Lateral Flow Device Buffer Dissolving Low Analyte Samples

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Solution Overview

Problem

Existing lateral flow devices for detecting drugs or drug metabolites in bodily fluids lack sensitivity, requiring large sample amounts and concentrations, making them unreliable for qualitative and quantitative analysis of low analyte levels.

Innovation Solution

A lateral flow device and method that includes a sample receiving portion, a probe zone with a labelled probe, and a test site with a immobilised capture reagent, using a buffer to dissolve and concentrate analytes, allowing for detection of analytes from 0.1 pg to 1 μg by capillary action, with a buffer comprising a water miscible organic solvent, surfactant, and buffering agent to enhance solubilization and detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional lateral flow devices are used for detecting drugs or drug metabolites in bodily fluids, then the detection can be performed with simple operation, but the sensitivity is insufficient requiring large sample amounts and concentrations

Engineering Contradiction:
Improvedetection sensitivityVSAvoidsample amount required
Core Design Contradiction:
Measurement precisionVSQuantity of substance

Solution Approach 1:

The device is divided into distinct functional zones: a sample receiving portion, a probe zone with labelled probes, and a test site with immobilised capture reagents. This segmentation allows each zone to perform its specific function optimally, with the probe zone concentrating labelled probes that bind to analytes, and the test site providing a concentrated readout, thereby increasing detection sensitivity while reducing required sample volume

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different regions of the device have different reagent concentrations and functions. The probe zone contains labelled probes at optimized concentrations for binding analytes, while the test site contains immobilised capture reagents positioned to concentrate the labelled analyte-probe complexes. This local optimization of reagent distribution enhances detection sensitivity without requiring proportionally larger sample volumes

Inventive Principle:
Principle #3Local quality

2Reliability

If conventional lateral flow devices are used, then the device structure remains simple, but the reliability for qualitative and quantitative analysis of low analyte levels is poor

Engineering Contradiction:
Improveanalysis reliabilityVSAvoiddevice structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The device is pre-configured with labelled probes in the probe zone and immobilised capture reagents in the test site before sample application. This preliminary arrangement ensures that when a small volume of sample is applied, the analytes are immediately available for binding by the pre-positioned labelled probes, and the complexes are captured at the pre-prepared test site, enabling reliable qualitative and quantitative analysis of low analyte levels without requiring complex sample preparation or device assembly during testing

Inventive Principle:
Principle #10Preliminary action

3Measurement precision

If conventional lateral flow devices are used, then the operation procedure is straightforward, but complex confirmation procedures are needed for accurate analysis

Engineering Contradiction:
Improveanalysis accuracyVSAvoidconfirmation procedures
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The device combines multiple functions into a single integrated platform: the labelled probes provide specific analyte binding, the capillary action provides automated sample and reagent transport, and the immobilised capture reagents at the test site provide concentrated signal amplification. This merging of functions allows accurate qualitative and quantitative analysis to be achieved in a single operation without requiring separate confirmation procedures, maintaining straightforward operation while improving analysis accuracy

Inventive Principle:
Principle #5Merging (Combining)

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 reliable detection and quantification of low analyte levels, improving sensitivity and reducing the need for complex confirmation procedures, allowing for accurate analysis of small sample volumes and concentrations.

Implementation Method 1

by capillary action, the sample will migrate along the strip

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

contacting at least a portion of the dissolved sample solution with a probe zone comprising a labelled probe to dissolve at least a portion of the labelled probe and allow the labelled probe to bind with the analyte

Methodology Applied
Scientific EffectBinding:

Implementation Method 3

passing the labelled probe and/or labelled probe complex through a test site comprising a first immobilised capture reagent capable of binding to the labelled probe

Methodology Applied
Scientific EffectBinding:

Implementation Method 4

dissolving at least a portion of the sample in a buffer to form a dissolved sample solution

Methodology Applied
Scientific EffectDissolution: Solvation

Data Source

PatentUS12259385B2Sample analysing device
Publication Date: 2025.03.25 INTELLIGENT FINGERPRINTING
  • US12259385B2 patent drawing
  • US12259385B2 patent drawing
  • US12259385B2 patent drawing

AI summary

The present invention relates to a device and a method for analysing a sample comprising from 0.1 pg to 1 μg of analyte, and more specifically to a lateral flow device and a method for testing the presence of very low amounts of drugs or drug metabolites in a sample. The present invention also relates to a method of dissolving a bodily fluid.