Automatic Analyzer Batch Parameter Management
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Solution Overview
Problem
Conventional automatic analyzers face challenges in accurately setting and updating analytical parameters for reagent batches, leading to potential abnormal measurement results and increased user burden, as fixed data settings may not account for batch-to-batch variations in reagent characteristics.
Innovation Solution
An automatic analyzer is designed with fixed and variable parameter information storage, allowing for batch-specific calibration and data checks, using reagent barcodes to manage and update parameters dynamically, ensuring accurate measurement results and reducing user input errors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If fixed analytical parameters are registered for each measurement item, then the analyzer can operate with standardized settings, but it cannot account for batch-to-batch variations in reagent characteristics
Solution Approach 1:
The patent applies dynamics by transitioning from fixed analytical parameters to dynamic parameters that automatically change based on reagent batch identification. The system reads barcode information containing batch-specific parameters and dynamically adjusts measurement settings, calibration ranges, and quality control limits according to the specific reagent batch being used, thereby maintaining measurement accuracy while adapting to batch variations.
Solution Approach 2:
The patent implements parameter changes by storing multiple sets of analytical parameters (measurement wavelengths, path lengths, calibration curves, quality control limits) corresponding to different reagent batches. The system automatically selects and applies the appropriate parameter set based on the barcode read from the reagent bottle, ensuring that each batch is measured with its optimal parameters while maintaining standardized operation.
2Reliability
If manual parameter setting and updating is required for each reagent batch, then parameters can be customized, but user burden and operational errors increase
Solution Approach 1:
The patent applies self-service by enabling the analyzer to automatically retrieve, store, and apply batch-specific parameters without user intervention. The system autonomously reads barcode information from reagent bottles, automatically updates the parameter database with batch-specific values, and selects appropriate parameters for measurement, thereby eliminating manual parameter setting while ensuring accuracy.
Solution Approach 2:
The patent replaces the manual mechanical process of parameter setting with an automated information system. Barcode scanning technology and automated database management substitute for manual keyboard entry and parameter selection, reducing user burden and operational errors while maintaining the ability to customize parameters for each batch.
3Ease of operation
If data checking uses fixed management values, then quality control is simplified, but false alarms occur when reagent batches have inherent variations
Solution Approach 1:
The patent applies parameter changes by implementing dynamic quality control limits that vary according to reagent batch characteristics. Different batches have their own specific management values for linearity checks, prozone checks, reaction limits, and calibration acceptance criteria. The system automatically selects the appropriate quality control parameters based on the batch being used, maintaining simple quality control procedures while eliminating false alarms caused by batch variations.
4Reliability
If calibration is performed for each reagent batch, then measurement accuracy is maintained, but analysis time and productivity decrease
Solution Approach 1:
The patent applies preliminary action by performing calibration and determining batch-specific parameters in advance during reagent manufacturing and initial setup. The barcode information containing pre-determined calibration data and analytical parameters is stored with each reagent batch, allowing the analyzer to directly apply these pre-calibrated values without requiring time-consuming calibration procedures for each batch change, thereby maintaining accuracy while improving productivity.
Data Source
AI summary
An automatic analyzer that allows appropriate setting of analytical parameters which incorporate batch-to-batch variations in reagents. The analytical parameters consist of fixed parameters and variable parameters. The fixed parameters include a reagent-dispensing quantity, a sample-dispensing quantity, measuring wavelength, and the like, each of which becomes a pivot for measurement of a sample, and parameters to be used are selected from an item code and bottle code assigned to a reagent bottle. The variable parameters include a linearity check value, a prozone check value, reaction limit absorbance, technical limits, first standard solution absorbance, variation allowable absorbance, and the like, each of which is associated with sample-measurement result checks. The automatic analyzer reads bar code information from the reagent bottle and adopts variable parameters of a corresponding version with the item code, the bottle code, and batch information relating to the reagent, as a key.