Lateral Flow Immunoassay for TRAIL and CRP Biomarker Detection

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Solution Overview

Problem

Current diagnostic technologies for distinguishing between bacterial and viral infections are inadequate, as they often yield low accuracy, require extensive time, fail to differentiate between pathogenic and non-pathogenic bacteria, and are limited in accessibility, leading to inappropriate antibiotic prescriptions and health complications.

Innovation Solution

A lateral flow immunoassay method measuring TNF-related apoptosis-inducing ligand (TRAIL) and C-reactive protein (CRP) polypeptides in a fluid sample, using labeled and immobilized monoclonal antibodies to accurately diagnose bacterial or viral infections, allowing for rapid differentiation between infection types.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If current diagnostic technologies (culture, PCR, immunoassays) are used to distinguish bacterial and viral infections, then diagnostic capability is provided, but diagnostic accuracy is poor and time consumption is high

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidtime consumption
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The invention segments the diagnostic process by using a lateral flow immunoassay format that simultaneously detects multiple biomarkers (TRAIL and CRP) in a single test strip. This segmentation allows rapid separation of bacterial and viral infection detection into distinct visual readouts, achieving both high diagnostic accuracy and rapid results within minutes without requiring sequential testing procedures.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention introduces specific monoclonal antibodies as intermediaries that bind to TRAIL and CRP biomarkers in the patient sample. These antibody-based mediators enable selective detection and differentiation of bacterial versus viral infections through the lateral flow immunoassay, providing accurate diagnostic results rapidly without the time-consuming procedures of traditional culture or PCR methods.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If current immunoassays are used for infection diagnosis, then infection detection is provided, but they fail to differentiate between pathogenic and non-pathogenic bacteria

Engineering Contradiction:
Improvedifferentiation accuracyVSAvoidassay complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The invention applies local quality by using pathogen-specific monoclonal antibodies targeted at unique biomarkers (TRAIL for bacterial infections, CRP for viral infections). This localized specificity at the molecular recognition level enables differentiation between pathogenic and non-pathogenic organisms without requiring complex whole-organism identification procedures, maintaining simple assay design while achieving high differentiation accuracy.

Inventive Principle:
Principle #3Local quality

3Measurement precision

If direct sampling of infection site is required for pathogen detection, then diagnostic specificity is improved, but accessibility is reduced for inaccessible tissues

Engineering Contradiction:
Improvediagnostic specificityVSAvoidsample accessibility
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The invention extracts the essential diagnostic information by detecting specific biomarkers (TRAIL and CRP) that are released into accessible body fluids during infection. This extraction approach allows diagnosis of infections in inaccessible tissues (such as pneumonia, sinusitis, otitis-media) by analyzing easily obtainable samples like blood or serum, eliminating the need for direct sampling from difficult-to-reach infection sites while maintaining high diagnostic specificity.

Inventive Principle:
Principle #2Taking out (Extraction)

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

This method provides rapid, accurate differentiation between bacterial, viral, and mixed infections, reducing the need for unnecessary antibiotic prescriptions and improving healthcare outcomes by enhancing diagnostic accuracy and accessibility.

Implementation Method 1

flowing said sample through a lateral flow immunoassay (LFI) device

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

a first mobile, labeled monoclonal antibody against said TRAIL; a second mobile labeled monoclonal antibody against said CRP

Methodology Applied
Scientific EffectAntigen-antibody binding:

Data Source

PatentEP3475702B3Measuring trail by lateral flow immunoassay
Publication Date: 2024.03.20 MEMED DIAGNOSTICS LTD
  • EP3475702B3 patent drawingFigure 1A~1B
  • EP3475702B3 patent drawingFigure 1C~1D
  • EP3475702B3 patent drawingFigure 1E~1F

AI summary

A method of measuring the amount of TNF-related apoptosis-inducing ligand (TRAIL) polypeptide in a fluid sample of a subject in need thereof is disclosed. The method uses a lateral flow immunoassay (LFI) device.