Haemostasis Test Calibration Adjustment for Instrument Variability
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Solution Overview
Problem
Existing methods for performing haemostasis tests face challenges in maintaining consistent results due to between-instrument variability and the degradation of liquid reagents over time, leading to difficulties in interpreting test results across different periods and instruments.
Innovation Solution
A method that adjusts the signal or activity measured by instruments using pre-calibrated reagents by defining a standard value for calibration adjusters, calculating any differences, and applying an adjustment coefficient to align measurements with the standard values, ensuring consistent results across instruments and over time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a standard pre-calibration curve is used for all instruments, then the calibration process is simple and standardized, but between-instrument variability increases and measurement precision deteriorates
Solution Approach 1:
The patent introduces dynamic calibration adjustment where the pre-calibration curve is not fixed but can be adjusted individually for each instrument based on its specific characteristics. This allows the calibration system to adapt to between-instrument variability while maintaining the simplicity of using a standard pre-calibration curve as a starting point.
Solution Approach 2:
The patent modifies the calibration parameters by introducing adjustment factors that can be applied to the pre-calibration curve. These parameters (adjustment factors) are changed based on instrument-specific characteristics, allowing precision improvement without complicating the overall calibration process.
2Duration of action of moving object
If liquid reagents are used for diagnostic tests, then the reagents remain functional for a certain time, but sensitivity decreases partially or varies over time due to ageing
Solution Approach 1:
The patent applies preliminary action by performing calibration adjustments at the beginning of the reagent's functional period or when variability is detected. This early intervention compensates for anticipated sensitivity loss due to ageing, maintaining measurement precision throughout the reagent's operational life.
Solution Approach 2:
The patent implements feedback mechanisms where the instrument monitors test results and can detect changes in reagent performance over time. This feedback information is used to adjust the calibration curve dynamically, compensating for sensitivity degradation without requiring reagent replacement.
3Productivity
If tests are performed over different periods with the same reagent, then productivity is maintained, but result interpretation becomes difficult due to sensitivity variations
Solution Approach 1:
The patent introduces dynamic calibration adjustment where the pre-calibration curve is not fixed but can be adjusted individually for each instrument based on its specific characteristics. This allows the calibration system to adapt to between-instrument variability while maintaining the simplicity of using a standard pre-calibration curve as a starting point.
Solution Approach 2:
The patent implements feedback mechanisms where the instrument monitors test results and can detect changes in reagent performance over time. This feedback information is used to adjust the calibration curve dynamically, compensating for sensitivity degradation without requiring reagent replacement.
Data Source
AI summary
A method is provided for adjusting either the signal measured or activity calculated by an instrument or a predefined calibration curve for a medical diagnostic test, performed on an instrument with pre-calibrated reagents. A calibration adjuster for a blood clotting diagnostic test is further provided.