Biosensor IgE Detection Removing Serum Protein Interference

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Solution Overview

Problem

Current blood-based anti-allergen specific IgE tests face challenges due to serum proteins like IgG competing with IgE, leading to false negative results, especially at low allergen levels, which complicates accurate diagnosis in allergy diagnoses.

Innovation Solution

A biosensor system is developed that includes a microfluidic device functionalizing a sensor surface with a binding ligand, conjugating an anti-analyte molecule with a nanoparticle, and using a sensor circuit to detect analyte characteristics, enhancing the sensitivity of IgE detection by minimizing interference from serum proteins.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a conventional blood-based anti-allergen specific IgE test is used, then the test can detect IgE levels, but serum proteins including IgG compete with IgE binding to the capture-allergen on the sensor surface leading to false negative results

Engineering Contradiction:
ImproveIgE detection accuracyVSAvoidinterference from serum proteins
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent extracts and removes interfering serum proteins (including IgG) from the sample before the IgE detection step. This is achieved through selective binding and separation techniques that isolate IgE from other serum components, eliminating the competition effect and enabling accurate low-level IgE detection without false negatives

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces an intermediary separation step between sample application and detection. This intermediary process uses specific binding agents or separation media that selectively interact with interfering proteins, allowing them to be removed or neutralized before the IgE-analyte interaction occurs on the sensor surface

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If the sensor surface is functionalized with capture-allergen to enable IgE binding, then IgE detection is possible, but competing serum proteins also bind to the capture-allergen reducing detection sensitivity

Engineering Contradiction:
Improvediagnostic reliabilityVSAvoiddetection sensitivity
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The patent performs preliminary removal of interfering serum proteins before the IgE binding step. By pre-clearing the sample of competing proteins through selective separation or inhibition, the capture-allergen on the sensor surface is preserved for specific IgE binding, enhancing both reliability and detection sensitivity

Inventive Principle:
Principle #10Preliminary action

3Measurement precision

If low levels of allergen are present in the immunoassay, then the test should detect low concentration IgE, but competing serum proteins make detection even more difficult

Engineering Contradiction:
Improvelow level detection capabilityVSAvoidcompetitive binding interference
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent extracts interfering serum proteins from the sample matrix before detection. This extraction/removal process concentrates or enriches the low-level IgE signal while eliminating competing proteins, enabling the detection of very low allergen-specific IgE levels that would otherwise be masked by background interference

Inventive Principle:
Principle #2Taking out (Extraction)

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 system improves the accuracy of IgE detection by providing a sensitive and specific method to quantify IgE levels, reducing false negatives and enhancing diagnostic reliability in allergy testing.

Implementation Method 1

the nanoparticle is configured to provide a binding signal to the biosensor when the nanoparticle binds to the analyte bound to the binding ligand on the at least a sensor surface

Methodology Applied
Scientific EffectBinding interaction: Adsorption

Data Source

PatentUS20230384319A1Apparatus and method for detecting an analyte
Publication Date: 2023.11.30 SIPHOX INC
  • US20230384319A1 patent drawing
  • US20230384319A1 patent drawing
  • US20230384319A1 patent drawing

AI summary

An apparatus for detecting an analyte, the apparatus includes a biosensor having at least a sensor surface functionalized with a binding ligand, wherein the at least a sensor surface is configured to selectively bind to an analyte, a microfluidic device configured to receive a sample fluid containing the analyte, incubate the biosensor with the sample fluid, and conjugate an anti-analyte molecule with a nanoparticle, wherein the nanoparticle is configured to provide a binding signal to the biosensor when the nanoparticle binds to the analyte bound to the binding ligand on the at least a sensor surface, and incubate the biosensor with the analyte bound to the binding ligand on the at least a sensor surface with the anti-analyte molecule conjugated with the nanoparticle, and a sensor circuit communicatively connected to the biosensor, wherein the sensor circuit is configured to detect at least an analyte characteristic of the analyte.