Immunochromatographic Test Strip with Line-Shaped Conjugate Section

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Solution Overview

Problem

Conventional immunochromatographic test strips face challenges with slow reaction completion times, high background interference, and non-uniform conjugate impregnation, making them difficult to automate and resulting in inconsistent performance.

Innovation Solution

The test strip design features a line-shaped conjugate section on the conjugate pad that is in contact with the insoluble membrane support, allowing for improved conjugate release and reaction efficiency, along with a manufacturing method that eliminates the need for impregnation, enabling automated and consistent production.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the conjugate pad is uniformly impregnated with the conjugate and dried, then the conjugate is retained in the pad, but the manufacturing process becomes difficult to automate and results in non-uniform impregnation causing performance variation

Engineering Contradiction:
Improveperformance consistencyVSAvoidautomation difficulty
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The conjugate pad is divided into a sample-supplying section and a line-shaped conjugate section. The conjugate is applied only to the line-shaped conjugate section rather than impregnating the entire pad, enabling automated application and ensuring uniform conjugate distribution for consistent performance.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different sections of the conjugate pad have different functions: the sample-supplying section supplies sample without conjugate, while the line-shaped conjugate section contains the conjugate for reaction. This localized conjugate placement improves automation and performance consistency.

Inventive Principle:
Principle #3Local quality

2Productivity

If the conjugate is retained in the conjugate pad through conventional impregnation, then the conjugate is available for reaction, but the conjugate is not easily released resulting in slow reaction completion and high background

Engineering Contradiction:
Improvereaction completion speedVSAvoidbackground interference
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The conjugate is extracted from the bulk of the conjugate pad and concentrated in a line-shaped section that is in contact with the insoluble membrane support. This allows the conjugate to be easily released into the reaction area, speeding up reaction completion and reducing background interference from retained conjugate.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The conjugate is arranged in a line-shaped configuration rather than being distributed throughout the pad volume. This dimensional change from three-dimensional impregnation to two-dimensional line placement facilitates easier release and reduces background while maintaining reaction efficiency.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

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 configuration reduces reaction time, enhances sensitivity, and ensures consistent performance by optimizing conjugate release and application, resulting in improved detection capabilities and reduced background interference.

Implementation Method 1

the lower surface of the conjugate section of the conjugate pad is in contact with the upper surface of the insoluble membrane support

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

an antibody or an antigen to its antigen or antibody defined as an analyte is immobilized onto an insoluble membrane support that is a chromatograph medium to create a detecting section

Methodology Applied
Scientific EffectAntigen-antibody reaction:

Implementation Method 3

a sample pad for supplying a sample, a conjugate pad for disposing the conjugate that is the mobile phase, an insoluble membrane support developing a complex between the sample and the conjugate

Methodology Applied
Scientific EffectWick action: Capillary Action

Data Source

PatentUS9435806B2Immunochromatographic test strip and manufacturing method thereof
Publication Date: 2016.09.06 SEKISUI MEDICAL CO LTD
  • US9435806B2 patent drawing
  • US9435806B2 patent drawing
  • US9435806B2 patent drawing

AI summary

An immunochromatographic test strip that achieves a shorter reaction completion time and excellent sensitivity is provided. The immunochromatographic test strip comprises: (1) a conjugate pad comprising a sample-supplying section supplying a sample possibly containing an analyte and a line-shaped conjugate section containing a conjugate in which an antibody or antigen immunologically reactive with the analyte is immobilized to a label on the downstream side relative to the sample-supplying section; and (2) an insoluble membrane support having at least one detecting section to which an antibody or antigen immunologically reactive with the analyte is immobilized, the lower surface of the sample-supplying section of the conjugate pad being not in contact with the upper surface of the insoluble membrane support, the lower surface of the conjugate section of the conjugate pad being in contact with the upper surface of the insoluble membrane support.