Biomarker Concentration Correction via Intermediary Marker
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Solution Overview
Problem
Non-invasive sample fluids, such as urine, saliva, and sweat, are prone to falsely predicting biomarker concentrations due to variations in sample volume, making it difficult to accurately determine health or disease indicators, as these samples are impacted by hydration status, metabolism, and other conditions, leading to false negatives or positives.
Innovation Solution
The use of immunoassays to determine concentration levels of biomarkers in non-invasive samples, where the concentration of a second biomarker, such as human serum albumin, is used to correct the concentration of a first biomarker, reflecting actual rates of excretion and sample validity, thereby improving the accuracy of health or disease indication.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If non-invasive sample fluids are used to estimate biomarker concentrations, then blood sampling is avoided and health assessment becomes non-invasive, but measurement accuracy deteriorates due to sample volume variations
Solution Approach 1:
The patent introduces a second biomarker (such as creatinine, albumin, or urea) as an intermediary substance that correlates with sample volume. By measuring the concentration of this second biomarker, the system can infer the sample volume and use it to correct the first biomarker measurement, thereby achieving accurate results without direct blood sampling.
Solution Approach 2:
The patent transforms the measurement approach by changing from direct biomarker concentration measurement to a corrected value that accounts for sample volume variations. The correction formula adjusts the first biomarker concentration based on the ratio of the first to second biomarker concentrations, effectively changing the parameter being measured from raw concentration to volume-corrected concentration.
2Adaptability or versatility
If biomarker concentrations are measured in non-invasive samples, then health status can be assessed without blood draws, but false positives and false negatives increase due to hydration status variations
Solution Approach 1:
The patent implements a feedback mechanism where the measurement of the second biomarker provides information about sample volume that is fed back into the calculation of the first biomarker concentration. This feedback loop continuously adjusts the interpretation of biomarker levels according to the actual sample volume, reducing false indications caused by hydration status.
Solution Approach 2:
The second biomarker serves as a mediator that reflects sample volume status. By using this intermediary marker, the system can compensate for the effects of hydration status on the primary biomarker measurement, thereby improving the reliability of disease indication while maintaining the accessibility of non-invasive testing.
3Ease of manufacture
If sample volume variations are not corrected, then measurement simplicity is maintained, but diagnostic accuracy deteriorates due to concentration range misinterpretation
Solution Approach 1:
The patent changes the measured parameter from raw biomarker concentration to volume-corrected concentration. The correction formula transforms the concentration value based on the sample volume indicator, thereby adjusting the parameter to reflect true excretion rate while maintaining a relatively simple measurement process using standard laboratory equipment.
Solution Approach 2:
The second biomarker acts as an intermediary that provides information about sample volume without requiring complex volumetric measurements. By using this intermediary, the system can accurately determine concentration ranges while keeping the overall measurement process simple and accessible for routine diagnostic use.
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 reduces sample bias and improves the accuracy of biomarker measurements, ensuring that concentrations outside normal ranges are reliably indicative of disease or health, and those within normal ranges accurately reflect general health, by accounting for sample volume variations.
Implementation Method 1
The use of immunoassays to determine concentration levels of biomarkers in non-invasive samples
Data Source
AI summary
A method for the analysis of one or more non-invasive sample biomarkers. Biomarkers within a normal concentration range may indicate not only the lack of disease, but also general health or lack of disease. These non-invasive sample biomarkers are corrected based on excretion of another non-invasive sample biomarker reflecting changes to the sample volume in a normal concentration range lacking disease. Method allows for indicating the existence of diseases, such as renal insufficiency, infections or other disease biomarkers by analyzing the concentration of biomarkers.