IVD Calibration Value Adaptation for Batch-Consistent Results
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
In-vitro diagnostic systems face high variability in measurement results due to batch-specific target value changes and control material variability, leading to inaccuracies and delays in diagnosis.
Innovation Solution
A system comprising an in-vitro diagnostic device and a control unit that detects deviations in internal calibration/control measurement parameters, accesses a database for evaluation, and modifies standard values using correction factors based on assay reagents, device components, and patient assay data to ensure consistent results.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If batch-specific target values are assigned to reagent batches, then measurement accuracy is improved, but the complexity of value management increases and fixed medical decision points are compromised
Solution Approach 1:
The system continuously monitors control material values and automatically adjusts reagent batch values based on measured deviations from target values. This closed-loop feedback mechanism maintains measurement accuracy without requiring manual intervention or complex manual value management, resolving the contradiction between precision and complexity.
Solution Approach 2:
The system performs self-calibration by automatically detecting deviations in control material and adjusting reagent batch values accordingly. This self-service capability eliminates the need for external manual calibration procedures, reducing operational complexity while maintaining high measurement accuracy across different reagent batches.
2Adaptability or versatility
If control material values are allowed to fluctuate within a range of up to 20%, then system flexibility is improved, but result consistency and measurement reliability deteriorate
Solution Approach 1:
The system dynamically adjusts control material acceptance criteria based on actual measured values. Instead of using fixed rigid ranges, the system adapts the acceptable value range according to the specific reagent batch characteristics and measured deviations, thereby maintaining both flexibility and consistency in measurement results.
Solution Approach 2:
The system changes the acceptance parameter for control material values from fixed percentage ranges to dynamically adjusted value ranges based on actual measurements. This parameter change allows the system to maintain result consistency while accommodating necessary flexibility in control material variations through automated value adaptation.
3Measurement precision
If individual system-specific values are requested for control materials, then measurement precision is improved, but diagnostic delays and operational complexity increase
Solution Approach 1:
The system automatically determines and applies system-specific values for control materials without requiring manual requests or interventions. The automated detection and adjustment of deviations from target values eliminates delays associated with manual value requests while maintaining high measurement precision through individual system calibration.
Solution Approach 2:
The system performs preliminary calibration and value determination during the automated control material testing process. By establishing system-specific values in advance through automated detection before patient testing begins, the system eliminates diagnostic delays that would otherwise result from manual value requests while maintaining high measurement precision.
Data Source
Figure 1
Figure 2~3
AI summary
The present invention relates to a system that enables the provision of a consistent result value by an in-vitro diagnostic device, comprising an in-vitro diagnostic device, at least one control unit that is bidirectionally connected to the in-vitro diagnostic device and is configured to evaluate the deviation of an internal calibration/control measurement parameter from a defined standard value of the at least one in-vitro diagnostic device, and wherein the control unit is configured to modify the standard value for which a deviating internal calibration/control measurement parameter has been detected and to transmit the modified standard value to the in-vitro diagnostic device; and a corresponding method.