Immunoassay Reagent Storage Stability via Dummy Carrier Segmentation

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Solution Overview

Problem

Existing immunoassay reagents with insoluble carriers face issues of storage stability due to dissociation of immobilized substances, affecting measurement accuracy.

Innovation Solution

An immunoassay reagent comprising a combination of insoluble carriers bound and unbound to the reactive substance, using a binding pair like biotin and biotin-binding protein, enhances storage stability by allowing rebinding of dissociated substances.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a substance is immobilized at an insoluble carrier in an immunoassay reagent, then the reagent can be used for immune reaction detection, but the substance may dissociate from the carrier during storage, causing measurement values to fluctuate

Engineering Contradiction:
Improvestorage stabilityVSAvoidmeasurement accuracy
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The patent divides the insoluble carrier into two distinct populations: carriers with immobilized substance and dummy carriers without substance. This segmentation allows the dummy carriers to specifically absorb dissociated substance without interfering with the immune reaction, thereby resolving the contradiction between storage stability and measurement precision

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The dummy carriers act as an intermediary component that mediates the dissociation issue. By providing additional binding sites that do not participate in the specific immune reaction, they capture dissociated substance and prevent it from affecting measurement accuracy, thus protecting the reliability of the assay

Inventive Principle:
Principle #24Intermediary (Mediator)

2Stability of the object's composition

If dummy particles are added to suppress dissociation, then storage stability improves, but the reagent composition becomes more complex

Engineering Contradiction:
Improvestorage stabilityVSAvoidreagent composition complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The dummy carriers are designed to be homogeneous in size, shape, and surface properties with the functional carriers, differing only in the absence of immobilized substance. This homogeneity simplifies the overall reagent system while maintaining the stability benefit, as the carriers behave similarly in the assay environment

Inventive Principle:
Principle #33Homogeneity

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

Maintains favorable measurement accuracy by ensuring a surplus of binding sites for the reactive substance, reducing free substance in the sample, and stabilizing the reagent during storage.

Implementation Method 1

the substance and the insoluble carrier are bound to each other via a binding pair that consists of a pair of substances having a function to bind to each other

Methodology Applied
Scientific EffectBiotin-biotin binding protein interaction: Chemical Bonding

Implementation Method 2

the coexistence of the insoluble-carrier particulate reagent and the dummy particles causes a shift in a balance of dissociation/adsorption toward the adsorption-side

Methodology Applied
Scientific EffectAdsorption: Adsorption

Data Source

PatentUS20250208120A1Immunoassay reagent and immunoassay method
Publication Date: 2025.06.26 SEKISUI MEDICAL CO LTD
  • US20250208120A1 patent drawing

AI summary

An immunoassay reagent, including: a substance that exhibits an immune reaction; and an insoluble carrier having a function to bind to the substance, the insoluble carrier including an insoluble carrier that is bound to the substance and an insoluble carrier that is not bound to the substance.