Lateral Flow Assay for Coccidioidomycosis Detection

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Solution Overview

Problem

Current diagnostic methods for coccidioidomycosis, or Valley fever, are inefficient, with existing antigen tests lacking specificity and speed, leading to delayed diagnoses and unnecessary antibiotic use, and existing antibody tests having high false-positive rates and requiring extensive laboratory expertise and time.

Innovation Solution

Development of a semi-quantitative host species-agnostic lateral flow assay (LFA) that detects anti-chitinase 1 (CTS1) antibodies, capable of producing results within 10 minutes, using CTS1 coupled to gold nanoparticles, which can be read visually or with a density reader, allowing for rapid and accurate detection in serum or plasma samples.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If enzyme immunoassay (EIA) is used for antibody detection, then detection speed is improved (2-3 hours), but false-positive rate increases and specificity deteriorates

Engineering Contradiction:

Improvedetection speedVSAvoidspecificity

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The patent extracts and isolates the CTS1 antigen from complex Coccidioides antigen preparations to create a purified, single-antigen diagnostic test. This extraction eliminates cross-reactivity with other fungal antigens that causes false positives in EIA, while maintaining rapid detection capability through the use of purified antigen in a streamlined assay format

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the antigen parameter from complex multi-antigen preparations to purified CTS1 antigen. This parameter change improves specificity by eliminating non-specific reactive components while maintaining the ability to detect anti-coccidioidal antibodies rapidly through optimized assay conditions for the purified antigen

Inventive Principle:

Principle #35Parameter changes

2Reliability

If immunodiffusion assay (ID) or complement fixation assay (CF) is used, then specificity is improved, but turnaround time increases (24-48 hours) and device complexity increases

Engineering Contradiction:

ImprovespecificityVSAvoidturnaround time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The patent replaces the complex mechanical and procedural systems of ID and CF assays with a simplified immunochromatographic lateral flow assay. This substitution maintains high specificity through purified CTS1 antigen while dramatically reducing turnaround time to 1-2 hours and eliminating the need for complex laboratory equipment and expert interpretation

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent segments the diagnostic process into simple, discrete steps: sample application, incubation, and visual reading. This segmentation eliminates the complex pre-analytic and post-analytic steps required by ID and CF, reducing turnaround time while maintaining specificity through the use of purified CTS1 antigen in each segment

Inventive Principle:

Principle #1Segmentation

3Measurement precision

If complex antigen preparations are used in EIA, then sensitivity is improved, but false-positive rate increases due to cross-reactivity

Engineering Contradiction:

ImprovesensitivityVSAvoidfalse-positive rate

Core Design Contradiction:

Measurement precisionVSReliability

Solution Approach 1:

The patent extracts CTS1 as the specific diagnostic antigen from complex Coccidioides antigen preparations. This extraction maintains sensitivity by preserving the key immunoreactive component while eliminating cross-reactive antigens that cause false positives, achieving both goals simultaneously through targeted antigen isolation

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent applies local quality by using purified CTS1 antigen specifically for antibody detection, rather than complex mixtures. This localized approach to antigen quality improves specificity by eliminating cross-reactivity while maintaining sensitivity through the preserved immunoreactivity of the CTS1 component

Inventive Principle:

Principle #3Local quality

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 LFA demonstrates high sensitivity and specificity, outperforming existing rapid tests like the sōna LFA, with 92.7% detection of human sera and significant correlation with clinical reference methods, enabling timely and accurate diagnosis and reducing unnecessary antibiotic use.

Implementation Method 1

a rapid antibody lateral flow assay to detect anti-chitinase 1 (CTS1) antibodies

Methodology Applied

Scientific EffectAntigen-antibody binding:

Implementation Method 2

using CTS1 coupled to gold nanoparticles, which can be read visually or with a density reader

Methodology Applied

Scientific EffectGold nanoparticle optical properties:

Data Source

PatentUS20250020644A1Methods and materials for detecting and treating coccidioidomycosis

Publication Date: 2025.01.16 MAYO FOUNDATION FOR MEDICAL EDUCATION & RESEARCH

AI summary

This document provides methods and materials involved in detecting and/or treating coccidioidomycosis (e.g., valley fever). For example, methods and materials for using a rapid antibody lateral flow assay to detect anti-CTS1 antibodies are provided. Methods and materials for treating coccidioidomycosis (e.g., valley fever) in a mammal (e.g., a human) identified as having anti-CTS1 antibodies via a lateral flow assay also are provided.