Multi-Analyte Quality Control Solution Stability

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Solution Overview

Problem

Current quality control solutions for electrochemical biological detection are mostly single-item, leading to instability and inaccurate detection results, and require refrigeration or freezing, making them inconvenient to use, especially for detecting multiple analytes like creatinine, urea, and uric acid, which are unstable in aqueous solutions.

Innovation Solution

A composite quality control solution comprising a buffer, polymer, EDTA or its salt, preservative, blood simulated dye, and at least two of the analytes urea, sodium urate, and creatinine, which maintains stability and allows for simultaneous detection of multiple analytes without the need for refrigeration, using a suitable Good's buffer and pH to ensure component stability and electrical signal integrity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If single-item quality control solutions are used for electrochemical detection, then the solution is simple to prepare, but the stability is poor and detection accuracy is reduced

Engineering Contradiction:
ImprovestabilityVSAvoidsolution complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines multiple analytes (creatinine, urea, uric acid) into a single composite quality control solution, replacing multiple separate single-item solutions. This merging approach improves reliability by providing comprehensive quality control in one solution while maintaining simplicity through a unified formulation containing all necessary components.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent uses composite material principles by creating a multi-component quality control solution containing buffer, polymer, EDTA, preservative, blood simulated dye, and multiple analytes. This composite formulation enhances stability through synergistic interactions between components while providing accurate detection for multiple parameters simultaneously.

Inventive Principle:
Principle #40Composite materials

2Reliability

If quality control solutions require refrigeration or freezing, then the stability is improved, but the ease of operation deteriorates

Engineering Contradiction:
ImprovestabilityVSAvoidconvenience of use
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent changes the physical and chemical parameters of the quality control solution by incorporating specific buffers (Good's buffers with pH 6.5-7.5), polymers (10%-40% w/w), and preservatives (0.1%-2% w/w). These parameter adjustments enable the solution to remain stable at room temperature without requiring refrigeration or freezing, thus improving ease of operation while maintaining reliability.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent introduces polymers and preservatives as intermediary substances that mediate between the analytes and the environment, protecting the analytes from degradation at room temperature. These intermediaries maintain solution stability without requiring cold storage, making the solution convenient for clinical use.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Productivity

If multiple analytes are detected simultaneously, then the productivity is improved, but the measurement precision may deteriorate due to mutual interference

Engineering Contradiction:
Improvedetection efficiencyVSAvoiddetection accuracy
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent applies local quality principles by using a blood simulated dye (0.1%-2% w/w) that localizes to the sample matrix, creating a controlled microenvironment for each analyte detection. This approach allows simultaneous detection of multiple analytes while maintaining precision by minimizing mutual interference through localized detection zones.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent creates a universal quality control solution that can detect multiple analytes (creatinine, urea, uric acid) simultaneously through a single formulation. This multi-functional solution improves productivity by eliminating the need for separate quality control solutions for each analyte while maintaining measurement precision through optimized component concentrations and electrochemical detection methods.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 solution provides a stable, multi-analyte quality control solution that can be stored at room temperature, enabling accurate and convenient detection of creatinine, urea, and uric acid without the need for separate quality control solutions for each analyte, maintaining stability and electrical signal quality over time.

Implementation Method 1

a buffer, the concentration of which is 0.01 mol/L to 2 mol/L and the pH of which is 6.5 to 7.5

Methodology Applied
Scientific EffectBuffer:

Implementation Method 2

a polymer, the concentration of which is 10% to 40% (w/w)

Methodology Applied
Scientific EffectSolvation: Solvation

Implementation Method 3

EDTA or a salt thereof, the concentration of which is 0.1% to 1% (w/w)

Methodology Applied
Scientific EffectChelation:

Implementation Method 4

a preservative, the concentration of which is 0.1% to 2% (w/w)

Methodology Applied
Scientific EffectPreservation: Preservative

Data Source

PatentEP4528273A1Quality control solution and use thereof
Publication Date: 2025.03.26 LEADWAY HK
  • EP4528273A1 patent drawingFigure 1~2
  • EP4528273A1 patent drawingFigure 3~4
  • EP4528273A1 patent drawingFigure 5

AI summary

The present invention provides a quality control solution and its use. Said quality control solution includes a buffer, a polymer, EDTA or a salt thereof, a preservative, a blood simulated dye and an analyte, said polymer being selected from PEG 2000~ 6000, propylene glycol, glycerol, or a combination thereof. The quality control solution of the present invention can be for performing quality control of at least one analyte. It does not require refrigeration, freezing or lyophilization, can be placed at room temperature, is relatively convenient to use and can be used in fields of immunological detection, biochemical detection and electrochemical detection.