Integrated Test Strip for Mucosal Carbohydrate Detection
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Solution Overview
Problem
Existing screening tests for cancerous and precancerous conditions are hindered by insensitivity, non-specificity, and complex procedures, leading to potential false negatives due to sampling or procedural errors.
Innovation Solution
A screening test method, device, and kit that utilize galactose oxidase and Schiff's Reagent to detect abnormal carbohydrates in mucus or body fluid, with a simplified process that minimizes handling procedures and enhances accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple liquid components and multiple steps are used in the test kit, then the detection capability is maintained, but the complexity of the procedure increases and false negatives occur through sampling or procedural errors
Solution Approach 1:
The patent combines multiple liquid components (galactose oxidase solution, buffer solution, and Schiff's reagent) into a single integrated test strip structure. The test strip contains galactose oxidase immobilized on a support material, along with buffer and Schiff's reagent in the same structure, eliminating the need for separate handling of multiple liquid components and reducing procedural steps while maintaining detection reliability
Solution Approach 2:
The test strip is designed to perform multiple functions automatically: the immobilized galactose oxidase catalyzes the oxidation of galactose-containing carbohydrates, the buffer maintains optimal pH conditions, and the Schiff's reagent automatically reacts with the oxidation products to produce color change. This self-contained system eliminates the need for external intervention at multiple steps, reducing procedural errors
2Ease of operation
If multiple handling procedures are required, then the test can be performed, but the risk of false negatives through sampling or procedural errors increases
Solution Approach 1:
By integrating all necessary reagents (galactose oxidase, buffer, and Schiff's reagent) into a single test strip, the patent reduces the number of handling steps from multiple separate operations to a single application step. The user simply applies the sample to the test strip, and all subsequent reactions occur automatically within the integrated structure, minimizing opportunities for sampling or procedural errors
Solution Approach 2:
The test strip acts as an intermediary device that mediates between the sample and the detection system. It contains the immobilized galactose oxidase that catalyzes the specific oxidation of galactose-containing carbohydrates, and the Schiff's reagent that produces the colorimetric signal. This intermediary structure ensures consistent and reliable interaction between the sample and reagents, reducing variability and false negatives
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 method provides improved accuracy in detecting cancerous and precancerous conditions by simplifying the testing process, reducing false negatives, and facilitating easier administration and interpretation.
Implementation Method 1
oxidizing marker carbohydrates in the mucus or body fluid that contains marker carbohydrates by reacting with galactose oxidase
Implementation Method 2
reacted with Schiff's Reagent... activating the Schiff reagent embedded in the test strip or membrane to contact the test strip or membrane
Data Source
AI summary
This disclosure relates to a screening test method, device, and kit for mucosal carbohydrates and associated conditions including, cancerous and precancerous conditions. Specifically, the method tests abnormal carbohydrates in mucus or body fluid using reagents of galactose oxidase, and Schiff's Reagent. The screening test method, device, and kit provides improved accuracy, and minimizes handling procedures. This disclosure further relates to the use of the device or kit in a healthcare facility for an initial evaluation for cancerous and precancerous conditions.