Magnetic Bead In Vitro Diagnosis Device for Centrifugation-Free Assays

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Solution Overview

Problem

Existing immunodiagnostic assays for detecting red blood cell antigens and antibodies are limited by sensitivity, specificity, and the need for centrifugation, which increases analysis time and costs.

Innovation Solution

An in vitro diagnosis device using a hydrophobic porous membrane with a hydrophilic reaction area and beads on which antibodies or antigens are fixed or adsorbed, allowing for improved signal retention and enhanced sensitivity and specificity without the need for mechanical handling.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional immunodiagnostic assays are used, then the detection of antigens and antibodies can be performed, but the sensitivity and specificity are limited and centrifugation is required

Engineering Contradiction:
Improvedetection sensitivity and specificityVSAvoidcentrifugation requirement
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces the mechanical centrifugation system with a magnetic field-based separation system. Magnetic beads functionalized with capturing agents (antibodies or antigens) are used to bind target analytes, and a magnet applies magnetic force to separate the bead-analyte complexes from the sample without requiring centrifugation. This substitution maintains high sensitivity and specificity while eliminating the need for complex mechanical handling.

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

Solution Approach 2:

The patent introduces magnetic beads as an intermediary carrier between the capturing agents and the detection system. These beads serve multiple functions: they provide a large surface area for capturing agents, enable magnetic separation, and enhance the signal for detection. This intermediary approach improves measurement precision while simplifying the overall device architecture.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If conventional immunodiagnostic assays are used, then antigens and antibodies can be detected, but analysis time and costs increase due to centrifugation

Engineering Contradiction:
Improveanalysis timeVSAvoidcapturing agent requirement
Core Design Contradiction:
ProductivityVSQuantity of substance

Solution Approach 1:

The patent changes the physical parameters of the capturing system by using magnetic beads with optimized magnetic properties and surface characteristics. This allows for faster binding kinetics and more efficient separation, reducing analysis time. The magnetic field application can be rapidly controlled and removed, enabling quick separation without the time-consuming centrifugation process.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs composite magnetic beads that combine magnetic core materials with functional surface coatings. This composite structure provides both the magnetic separation capability and the biological recognition function in a single particle, reducing the total amount of capturing agent needed while improving efficiency and reducing analysis time.

Inventive Principle:
Principle #40Composite materials

3Quantity of substance

If conventional immunodiagnostic assays are used, then detection can be performed, but the amount of capturing agent required is high

Engineering Contradiction:
Improvecapturing agent quantityVSAvoiddetection sensitivity
Core Design Contradiction:
Quantity of substanceVSMeasurement precision

Solution Approach 1:

The patent transitions from a two-dimensional surface-based capture system to a three-dimensional particle-based system. Magnetic beads provide a volumetric distribution of capturing agents throughout the sample, increasing the effective concentration and reducing the total amount of capturing agent needed. The spherical geometry of beads maximizes surface area to volume ratio, enhancing capture efficiency.

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

Solution Approach 2:

The magnetic beads act as intermediaries that concentrate and amplify the signal from the capturing agents. By providing a large surface area and magnetic amplification effect, fewer capturing agents are needed to achieve the same detection sensitivity, thereby reducing the quantity of substance required while maintaining measurement precision.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 device achieves higher sensitivity and specificity in detecting and identifying antigens and antibodies, reducing the amount of capturing agent required and minimizing analysis time and costs.

Implementation Method 1

a hydrophobic porous membrane with a hydrophilic reaction area

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

beads on which antibodies or antigens are fixed or adsorbed

Methodology Applied
Scientific EffectAdsorption: Adsorption

Implementation Method 3

detecting and/or identifying an antigen and/or an antibody from a sample of biological fluid

Methodology Applied
Scientific EffectAntigen-antibody binding:

Data Source

PatentUS12241894B2In vitro diagnosis device comprising beads and uses thereof
Publication Date: 2025.03.04 DIAGAST
  • US12241894B2 patent drawing
  • US12241894B2 patent drawing
  • US12241894B2 patent drawing

AI summary

The present invention relates to an in-vitro diagnosis device for detecting and/or identifying antigen and/or antibody from a sample of biological fluid, particularly from a sample of blood or sample of blood components. The invention also relates to different uses of this device such as the detection and/or the identification of red blood cells antigens, platelet antigens, viral antigens, bacterial antigens, parasite antigens, the detection and/or the identification of anti-red blood cells antibodies, antiplatelet antibodies, antiviral antibodies, antibacterial antibodies and antiparasitic antibodies.