Immunoassay method, non-specific reaction suppression method, immunoassay reagent, immunoassay reagent kit, composition, non-specific reaction suppressing agent, and use

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Solution Overview

Problem

Existing non-specific reaction suppressing agents in immunoassays, such as anti-human IgM polyclonal antibodies, are ineffective against certain non-specific reactions, and preparation methods impose restrictions on antibody usage.

Innovation Solution

Incorporating anti-immunoglobulin L chain lambda and kappa monoclonal antibodies into the immunoassay process to suppress non-specific reactions, particularly in homogeneous methods like latex turbidimetric immunoassays.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If anti-human IgM polyclonal antibodies are used to suppress non-specific reactions, then some non-specific reactions are suppressed, but certain non-specific reactions remain unsuppressed and preparation methods impose restrictions

Engineering Contradiction:

Improvesuppression of non-specific reactionsVSAvoidapplicability to different antibody types

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent changes the specificity parameter of the suppressing antibody from class-specific (anti-IgM, anti-IgG, anti-IgA) to isotype-universal (anti-L chain lambda and anti-L chain kappa). By targeting the constant region of the light chain that is common to all immunoglobulin classes, the suppressing agent achieves universal suppression across all antibody types without being restricted by class specificity.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent creates a universal suppressing agent that can suppress non-specific reactions caused by any type of immunoglobulin (IgM, IgG, IgA, etc.). The anti-L chain lambda and anti-L chain kappa monoclonal antibodies serve multiple functions by blocking heterophilic antibodies, rheumatoid factors, and other non-specific factors regardless of the class of the detection antibody used in the immunoassay.

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Reliability

If polyclonal antibodies from the same animal type are used for suppression, then non-specific reactions are suppressed, but preparation methods and antibody selection are restricted

Engineering Contradiction:

Improvesuppression of non-specific reactionsVSAvoidpreparation flexibility

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The patent employs monoclonal antibodies that can be produced in large quantities through hybridoma technology or recombinant methods, replacing the need for preparing polyclonal antibodies from immunized animals. This approach provides a standardized, easily manufacturable suppressing agent that does not require complex animal immunization protocols or matching animal types.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Measurement precision

If conventional non-specific reaction suppressing agents are used, then measurement accuracy improves for some cases, but measurement errors persist due to unsuppressed non-specific reactions

Engineering Contradiction:

Improveaccuracy of immunoassay measurementVSAvoidremaining non-specific reactions

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent introduces anti-L chain lambda and anti-L chain kappa monoclonal antibodies as intermediary substances that mediate the suppression of non-specific reactions. These intermediaries bind to the light chains of immunoglobulins and block the interaction between heterophilic antibodies and animal-derived antibodies, thereby preventing non-specific reactions and improving measurement accuracy.

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

Effectively suppresses non-specific reactions not addressed by current agents, enabling accurate immunoassay measurements.

Implementation Method 1

Since the immunoassay method uses an antigen-antibody reaction, the measuring method has very high specificity

Methodology Applied

Scientific EffectAntigen-antibody reaction:

Data Source

PatentUS20260009793A1Immunoassay method, non-specific reaction suppression method, immunoassay reagent, immunoassay reagent kit, composition, non-specific reaction suppressing agent, and use

Publication Date: 2026.01.08 SEKISUI MEDICAL CO LTD

AI summary

An immunoassay method that is an immunologically measuring method of a target substance to be measured in a sample, the immunoassay method including performing an immunoreaction in a presence of an anti-immunoglobulin L chain lambda monoclonal antibody and an anti-immunoglobulin L chain kappa monoclonal antibody, in a presence of the anti-immunoglobulin L chain lambda monoclonal antibody, or in a presence of the anti-immunoglobulin L chain kappa monoclonal antibody. This immunoassay method enables suppression of a non-specific reaction that could not be resolved by non-specific reaction suppressing agents in the related art.