Selective Calibration Curve Correction in Clinical Analyzers

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Solution Overview

Problem

Existing calibration curve creation methods in clinical analyzers require all measurement values to be remeasured when an error is detected, increasing the burden of correcting the curve and risking erroneous calibrator preparation.

Innovation Solution

A method and system for selectively re-measuring and replacing measurement values suspected to be in error, using the analyzer to automatically prepare and dilute calibrators, allowing for the creation of a new calibration curve without user error, ensuring accurate blood coagulation analysis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If all measurement values are remeasured when an error is detected in the calibration curve, then the calibration curve accuracy is improved, but the time and labor required for correction increases significantly

Engineering Contradiction:
Improvecalibration curve accuracyVSAvoidcorrection time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent divides the calibration curve correction process into segments by identifying and selectively remeasuring only the specific measurement values that are suspected to be erroneous, rather than remeasuring all measurement values. This segmentation approach reduces the time and labor required while maintaining calibration curve accuracy.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent applies local quality by focusing correction efforts on specific problematic measurement points in the calibration curve rather than applying uniform correction to all points. The system identifies erroneous measurement values and targets only those for remeasurement, optimizing the correction process.

Inventive Principle:
Principle #3Local quality

2Ease of operation

If manual preparation of calibrators is performed for remeasurement, then flexibility in selecting which values to remeasure is improved, but the risk of user error increases

Engineering Contradiction:
Improveselectivity in remeasurementVSAvoidcalibrator preparation accuracy
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent implements self-service by enabling the analyzer to automatically prepare and dispense calibrators for remeasurement without requiring manual user intervention. The system autonomously identifies which calibrators need remeasurement and performs the preparation and dispensing operations automatically, eliminating user error while maintaining selectivity.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent replaces the manual mechanical process of calibrator preparation with an automated mechanical system. The analyzer's automatic calibrator preparation mechanism substitutes for manual user actions, reducing the risk of user error in calibrator preparation and dilution.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If the analyzer automatically prepares and dilutes calibrators, then the risk of user error is reduced, but the device complexity increases

Engineering Contradiction:
Improvecalibrator preparation accuracyVSAvoidanalyzer system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies universality by designing the analyzer with multi-functional capabilities that allow it to perform both routine analysis and automatic calibrator preparation for calibration curve correction. The same dispensing and preparation mechanisms used for regular operations are utilized for calibrator preparation, avoiding the need for separate dedicated components and minimizing additional complexity.

Inventive Principle:
Principle #6Universality (Multi-functionality)

4Productivity

If selective remeasurement of specific measurement values is implemented, then the correction burden is reduced, but the complexity of identifying erroneous values increases

Engineering Contradiction:
Improvecorrection efficiencyVSAvoiderror detection system complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent implements feedback by using the validation sample results to provide information about which measurement values in the calibration curve may be erroneous. The system compares validation measurements with calibration curve predictions, generates feedback about discrepancies, and uses this feedback to identify specific measurement values that require remeasurement.

Inventive Principle:
Principle #23Feedback

Data Source

PatentEP3629031B1Calibration curve creation method, analyzer and non-transitory storage medium
Publication Date: 2024.05.29 SYSMEX CORP
  • EP3629031B1 patent drawingFigure 1
  • EP3629031B1 patent drawingFigure 2
  • EP3629031B1 patent drawingFigure 3

AI summary

Disclosed is a calibration curve creation method performed by an analyzer, the calibration curve creation method including: preparing a plurality of calibrators at different dilution rates by dispensing a calibrator in a container into one or more different containers; obtaining a plurality of measurement values by measuring each of the prepared plurality of calibrators; creating a calibration curve by use of the plurality of measurement values; selecting a first measurement value to be re-measured, among the plurality of measurement values used for the calibration curve; preparing another calibrator at a dilution rate corresponding to a calibrator from which the selected first measurement value is obtained; obtaining a second measurement value by measuring the prepared another calibrator; and creating a new calibration curve by replacing the first measurement value, among the plurality of measurement values, with the second measurement value.