Bone Turnover Marker Correction for Pre-Analytical Variability
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Solution Overview
Problem
Existing methods for analyzing bone turnover markers (BTMs) in clinical practice are challenged by pre-analytical and analytical variability, which affect their accuracy and reliability, particularly in elderly patients with multiple influencing factors.
Innovation Solution
A method and device that utilize a mathematical model to correct BTM concentrations by filtering out the effects of at least three factors, such as age, circadian rhythm, and uncontrollable clinical risk factors, to provide an adjusted value that reflects the patient's actual bone health status.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If BTM concentration is measured directly without correction, then the measurement process is simple, but the reliability and accuracy are reduced due to pre-analytical variability
Solution Approach 1:
The patent applies preliminary action by developing and applying a mathematical correction model before final interpretation of BTM results. The model pre-adjusts for known pre-analytical variability factors (age, gender, circadian rhythm, fasting status, medication) so that the actual measurement process remains simple while the final result is reliable and corrected
Solution Approach 2:
The patent changes the parameter state of BTM measurement by transforming raw concentration values into corrected values through mathematical adjustment. The correction model modifies the measured concentration by applying correction factors based on patient-specific parameters, thereby changing the parameter from uncorrected to corrected concentration that reflects true bone turnover status
2Measurement precision
If BTM is used to diagnose osteoporosis, then early detection is possible, but diagnostic accuracy is reduced due to influence of non-disease factors
Solution Approach 1:
The patent extracts and removes the harmful pre-analytical variability components from the BTM measurement. The correction model identifies and separates the influence of factors such as age, gender, circadian rhythm, fasting status, and medication from the actual bone turnover signal, extracting only the disease-relevant information for accurate diagnosis
Solution Approach 2:
The patent introduces a mathematical correction model as an intermediary between raw BTM measurement and clinical interpretation. This intermediary layer processes the raw data by applying correction factors, mediating the transition from uncorrected concentration to corrected value that accurately reflects bone health status independent of pre-analytical factors
3Measurement precision
If multiple influencing factors are considered in correction, then the corrected value more accurately reflects bone health status, but the model complexity increases
Solution Approach 1:
The patent systematically changes multiple parameters simultaneously in the correction model, including age, gender, circadian rhythm, fasting status, and medication use. By incorporating these multiple parameter changes into a unified mathematical framework, the model achieves high measurement precision while maintaining manageable complexity through structured integration of correction factors
Data Source
AI summary
A method is for correcting a concentration of a bone turnover marker to obtain an adjusted value which gives an indication of an individual's bone health status or amount of changes occurred over time or by treatment while eliminating the influence of possible pre-analytical variability. The method includes: obtaining the concentration of the bone turnover marker of a sample; correcting the obtained concentration using a mathematical model which comprises at least three factors, different from the bone health status, such that for the adjusted value variabilities in the concentration of the bone turnover marker, that are caused by the at least three factors, are substantially filtered out by the mathematical model.