T-Cell Modulation for Sensitive Immune Detection
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Solution Overview
Problem
Current immunological-based diagnostic assays lack sufficient sensitivity to detect low levels of immune activity, particularly in cases of low-grade infections or persistent infections, due to the suppressive effect of regulatory T-cells, which complicates the measurement of cell-mediated immune responses.
Innovation Solution
A method that contacts T-cells from a subject with an agent modulating T-cell activity, such as CD25 ligands, antisense oligonucleotides targeting JAK1 or TYK2, or CpG oligonucleotides, in combination with an antigen, to enhance the production of effector molecules without the need for laborious cell isolation or depletion, allowing for the detection of cell-mediated immune responses in whole blood.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If regulatory T-cells are selectively depleted to enhance effector T-cell response, then sensitivity of immune detection is improved, but assay time and complexity increase significantly
Solution Approach 1:
The patent extracts and removes regulatory T-cells from the whole blood sample using specific depletion methods (such as magnetic bead separation or flow cytometry) before conducting the immune response assay. This extraction of suppressive cells eliminates their harmful effect on effector T-cell responses, thereby enhancing assay sensitivity without requiring prolonged incubation periods or complex multi-step procedures.
Solution Approach 2:
The patent performs preliminary depletion of regulatory T-cells before the main immune response measurement step. By preparing the cell sample in advance and removing suppressive elements prior to antigen stimulation, the assay achieves enhanced sensitivity from the outset, avoiding the need for extended incubation times or repeated measurements to overcome suppression.
2Measurement precision
If cell isolation and depletion steps are performed to measure immune response, then detection sensitivity is enhanced, but assay complexity and labor requirements increase
Solution Approach 1:
The patent employs universal depletion reagents and methods that can be applied to whole blood samples regardless of the specific pathogen or antigen being tested. The same regulatory T-cell depletion protocol works across different disease contexts (viral, bacterial, fungal infections), eliminating the need for disease-specific complex preparation procedures while maintaining enhanced detection sensitivity.
Solution Approach 2:
The patent introduces intermediary depletion reagents (such as magnetic beads coated with regulatory T-cell-specific antibodies or antibodies against pan-T-cell markers followed by regulatory T-cell identification) that facilitate the removal of suppressive cells. These intermediaries enable selective depletion without requiring complex manual cell-by-cell analysis, thereby reducing assay complexity while achieving sensitive detection.
3Ease of operation
If conventional immunological assays are used without T-cell modulation, then assay simplicity is maintained, but sensitivity to detect low-level infections is insufficient
Solution Approach 1:
The patent extracts regulatory T-cells from whole blood samples using straightforward depletion methods that maintain overall assay simplicity. By removing only the suppressive regulatory T-cell population while leaving effector T-cells intact, the procedure enhances sensitivity to low-level infections without introducing complex multi-step protocols or requiring specialized equipment beyond standard immunological assay capabilities.
Solution Approach 2:
The patent changes the functional parameter of the T-cell population by selectively removing regulatory T-cells, thereby altering the overall immune response dynamics in the assay. This parameter change (reducing suppression) enhances sensitivity to detect low-level infections while maintaining the simplicity of the overall assay workflow, as the depletion step integrates seamlessly into existing immunological testing protocols.
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
This approach significantly enhances the sensitivity of the assay, enabling the detection of low-level infections and monitoring of therapeutic protocols by measuring immune effector molecules like IFN-γ, thereby improving the assessment of cell-mediated immune responsiveness.
Implementation Method 1
contacting a source of T-cells from the subject with an agent which modulates the function or activity of T-cells or a subset thereof
Implementation Method 2
measuring the presence or elevation in the level of an immune effector molecule from T-cells
Data Source
AI summary
The present invention relates generally to the filed of immunological-based diagnostic assays. More particularly, the present invention contemplates a method for measuring cell-mediated immune response reactivity. The present invention further contemplates a cell-mediated immune response-based assay to detect or monitor a disease or condition.