In-line Analyte Detection System with Rapid Lateral Flow Assay

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Solution Overview

Problem

Traditional analyte detection systems in clinical chemistry and food sanitation diagnostics are limited by slow testing speeds, high costs, lack of ruggedness, and ease of use, particularly in non-laboratory settings, and are susceptible to fraudulent use of pre-run assays.

Innovation Solution

A lateral flow assay system with an integrated reader and incubator that includes a hood for rapid assay testing, an inclined cavity for optimal sample flow, an auto-sampler for closed-loop recirculation, and an optical detector for quick and accurate detection of analytes, generating results within 15 seconds to 1 minute, and a method for in-line testing and product delivery that blocks downstream delivery upon positive test results.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If traditional reagent strips and films are used for analyte detection, then the testing can be performed in controlled laboratory environments, but the testing speed is slow and the equipment cost is high

Engineering Contradiction:
Improvetesting speedVSAvoidequipment complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The system divides the testing function into two separate components: a simple, portable reagent strip for analyte detection and a separate optical reader for result measurement. This segmentation allows the reagent strip to remain simple and inexpensive while the reader handles the complex optical measurement, thereby increasing testing speed without requiring complex equipment at the point of care.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces an optical reader as an intermediary device between the reagent strip and the user. The optical reader serves as a mediator that measures the optical properties (absorbance, reflectance, or fluorescence) of the reagent strip, enabling rapid and accurate analyte detection without requiring the user to perform complex measurements themselves.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If traditional testing systems are used, then the test results can be obtained, but the systems lack ruggedness and ease of use in non-laboratory settings

Engineering Contradiction:
Improveease of useVSAvoidruggedness
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The reagent strip is designed as a disposable, single-use component that is inexpensive and easy to handle. This disposable nature eliminates the need for complex cleaning, maintenance, or calibration procedures, making the system ideal for point-of-care testing in non-laboratory settings where ruggedness and ease of operation are critical.

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

Solution Approach 2:

The reagent strip performs the analyte detection function autonomously through its built-in reagents and optical properties. The strip automatically reacts with the analyte in the sample and produces a measurable signal, eliminating the need for complex sample preparation or manual measurement procedures, thereby enhancing ease of operation.

Inventive Principle:
Principle #25Self-service

3Productivity

If pre-run assays are allowed to be used, then testing can be performed, but fraudulent use of pre-run assays compromises test validity

Engineering Contradiction:
Improvetesting efficiencyVSAvoidtest result validity
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The system performs preliminary optical measurements of the reagent strip before the actual analyte testing begins. By measuring the optical properties of the strip in advance, the system can detect if the strip has been pre-run or compromised, and prevent invalid test results from being reported, thereby maintaining test validity while allowing efficient testing.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The optical reader provides feedback about the state of the reagent strip by measuring its optical properties. This feedback mechanism allows the system to detect fraudulent pre-run assays and reject them, ensuring that only valid test results are reported while maintaining high testing efficiency.

Inventive Principle:
Principle #23Feedback

4Productivity

If rapid testing is implemented, then testing speed increases, but the detection accuracy and reliability may be compromised

Engineering Contradiction:
Improvetesting speedVSAvoiddetection accuracy
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The reagent strip is designed with specific optical parameters (absorbance, reflectance, or fluorescence characteristics) that enable rapid detection while maintaining accuracy. By optimizing these optical parameters, the system achieves fast testing speeds without compromising detection accuracy, as the optical reader can quickly and reliably measure the analyte concentration based on the strip's optical response.

Inventive Principle:
Principle #35Parameter changes

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 system provides rapid, efficient, and reliable analyte detection, enhancing the ruggedness and ease of use, while preventing fraudulent use of pre-run assays, and ensuring valid test results in various settings.

Implementation Method 1

The presence and, in some cases, the concentration, of an analyte on a reagent strip may be determined by measuring the optical reflectance from an area of development on the strip

Methodology Applied
Scientific EffectOptical reflectance measurement: Reflection

Implementation Method 2

The sample is carried to the opposite end of the membrane strip by a mobile phase that traverses the membrane strip, for example by capillary action

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Data Source

PatentEP3759469B1In-line testing development diagnostic analysis
Publication Date: 2023.09.06 CHARM SCIENCES INC
  • EP3759469B1 patent drawingFigure 1
  • EP3759469B1 patent drawingFigure 2
  • EP3759469B1 patent drawingFigure 3

AI summary

In-line testing and product delivery assemblies, methods, operations, and systems are shown and described. In one embodiment, an in-line testing and product delivery system includes a supply of product having at least one outlet with a valve closure and a downstream delivery line, a recirculation closed loop in fluid communication with the outlet and supply, and a reader to generate a rapid test result from a single use assay for detection of a presence or an absence of an analyte in the supply. The result provides monitoring of a detection of the analyte to block release of product supply into the delivery line.