Urine Biomarker Cassette With Creatinine Normalization for Home Testing
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Solution Overview
Problem
Existing urine tests for hormone and metabolite concentrations are affected by variations in urine concentration, leading to inaccurate measurements and masking of significant changes, necessitating central laboratory normalization which is costly and invasive.
Innovation Solution
A device and method for at-home urine testing that includes a cassette with multiplex lateral flow assays and a normalization assay to correct for urine concentration fluctuations, combined with a reader unit for quantification and normalization, enabling accurate measurement and monitoring of hormone and metabolite levels.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If at-home urine testing is performed without normalization, then ease of operation is improved, but measurement precision deteriorates due to urine concentration variability
Solution Approach 1:
The patent introduces an intermediary normalization process using creatinine concentration as a reference standard. The device first measures creatinine levels in the urine sample, then uses this measurement to normalize the hormone analyte concentrations. This intermediary step corrects for urine dilution effects while maintaining the simplicity of at-home testing, as the normalization is automatically performed by the device without requiring additional user actions.
2Measurement precision
If central laboratory normalization is used, then measurement precision is improved, but device complexity and healthcare costs increase
Solution Approach 1:
The patent extracts the normalization function from the complex central laboratory setting and integrates it directly into the simple at-home testing device. By incorporating an on-device creatinine normalization assay, the system performs the previously laboratory-only function locally, eliminating the need for sample transport and centralized processing while maintaining measurement accuracy.
Solution Approach 2:
The device performs self-normalization by automatically measuring creatinine concentration and using it to correct the hormone analyte measurements. The system serves itself by incorporating all necessary normalization capabilities within the testing device, eliminating dependence on external laboratory infrastructure and reducing overall system complexity.
3Productivity
If frequent urine testing is performed, then symptom prediction capability is improved, but urine concentration variability increases measurement uncertainty
Solution Approach 1:
The patent applies preliminary normalization action by measuring creatinine concentration first and using it to establish a correction factor before determining hormone levels. This preliminary step ensures that subsequent hormone measurements are already adjusted for urine concentration, allowing frequent testing without accumulating measurement errors from variability.
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
Provides frequent, normalized at-home hormone measurement for symptom prediction, trigger identification, and intervention efficacy, reducing healthcare costs and improving clinical trial inclusivity by allowing continuous monitoring outside traditional labs.
Implementation Method 1
lateral flow assays
Implementation Method 2
hormone or metabolite assays (e.g. fluorometric or colorimetric)
Implementation Method 3
hormone or metabolite assays (e.g. fluorometric or colorimetric)
Data Source
AI summary
A device, system and method for measuring and monitoring analyte concentrations in urine. The device is a cassette comprising two or more hormone or metabolite fluorometric or colorimetric assays, one of which can quantify urine dilution or concentration relative to population standards. The cassette can accommodate multiple lateral flow and/or dry chemistry assays, wherein the fluorometric or colorimetric results are readable quantitatively by a countertop or handheld reader and the results are normalized by the urine concentration measurement. In preferred embodiments, the analytes relate to symptoms of menopausal transition and have dynamic ranges sufficient to handle the known analyte fluctuations during such transition.