Psoriasis Food Sensitivity Test Kit With Gender-Stratified IgG Cutoffs
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Solution Overview
Problem
Current food sensitivity tests for psoriasis suffer from high false positive rates, high intra-patient variability, and inter-laboratory variability, rendering them nearly useless in identifying trigger foods with certainty.
Innovation Solution
A test kit and method using distinct food preparations coupled to individually addressable solid carriers, with an average discriminatory p-value of ≤0.07 or ≤0.10, and gender-stratified cutoff values to measure IgG binding, allowing for improved food intolerance testing in psoriasis patients.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If standardized food sensitivity tests are used, then testing efficiency is improved, but measurement precision deteriorates due to high false positive rates and inter-laboratory variability
Solution Approach 1:
The patent applies parameter changes by establishing specific discriminatory p-value thresholds (≤0.07 or ≤0.10) to filter and validate food preparations. This statistical parameter change ensures that only food items with sufficient discriminatory power between psoriasis patients and controls are included in the test panel, thereby reducing false positives while maintaining standardized testing procedures
Solution Approach 2:
The patent implements feedback mechanisms through iterative validation processes where test results are continuously refined. The methodology includes comparing test outcomes against established discriminatory p-values and adjusting the food preparation panel based on performance metrics, creating a feedback loop that improves measurement precision across laboratories
2Measurement precision
If gender-stratified cutoff values are implemented, then measurement precision is improved by accounting for gender variability, but device complexity increases
Solution Approach 1:
The patent applies segmentation by dividing the test population into gender-specific groups with separate cutoff values. The test kit is structured to provide gender-stratified reference values, allowing for more accurate interpretation of IgG binding results. This segmentation approach improves predictive power by accounting for gender-related biological variations in food sensitivity responses
Solution Approach 2:
The patent implements local quality by providing different reference criteria tailored to specific subgroups (male and female patients). Each gender group has its own optimized cutoff values and interpretation guidelines, ensuring that the test methodology is locally optimized for each population segment rather than using a single universal standard
3Measurement precision
If multiple distinct food preparations are tested, then measurement precision is improved by identifying specific trigger foods, but loss of time increases due to extensive testing requirements
Solution Approach 1:
The patent applies preliminary action by pre-selecting and validating a specific panel of food preparations before they are used in clinical testing. The food items undergo prior discrimination analysis to establish their p-values, and only those meeting the threshold criteria are included in the final test kit. This preliminary filtering reduces the number of foods that need to be tested while maintaining high identification certainty
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
Reduces false positives and negatives, significantly increasing the predictive power of food sensitivity tests by accounting for gender variability and providing a standardized method to identify trigger foods with high certainty.
Implementation Method 1
contacting a food preparation with a bodily fluid of a patient that is diagnosed with or suspected to have psoriasis... under conditions that allow IgG from the bodily fluid to bind to at least one component of the food preparation
Data Source
AI summary
Contemplated test kits and methods for food sensitivity are based on rational-based selection of food preparations with established discriminatory p-value. Exemplary kits include those with a minimum number of food preparations that have an average discriminatory p-value of ≤0.07 as determined by their raw p-value or an average discriminatory p-value of ≤0.10 as determined by FDR multiplicity adjusted p-value. In further contemplated aspects, compositions and methods for food sensitivity are also stratified by gender to further enhance predictive value.