Electrochemical Biosensor for Tear Analyte Detection

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Solution Overview

Problem

Current lateral flow assays for detecting biomarkers in tears are unreliable due to low volume, low concentration, and variable viscosity, leading to inconsistent results, which limits their acceptance for diagnosing dry eye disease.

Innovation Solution

Development of biosensors with a carbon layer, sensor electrodes, and specific ligands for analytes like MMP-9 and lacritin, capable of detecting analytes and osmolarity in small biological samples, providing quantitative results without the need for sample dilution.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If lateral flow assays are used for detecting biomarkers in tears, then the testing can be performed, but the results are inconsistent and unreliable due to low volume, low concentration, and variable viscosity

Engineering Contradiction:
Improveresult accuracyVSAvoidsample volume
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent changes the detection parameters by using electrochemical impedance spectroscopy (EIS) instead of visual colorimetric detection. This allows for quantitative measurement of analyte binding events, providing reliable results even with low sample volumes and concentrations. The EIS technique measures changes in electrical impedance caused by analyte-ligand interactions, enabling sensitive detection without requiring large sample volumes or concentration adjustments.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent replaces the mechanical/visual readout system of lateral flow assays with an electrical detection system. Instead of relying on visual interpretation of color bands that are affected by sample viscosity and volume, the invention uses electrochemical sensors to detect binding events through electrical impedance changes. This substitution eliminates the subjectivity and inconsistency associated with visual reading and provides objective, quantitative measurements.

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

2Measurement precision

If lateral flow assays are used for detecting biomarkers in tears, then the testing can be performed, but the results show high variability requiring dilution which further increases variability

Engineering Contradiction:
Improvedetection accuracyVSAvoidsample preparation complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The biosensor performs self-calibration and automatic compensation for sample matrix effects through the EIS measurement technique. The system inherently accounts for variations in sample composition by measuring impedance changes relative to a baseline, eliminating the need for manual dilution series or complex calibration procedures. The sensor automatically adapts to different sample types (tears, serum, plasma) without requiring operator intervention for sample preparation adjustments.

Inventive Principle:
Principle #25Self-service

3Reliability

If lateral flow assays are used for diagnosing dry eye disease, then diagnosis can be performed, but the inconsistent results limit acceptance by providers and insurance companies

Engineering Contradiction:
Improvediagnostic reliabilityVSAvoiduser operation simplicity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The EIS-based biosensor provides real-time feedback during the measurement process, continuously monitoring impedance changes as analytes bind to ligands. This allows for dynamic assessment of binding kinetics and equilibrium, providing robust diagnostic data that is less susceptible to timing variations or operator technique differences. The system can automatically determine when measurement is complete based on signal stabilization, reducing variability from manual reading timing.

Inventive Principle:
Principle #23Feedback

4Measurement precision

If new biosensor methods are developed for detecting analytes in low volume samples, then quantitative results can be provided, but the device complexity increases

Engineering Contradiction:
Improvequantitative detection capabilityVSAvoidbiosensor structure complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The electrochemical biosensor platform is designed to be universal, capable of detecting multiple different analytes by simply changing the ligand layer. The same EIS detection circuitry and measurement protocol can be used for detecting MMP-9, lacritin, or other biomarkers, eliminating the need for multiple specialized devices. This multi-functionality reduces overall system complexity while maintaining quantitative detection capabilities across different analytes and sample types.

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

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 biosensors offer reliable, quantitative detection of analytes and osmolarity, improving diagnostic accuracy for dry eye disease with higher sensitivity and specificity compared to existing methods, reducing variability and processing time.

Implementation Method 1

The detector can detect binding or interaction of the one or more analytes and the ligands due to a change in electrical impedance caused by binding or interaction of the one or more analytes in the sample with the ligands

Methodology Applied
Scientific EffectElectrical impedance change: Electrical Resistance

Data Source

PatentUS20240377391A1Point of Care Device for Detection of Analytes in Tear Film and Other Biological Samples
Publication Date: 2024.11.14 INNSIGHT TECHNOLOGY INC
  • US20240377391A1 patent drawing
  • US20240377391A1 patent drawing
  • US20240377391A1 patent drawing

AI summary

Biosensors for the detection of at least one analyte and osmolarity in a biological sample are provided. The biosensors can comprise a carbon layer, at least one sensor electrode, ligands for the one or more analytes in contact with the carbon layer and/or the at least one sensor electrode, and a substrate.