Macromolecular Analyte Detection via Segmented Reagent System

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Solution Overview

Problem

Current methods for detecting macromolecular analytes, such as antibodies, in clinical samples require large amounts of reagents that bind non-specifically to all macromolecules, leading to inefficiencies and interference, making it difficult to accurately measure low concentrations of specific analytes.

Innovation Solution

A method involving a reagent system where only a specific binding partner for the macromolecular analyte is used, with a small molecule and its labeled binding partner, allowing for precise detection by blocking or hindering the binding of the labeled partner to the analyte, thereby reducing unnecessary reagent interactions and interference.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a reagent that binds to all macromolecules is used, then all antibodies in the sample can be captured, but the reagent binds non-specifically to many antibodies not directed to the specific antigen, requiring large amounts of reagent and causing interference

Engineering Contradiction:
Improveability to bind all antibodiesVSAvoidspecificity for target antigen
Core Design Contradiction:
Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The invention segments the antibody population by using multiple reagents with different specificities. Instead of one reagent binding to all antibodies, the system uses a first reagent that binds to antibodies against the specific antigen and a second reagent that binds to other antibodies. This segmentation allows selective capture and measurement of the target analyte while excluding non-specific binding interference.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention extracts the specific binding function from the non-specific binding background. By using reagents that specifically target only the antibodies against the antigen of interest (and not all antibodies), the method extracts the signal from the relevant subset while removing the interfering background signal from non-specific binders.

Inventive Principle:
Principle #2Taking out (Extraction)

2Adaptability or versatility

If a reagent binding to all macromolecules is used, then comprehensive detection is achieved, but the amount of reagent required increases due to non-specific binding

Engineering Contradiction:
Improvecomprehensive detection capabilityVSAvoidamount of reagent
Core Design Contradiction:
Adaptability or versatilityVSQuantity of substance

Solution Approach 1:

The reagent system is segmented into functionally distinct components: a first reagent for binding to antibodies against the specific antigen, and a second reagent for binding to other antibodies. This segmentation enables selective reagent usage, reducing the total amount of reagent needed compared to a single non-specific reagent that would require excess amounts to account for non-specific binding.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The method extracts the non-specific binding component from the reagent system by using specific reagents that target only relevant antibodies. This extraction eliminates the need for excessive reagent amounts that would be required to compensate for non-specific binding, thereby reducing the quantity of substance needed.

Inventive Principle:
Principle #2Taking out (Extraction)

3Adaptability or versatility

If non-specific reagents are used to capture all antibodies, then complete sample coverage is achieved, but interference from non-specific binding increases

Engineering Contradiction:
Improvesample coverageVSAvoidnon-specific binding interference
Core Design Contradiction:
Adaptability or versatilityVSObject-generated harmful factors

Solution Approach 1:

The binding system is segmented into specific and non-specific pathways. The first reagent provides specific binding to antibodies against the target antigen, while the second reagent provides specific binding to other antibodies. This segmentation prevents non-specific interference by ensuring that each reagent has a defined specific target, eliminating the harmful non-specific binding effect while maintaining comprehensive sample coverage.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The method extracts the non-specific binding interference from the measurement system by using reagents that specifically target only the relevant antibody population. This extraction removes the harmful factor of non-specific binding while preserving the ability to detect all antibodies of interest through the coordinated action of the two reagents.

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

This approach minimizes the amount of reagents needed and reduces interference, enabling accurate detection of macromolecular analytes by focusing on specific interactions, thus improving sensitivity and reducing costs.

Implementation Method 1

a reagent comprising a small molecule and a binding partner for the macromolecular analyte

Methodology Applied
Scientific EffectSpecific binding interaction:

Implementation Method 2

The reagent and a labeled binding partner for the small molecule are combined

Methodology Applied
Scientific EffectMolecular recognition:

Data Source

PatentUS10725034B2Assays for macromolecular analytes
Publication Date: 2020.07.28 SIEMENS HEALTHCARE DIAGNOSTICS INC
  • US10725034B2 patent drawing
  • US10725034B2 patent drawing

AI summary

A method of determining a macromolecular analyte in a sample suspected of containing the macromolecular analyte is disclosed. The sample and a conjugate reagent comprising a small molecule and a binding partner for the macromolecular analyte are combined in a medium. The conjugate reagent and a labeled binding partner for the small molecule are combined. The conjugate reagent or the medium is examined for an amount of labeled binding partner for the small molecule that is bound to the small molecule, which is related to the amount of the macromolecular analyte in the sample.