Personal Reference Range Calculation Method for Medical Laboratory Tests
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Solution Overview
Problem
Population-based reference ranges for laboratory tests do not accurately reflect individual physiological changes, leading to medical errors in result interpretation, as they do not account for within-person biological and analytical variations.
Innovation Solution
A method to determine personal reference ranges by calculating the total variation including within-person biological and analytical variations using previous healthy test results, involving multiple measurements, removing extreme values, and performing trend analysis to establish a homeostatic set point and total variation, thereby setting individual-specific lower and upper limits.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If population-based reference ranges are used, then the reference ranges can be established using general population data, but the accuracy of individual result interpretation deteriorates because they do not reflect individual physiological changes
Solution Approach 1:
The system performs preliminary actions by collecting multiple laboratory test results during a healthy period before disease diagnosis. These preliminary data are used to calculate individual-specific reference ranges that will serve as the baseline for subsequent disease detection and monitoring.
Solution Approach 2:
The system enables self-service by using each patient's own historical laboratory data to establish their personal reference range. This self-service approach allows the system to automatically generate individualized reference ranges without requiring external population data, thereby improving interpretation accuracy while maintaining ease of implementation.
2Measurement precision
If multiple laboratory tests are performed to establish personal reference ranges, then the accuracy of individual assessment improves, but the complexity of data collection and processing increases
Solution Approach 1:
The system achieves universality by creating a multi-functional platform that can handle various laboratory test types, automatically collects data from multiple sources, performs comprehensive analysis including trend evaluation and extreme value detection, and generates personalized reference ranges for different medical conditions. This unified approach improves accuracy without proportionally increasing complexity.
Solution Approach 2:
The system implements feedback mechanisms by continuously monitoring laboratory results, comparing them against established personal reference ranges, and providing feedback on whether values fall within or outside the calculated range. This feedback loop enables automatic adjustment and refinement of reference ranges over time, improving accuracy while maintaining manageable processing complexity through automated decision-making.
Data Source
AI summary
The present invention relates to a method (100) which enables to calculate a personal reference range in order to compare results of measurements that are carried out in case of suspicion of disease by using the results of laboratory tests measured in a period when persons feel healthy.