Arch-Bridge Test Strip Structure for Small-Volume Chromatography

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Solution Overview

Problem

Existing point-of-care testing technologies struggle with low sensitivity and precision when dealing with small sample volumes, particularly in clinical scenarios where samples like tear fluid are limited, leading to potential misdiagnosis and increased operational complexity.

Innovation Solution

A test stick design featuring a specialized shell structure that controls the flow direction and speed of chromatography on a test strip, utilizing a three- or four-layer test strip configuration with specific clamp slot structures and bulges to support the strip, forming an 'arch-bridge' structure, which enhances the accuracy and precision of testing small sample volumes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If additional processing steps such as dilution are applied to small sample volumes, then the sample can be processed through existing testing systems, but the testing sensitivity, precision and accuracy are reduced

Engineering Contradiction:
Improvecompatibility with existing testing systemsVSAvoidtesting sensitivity and accuracy
Core Design Contradiction:
Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The test stick is divided into functionally independent modules: sample loading hole, testing liquid hole, reaction window, and test strip with distinct zones. This segmentation allows each module to be optimized for its specific function while maintaining overall system compatibility, enabling direct testing of small samples without dilution

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention transitions from conventional horizontal test strip layout to a vertical three-dimensional configuration where the test strip is fixed upright between top and bottom covers. This dimensional change enables gravity-assisted liquid flow and improves sample utilization efficiency, allowing direct testing of small volume samples without compromising sensitivity

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

2Adaptability or versatility

If additional processing steps are introduced for small samples, then testing can proceed, but the complexity of testing operation increases

Engineering Contradiction:
Improveability to process small samplesVSAvoidcomplexity of testing operation
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

Multiple functions are merged into integrated components: the test strip combines sample application area, reaction zone, and detection area in one continuous structure. The top and bottom covers integrate sample loading, liquid addition, and result observation functions. This merging eliminates intermediate processing steps and simplifies operation

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The test stick is designed as a self-contained system where the test strip automatically draws liquid through capillary action from the sample loading hole through the reaction zone to the detection area. The built-in clamp slot structure and bulge stage automatically control liquid flow and maintain test strip positioning without external intervention, enabling simple one-step testing

Inventive Principle:
Principle #25Self-service

3Ease of manufacture

If the test strip is freely positioned in the clamp slot, then assembly is simple, but the flow direction of testing liquid and chromatography speed cannot be controlled

Engineering Contradiction:
Improvesimplicity of assemblyVSAvoidcontrol over liquid flow and chromatography
Core Design Contradiction:
Ease of manufactureVSMeasurement precision

Solution Approach 1:

The clamp slot structure incorporates localized features with specific functions: the support bulge provides mechanical support at a specific position, the clamp slot walls guide liquid flow direction, and the bulge stage creates controlled flow resistance. These localized structural qualities enable precise control of liquid chromatography while maintaining simple overall assembly

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The support bulge acts as an intermediary element between the clamp slot structure and the test strip. It provides controlled support points that guide the test strip into proper positioning while allowing automatic alignment during assembly. This intermediary structure mediates between simple assembly requirements and precise flow control needs

Inventive Principle:
Principle #24Intermediary (Mediator)

4Ease of manufacture

If conventional test stick design is used, then manufacturing is straightforward, but sensitivity reaches only 0.05 ng/mL which is insufficient for small samples

Engineering Contradiction:
Improvemanufacturing simplicityVSAvoidtesting sensitivity
Core Design Contradiction:
Ease of manufactureVSMeasurement precision

Solution Approach 1:

The invention changes critical parameters: sensitivity is improved to 0.15 ng/mL through optimized test strip composition and structure. The vertical configuration increases sample-conjugate interaction time and efficiency. These parameter changes enhance sensitivity while maintaining manufacturing feasibility through standardized production processes

Inventive Principle:
Principle #35Parameter changes

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

The design allows for precise testing of small sample volumes, improving sensitivity and reducing errors, enabling accurate diagnosis within 10-15 minutes with sensitivity enhanced to 0.15 ng/mL and precision of 5-10% CV.

Implementation Method 1

the testing liquid under chromatography passes through the position of the sample loading hole to dissolve the antibody nanospheres on the conjugate pad

Methodology Applied
Scientific EffectChromatography: Chromatography

Implementation Method 2

the testing liquid under chromatography passes through the position of the sample loading hole to dissolve the antibody nanospheres on the conjugate pad

Methodology Applied
Scientific EffectDiffusion: Diffusion

Data Source

PatentUS12467919B2Test stick, testing method and application
Publication Date: 2025.11.11 SEINDA BIOMEDICAL CORP
  • US12467919B2 patent drawing
  • US12467919B2 patent drawing
  • US12467919B2 patent drawing

AI summary

A test stick, a testing method and application. A top cover and a bottom cover are engaged by means of positioning holes (D01) and positioning posts (G01) so as to fix a test strip; clamp slot structures (D02, D06) and a bulge stage (D04) are provided inside the bottom cover; each of the clamp slot structures (D02, D06) is internally provided with a support bulge (D03), with the height of the support bulge (D03) being less than or equal to the height of the bulge stage (D04); the top cover is provided with fixing plates (G02, G03, G04, G06), a reaction window (G05), a sample loading hole (A) and a testing liquid hole (B); and after the top cover and the bottom cover are engaged by means of the positioning holes (D01) and the positioning posts (G01), under the pressing of the fixing plates (G02, G03, G04, G06) and the testing liquid hole (B) of the top cover, the middle of the test strip bulges upward to form an “arch-bridge” structure with a horizontal plane. With such an “arch-bridge” structure, the flow direction of a testing liquid on the test strip and the speed of chromatography are controlled so as to improve the accuracy and precision of the testing result of the test stick to achieve the purpose of accurately testing a small amount of sample.