IVD Calibration Management Using Buffer Time Interruption
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Solution Overview
Problem
In-vitro diagnostic systems face challenges with signal instability due to aging reagents and interference from substances, leading to measurement errors and the need for frequent calibrations, which disrupt sample processing and increase costs and delays, especially in critical care settings.
Innovation Solution
A computer-implemented method for automatically managing calibration by executing calibration cycles with buffer times, allowing interruptions for sample testing and resuming calibration procedures, using series of calibration solutions with varying validity periods to ensure timely and reliable test results.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If frequent calibrations are performed to maintain measurement reliability, then measurement precision is improved, but system availability and productivity deteriorate
Solution Approach 1:
The system performs calibration automatically in advance before it is needed, scheduling calibration cycles that complete before the next required measurement. This preliminary calibration action ensures measurement reliability is maintained without interrupting sample processing, as the calibration is already complete when needed.
Solution Approach 2:
The calibration process is designed to continue in the background during sample processing operations. The system maintains continuous calibration cycles that run concurrently with sample analysis, ensuring both calibration freshness and sample processing continuity without one activity blocking the other.
2Reliability
If calibration procedures are executed continuously without interruption, then measurement reliability is maintained, but operator wait time and sample processing time increase
Solution Approach 1:
The calibration schedule is dynamic and adapts to sample processing needs. The system can pause calibration cycles when sample processing is occurring and resume them when sample processing completes, allowing the calibration to be flexible rather than rigid. This dynamic adjustment ensures calibration is performed when needed without forcing interruptions to sample processing.
Solution Approach 2:
The system implements periodic calibration cycles that repeat at predetermined intervals, with the period length adjustable based on reagent aging and signal stability requirements. This periodic action ensures calibration is performed regularly to maintain reliability without requiring continuous uninterrupted calibration, allowing sample processing to occur between periods.
3Ease of operation
If manual calibration management is used, then operational flexibility is maintained, but productivity and time efficiency deteriorate
Solution Approach 1:
The system performs self-calibration automatically without requiring manual operator intervention. The calibration management system schedules, executes, and monitors calibration cycles autonomously, selecting appropriate calibration solutions and performing measurements automatically. This self-service approach eliminates the time operators would spend on manual calibration while maintaining the necessary operational flexibility through programmable control.
Data Source
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AI summary
A computer-implemented method of automatically managing calibration of an in-vitro diagnostic (IVD) system comprising executing calibration cycles/procedures comprising using calibration solutions, using a calibration solution comprising a first step of transporting the calibration solution to a measurement unit and a second step of measuring the calibration solution by the measurement unit. For each calibration cycle the method comprises starting repetition of the calibration procedure at the earliest at a start of a buffer time period before expiry of a respective calibration validity period, interrupting the calibration procedure upon receiving an order to execute a sample IVD test and restarting or resuming the calibration procedure after executing the sample IVD test, as long as repetition of the calibration procedure can be restarted or resumed within the buffer time period. Interrupting the calibration procedure comprises different steps depending on whether the order to execute a sample IVD test is received during using a first calibration solution or a subsequent calibration solution in a series of calibration solutions and whether it is received during the first step of transporting the first or a subsequent calibration solution to the measurement unit or the second step of measuring the first or a subsequent calibration solution. An IVD system performing operations associated with the method of automatically managing calibration is also disclosed.