Fluorescent Pathogen Detection Test Strip with Optical Readout

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Solution Overview

Problem

Current point-of-care (PoC) tests are limited in detecting a wide range of pathogens and cells, particularly for life-threatening diseases like malaria, tuberculosis, and foodborne pathogens, requiring complex laboratory equipment and expertise, which is not readily available in many regions, and existing rapid tests often rely on surface antigens, making them ineffective for pathogen or cell diagnosis.

Innovation Solution

A test system that permeabilizes and labels pathogens and cells, allowing for optical read-out using an optical magnifying unit or mobile processor, enabling the detection of pathogens and cells independently of surface antigens through fluorescent labeling and image processing, facilitating rapid and cost-effective diagnosis at the point of care.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If microscopy-based methods are used for pathogen detection, then diagnostic accuracy is improved, but device complexity and cost increase

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidequipment complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces complex mechanical microscopy systems with a simplified optical detection system. Instead of requiring trained operators to visually examine stained smears under microscopes, the invention uses fluorescently labeled antibodies that bind to pathogen-specific antigens, enabling automated optical detection and image analysis that eliminates the need for expensive microscopy equipment and expert personnel.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent creates optical copies (fluorescent signals) of pathogen structures that can be detected without direct microscopic examination. By labeling pathogen antigens with fluorescent markers, the system generates visible optical signals that replicate the diagnostic information normally obtained through microscopy, allowing detection through simpler optical devices.

Inventive Principle:
Principle #26Copying

2Productivity

If lateral flow rapid tests are used, then test speed is improved, but pathogen detection capability deteriorates

Engineering Contradiction:
Improvetest speedVSAvoidpathogen detection capability
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent segments the detection process into distinct functional zones within the test strip: a sample application area, a reaction area with capture antibodies, and a detection area with fluorescently labeled detection antibodies. This segmentation allows the test to maintain rapid lateral flow characteristics while incorporating fluorescent labeling that enables specific pathogen detection, combining the speed of rapid tests with the accuracy of pathogen identification.

Inventive Principle:
Principle #1Segmentation

3Ease of operation

If surface antigen-based rapid tests are used, then ease of operation is improved, but adaptability to different pathogens deteriorates

Engineering Contradiction:
Improveoperational simplicityVSAvoidpathogen detection range
Core Design Contradiction:
Ease of operationVSAdaptability or versatility

Solution Approach 1:

The patent creates a universal detection platform where fluorescently labeled antibodies can detect multiple different pathogen antigens. The system uses pathogen-specific capture antibodies immobilized on the test strip, combined with universal fluorescent detection antibodies, allowing a single test device to detect various pathogens (bacteria, viruses, parasites) by simply changing the capture antibody layer, thereby achieving both ease of operation and broad adaptability.

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

4Measurement precision

If complex laboratory examinations are used, then diagnostic accuracy is improved, but loss of time increases

Engineering Contradiction:
Improvediagnostic accuracyVSAvoiddiagnosis time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent performs preliminary action by pre-immobilizing pathogen-specific capture antibodies on the test strip during manufacturing. This allows the test to be performed rapidly at the point of care without requiring complex laboratory preparation steps. The sample is applied directly to the pre-prepared strip, and results are obtained quickly through automated fluorescent detection, eliminating the time-consuming sample preparation and staining procedures required by traditional microscopy methods.

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 rapid and cost-effective detection of various pathogens and cells directly from body fluids or food samples, reducing the need for laboratory equipment and expertise, and providing a robust diagnostic tool for emergency medicine and field applications.

Implementation Method 1

at least one means for permeabilizing and/or lysing at least one pathogen and/or at least one cell

Methodology Applied
Scientific EffectPermeabilization and lysis:

Implementation Method 2

a means for image processing, whereby an optical read-out of at least one means for localization, immobilization and/or enrichment can be carried out

Methodology Applied
Scientific EffectOptical detection and image processing:

Data Source

PatentUS11796542B2Rapid test for the detecting pathogens and cells and method
Publication Date: 2023.10.24 ZENDIA
  • US11796542B2 patent drawing
  • US11796542B2 patent drawing
  • US11796542B2 patent drawing

AI summary

Provided is a test system including at least the following: permeabilising means and/or lysis of at least one pathogen and/or at least one cell, means for capturing and/or making parts of the pathogens and/or cells, means for localising, immobilising and/or enriching at least one component of a pathogen and/or a cell, means for image processing preferably including an optical magnifying unit, enabling an optical reading out of at least one means for localising, immobilising and/or enriching can be carried out.