Lateral Flow Assay for Sinus Pathogen Detection

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Solution Overview

Problem

Current methods for diagnosing sinusitis lack a definitive and rapid test to distinguish between viral and bacterial etiology, leading to unnecessary antibiotic prescriptions and potential antibiotic resistance, as existing tests cannot accurately determine the presence of bacterial infections in upper respiratory symptoms.

Innovation Solution

Development of apparatuses and methods for rapid and definitive diagnosis using lateral flow assays and sinus collection devices to detect specific pathogens such as Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pneumoniae, and viruses like influenza and coronavirus from mucus samples, allowing for targeted treatment based on the test results.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If rapid diagnostic testing is implemented to distinguish viral and bacterial infections, then treatment accuracy and antibiotic stewardship improve, but device complexity and manufacturing costs increase

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidtesting device complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The testing device is segmented into distinct functional modules: a sample collection component (swab with collection well), a lysis buffer reservoir, and a lateral flow assay strip with separate detection zones for bacterial antigens, viral antigens, and control lines. This segmentation allows each component to be optimized independently while maintaining overall system simplicity

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The lateral flow assay device is designed as a multi-functional universal tester that simultaneously detects multiple pathogens (bacterial antigens, viral antigens) and includes built-in quality control features. A single device performs what would traditionally require multiple separate tests, reducing overall complexity while improving diagnostic accuracy

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Reliability

If comprehensive pathogen detection is performed to reduce unnecessary antibiotic use, then public health outcomes improve, but healthcare costs and testing time increase

Engineering Contradiction:
Improvetreatment reliabilityVSAvoiddiagnosis time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The device merges multiple detection functions into a single integrated lateral flow assay that simultaneously detects bacterial antigens, viral antigens, and control indicators on one strip. The sample processing, antigen detection, and control verification all occur in parallel within a single device, providing comprehensive pathogen detection without requiring sequential testing

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The device includes pre-loaded lysis buffer and pre-prepared lateral flow strips with immobilized antibodies. The lysis buffer is prepared in advance to rapidly lyse cells and release antigens upon sample addition. These preliminary preparations enable immediate testing upon sample collection, reducing total diagnosis time while maintaining comprehensive detection capability

Inventive Principle:
Principle #10Preliminary action

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

Enables accurate and timely diagnosis of bacterial sinusitis, reducing unnecessary antibiotic use, improving patient treatment, and decreasing healthcare costs by providing a rapid and reliable method to differentiate between viral and bacterial infections.

Implementation Method 1

lateral flow assays and sinus collection devices to detect specific pathogens such as Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pneumoniae, and viruses like influenza and coronavirus from mucus samples

Methodology Applied
Scientific EffectAntigen-antibody binding:

Data Source

PatentUS11650213B2Devices and assays for diagnosis of viral and bacterial infections
Publication Date: 2023.05.16 ENTVANTAGE DIAGNOSTICS INC
  • US11650213B2 patent drawing
  • US11650213B2 patent drawing
  • US11650213B2 patent drawing

AI summary

Methods and kits for sampling mucous from within a sinus to determine if a single sample includes one or more bacterial types indicating a bacterial infection, such as bacterial sinusitis, and one or more viruses indicating a viral infection, such as influenza.