Derivatization Kit Expands FPIA Concentration Range

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Solution Overview

Problem

The fluorescence polarization immunoassay (FPIA) method has limitations in estimating the concentration of substances with low molecular weight haptens due to limited affinity range between the substance and antibodies, restricting the measurable concentration range.

Innovation Solution

A concentration estimation kit and method involving a derivatization reagent to modify antigens in a specimen, creating samples with varying derivatization rates, combined with an antibody and dye-labeled antigen, allowing for the measurement of fluorescence polarization to estimate substance concentration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If FPIA uses a single antibody with fixed affinity to measure antigen concentration, then the measurement is simple and quick, but the measurable concentration range is limited

Engineering Contradiction:
Improvemeasurement speedVSAvoidmeasurable concentration range
Core Design Contradiction:
ProductivityVSAdaptability or versatility

Solution Approach 1:

The patent changes the affinity parameter of the antigen-antibody interaction by introducing derivatization reagents that modify the antigen. By controlling the derivatization rate (ratio of derivatized to non-derivatized antigen), the system creates multiple samples with different affinities, allowing measurement across a broader concentration range while maintaining rapid FPIA detection

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent segments the antigen population into multiple groups with different derivatization rates (e.g., 0%, 25%, 50%, 75%, 100% derivatized). Each segment interacts with the antibody at a different affinity level, enabling the system to measure concentrations that would otherwise be outside the detection range of a single affinity antibody

Inventive Principle:
Principle #1Segmentation

2Adaptability or versatility

If multiple antibodies with different affinities are used to expand measurement range, then the measurable concentration range increases, but the device complexity and operation become more complicated

Engineering Contradiction:
Improvemeasurable concentration rangeVSAvoidassay system complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent performs preliminary derivatization of the antigen before the actual FPIA measurement. By pre-preparing samples with different derivatization rates and storing them, the system eliminates the need to handle multiple antibodies during measurement, reducing operational complexity while maintaining expanded measurement capability

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The derivatization reagent acts as an intermediary that modifies the antigen to create different affinity variants. This intermediary approach allows the system to achieve multiple affinity levels without directly using multiple antibodies, simplifying the assay system while expanding the measurable concentration range

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

Expands the measurable concentration range of substances by altering the affinity between the antigen and antibody through derivatization, enabling more precise estimation of low molecular weight substances.

Implementation Method 1

a derivatization reagent that derivatizes at least a portion of an antigen included in a mixed specimen

Methodology Applied
Scientific EffectChemical Bonding: Chemical Bonding

Implementation Method 2

the antigen modified with a dye

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Implementation Method 3

an antibody that binds to the antigen

Methodology Applied
Scientific EffectAdsorption: Adsorption

Data Source

PatentUS20230393123A1Concentration estimation kit and concentration estimation method
Publication Date: 2023.12.07 TIANMA JAPAN LTD
  • US20230393123A1 patent drawing
  • US20230393123A1 patent drawing
  • US20230393123A1 patent drawing

AI summary

A concentration estimation kit includes a derivatization reagent that derivatizes at least a portion of an antigen included in a mixed specimen, and that is for obtaining a plurality of samples having different derivatization rates, the derivatization rate being a ratio of a derivatized antigen relative to the antigen included in the specimen; an antibody that binds to the antigen; and the antigen modified with a dye.