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
Engineering 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
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.
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.
2Reliability
If quality control solutions require refrigeration or freezing, then the stability is improved, but the ease of operation deteriorates
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.
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.
3Productivity
If multiple analytes are detected simultaneously, then the productivity is improved, but the measurement precision may deteriorate due to mutual interference
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.
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.
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
Implementation Method 2
a polymer, the concentration of which is 10% to 40% (w/w)
Implementation Method 3
EDTA or a salt thereof, the concentration of which is 0.1% to 1% (w/w)
Implementation Method 4
a preservative, the concentration of which is 0.1% to 2% (w/w)
Data Source
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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.