Multiplexed Fluorescence Assay Cartridge for Simultaneous Pathogen Detection

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Solution Overview

Problem

Current diagnostic systems for infectious diseases, particularly in point-of-care settings, face challenges such as high cost, complexity, and the need for extensive training due to reliance on multiple devices and instruments, which limits their effectiveness in resource-limited settings and hinders early detection of diseases like HIV and its co-infections.

Innovation Solution

A system comprising a cartridge with an optical waveguide and a reader instrument that uses fluorescence assays to detect multiple analytes simultaneously, allowing for rapid, quantitative, and qualitative analysis of disease markers, including HIV, syphilis, and hepatitis C virus, using a small sample volume and providing automated quality control and electronic data management.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If multiple different serological diagnostic tools are used to diagnose HIV and co-infections, then diagnostic accuracy is improved, but cost and complexity increase

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

Solution Approach 1:

The patent combines multiple serological diagnostic tools into a single multiplexed assay system that can detect HIV, syphilis, and hepatitis C virus simultaneously using one cartridge and one reader instrument, eliminating the need for multiple separate diagnostic tools while maintaining diagnostic accuracy for each pathogen

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The diagnostic system is designed with universal functionality to detect multiple pathogens (HIV, syphilis, hepatitis C virus) using a single platform that accepts one type of cartridge, making the system adaptable to various diagnostic needs without requiring multiple specialized devices

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

2Measurement precision

If multiple different serological diagnostic tools are used for co-infection detection, then diagnostic completeness is improved, but ease of operation deteriorates

Engineering Contradiction:
Improvediagnostic completenessVSAvoidease of operation
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The system merges multiple diagnostic functions into a single operational workflow where one cartridge contains all necessary reagents and capture molecules for detecting multiple pathogens, allowing complete co-infection detection through a single test operation rather than multiple separate procedures

Inventive Principle:
Principle #5Merging (Combining)

3Adaptability or versatility

If multiple devices and instruments are used for infectious disease diagnosis, then detection capability is improved, but device complexity increases

Engineering Contradiction:
Improvedetection capabilityVSAvoidinstrumentation requirements
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The system employs a universal reader instrument that can read all types of cartridges containing different capture molecules for various pathogens, providing broad detection capability across multiple diseases without requiring multiple specialized instruments, each with specific reading requirements

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

4Measurement precision

If standardized sample preparation and readout procedures are implemented, then measurement precision is improved, but ease of operation deteriorates

Engineering Contradiction:
Improvequantitative result accuracyVSAvoidprocedure standardization
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The cartridge is designed with pre-measured reagents and pre-formed capture molecules that automatically perform standardized sample preparation functions, eliminating the need for operators to manually execute complex standardized procedures while ensuring consistent quantitative results through built-in calibration features

Inventive Principle:
Principle #25Self-service

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, accurate, and cost-effective detection of multiple pathogens in a single assay, improving treatment prioritization and anti-retroviral drug selection, while reducing the need for extensive training and instrumentation, thus enhancing healthcare efficiency in resource-limited settings.

Implementation Method 1

The system includes a cartridge, containing an optical waveguide, and a reader instrument, containing an imaging system and a light source for reading light signal from an analyte-containing cartridge

Methodology Applied
Scientific EffectOptical waveguide: Waveguide (optics)

Implementation Method 2

A system comprising a cartridge with an optical waveguide and a reader instrument that uses fluorescence assays to detect multiple analytes simultaneously

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Data Source

PatentEP2616797B1System and method for detecting multiple molecules in one assay
Publication Date: 2017.01.11 LIGHTDECK DIAGNOSTICS INC
  • EP2616797B1 patent drawingFigure 1
  • EP2616797B1 patent drawingFigure 2

AI summary

A rapid diagnostic system that delivers a panel of serologic assay results using a small amount of blood, serum, or plasma is described. The system includes a disposable cartridge and a reader instrument, based on planar waveguide imaging technology. The cartridge incorporates a microarray of recombinant antigens and antibody controls in a fluidic channel, providing multiple parallel fluorescence assay results for a single sample.