Magnetic Particle Analyte Purification for Automated Clinical Testing

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Solution Overview

Problem

Existing methods for quantifying analytes in samples require complex and laborious pre-analytical purification steps, including delipidation and centrifugation, which increase turn-around time, introduce potential errors, and are not suitable for routine clinical use due to the need for toxic solvents and manual manipulations.

Innovation Solution

A one-step purification method involving mixing the sample with a delipidation agent and analyte binding partner-coated magnetic particles in a container, followed by magnetic separation and elution, eliminating the need for manual operations and reducing the number of equipment required, allowing for fully automated processing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If complex manual purification steps (delipidation, centrifugation) are used, then analyte purification is achieved, but turn-around time increases and method complexity increases

Engineering Contradiction:
Improveanalyte purification qualityVSAvoidturn-around time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent combines delipidation, analyte binding, and separation into a single integrated step using magnetic particles. The magnetic particles simultaneously perform lipid removal and analyte capture in one mixture, eliminating the need for separate delipidation and binding steps. This merging of operations directly reduces turn-around time while maintaining purification quality.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent replaces manual centrifugation operations with magnetic field-based separation. Instead of requiring centrifuges and manual pipetting for separation, magnetic particles enable rapid separation through magnetic field application, which can be automated. This substitution eliminates complex mechanical operations and reduces method complexity.

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

2Reliability

If multiple manual manipulation steps are used, then purification is achieved, but potential errors increase and traceability decreases

Engineering Contradiction:
Improvepurification effectivenessVSAvoidconcentration determination accuracy
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The magnetic particles self-assemble and self-separate under magnetic field influence, eliminating the need for manual manipulation steps. The particles automatically bind to the analyte and can be separated by simply applying a magnetic field, reducing human intervention and associated errors. This self-service mechanism improves traceability and reduces potential errors in concentration determination.

Inventive Principle:
Principle #25Self-service

3Reliability

If organic solvents and evaporation equipment are used, then lipid removal is achieved, but device complexity increases and operational convenience decreases

Engineering Contradiction:
Improvelipid removal effectivenessVSAvoidequipment requirements
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent extracts and removes the need for organic solvents and evaporation equipment by using aqueous-based magnetic particle separation. Lipids are removed through the magnetic particle binding mechanism rather than organic solvent extraction, eliminating the requirement for complex evaporation equipment and toxic solvents while maintaining lipid removal effectiveness.

Inventive Principle:
Principle #2Taking out (Extraction)

4Reliability

If complex purification protocols are used, then analyte purity is improved, but ease of operation decreases

Engineering Contradiction:
Improveanalyte purityVSAvoidoperational simplicity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent changes the physical state and properties of the purification system by using magnetic particles with specific magnetic susceptibility. This parameter change enables separation through magnetic field application rather than complex mechanical operations. The magnetic particles can be easily manipulated by applying and removing magnetic fields, dramatically simplifying operational steps while maintaining analyte purity.

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

This method significantly reduces turn-around time, enhances traceability, and is more cost-effective, making it suitable for routine clinical use by simplifying the quantification process while maintaining accuracy.

Implementation Method 1

subjecting the first container to a magnetic field so as to magnetically attracting the first magnetic particles to an inner wall portion of the first container

Methodology Applied
Scientific EffectMagnetic field: Magnetic Field

Implementation Method 2

incubating the mix contained in the first container so as to precipitate lipids contained in the sample

Methodology Applied
Scientific EffectPrecipitation: Precipitation

Implementation Method 3

bind the analyte contained in the sample to the first analyte binding partners

Methodology Applied
Scientific EffectAdsorption: Adsorption

Data Source

PatentUS10473653B2Method for quantifying an analyte, and an automatic analytical device configured to implement said method
Publication Date: 2019.11.12 IMMUNODIAGNOSTIC SYST
  • US10473653B2 patent drawing
  • US10473653B2 patent drawing
  • US10473653B2 patent drawing

AI summary

A novel method for determining the amount of an analyte in a sample comprising an initial purification step, occurring in a first container, comprising the following steps of mixing the sample, a delipidation agent and magnetic particles coated with first analyte binding partners in the first container, incubating the mix, removing the unbound reagents from the mix, and eluting the bound analyte in an elution solution; a transferring step consisting transferring in a volume of the elution solution comprising the analyte from the first container to a second container; and a quantification step, occurring in the second container, consisting of quantifying the analyte in said elution solution.