Lateral Flow Assay Preconcentration Kit for Low Concentration Biomarker Detection

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Solution Overview

Problem

Current lateral flow assays struggle to detect biomarkers at low concentrations due to limitations in sample preconcentration and sensitivity, especially when analyzing small sample amounts.

Innovation Solution

A preconcentration kit is integrated into the lateral flow assay strip, utilizing a selective ion permeable membrane and electrodes to apply an electric field, facilitating ion concentration polarization and enhancing the concentration of analytes, which are then transferred to a conjugate pad for detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a conventional lateral flow assay is used to detect biomarkers, then the assay can be performed with simple equipment and操作流程, but it cannot detect biomarkers at low concentrations due to insufficient sensitivity

Engineering Contradiction:
Improvedetection sensitivityVSAvoidassay system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The lateral flow assay strip is divided into distinct functional modules: a sample pad with preconcentration kit, a conjugate pad, a test pad, and a control pad. The preconcentration kit itself is segmented into a membrane electrode assembly and a counter electrode assembly, allowing independent optimization of each component's function while maintaining overall system sensitivity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The preconcentration of analytes is performed before the actual detection step by applying an electric field to the sample pad, which concentrates the target biomarkers onto the membrane electrode assembly. This preliminary concentration step enhances the sensitivity of subsequent detection without requiring complex post-sample processing equipment.

Inventive Principle:
Principle #10Preliminary action

2Measurement precision

If samples with low analyte concentration are analyzed using conventional lateral flow assay, then the sample volume can be kept small, but the detection accuracy deteriorates due to insufficient analyte concentration

Engineering Contradiction:
Improvedetection accuracyVSAvoidanalyte concentration
Core Design Contradiction:
Measurement precisionVSQuantity of substance

Solution Approach 1:

The preconcentration step is performed in advance by applying an electric field to concentrate analytes from the sample onto the membrane electrode assembly before the lateral flow detection begins. This preliminary concentration ensures sufficient analyte quantity for accurate detection even when the original sample concentration is low.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The conventional passive diffusion-based sample application is replaced with an active electric field-driven preconcentration mechanism. The electric field applies electrostatic forces to charged analytes, concentrating them efficiently onto the detection zone, thereby improving detection accuracy for low-concentration samples.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Ease of operation

If the conjugate pad is pre-connected to the sample pad in the lateral flow assay strip, then the assay操作流程 is simplified, but the preconcentration efficiency deteriorates due to premature analyte transfer

Engineering Contradiction:
Improveassay操作流程 simplicityVSAvoidpreconcentration efficiency
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The connection state between the sample pad and conjugate pad is made dynamic rather than fixed. The strips can be supplied in a pre-assembled state for ease of storage and handling, but the connection is designed to be temporarily separable, allowing the user to disconnect them after sample application and preconcentration, then reconnect for detection. This dynamic configuration balances operational simplicity with preconcentration efficiency.

Inventive Principle:
Principle #15Dynamics

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 method allows for the effective detection of biomarkers at low concentrations by preconcentrating analytes, improving sensitivity and enabling the detection of previously undetectable biomarkers, such as proteins and hormones, through enhanced ion concentration polarization.

Implementation Method 1

preconcentrating the analytes by attaching a preconcentration kit to the sample pad... The preconcentration of the analytes may be carried out by applying an electric field to the preconcentration kit

Methodology Applied
Scientific EffectIon concentration polarization: Electrophoresis

Implementation Method 2

a preconcentration kit integrated into the lateral flow assay strip, utilizing a selective ion permeable membrane and electrodes to apply an electric field

Methodology Applied
Scientific EffectIon permeation through selective membrane: Permeation

Implementation Method 3

The lateral flow assay method is being used in a variety of areas including pregnancy testing... HCG in urine is bound to the HCG antibody in the pregnancy test kit to produce a HCG complex which migrates along the kit

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Data Source

PatentUS12123872B2Concentration kit for lateral flow assay strip
Publication Date: 2024.10.22 CALTH INC
  • US12123872B2 patent drawing
  • US12123872B2 patent drawing
  • US12123872B2 patent drawing

AI summary

Embodiments of the present invention provide a lateral flow assay method and strip wherein a sample is injected into a sample pad, a preconcentration kit is coupled to the sample pad to preconcentrate analytes, and a conjugate pad or a test pad is connected to the sample pad to transfer the analytes to the conjugate pad or the test pad, whereby a biomarker present at a low concentration can be detected.