Interaction Assay Signal Modulation for Wider Immunoassay Range

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Solution Overview

Problem

Current immunoassays struggle to cover the entire analyte concentration range in clinical samples, requiring dilution steps that increase workload and assay time, and existing modulators can adversely affect antibody-antigen affinity or disrupt the 3-D structure of antibodies.

Innovation Solution

The use of Poly-(4-styrenesulfonic acid-co-maleic acid) (PSSM), aminodextran, carboxymethyldextran, Poly-(2-acrylamido-2-methyl-1-propanesulfonic acid (PAMPS), triethylamine, and triethylamine, and dodecylsulfate as modulators to modulate the interaction between analyte and detection agent interaction between analyte and detection agent interaction between analyte and detection agent in interaction assays, enhancing or retarding the agglutination reaction based on analyte concentration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If dilution steps are performed to measure high analyte concentrations, then the measurable concentration range is extended, but the workload and assay time increase

Engineering Contradiction:
Improvemeasurable concentration rangeVSAvoidassay time
Core Design Contradiction:
Adaptability or versatilityVSProductivity

Solution Approach 1:

The patent applies parameter changes by introducing chaotropic reagents (urea, guanidine hydrochloride) that modify the chemical environment of the assay. These reagents change the physical-chemical parameters of the solution to reduce signal intensity at high analyte concentrations, enabling direct measurement without dilution and thus maintaining productivity while extending the measurable concentration range.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

Chaotropic reagents serve as intermediaries between the analyte and the detection system. They mediate the interaction by disrupting the agglutination reaction proportionally to analyte concentration, allowing the assay to handle high concentrations directly. This intermediary approach eliminates the need for dilution steps while preserving assay accuracy.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Adaptability or versatility

If chaotropic reagents are used to reduce signal intensity at high analyte concentrations, then the upper measuring range is extended, but the 3-D structure of antibodies may be disrupted

Engineering Contradiction:
Improveupper measuring rangeVSAvoidantibody structure integrity
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent carefully controls the concentration and type of chaotropic reagent to achieve parameter changes that extend the upper measuring range. By optimizing the reagent conditions, the patent achieves sufficient signal reduction at high analyte concentrations while maintaining antibody structural integrity and functionality.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent applies partial action by using sub-disruptive concentrations of chaotropic reagents. Instead of using concentrations that would completely denature antibodies, the patent uses optimized lower concentrations that provide sufficient signal modulation for extended range measurement while preserving antibody structure and binding capability.

Inventive Principle:
Principle #16Partial or excessive action

3Measurement precision

If interaction modulators are used to enhance signal intensity at low analyte concentrations, then analytical sensitivity is improved, but the dynamic range may be reduced

Engineering Contradiction:
Improveanalytical sensitivityVSAvoiddynamic range
Core Design Contradiction:
Measurement precisionVSAdaptability or versatility

Solution Approach 1:

The patent employs parameter changes by introducing interaction modulators that enhance signal intensity at low analyte concentrations through controlled modification of the reaction environment. This allows improved analytical sensitivity while maintaining an acceptable dynamic range for clinical measurements.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent applies partial action by using optimized concentrations of interaction modulators that provide sufficient signal enhancement at low analyte levels without excessively compressing the upper end of the dynamic range. This balanced approach maintains both sensitivity and adaptability across the measurement range.

Inventive Principle:
Principle #16Partial or excessive action

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

Enhances the analytical sensitivity and improves the accuracy of immunoassays by providing a method for determining the interaction between analyte and detection agent interaction between the interaction between the interaction between analyte and detection agent interaction between analyte and detection agent interaction between the interaction between the interaction between analyte and detection agent.

Implementation Method 1

the magnitude of the agglutination resulting from the complex formation of the binding partners is determined

Methodology Applied
Scientific EffectAgglutination: Coagulation

Implementation Method 2

turbidimetric or nephelometric measurements of the sample

Methodology Applied
Scientific EffectTurbidimetric measurement: Scattering

Data Source

PatentEP4726390A2Methods for modulating signal intensity in interaction assays
Publication Date: 2026.04.15 ROCHE DIAGNOSTICS GMBH
  • EP4726390A2 patent drawingFigure 1A~1B
  • EP4726390A2 patent drawingFigure 1C
  • EP4726390A2 patent drawingFigure 2A~2B

AI summary

The present invention relates to a method for determining an analyte in a sample in an interaction assay, said method comprising contacting said sample with an interaction modulator, wherein said interaction modulator is selected from the list consisting of Poly-(2-acrylamido-2-methyl-1-propanesulfonic acid (PAMPS), aminodextran, carboxymethyldextran, triethylamine, triethanolamine, taurine, and dodecylsulfate. The present invention further relates to a kit comprising a detection agent specifically detecting an analyte in a sample and at least one interaction modulator of the present invention. Further, the present invention relates to devices and in vitro uses relating to the methods and kits of the present invention.