Immune Response Assay Composition Using Non-Reducing Sugars
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Solution Overview
Problem
Existing immunological-based diagnostic assays for cell-mediated immune responses lack sufficient sensitivity and storage stability, particularly when antigens are combined with simple sugars like dextrose, leading to reduced assay sensitivity over time.
Innovation Solution
Incorporating non-reducing sugars, such as trehalose, with antigens in a single composition enhances immune effector molecule production and maintains assay sensitivity even after prolonged storage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If simple sugars such as dextrose and glucose are added to increase IFN-gamma production and improve sensitivity, then assay sensitivity is improved, but storage stability deteriorates over time
Solution Approach 1:
The patent changes the chemical parameter of the sugar from reducing sugars (dextrose, glucose) to non-reducing sugars (sucrose, trehalose, maltose). This parameter change resolves the contradiction because non-reducing sugars maintain assay sensitivity while providing superior storage stability, preventing the degradation that occurs with reducing sugars over time.
Solution Approach 2:
The patent employs readily available non-reducing sugars (particularly sucrose) that are cost-effective and stable for long-term storage. These sugars serve as energy sources during the assay while maintaining stability in the stored composition, eliminating the need for complex stabilization systems.
2Ease of operation
If simple sugars are included together with antigen in a single composition to simplify the method, then ease of operation is improved, but storage stability deteriorates
Solution Approach 1:
The patent changes the sugar type parameter from reducing to non-reducing, which fundamentally alters the storage stability characteristic. This allows the composition to maintain both ease of use (single-tube formulation) and storage stability simultaneously, as non-reducing sugars do not undergo the degradation reactions that limit shelf-life.
3Measurement precision
If reducing sugars are used to enhance immune cell energy utilization and IFN-gamma production, then assay sensitivity is improved, but reliability deteriorates over time
Solution Approach 1:
The patent changes the chemical structure parameter of the sugar from reducing to non-reducing form. This parameter change resolves the reliability issue by preventing the time-dependent degradation associated with reducing sugars, while still providing the necessary energy source for immune cells during the assay period.
Solution Approach 2:
The patent utilizes stable, readily available non-reducing sugars that maintain assay reliability over extended storage periods. These sugars provide consistent energy source without the degradation issues that affect reducing sugars, ensuring reliable assay results over time.
Data Source
AI summary
This disclosure relates generally to the field of immunological-based diagnostic assays including an assay to measure cell-mediated immunoresponsiveness. The present disclosure teaches diagnosis of a subject's exposure to an antigen based on cell-mediated immunoresponsiveness with enhanced sensitivity which is achieved by adding a non-reducing sugar during incubation of the sample with the antigen.