Multiplexed Biomarker Detection via Capillary Flow LFA

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Solution Overview

Problem

Current multiplexed assays for detecting biomarkers, such as those for breast cancer, face challenges in simplicity, rapidity, and sensitivity due to the need for elaborate imaging devices and complex microfabrication processes, limiting their application in point-of-care settings.

Innovation Solution

A channel flow-based detection device with a solid support having distinct capture molecule groups for multiple biomarkers, a cover plate, and an absorbent material, allowing for simple and rapid detection through capillary action, and utilizing an optical reader for quantification.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If multiplexed LFAs are used for sensitive detection, then measurement precision is improved, but device complexity increases due to elaborate imaging devices required

Engineering Contradiction:

Improvedetection sensitivityVSAvoidimaging device complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces complex optical imaging systems with a simpler colorimetric detection system. The LFA device uses visual color changes at test lines to indicate biomarker presence, eliminating the need for elaborate imaging devices while maintaining detection capability through human visual inspection or simple photodetection

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The invention utilizes colorimetric detection where different colors indicate presence of specific biomarkers. The LFA strips incorporate color-coded test lines or colorimetric labels that change color based on biomarker binding, allowing sensitive detection through visual color assessment rather than complex imaging

Inventive Principle:

Principle #32Color changes

2Measurement precision

If microfabricated flow channels are used for multiplexed assays, then measurement precision is improved, but ease of operation deteriorates due to sequential detection requirements

Engineering Contradiction:

Improvemultiplexed sensitivityVSAvoiddetection process simplicity

Core Design Contradiction:

Measurement precisionVSEase of operation

Solution Approach 1:

The patent divides the detection function into separate, independent LFA strips for each biomarker or biomarker group. Each strip is a self-contained unit with its own capture zones and test lines, allowing simultaneous independent detection without sequential processing requirements

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The LFA platform provides a universal detection method that can detect multiple biomarkers simultaneously using the same operational procedure. A single drop of sample can be applied to multiple strips at once, and all biomarkers are detected through the same colorimetric readout mechanism

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Measurement precision

If microfabricated flow channels with peristaltic pumps are used, then measurement precision is improved, but device complexity increases due to multiple incubation and wash steps

Engineering Contradiction:

Improvemultiplexed sensitivityVSAvoidassay process complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The LFA device performs incubation and washing automatically through capillary action and gravity-driven flow. The sample naturally flows through the test strip, incubating with capture molecules, and excess sample is automatically washed away, eliminating the need for external pumps and multiple manual steps

Inventive Principle:

Principle #25Self-service

4Manufacturing precision

If PDMS microfabrication facilities are used, then manufacturing precision is improved, but ease of manufacture deteriorates due to elaborate fabrication requirements

Engineering Contradiction:

Improveflow channel precisionVSAvoidfabrication simplicity

Core Design Contradiction:

Manufacturing precisionVSEase of manufacture

Solution Approach 1:

The patent uses disposable LFA strips with pre-formed flow paths on nitrocellulose membranes or similar substrates. These strips can be manufactured using simpler, lower-cost techniques compared to PDMS microfabrication, and are discarded after single use, eliminating the need for complex cleanroom facilities

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 simultaneous and sensitive detection of multiple biomarkers in a compact, automated format, facilitating rapid diagnostic assays and improved patient outcomes by simplifying the detection process and reducing the need for complex equipment.

Implementation Method 1

allowing for simple and rapid detection through capillary action

Methodology Applied

Scientific EffectCapillary action: Capillary Action

Data Source

PatentUS9366668B2Device, array, and methods for disease detection and analysis

Publication Date: 2016.06.14 LAWRENCE LIVERMORE NAT SECURITY LLC

AI summary

A device and array coupled to capture molecules are provided. Specifically, the device and array can be used for detecting the presence and concentration of biomarkers in a sample from a subject. The device and array can also allow the use of a method for scoring a sample for, e.g., the purpose of diagnosing a disease. The method can also be advantageous to applications where there is a need to accurately determine the disease stage of a subject for the purpose of making therapeutic decisions.