Urease Detection Kit Segmentation for Shelf Life
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Solution Overview
Problem
Current rapid urease tests for gastrointestinal disorders, such as those using the CLO test, have a short shelf life due to degradation of urea and reagents, requiring refrigeration and resulting in high storage costs and logistical challenges, especially in developing countries, and fail to preserve bacterial samples for further testing.
Innovation Solution
A urease detection kit with a composition containing a pH indicator and a preservative, along with a delivery tool that includes a powdered urea coating on its sampling part, allowing for stable storage and preservation of tissue samples, eliminating the need for refrigeration and enabling sample preservation for additional testing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the gel composition containing urea and pH indicator is formulated for rapid urease testing, then the test can detect Helicobacter pylori effectively, but the composition degrades over time resulting in short shelf life
Solution Approach 1:
The kit is divided into separate components: a stable gel composition containing pH indicator and buffer, a separate urea source on the delivery tool, and a preservative component. This segmentation prevents premature degradation reactions while maintaining detection capability when components are combined during use.
Solution Approach 2:
The delivery tool is pre-coated with urea powder before use, and the gel composition is pre-prepared with indicator and buffer. This preliminary preparation allows components to be stable during storage and only react when deliberately combined during the testing procedure, extending shelf life while ensuring reliable detection.
2Duration of action of stationary object
If the CLO test kit is refrigerated to slow down composition degradation, then shelf life is extended, but storage costs and logistical complexity increase significantly
Solution Approach 1:
The chemical composition parameters are modified by using a buffered gel system with specific pH stability and separate urea delivery. This formulation change allows the composition to remain stable at room temperature, eliminating the need for refrigeration infrastructure while maintaining extended shelf life.
3Duration of action of stationary object
If the CLO test kit is refrigerated, then shelf life is extended, but capital costs and running maintenance costs increase
Solution Approach 1:
By changing the formulation parameters to use stable buffered gel composition with separate urea delivery and appropriate preservatives, the product achieves room temperature stability. This eliminates the need for expensive refrigeration equipment and associated capital and running costs.
4Reliability
If the CLO test kit is used, then urease detection is performed, but the bacterial sample is not preserved requiring additional endoscopy for DNA testing
Solution Approach 1:
The gel composition serves multiple functions: it enables rapid urease detection through pH indicator change, preserves the bacterial sample for future DNA testing, and maintains sample viability. This multi-functionality allows a single procedure to support both immediate diagnosis and subsequent confirmatory testing.
Solution Approach 2:
The gel composition acts as an intermediary medium that both detects urease activity through chemical reaction and simultaneously preserves bacterial samples. The preservative components in the gel maintain sample integrity without interfering with either the colorimetric detection or subsequent molecular testing.
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 extends the shelf life of urease detection tests, reduces storage and transportation costs, and allows for the preservation of bacterial samples, improving diagnostic efficiency and patient treatment timelines.
Implementation Method 1
a gel composition that contains urea and a pH indicator that changes colour when there is a rise in pH
Implementation Method 2
the ability of urease enzyme to convert urea into ammonia and carbon dioxide
Implementation Method 3
a preservative arranged to preserve a tissue sample delivered into the composition
Data Source
AI summary
The present invention relates to a kit for the detection of urease and to a tool and a composition forming part of the kit. In particular, the present invention relates to a kit for the detection of urease which comprises a composition containing an indicator; a delivery tool arranged to deliver a tissue sample into contact with the composition; and urea carried on the delivery tool, whereby the urea is arranged to be delivered to the composition together with the tissue sample.