure

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The lateral flow test strip is designed as a universal platform that can detect multiple different pathogens simultaneously through parallel lanes. Each lane is optimized for a specific pathogen but the overall device structure and operating procedure remain uniform, allowing high measurement precision without proportionally increasing operational complexity.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent combines multiple single-antigen tests into a single multi-antigen test strip by merging the detection functions in parallel lanes. This consolidation improves measurement precision through multi-pathogen detection while reducing the need for multiple separate testing procedures, thereby managing overall device complexity.

Inventive Principle:

Principle #5Merging (Combining)

3Productivity

If traditional immunofluorescence assay is used, then the equipment is simple, but the testing time is long and cannot be completed rapidly during a regular appointment

Engineering Contradiction:

Improvetesting speedVSAvoiddiagnosis time

Core Design Contradiction:

ProductivityVSLoss of time

Solution Approach 1:

The patent replaces the mechanical and time-intensive immunofluorescence assay with a lateral flow immunoassay that uses capillary action and visual detection. This substitution eliminates the need for complex incubation steps, washing procedures, and fluorescence microscopy equipment, enabling rapid results within minutes during a regular veterinary appointment.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

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 method significantly reduces false positive and false negative results, providing a rapid and accurate detection of these parasitic diseases, improving sensitivity and specificity, and enabling simultaneous testing for multiple pathogens.

Implementation Method 1

determining the presence or absence of antibodies against the target parasite by detecting immunobinding of the antigens within each subset to antibodies against said target parasites

Methodology Applied

Scientific EffectImmunobinding:

Data Source

PatentUS20250020642A1Method and antigen composition for rapid detection of chagas disease, leishmaniasis, and/or heartworm in humans and animals

Publication Date: 2025.01.16 VIDA PHARMACAL INC

AI summary

Among several illnesses common to pets such as dogs that can also affect humans, American trypanosomiasis, commonly known as Chagas disease, is a parasitic 20 condition caused by the hemoflagellated protozoa, Trypanosoma cruzi. Active transmission is through triatomine vectors known as kissing bugs, which are prevalent in North and South America. Diagnostic methods, systems, test strips, test kits, and other immunoassay materials are provided for the detection of antibodies to one or more specific parasites of veterinary and human concern in biological samples, including those that are responsible for Chagas disease (Trypanosoma cruzi), Leishmaniasis (Leishmania infantum), and Heartworm (Dirofilaria immitis).