Lateral Flow Test Strip Mucolytic Agent Integration

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Solution Overview

Problem

Current lateral flow immunoassays require a separate lysis or mucolysis step to access antigens masked in complexes or behind cell membranes, which complicates and delays the testing process, especially in point-of-care settings where timeliness and simplicity are crucial.

Innovation Solution

Incorporating lysis or mucolytic agents directly into the point-of-care testing device, such as a chromatography test strip, to perform lysis or mucolysis in situ, eliminating the need for a separate preparation step by breaking down cells or mucus within the device itself.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a separate lysis or mucolysis step is performed before lateral flow immunoassay, then antigens masked in complexes or behind cell membranes become accessible, but the testing process becomes complicated and delayed

Engineering Contradiction:
Improveantigen accessibilityVSAvoidtesting process complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines the lysis/mucolysis function with the lateral flow immunoassay device by incorporating lysis agents directly into the test strip matrix. This merging eliminates the need for separate preparation steps, allowing antigen release and detection to occur in a single integrated process, thereby reducing complexity while maintaining antigen accessibility

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The lysis agents are pre-incorporated into the test strip matrix before use. When the sample is applied, the lysis agents are already in position to immediately act on the sample, releasing antigens in advance of the detection process. This preliminary action eliminates the need for separate lysis steps and accelerates the overall testing process

Inventive Principle:
Principle #10Preliminary action

2Measurement precision

If a separate lysis or mucolysis step is performed before lateral flow immunoassay, then antigens masked in complexes or behind cell membranes become accessible, but the testing time is increased

Engineering Contradiction:
Improveantigen accessibilityVSAvoidtesting time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent merges the lysis/mucolysis step with the lateral flow immunoassay into a single integrated process. The lysis agents are incorporated into the test strip matrix, allowing antigen release and detection to occur simultaneously in one continuous process, thereby eliminating the time required for separate preparation steps

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The lysis agents are pre-positioned within the test strip matrix to immediately act on the sample upon application. This preliminary positioning ensures that antigen release begins instantly without waiting for separate lysis procedures, significantly reducing the overall testing time while maintaining complete antigen accessibility

Inventive Principle:
Principle #10Preliminary action

3Ease of operation

If lysis or mucolytic agents are incorporated into the test strip, then antigens are accessible without additional handling, but the device structure becomes more complex

Engineering Contradiction:
Improvesample preparation simplicityVSAvoidtest strip structure
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent utilizes the porous matrix structure of the lateral flow test strip to incorporate and hold lysis agents. The porous nature of the matrix allows easy integration of the agents while maintaining the strip's existing structure and function. This approach adds minimal structural complexity while enabling the lysis function to be performed within the existing device framework

Inventive Principle:
Principle #31Porous materials

Solution Approach 2:

The lateral flow test strip is designed to perform multiple functions: it serves as both the detection platform and the lysis/mucolysis medium. By incorporating lysis agents into the matrix, the same structure that guides sample flow and enables detection also performs antigen release, eliminating the need for separate handling steps and reducing operational complexity

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 approach enhances efficiency, stability, and rapidity of testing by ensuring antigens are accessible without additional handling, reducing interference and allowing for more accurate and timely detection of analytes.

Implementation Method 1

mucolytic agents including n-acetyl cysteine (NAC)... breaking down cells or mucus within the device itself

Methodology Applied
Scientific EffectMucolysis:

Data Source

PatentUS20210302419A1Methods and devices for using mucolytic agents including n-acetyl cysteine (NAC)
Publication Date: 2021.09.30 RAPID PATHOGEN SCREENING INC
  • US20210302419A1 patent drawing
  • US20210302419A1 patent drawing
  • US20210302419A1 patent drawing

AI summary

Devices and methods incorporate mucolytic agents into a point-of-care testing device. The sample is loaded, and then the sample travels until it encounters one or more lysis agents and/or mucolytic agents. The mucolytic agent is preferably pre-loaded onto the collection device. In a preferred embodiment, the mucolytic agent is localized between the sample application zone and the conjugate zone. In embodiments with a sample compressor, one or more mucolytic agents may be pre-loaded and dried on the sample compressor, the sample collector, in various locations on the test strip, or in the running buffer.