Dual Enzyme Urine Verification Reagent System

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Solution Overview

Problem

Current drug-of-abuse (DOA) testing methods are unreliable in detecting counterfeit urine products, which can mimic human-derived urine, leading to false negatives and the need for additional tests, and existing DNA verification techniques are expensive and not suitable for automated analyzers.

Innovation Solution

A dual reagent system using acid phosphatase (AP) and alkaline phosphatase (ALP) markers, which are unique to human urine and labile, making them impractical for counterfeit products, and detectable through chromogenic substrates that produce distinct color changes, allowing for quick and cost-effective differentiation between true and counterfeit urine.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If standard urine testing methods are used, then testing can be performed with simple equipment, but counterfeit urine products cannot be reliably detected

Engineering Contradiction:

Improvedetection reliabilityVSAvoidtesting system complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent changes the detection parameter from general urine constituents (pH, specific gravity, creatinine) to specific enzyme markers (acid phosphatase and alkaline phosphatase) that are unique to human urine and labile, making them impractical for counterfeit products

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent replaces complex DNA verification techniques with a simpler enzymatic colorimetric assay system that uses chromogenic substrates to produce visible color changes, making the system suitable for both automated analyzers and on-site testing

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If DNA verification techniques are used, then counterfeit urine can be detected, but the cost and complexity increase significantly

Engineering Contradiction:

Improvecounterfeit detection accuracyVSAvoidimplementation cost

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The patent employs labile enzyme markers (acid phosphatase and alkaline phosphatase) that are naturally present in human urine but degrade over time and are impractical to add to counterfeit products, providing a cost-effective alternative to expensive DNA verification

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent uses chromogenic substrates that produce distinct color changes when acted upon by the enzyme markers, providing a simple visual or spectrophotometric detection method that is both reliable and cost-effective

Inventive Principle:

Principle #32Color changes

3Measurement precision

If multiple testing steps are performed, then detection accuracy improves, but the time required for testing increases

Engineering Contradiction:

Improvesample verification accuracyVSAvoidtesting duration

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The patent combines multiple verification functions into a single enzymatic assay system that simultaneously assesses sample integrity, detects counterfeit products, and can indicate sample age through the presence or absence of labile enzyme markers

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The labile enzyme markers naturally degrade over time in human urine, providing built-in information about sample age and handling integrity without requiring additional testing steps

Inventive Principle:

Principle #25Self-service

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 system effectively differentiates true human urine from counterfeit samples using distinct color changes, providing a reliable and cost-effective method for on-site testing and automated analyzers, while also indicating sample age and handling integrity.

Implementation Method 1

Methodology Applied

Scientific EffectEnzyme catalysis: Enzyme

Implementation Method 2

detectable through chromogenic substrates that produce distinct color changes

Methodology Applied

Scientific EffectChromogenic reaction: Chemiluminescence

Data Source

PatentUS11460409B1Methods and reagents useful for verification of the integrity of a urine sample and the detection of counterfeit urine

Publication Date: 2022.10.04 VISION DIAGNOSTICS INC

AI summary

The problem of detecting whether a urine sample is true human urine or a counterfeit urine product is solved by the use of reagent systems that detect two markers normally present in human urine. The markers acid phosphatase and alkaline phosphatase catalyze the substrates thymolphthalein monophosphate and p-nitrophenol phosphate, respectively. These substrates are formulated as spot tests on a dip stick or as reagents for use in automated chemical analyzers. The presence of the markers can be qualitatively detected by color-changes in the sample, formed by the pH-specific chromogens that result from catalysis of the substrates with the markers. The control reagent can further indicate whether a counterfeit urine product contains one or both of the chromogens.