Urine Biomarker Quantification for Kidney Function Assessment
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Solution Overview
Problem
Current methods for assessing kidney function, such as serum creatinine and glomerular filtration rate (GFR) tests, are invasive, lack specificity, and are confounded by various variables, making them inadequate for accurately distinguishing between different causes of kidney function or injury.
Innovation Solution
The development of methods that quantify the presence of biomarkers like asymmetric dimethylarginine (ADMA) and symmetrical dimethylarginine (SDMA) in urine, which are then used to estimate glomerular filtration rate (GFR) through techniques such as lateral flow assays and enzyme-linked immunosorbent assays (ELISAs).
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If serum creatinine (SCr) blood test is used to measure renal function, then the cost of the test is low, but the test is invasive and lacks specificity due to confounding variables
Solution Approach 1:
The patent uses urinary biomarkers (ADMA, SDMA, beta-2 microglobulin, cystatin C) as intermediary substances to indirectly assess kidney function. These urinary markers serve as mediators that reflect glomerular filtration rate without requiring direct blood sampling, thereby eliminating the invasive nature of SCr tests while maintaining measurement precision through multiple specific biomarkers
Solution Approach 2:
The patent replaces the mechanical blood draw procedure with a non-invasive urine collection method. By substituting the sampling mechanism from blood (invasive) to urine (non-invasive), the system eliminates the harmful factor of needle insertion while preserving the ability to obtain diagnostic information through alternative biomarkers in urine
2Measurement precision
If glomerular filtration rate (GFR) tests are used to evaluate kidney function, then the measurement of plasma filtration is achieved, but the tests require blood samples and demographic data collection which limits non-invasive application
Solution Approach 1:
The patent extracts the essential function of GFR measurement (assessing kidney filtration capability) from the complex blood sampling and demographic data collection process. By isolating and measuring specific urinary biomarkers that directly reflect glomerular filtration, the system removes the unnecessary complexity of blood draws and extensive demographic questioning while preserving the core measurement accuracy
Solution Approach 2:
The patent changes the measurement parameters from serum-based markers (SCr) requiring blood sampling to urine-based markers (ADMA, SDMA, beta-2 microglobulin, cystatin C) that can be non-invasively collected. This parameter substitution maintains the ability to accurately assess GFR while eliminating the need for blood sampling and reducing demographic data requirements
3Ease of manufacture
If serum creatinine test is used, then the cost is low, but the test is confounded by multiple variables including volume depletion, infection, obstruction, gender, hydration status, diet and muscle mass
Solution Approach 1:
The patent combines multiple urinary biomarkers (ADMA, SDMA, beta-2 microglobulin, and cystatin C) into a single diagnostic system. This merging of multiple specific markers compensates for the lack of specificity in individual markers, providing a comprehensive and accurate assessment of kidney function that overcomes the confounding variables affecting single-marker tests like SCr
Solution Approach 2:
The patent creates a composite diagnostic approach by integrating multiple urinary biomarkers into a unified testing system. This composite methodology combines the advantages of different markers (ADMA for endothelial function, SDMA for filtration, beta-2 microglobulin for tubular function, cystatin C for GFR) to produce a robust diagnostic tool that maintains cost-effectiveness while achieving high specificity
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
These methods provide a non-invasive, accurate, and cost-effective means to assess kidney function, reducing the reliance on invasive blood tests and improving the ability to differentiate between various kidney function or injury scenarios.
Implementation Method 1
coupling a reagent to asymmetric dimethylarginine (ADMA)
Implementation Method 2
detecting an amount of asymmetric dimethylarginine (ADMA), symmetrical dimethylarginine (SDMA), or both ADMA and SDMA in the sample
Data Source
AI summary
Disclose are methods, compositions and kits for the determination of kidney function that provide an alternative to the standard-of-cure used for eGFR calculations. Described herein are methods for quantitative measurement of ADMA and hydration markers in a urine sample, and process used to transform the input of these methods into a measure of kidney function. The methods allow ADMA and other biomarkers to be detected in urine samples from a subject using a simple and inexpensive assay that can be easily performed noninvasively and only require urine samples for the prediction of kidney function.