Dual-Path Immunoassay Layout for IgM and IgG Differentiation

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Solution Overview

Problem

Existing lateral flow immunoassay devices struggle to efficiently detect and differentiate multiple analytes in a single sample, particularly for infections caused by pathogens like Borrelia species, such as Lyme disease, with limited sensitivity and specificity in distinguishing between early and late-stage infections.

Innovation Solution

A lateral flow immunoassay device with two separate fluid flow paths, each containing mobilizable detectable species that bind to specific antibodies, and immobilized species on test lines, allowing for the detection and differentiation of two analytes, such as IgM and IgG antibodies, by using non-human anti-human antibodies and peptide antigens specific to Borrelia species, with optical detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a single fluid flow path is used in lateral flow immunoassay devices, then the device structure remains simple, but the ability to detect and differentiate multiple analytes in a single sample is limited

Engineering Contradiction:

Improvedetection and differentiation of multiple analytesVSAvoiddevice structure

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The device is divided into two separate fluid flow paths, each capable of detecting different analytes (IgM and IgG antibodies). This segmentation allows simultaneous detection of multiple analytes while maintaining relatively simple individual path structures, resolving the contradiction between versatility and complexity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Each fluid flow path is designed with universal components (sample receiving zone, label zone, test line, reference line) that can detect different analytes through specific binding reagents. This multi-functionality enables the device to detect multiple analytes while reusing structural elements, balancing versatility with structural simplicity.

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Measurement precision

If conventional lateral flow immunoassay devices are used, then the device simplicity is maintained, but the sensitivity and specificity for distinguishing early and late-stage infections are limited

Engineering Contradiction:

Improvedetection sensitivity and specificityVSAvoiddevice structure

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

Each fluid flow path is equipped with specific binding reagents tailored to detect particular analytes (IgM-specific reagents in one path, IgG-specific reagents in the other). This local specialization of binding properties enhances measurement precision for distinguishing infection stages while maintaining overall device simplicity through modular design.

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 device provides sensitive and specific detection of Lyme disease, distinguishing between early and late-stage infections by detecting IgM and IgG antibodies within 10 minutes, achieving sensitivity greater than 70% within two weeks of exposure.

Implementation Method 1

Each of the first and second label zones comprise, respectively, a first mobilizable, detectable species and a second mobilizable, detectable species, each mobilizable, detectable species able to bind separate, distinct antibodies against the infectious agent

Methodology Applied

Scientific EffectAntigen-antibody binding:

Implementation Method 2

a first test line in the first fluid flow path positioned downstream of the first label zone, the first test line comprising an immobilized species with binding affinity for the first mobilizable detectable species

Methodology Applied

Scientific EffectAffinity binding:

Implementation Method 3

the sample receiving zone positioned to distribute the sample along a first fluid flow path to a first label zone and along a second fluid flow path to a second label zone

Methodology Applied

Scientific EffectCapillary action: Capillary Action

Data Source

PatentUS12590960B2Immunoassay test device with two fluid flow paths for detection and differentiation of two or more analytes

Publication Date: 2026.03.31 ORTHO CLINICAL DIAGNOSTICS INC

AI summary

A device for determining presence or absence of infection due to an infectious agent is described. The device comprises a sample receiving zone configured to receive a liquid sample from a subject suspected of having an infection due to an infectious agent, the sample receiving zone positioned to distribute the sample along a first fluid flow path to a first label zone and along a second fluid flow path to a second label zone. Test lines in each fluid flow path capture a mobile detectable species as an indicator of presence or absence of the infectious agent. The device also comprises a reference line positioned in the one of the fluid flow paths. The bidirectional fluid flow paths emanate from a common sample zone and provide an efficient approach to detection and differentiate two species as indicators of the same infectious agent or as indicators of two different infectious agents.