Dual Electrochemical Sensor Immunoassay Device for Troponin Detection

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Solution Overview

Problem

Current point-of-care (POC) sample analysis systems for cardiac troponin testing lack the precision and sensitivity of central laboratory assays, with a growing gap in analytical sensitivity, limiting their ability to detect low levels of troponin effectively.

Innovation Solution

A device with a combination of electrochemical sensors and a magnetic field is used, featuring a first sensor for high-end sensitivity and a second sensor for low-end sensitivity, along with a scavenging electrode, to extend the range of analyte concentrations detectable, utilizing immobilized antibodies and magnetic beads to enhance signal generation and reduce background noise.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a single electrochemical sensor is used in POC systems, then the device complexity is low, but the measurement precision and sensitivity are insufficient to detect low levels of troponin

Engineering Contradiction:
ImprovesensitivityVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The device is segmented into two distinct electrochemical sensors: a first sensor for detecting high concentrations of troponin and a second sensor for detecting low concentrations. This segmentation allows each sensor to be optimized for its specific detection range, thereby improving overall measurement precision without requiring a single complex sensor to handle all concentration levels

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces a spatial dimension by positioning sensors at different locations within the cartridge and using a magnetic field applied at specific times during the assay. This dimensional approach allows the system to differentiate between high and low concentration detections by combining spatial positioning with temporal magnetic field application, enhancing sensitivity while maintaining manageable device complexity

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

2Measurement precision

If multiple sensors are used to extend the detection range, then the measurement precision improves, but the device complexity increases

Engineering Contradiction:
ImprovesensitivityVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent merges two electrochemical sensors with different sensitivities into a single integrated cartridge that operates as one cohesive system. By combining the first sensor (optimized for high concentrations) and the second sensor (optimized for low concentrations) within the same device architecture, the system achieves extended detection range and improved precision while presenting a unified, manageable device to the user

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The system changes operational parameters by applying a magnetic field at specific time points during the assay to selectively activate or enhance the response of one sensor over the other. This parameter-based control allows the device to switch between detection modes (high concentration vs. low concentration) without requiring physically separate devices, thereby managing complexity while extending the effective measurement range

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If a magnetic field is applied to enhance signal generation, then the sensitivity improves, but the device complexity and manufacturing difficulty increase

Engineering Contradiction:
ImprovesensitivityVSAvoidease of manufacture
Core Design Contradiction:
Measurement precisionVSEase of manufacture

Solution Approach 1:

The magnetic field is applied periodically or at specific time points during the assay protocol rather than continuously. This periodic application enhances signal generation at critical moments (such as during the detection phase) while minimizing the overall complexity of the magnetic field generation system, making the device more manufacturable

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The patent uses magnetic beads as intermediaries that carry the detection antibodies and concentrate at the sensor surface when the magnetic field is applied. These beads serve as a mediator between the magnetic field and the electrochemical sensor, enhancing signal generation without requiring the magnetic field to directly interact with the sensor, thereby simplifying the overall system architecture and manufacturing

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

This approach improves the sensitivity and precision of POC systems, allowing for the detection of troponin at lower concentrations, bridging the sensitivity gap with central laboratory assays and enabling more accurate patient diagnosis.

Implementation Method 1

The second electrochemical sensor includes a magnetic field disposed locally around the second electrochemical sensor, and the magnetic field is configured to attract magnetic beads onto a surface of the second electrochemical sensor

Methodology Applied
Scientific EffectMagnetic field: Magnetic Field

Implementation Method 2

The first electrochemical sensor includes an immobilized layer of antibodies configured to bind to a first complex of signal antibodies and the analyte to form a second complex

Methodology Applied
Scientific EffectAntibody binding:

Data Source

PatentUS10935511B2Ameliorated crosstalk immunoassay test device for determining a concentration of an analyte
Publication Date: 2021.03.02 ABBOTT POINT OF CARE INC
  • US10935511B2 patent drawing
  • US10935511B2 patent drawing
  • US10935511B2 patent drawing

AI summary

The present invention relates to systems that utilize a combination of immunoassay and magnetic immunoassay techniques to detect an analyte within an extended range of specified concentrations. In particular, a device includes a first electrochemical sensor positioned within a conduit adjacent to a second electrochemical sensor and spaced apart from one another at a predetermined distance. The first electrochemical sensor includes an immobilized layer of antibodies. The second electrochemical sensor includes a magnetic field disposed locally around the second electrochemical sensor, and the magnetic field is configured to attract magnetic beads onto a surface of the second electrochemical sensor. The device further includes a scavenging electrode positioned between the first electrochemical sensor and the second electrochemical sensor. The scavenging electrode is configured to prevent crosstalk between the first electrochemical immunosensor and the second electrical immunosensor.