Digoxin Immunochromatographic Test Strip with Fluorescent Microspheres

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Solution Overview

Problem

Current methods for detecting digoxin, such as mass spectrometry, high-performance liquid chromatography, immunoturbidimetry, and chemiluminescence, are costly, require complex sample preparation, have long detection times, and are not suitable for high-throughput or timely monitoring in clinical settings, especially in small hospitals or for individual patient use.

Innovation Solution

An immunochromatographic test strip with a digoxin-specific antibody-fluorescent microsphere complex on a glass fiber mat and a nitrocellulose membrane, allowing for quick, high-throughput detection of digoxin in serum, plasma, or whole blood without the need for refrigeration, with a low detection cost and single-serving packaging.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If mass spectrometry or high-performance liquid chromatography is used for digoxin detection, then measurement precision is improved, but device complexity and cost increase, and productivity decreases due to long detection time and requirement for complex sample preparation

Engineering Contradiction:
Improvedigoxin detection accuracyVSAvoiddetection throughput
Core Design Contradiction:
Measurement precisionVSProductivity

Solution Approach 1:

The patent replaces complex mechanical instrumentation systems (mass spectrometry, high-performance liquid chromatography) with a simplified immunochromatographic test strip system that uses antibody-antigen recognition and capillary action for detection, eliminating the need for complex sample preparation and instrumentation while maintaining detection accuracy

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

Solution Approach 2:

The patent employs disposable test strips with pre-coated antibodies and fluorescent microspheres that can be used once and discarded, eliminating the need for expensive, complex instruments and refrigerated storage while enabling rapid, point-of-care detection

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Productivity

If immunoturbidimetry or chemiluminescence methods are used for digoxin detection, then productivity is improved through high-throughput capability, but device complexity and cost increase due to requirement for expensive instruments and refrigerated storage

Engineering Contradiction:
Improvedetection throughputVSAvoidinstrumentation and storage requirements
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent replaces expensive instrumentation systems (biochemical analyzers, chemiluminescence instruments) with a simple immunochromatographic test strip that uses capillary action and fluorescent microscopy for detection, eliminating the need for refrigerated storage and complex instruments while maintaining high-throughput capability

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

Solution Approach 2:

The patent creates a simplified copy of the immunoturbidimetry principle using fluorescent microspheres instead of turbidimetric detection, maintaining the high-throughput advantage while eliminating the need for expensive instruments and refrigerated storage

Inventive Principle:
Principle #26Copying

3Productivity

If enzyme multiplied immunization method is used for digoxin detection, then productivity is improved through simultaneous determination of multiple samples, but device complexity increases due to requirement for automatic biochemical analyzer and cold-chain transportation

Engineering Contradiction:
Improvesimultaneous sample determination capabilityVSAvoidautomated analyzer and cold-chain requirements
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent replaces automated biochemical analyzers with manual immunochromatographic test strips that use capillary action for sample migration and fluorescent microscopy for detection, eliminating the need for cold-chain transportation and automated instrumentation while maintaining the ability to process multiple samples

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

Solution Approach 2:

The patent uses disposable test strips instead of reusable automated analyzers, eliminating the need for cold-chain storage and complex instrumentation while enabling rapid, point-of-care detection of multiple samples through parallel testing

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

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 immunochromatographic test strip provides rapid, accurate, and stable digoxin detection with high sensitivity and repeatability, overcoming the limitations of existing methods by reducing costs, simplifying sample preparation, and enabling timely monitoring at room temperature with single-serving packaging.

Implementation Method 1

the glass fiber mat is sprayed with a digoxin-specific antibody-fluorescent microsphere complex

Methodology Applied
Scientific EffectAntibody-antigen recognition:

Implementation Method 2

the nitrocellulose membrane is sequentially provided with a detection line coated with digoxin protein conjugate

Methodology Applied
Scientific EffectProtein conjugation:

Implementation Method 3

a sample pad, a glass fiber mat, a nitrocellulose membrane and a water absorbing paper which are sequentially overlapped on the bottom plate

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Data Source

PatentEP3783365B1Immunochromatographic test strip for detecting digoxin and use thereof
Publication Date: 2023.06.07 BEIJING DIAGREAT BIOTECH CO LTD
  • EP3783365B1 patent drawingFigure 1~2
  • EP3783365B1 patent drawing
  • EP3783365B1 patent drawing

AI summary

The present invention provides an immunochromatographic test strip for detecting digoxin and a use thereof, and relates to the field of immunodetection technology. The immunochromatographic test strip for detecting digoxin provided by the present invention includes a bottom plate, and a sample pad, a glass fiber mat, a nitrocellulose membrane and a water absorbing paper which are sequentially overlapped on the bottom plate; the glass fiber mat is sprayed with a digoxin-specific antibody-fluorescent microsphere complex; and the nitrocellulose membrane is sequentially provided with a detection line coated with digoxin protein conjugate and a quality control line coated with a secondary antibody; the digoxin-specific antibody-fluorescent microsphere complex is obtained by conjugation between a digoxin monoclonal antibody or a digoxin polyclonal antibody and a fluorescent microsphere; and the digoxin protein conjugate includes a digoxin-conjugated rabbit albumin or a digoxin-conjugated rabbit ovalbumin. The test strip provided by the present invention has a low cost, is simple and rapid in operation, can be stored and transported at room temperature, has a wide variety of test samples, and has excellent stability and high sensitivity.