Lateral Flow Assay Device Dry Reagent Extraction

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Solution Overview

Problem

Current automated laboratory instruments for immunoassays are complex, unreliable, and costly due to the need for precise control of wet reagents and multiple mechanisms, limiting their ability to perform multiplex testing and increasing production costs.

Innovation Solution

The implementation of lateral flow assay devices that incorporate dry reagents and allow for multiplexing on a single device, reducing the need for separate wet reagents and complex mechanisms, enabling room temperature storage and simplified instrument design.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If automated laboratory instruments use wet reagents with strict storage conditions and multiple processing mechanisms, then measurement precision and reliability are maintained, but device complexity and production costs increase significantly

Engineering Contradiction:
Improveassay processing reliabilityVSAvoidinstrument complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent extracts the reagent storage and delivery functions from the automated instrument by using dry reagent strips that are self-contained. The dry reagent strips eliminate the need for complex wet reagent storage systems with temperature control, humidification, and precise delivery mechanisms, while maintaining assay reliability through the stable dry format.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent employs disposable dry reagent strips that are pre-prepared and stable at room temperature. These single-use strips eliminate the need for expensive, complex, and reliable wet reagent systems, allowing the instrument to be simpler while maintaining processing reliability through consistent, pre-calibrated dry reagent performance.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Measurement precision

If multiple mechanisms are used for precise incubation, washing, and metering in automated immunoassay systems, then measurement precision is improved, but device complexity and costs increase

Engineering Contradiction:
Improveanalyte detection precisionVSAvoidmechanism complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts the incubation, washing, and metering functions from the automated instrument by incorporating them into the dry reagent strip design itself. The strip's physical structure and reagent formulation provide built-in timing and fluid handling characteristics, eliminating the need for separate incubation chambers, washing mechanisms, and precise metering pumps.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The dry reagent strips are designed to perform their own incubation, washing, and fluid handling functions without external mechanical assistance. The strips self-regulate the assay process through their physical design and reagent properties, allowing the automated instrument to be much simpler while maintaining measurement precision.

Inventive Principle:
Principle #25Self-service

3Quantity of substance

If large liquid volumes of expensive reagents are used in standard immunoassays, then adequate reagent availability is ensured, but production costs increase significantly

Engineering Contradiction:
Improvereagent volumeVSAvoidproduction cost
Core Design Contradiction:
Quantity of substanceVSEase of manufacture

Solution Approach 1:

The patent uses thin film dry reagent strips instead of bulk liquid reagents. This format dramatically reduces the quantity of expensive reagent materials needed while ensuring adequate coverage for the assay. The thin film format allows the same functional reagent capacity with minimal material usage, significantly reducing production costs.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The patent changes the physical state of the reagents from liquid to dry form. This parameter change allows the reagents to be stored and delivered in a highly concentrated, space-efficient format, reducing the overall volume and mass of reagent materials needed while maintaining adequate reagent availability for accurate testing.

Inventive Principle:
Principle #35Parameter changes

4Measurement precision

If frequent calibration and tight control of reagent storage conditions are required, then measurement precision is maintained, but ease of operation decreases

Engineering Contradiction:
Improveassay accuracyVSAvoidoperational simplicity
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent uses disposable dry reagent strips that are stable at room temperature and do not require complex storage conditions. Each strip is pre-calibrated and designed for single use, eliminating the need for frequent instrument calibration and tight storage control, while maintaining measurement precision through consistent manufacturing of the dry strips.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The dry reagent strips contain built-in references and controls that self-validate the assay conditions. The strips themselves provide the calibration standards and quality controls needed, eliminating the need for separate frequent calibration procedures and complex storage monitoring systems, thereby improving ease of operation while maintaining precision.

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

This approach significantly reduces instrument complexity and costs by up to 50%, enhances throughput by up to 10 times, and allows for faster reaction times, making it suitable for both clinical and point-of-care applications while maintaining quality and calibration reliability.

Implementation Method 1

The sample is affected by a porous spreading layer relative to a reagent layer of the slide element

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Data Source

PatentEP3594690B1System for processing lateral flow assay devices
Publication Date: 2021.04.07 ORTHO CLINICAL DIAGNOSTICS INC
  • EP3594690B1 patent drawingFigure 1
  • EP3594690B1 patent drawingFigure 2
  • EP3594690B1 patent drawingFigure 3

AI summary

A lateral flow device for use in a mainframe or point-of-care clinical analyzer, in which the lateral flow device includes a planar support having at least one sample addition area and at least one reaction area disposed thereon. The sample addition area and reaction area are fluidly interconnected to one another and form at least one lateral fluid flow path. The lateral flow device is sized for retention within a storage cartridge of the analyzer defined by a hollow interior and having a plurality of lateral flow assay devices retained in stacked relation therein.