Enzyme Diagnostic Cassette Quantitative Analysis

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Solution Overview

Problem

Current lateral flow chromatographic immunoassay tests are limited to providing only qualitative results, making it difficult to diagnose conditions at the point of care without access to medical facilities or laboratories, and there is a need for devices and methods that can provide quantitative results while maintaining ease of use.

Innovation Solution

The development of an enzyme-based assay system that includes a lateral-flow chromatographic assay cassette and a testing device with data collection and analysis capabilities, utilizing an interpretive algorithm to convert detectable signals into numerical values for quantifying enzyme activity or substrate concentration, and featuring calibration standards for accurate measurement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If lateral flow chromatographic immunoassay tests are used, then ease of use and rapid results are achieved, but only qualitative results can be provided

Engineering Contradiction:

Improveease of useVSAvoidquantitative capability

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The patent merges the simplicity of lateral flow chromatographic immunoassay with quantitative measurement capabilities by integrating a digital imaging system and interpretive algorithm into the test cassette system, allowing both ease of use and quantitative results to be achieved simultaneously

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The patent introduces an intermediary system consisting of a reader device with digital imaging capabilities and an interpretive algorithm that converts visual test results into quantitative numerical values, bridging the gap between simple qualitative assessment and precise quantitative measurement

Inventive Principle:

Principle #24Intermediary (Mediator)

2Measurement precision

If centralized clinical testing equipment is used, then quantitative results can be obtained, but cost and complexity increase

Engineering Contradiction:

Improvequantitative capabilityVSAvoidequipment complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent employs a disposable lateral flow chromatographic immunoassay test cassette that is simple in design but enhanced with quantitative capabilities through integrated barcodes and fluorescent markers, eliminating the need for expensive reusable centralized testing equipment

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent uses a reader device that captures digital images of the test cassette and uses interpretive algorithms to calculate quantitative results from the visual data, effectively copying the function of expensive laboratory equipment into a portable, affordable device

Inventive Principle:

Principle #26Copying

3Productivity

If lateral flow chromatographic immunoassay tests are used, then rapid testing is achieved, but accurate quantification is limited

Engineering Contradiction:

Improvetesting speedVSAvoidquantification accuracy

Core Design Contradiction:

ProductivityVSMeasurement precision

Solution Approach 1:

The patent incorporates barcodes and fluorescent markers into the test cassette during manufacturing, preparing quantitative measurement capabilities in advance so that when the test is performed, both rapid qualitative and accurate quantitative results can be obtained simultaneously without additional steps

Inventive Principle:

Principle #10Preliminary action

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 affordable laboratory-quality quantitative testing at the point of care, eliminating the need for expensive centralized clinical testing equipment and technical personnel, while providing automated data reporting and decision support.

Implementation Method 1

a lateral-flow chromatographic immunoassay test cassette

Methodology Applied

Scientific EffectCapillary action: Capillary Action

Implementation Method 2

a testing device with data collection and data analysis capabilities that is configured to interface with the lateral-flow chromatographic assay cassette

Methodology Applied

Scientific EffectOptical detection: Absorption Spectroscopy

Implementation Method 3

enzymatic degradation of a substrate can be used either to determine the activity or concentration of an enzyme in a sample

Methodology Applied

Scientific EffectEnzymatic degradation: Enzyme

Implementation Method 4

utilizing an interpretive algorithm to convert detectable signals into numerical values for quantifying enzyme activity

Methodology Applied

Scientific EffectCatalysis: Catalysis

Data Source

PatentUS20230095831A1Device for performing an enzyme-based diagnostic test and methods for use thereof

Publication Date: 2023.03.30 I CALQ LLC

AI summary

Enzyme-based diagnostic testing systems for detecting and quantifying at least one of the activity level or the concentration of an enzyme or a biochemical analyte in a biological sample. Such enzyme-based diagnostic testing systems can provide rapid, accurate, affordable laboratory-quality testing at the point of care. An enzyme-based diagnostic testing system may include a lateral-flow chromatographic assay cassette that is configured for assaying an amount or activity of an enzyme in a sample or for enzymatically determining the concentration of an enzyme substrate in a sample. Additionally, the enzyme-based diagnostic testing systems may include testing devices (e.g., a smartphone or a similar remote computing device) having data collection and data analysis capabilities. Such testing devices may also include automated data reporting and decision support.