Ready-to-Constitute Analytical Platforms with Separated Standards
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Solution Overview
Problem
Existing analytical toxicology laboratories face challenges in stabilizing unstable analytes and process controls due to enzymatic degradation, requiring on-demand sample preparation and matrix-matched standards, which are not suitable for long-term storage or transportation.
Innovation Solution
Development of 'ready-to-use' devices and kits that separate matrix solutions (e.g., urine, blood, saliva) and standard solutions (e.g., calibration, quality control, internal standards) to prevent enzymatic degradation, allowing for stable storage and easy quantification of analytes like opioids and metabolites.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If samples are incubated with beta-glucuronidase enzymes to hydrolyze glucuronic acid metabolites, then free drugs can be quantified, but glucuronic acid standards used as process controls are rapidly degraded
Solution Approach 1:
The kit is divided into separate components: process control samples containing glucuronic acid metabolites are stored separately from beta-glucuronidase enzymes. The enzyme is provided in a separate reagent that is added during the testing process, preventing premature enzymatic degradation of the standards while enabling accurate quantification when needed.
Solution Approach 2:
Process control samples are pre-prepared and stabilized in a frozen state with the enzyme activity inhibited. The beta-glucuronidase enzyme is pre-packaged in a stable form that only becomes active when the kit is thawed and used, allowing the standards to be manufactured and stored in advance without degradation.
2Measurement precision
If unstable analytes like heroin and 6-MAM are stored in biological matrices, then matrix-matched standards can be prepared, but the analytes rapidly degrade into other compounds
Solution Approach 1:
The kit separates unstable analytes into distinct components: process control samples containing the analytes are frozen and stored separately from biological matrices. The biological matrix (urine, blood, or saliva) is provided as a separate component that is mixed with the frozen analyte standards only when the kit is activated, preventing degradation during storage while enabling matrix-matched testing during use.
Solution Approach 2:
The kit utilizes temperature as a control parameter to prevent degradation. Process control samples are manufactured and stored in a frozen state where enzymatic and chemical degradation is minimized. When the kit is thawed and used, the temperature increase activates the enzymatic reactions needed for hydrolysis and quantification, allowing the analytes to remain stable during storage but become reactive during testing.
3Stability of the object's composition
If laboratories build process control samples and matrix-matched standards on demand, then degradation is minimized, but time and resource efficiency are reduced
Solution Approach 1:
The kit allows process control samples and matrix-matched standards to be pre-manufactured and stabilized in a frozen state before use. This preliminary preparation eliminates the need for laboratories to prepare these controls on demand, significantly improving efficiency while maintaining analyte integrity through frozen storage that prevents degradation.
Solution Approach 2:
The kit is designed as a self-contained system where all necessary components (process control samples, biological matrices, beta-glucuronidase enzyme, and reagents) are pre-packaged and ready to use. The kit automatically maintains stability through its design, requiring only simple thawing and mixing steps by the user, thereby eliminating time-consuming preparation steps while ensuring analyte integrity throughout storage and use.
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 stable, pre-manufactured test kits that maintain analyte integrity, enabling efficient and accurate quantification of multiple drugs in biological samples without the need for on-site preparation, thus enhancing efficiency and reliability in drug testing.
Implementation Method 1
This class of enzyme specifically hydrolyzes glucuronic acid metabolites to yield free drugs that can be easily quantified
Implementation Method 2
Development of 'ready-to-use' devices and kits that separate matrix solutions (e.g., urine, blood, saliva) and standard solutions (e.g., calibration, quality control, internal standards) to prevent enzymatic degradation
Data Source
AI summary
A device for quantifying the concentration of at least one analyte in a liquid test sample, the device comprising: a receptacle or plurality of receptacles, each receptacle configured to hold a liquid sample wherein each receptacle independently comprises: a) a matrix solution, and b) an analyte standard solution comprising at least one analyte standard, wherein the at least one analyte standard corresponds to the at least one analyte being assayed; wherein the matrix solution is separated from the analyte standard solution in said receptacle or plurality of receptacles, and the matrix solution and the analyte standard solution are not in substantial admixture.