Immunoassay Detection with Non-Identical Labels to Reduce Interference

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Solution Overview

Problem

Existing immunoassays face interference issues due to anti-label effects, leading to false-positive or false-negative results, and current methods to mitigate these interferences either reduce signal yield or are inefficient.

Innovation Solution

The use of two non-identical detector compounds, each with a unique binding moiety and label, allows for simultaneous detection and differentiation of analyte complexes, reducing interference by providing multiple detection signals.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a single detector compound with a single label is used in immunoassays, then the assay is simple and cost-effective, but anti-label interferences cause false-positive or false-negative results

Engineering Contradiction:
Improveaccuracy of immunoassay resultsVSAvoidnumber of detector compounds
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent divides the detection system into multiple independent detector compounds, each with distinct labels. This segmentation allows the assay to distinguish between different binding events and reduces interference from anti-label antibodies, as each detector compound represents an independent detection channel that can be evaluated separately.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces a new dimension of differentiation by using multiple non-identical labels on different detector compounds. This dimensional approach enables simultaneous detection of multiple analytes or detection of the same analyte through different binding moieties, making it possible to identify and exclude interfering signals based on label specificity.

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

2Measurement precision

If multiple detector compounds with non-identical labels are used, then interference is reduced and detection accuracy is improved, but the complexity of the assay increases

Engineering Contradiction:
Improvedetection accuracyVSAvoidnumber of detector compounds
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent designs detector compounds that can serve multiple functions: each detector compound binds to specific analytes through its binding moiety while its unique label provides both detection capability and interference resistance. The system universally applies the same multi-functional design across different analyte detections, allowing one assay platform to handle multiple detection scenarios with reduced interference.

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

Solution Approach 2:

The patent uses multiple detector compounds that are copies of each other with identical binding moieties but different labels. These copies detect the same analyte through the same binding mechanism, providing redundant detection channels that can cross-validate results and identify interference patterns, thereby improving measurement precision without requiring fundamentally different detection mechanisms.

Inventive Principle:
Principle #26Copying

3Reliability

If multiple detector compounds are used to detect the same analyte, then interference is minimized, but the cost and complexity of the assay increase

Engineering Contradiction:
Improvereliability of test resultsVSAvoidassay complexity
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent changes the parameter of label identity while maintaining constant binding moiety characteristics. By systematically varying only the label parameter across multiple detector compounds, the assay achieves improved reliability through interference reduction while maintaining manufacturing simplicity, as the binding moieties and assay protocol remain identical across all detector compounds.

Inventive Principle:
Principle #35Parameter changes

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 enhances the accuracy of immunoassays by minimizing interference and maintaining signal integrity, thereby improving the reliability of test results.

Implementation Method 1

contacting said sample with at least a first and a second detector compound; determining the amount of complexes comprising at least one detector compound

Methodology Applied
Scientific EffectSpecific binding:

Data Source

PatentUS12411129B2Reduction of interferences in immunoassays
Publication Date: 2025.09.09 ROCHE DIAGNOSTICS OPERATIONS INC

AI summary

The present invention relates to a method for determining an analyte in a sample, comprising a) contacting said sample with at least a first and a second detector compound; b) determining the amount of complexes comprising at least one detector compound; and, c) determining said analyte in a sample based on the result of step b), wherein said first detector compound comprises a first binding moiety and a first label, and said second detector compound comprises a second binding moiety and a second label, and wherein the first label and the second label are non-identical. The present invention further relates to a kit for detecting an analyte in a sample, comprising at least a first and a second detector compound for said analyte, wherein said first detector compound comprises a first binding moiety and a first label, and said second detector compound comprises a second binding moiety and a second label, and wherein the first label and the second label are non-identical; and to a device for determining an analyte in a sample, comprising at least a first and a second detector compound for said analyte, wherein said first detector compound comprises a first binding moiety and a first label, and said second detector compound comprises a second binding moiety and a second label, and wherein the first label and the second label are non-identical; and means for determining at least one signal obtained from said first label and said second label; and to the use of a composition comprising at least a first and a second detector compound for detecting an analyte, wherein said first detector compound comprises a first binding moiety and a first label, and said second detector compound comprises a second binding moiety and a second label, and wherein the first label and the second label are non-identical.