In-Vitro Diagnostic Analyzer Calibration Method
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Solution Overview
Problem
In-vitro diagnostic analyzers face inefficiencies in calibration procedures, leading to increased time, costs, and potential errors due to frequent recalibrations and the inability to distinguish between systematic and random errors, which can result in instrument downtime and resource wastage.
Innovation Solution
A computer-implemented method for calibrating in-vitro diagnostic analyzers through a multipoint calibration procedure that identifies failed calibration points, allowing for targeted re-measurement and recalibration, thereby reducing the need for repeated full calibrations and enabling discrimination between systematic and random errors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If full calibration procedure is repeated after failure, then calibration reliability is improved, but calibration time and operational efficiency deteriorate
Solution Approach 1:
The calibration procedure is segmented into multiple independent calibration points. When a calibration failure occurs, only the failed specific calibration point is re-measured rather than repeating the entire calibration sequence. This segmentation allows targeted correction of failures while preserving successfully measured points, thereby improving operational efficiency without compromising calibration reliability.
2Measurement precision
If multiple calibration levels are measured, then measurement precision is improved, but calibration time and resource consumption increase
Solution Approach 1:
The system performs partial calibration by measuring only the necessary calibration points rather than always executing complete multi-level calibration. When calibration succeeds at fewer points, the system stops early, avoiding unnecessary measurements. This partial action approach maintains measurement precision where needed while reducing overall calibration time and calibrator consumption.
3Reliability
If calibration is performed frequently, then instrument reliability is improved, but operational downtime and costs increase
Solution Approach 1:
The calibration system includes automatic evaluation and decision-making capabilities that enable self-service calibration management. The system automatically determines whether calibration succeeded or failed, identifies specific failed points, and triggers selective re-measurement without requiring operator intervention for full recalibration. This automation reduces unnecessary downtime while maintaining reliability through intelligent, frequency-optimized calibration execution.
Data Source
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AI summary
A computer-implemented method of calibrating an in-vitro diagnostic analyzer is disclosed. The method comprises executing a multi-point calibration procedure (100, 100', 100", 100''') comprising measuring a plurality of calibrator levels (10, 11, 12) and thereby obtaining a plurality of respective calibration points (1-n). The method further comprises calculating a result (20) of the multi-point calibration procedure (100, 100', 100", 100''') and determining (30) failure or passing of the multi-point calibration procedure (100, 100', 100", 100"') based on the calculated result (20). In case of failure of the multi-point calibration procedure (100, 100', 100", 100"') the method comprises determining (40) if failure is related to one or more individual failed calibration point(s) (1-n), and in the affirmative (50, 51) triggering a repetition (60, 62, 66) of measuring the calibrator level(s) (10) only with respect to the failed calibration point(s) (1, 3, 6) and recalculating the result (20') of the multi-point calibration procedure (100, 100', 100", 100''') after replacing only the failed calibration point(s) (1, 3, 6) with the newly obtained calibration point(s) (1, 3, 6).