Microfluidics Assay Device Magnetic Separation

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Solution Overview

Problem

Current microfluidic assay systems face challenges in accuracy and precision due to variations in reagent concentrations and strip volume, as well as difficulties in reproducibly collecting and presenting paramagnetic particles to the detection area, especially when using accumulation methodologies.

Innovation Solution

A novel subtractive assay method where all reagents are initially located within the detection zone, allowing for accurate measurement of analyte concentration by measuring the concentration of unbound labels before and after magnetic separation, which corrects for variations in reagent concentrations and strip volume, and removes bound particles from the detection area to improve precision and sensitivity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If magnetic particles are accumulated within a detection zone to measure analyte concentration, then sensitivity is improved, but measurement precision deteriorates due to variations in reagent concentrations and strip volume

Engineering Contradiction:
Improveanalyte concentration measurementVSAvoidreproducibility
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent implements a feedback mechanism by measuring the concentration of magnetic particles in the detection zone and using this information to correct the analyte concentration measurement. The system adjusts the measurement based on the actual particle concentration, compensating for variations in reagent concentrations and strip volume, thereby improving both precision and reliability

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent changes the measurement parameter from direct analyte concentration measurement to a corrected measurement that accounts for magnetic particle concentration variations. By monitoring and adjusting based on particle concentration parameters, the system compensates for manufacturing variations and improves measurement reliability

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If a separate reference zone is used for background correction, then accuracy is improved, but device complexity increases

Engineering Contradiction:
Improvebackground correction accuracyVSAvoiddetection zone configuration
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent merges the reference zone and detection zone into a single detection zone, eliminating the need for separate reference and detection areas. This consolidation simplifies the device structure while maintaining background correction capability through the feedback mechanism that measures and corrects based on particle concentration

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The single detection zone serves multiple functions: it acts as both the reference zone for background measurement and the detection zone for analyte measurement. This multi-functionality reduces device complexity while maintaining the ability to perform accurate background correction

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Measurement precision

If unbound label is kept away from the detection zone, then measurement accuracy is improved, but loss of substance increases

Engineering Contradiction:
Improveanalyte detection accuracyVSAvoidlabel concentration
Core Design Contradiction:
Measurement precisionVSLoss of substance

Solution Approach 1:

The system uses feedback to measure the concentration of unbound label particles in the detection zone and corrects the analyte measurement based on this information. This allows unbound label to remain in the detection zone without compromising measurement accuracy, thereby reducing label loss

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent changes the approach from physically removing unbound label to mathematically correcting for its presence. By adjusting the measurement parameter to account for unbound label concentration, the system maintains accuracy without requiring label removal, reducing substance loss

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 approach enhances the accuracy and precision of analyte detection by normalizing strip volume and correcting for reagent concentration variations, leading to improved assay performance and the ability to perform multiple assays with a single cartridge design.

Implementation Method 1

magnetic particles and associated bound species which give detectable changes are brought to a detection zone via a magnetic field

Methodology Applied
Scientific EffectMagnetic field: Magnetic Field

Implementation Method 2

measuring the concentration of unbound labels before and after magnetic separation

Methodology Applied
Scientific EffectMagnetic separation: Magnetic Field

Data Source

PatentUS10261077B2Microfluidics based assay device
Publication Date: 2019.04.16 LUMIRADX UK LTD
  • US10261077B2 patent drawing
  • US10261077B2 patent drawing
  • US10261077B2 patent drawing

AI summary

A subtractive corrective assay device and methodology, whereby ail required binding and label detection reagents are initially located within the detection zone. Application of a magnetic field is used to selectively remove bound label from the detection zone by means of paramagnetic particles. The relationship between measured label concentration before and after the application of a magnetic field within the detection zone is used to accurately measure analyte concentration within the sample.