Analyte Detection Using Trapping Molecule to Release Bound Analytes

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Solution Overview

Problem

Current methods struggle to determine the total amount or concentration of a target analyte in bodily samples when a binding molecule, such as a therapeutic antibody, is present, as the binding molecule interferes with detection techniques, requiring removal before analysis which is often impractical.

Innovation Solution

An in vitro method involving a trapping molecule that binds to the binding molecule, allowing a detection molecule to form a complex with the analyte, enabling the determination of both free and bound analyte without removing the binding molecule from the sample, using a kit comprising a detection molecule, a trapping molecule, and optionally a capture molecule for immobilization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a binding molecule is present in the sample to bind the analyte, then the therapeutic efficacy is improved, but the detection of total analyte concentration is hindered

Engineering Contradiction:
Improvetherapeutic efficacyVSAvoidanalyte concentration determination
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The invention introduces a trapping molecule as an intermediary that specifically binds to the binding molecule to release the analyte. This mediator enables the detection of total analyte concentration by converting the bound analyte-backing molecule complex into free analyte that can be detected, while the trapping molecule itself does not interfere with the therapeutic action of the binding molecule on the analyte.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If the binding molecule is removed from the sample prior to detection, then the analyte detection accuracy is improved, but the sample processing complexity and time are increased

Engineering Contradiction:
Improveanalyte detection accuracyVSAvoidsample processing steps
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

Instead of removing the binding molecule from the sample through complex separation procedures, the invention extracts or releases the analyte from the binding molecule using a trapping molecule. This approach simplifies the process by keeping the binding molecule in the sample while selectively releasing and detecting the analyte, avoiding the need for time-consuming removal steps.

Inventive Principle:
Principle #2Taking out (Extraction)

3Object-affected harmful factors

If washing steps are performed to remove the binding molecule, then the detection interference is reduced, but the loss of analyte and increased processing time occur

Engineering Contradiction:
Improvedetection interferenceVSAvoidanalyte loss
Core Design Contradiction:
Object-affected harmful factorsVSLoss of substance

Solution Approach 1:

The trapping molecule acts as a mediator that specifically displaces the analyte from the binding molecule without requiring washing steps. This allows the binding molecule to remain in the sample while the analyte is released and detected, eliminating detection interference without causing analyte loss that would occur during washing procedures.

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

Enables accurate determination of the total analyte concentration in the presence of binding molecules, eliminating the need for sample washing and allowing for monitoring of therapeutic efficacy and disease progression without disrupting the sample's composition.

Implementation Method 1

contacting a sample comprising the analyte and the binding molecule with a trapping molecule directed against the binding site of the binding molecule

Methodology Applied
Scientific EffectSpecific binding: Absorption (physical)

Implementation Method 2

a detection molecule capable of forming a complex with the analyte, and detecting the detection molecule-analyte complex

Methodology Applied
Scientific EffectComplex formation: Chemical Bonding

Data Source

PatentUS12158466B2Method for determining the total amount and/or concentration of an analyte in the presence of a binding molecule as well as kits, compositions and uses relating thereto
Publication Date: 2024.12.03 ROCHE DIAGNOSTICS OPERATIONS INC
  • US12158466B2 patent drawing
  • US12158466B2 patent drawing
  • US12158466B2 patent drawing

AI summary

The present invention relates to a method for determining the total amount and/or concentration of an analyte in the presence of a binding molecule as well as kits, compositions and uses relating thereto.