Hemoglobin A1C Analysis Kit Enzyme Stabilization

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Solution Overview

Problem

Existing enzyme assay reagents for glycated hemoglobin (HbA1c) measurement have limitations in long-term stability, storage, accuracy, portability, and convenience of use, particularly due to poor thermal stability of fructosyl peptide oxidase (FPOX).

Innovation Solution

A kit for quantitative analysis of HbA1c comprising a combination of saccharides, nitrite compounds, amino acids, sugar alcohols, polyamines, proteolytic enzymes, oxidizing agents, and fructosyl amino acid oxidase (FAOD) with stabilizers like trehalose and buffers, which improves the thermal stability and durability of the reagents.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If fructosyl peptide oxidase (FPOX) is used as the enzyme reagent for HbA1c measurement, then the measurement can be performed using enzyme assay method, but the thermal stability is poor and activity is significantly decreased with time at room temperature

Engineering Contradiction:
Improvemeasurement reliabilityVSAvoidenzyme thermal stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent changes the physical state of the enzyme reagent from liquid solution to dried powder form. This parameter change fundamentally improves thermal stability because the dried state reduces molecular mobility and prevents denaturation reactions that occur in liquid solutions at room temperature. The enzyme maintains its activity when dried and can be reconstituted when needed, solving the contradiction between measurement reliability and thermal stability.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If enzyme assay reagents are manufactured and sold as solutions, then they can be used immediately for measurement, but they have limitations on long-term stability and storage

Engineering Contradiction:
Improveconvenience of useVSAvoidstorage duration
Core Design Contradiction:
Ease of operationVSDuration of action of stationary object

Solution Approach 1:

The patent performs the drying action in advance during manufacturing, converting the reagent to a stable dried state for long-term storage. When needed, the user simply adds buffer solution to reconstitute the enzyme, which is a minimal preliminary action. This resolves the contradiction by preparing the reagent in its most stable form beforehand while maintaining ease of use through simple reconstitution.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If various kinds of reagents and sensors are provided and installed respectively in large equipments, then the measured values are highly reliable, but the place of use is limited and maintenance is cumbersome

Engineering Contradiction:
Improvemeasurement reliabilityVSAvoidequipment complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges multiple reagents (hemolytic reagent, protease, FPOX, peroxidase, color developing reagent) into a single integrated cartridge system. This combination maintains measurement reliability through proper reagent formulation while dramatically reducing device complexity and improving portability. The single cartridge format eliminates the need for separate reagent storage and handling, making the system suitable for POCT applications.

Inventive Principle:
Principle #5Merging (Combining)

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

The kit achieves excellent long-term stability of enzyme reagents, overcoming the disadvantages of conventional reagents in terms of storage, accuracy, portability, and convenience, maintaining activity and stability over extended periods.

Implementation Method 1

a third composition containing at least one kind selected from the group consisting of a saccharide and an organic polymer; and a fructosyl amino acid oxidase (FAOD)

Methodology Applied
Scientific EffectEnzyme catalysis: Enzyme

Implementation Method 2

a second composition containing at least one selected from the group consisting of a saccharide, an amino acid, a sugar alcohol, and a polyamine; a proteolytic enzyme; and an oxidizing agent

Methodology Applied
Scientific EffectOxidation: Oxidation

Implementation Method 3

a first composition containing a saccharide and a nitrite compound

Methodology Applied
Scientific EffectChemical reaction: Reaction (physics)

Implementation Method 4

improves the thermal stability and durability of the reagents

Methodology Applied
Scientific EffectThermal stability enhancement:

Data Source

PatentUS11262365B2Kit for hemoglobin A1C quantitative analysis
Publication Date: 2022.03.01 I SENS INC
  • US11262365B2 patent drawing
  • US11262365B2 patent drawing
  • US11262365B2 patent drawing

AI summary

The present invention relates to a kit for quantitative analysis of glycated hemoglobin (HbA1c), and the kit for quantitative analysis of HbA1c according to the present invention has excellent long-term stability of an enzyme reagent and thus has an effect of easily overcoming the disadvantages of the conventional reagents used in enzyme assays (e.g., storage, accuracy, portability, convenience of use, etc.).