Lateral Flow Cassette Quantification via Optical Calibration

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Solution Overview

Problem

Current lateral flow chromatographic immunoassay tests are limited to providing qualitative results, lacking the capability for quantitative analysis, which restricts their use in diagnosing and managing conditions at the point of care without centralized clinical testing facilities.

Innovation Solution

Development of a diagnostic test system that includes a lateral-flow chromatographic assay cassette and a compact, portable testing device with data collection and analysis capabilities, utilizing a capture ligand, reporter molecules, and calibration standards to generate a calibration curve for quantifying analytes in biological samples, and interfacing with handheld devices for data analysis and reporting.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If lateral flow chromatographic immunoassay cassettes are used for point-of-care testing, then ease of use and rapid results are improved, but the capability for quantitative analysis deteriorates (limited to qualitative results only)

Engineering Contradiction:
Improveease of useVSAvoidquantitative analysis capability
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent combines the simplicity of lateral flow chromatographic immunoassay cassettes with quantitative analysis capabilities by integrating optical detection systems and calibration curves directly into the point-of-care device, merging qualitative and quantitative functions in a single system

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent introduces optical detectors and calibration standards as intermediary elements between the lateral flow cassette and the final quantitative result, enabling the translation of qualitative visual signals into precise quantitative measurements

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If centralized clinical testing facilities are used, then quantitative analysis capability is improved, but device complexity and cost deteriorate (expensive equipment and technical personnel required)

Engineering Contradiction:
Improvequantitative analysis capabilityVSAvoidequipment complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts the quantitative analysis capability from complex centralized laboratory equipment and transfers it to a simplified point-of-care device by using portable optical detectors and pre-calibrated cassettes, eliminating the need for expensive centralized equipment

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent employs disposable lateral flow cassettes with integrated calibration standards and optical detection, replacing expensive reusable centralized equipment with affordable single-use units that provide equivalent quantitative analysis capability

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

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 testing at the point of care, providing quantitative results and eliminating the need for expensive centralized testing equipment and technical personnel, while supporting automated data reporting and decision-making.

Implementation Method 1

lateral-flow chromatographic immunoassay cassettes

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

lateral-flow chromatographic immunoassay cassettes

Methodology Applied
Scientific EffectChromatography: Chromatography

Implementation Method 3

detection and determination of an analyte substance that is a member of a specific binding pair consisting of a ligand and a receptor

Methodology Applied
Scientific EffectSpecific binding:

Implementation Method 4

Immunological assays involving reactions between antibodies and antigens

Methodology Applied
Scientific EffectImmunological reaction:

Data Source

PatentUS10613082B2Device for performing a diagnostic test and methods for use thereof
Publication Date: 2020.04.07 I CALQ LLC
  • US10613082B2 patent drawing
  • US10613082B2 patent drawing
  • US10613082B2 patent drawing

AI summary

Assay cassettes and testing devices that can be used to provide rapid, accurate, affordable, laboratory-quality testing at the point of care. Such assay cassettes and testing devices are designed to provide rapid, quantitative test results in a point-of-care setting or the like. Likewise, such assay cassettes and testing devices may eliminate or replace expensive, centralized clinical testing equipment and technical personnel. Such testing device may include automated data reporting and decision support. Methods for performing point of care diagnostic tests are also disclosed.