Virtual Control Sample Database for Flow Cytometer Quality
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Solution Overview
Problem
Current measurement apparatuses for cell analysis, particularly particle analyzers like flow cytometers, face challenges in maintaining measurement accuracy and reproducibility without commercially available control samples, especially for low-frequency test items.
Innovation Solution
A measurement apparatus with a measurement unit, display unit, and processing unit that allows users to set an evaluation criterion for quality control and display quality control results, enabling effective quality control even without commercially available control samples.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If control samples are prepared in each clinical laboratory for low-frequency test items, then quality control can be performed, but preparation time and working hours increase
Solution Approach 1:
The system creates virtual control samples by storing measurement data from actual control samples in a database. These virtual control samples can be repeatedly used without physical preparation, eliminating the need to prepare new control samples for each test while maintaining quality control capability.
Solution Approach 2:
Measurement data from control samples is collected and stored in advance in the database. When quality control is needed, the system retrieves pre-stored data instead of requiring new sample preparation, thus performing the quality control function without current preparation time investment.
2Ease of operation
If commercially available control samples are used, then quality control is simplified, but control samples are not available for low-frequency test items
Solution Approach 1:
The system provides a universal quality control solution that works for both high-frequency and low-frequency test items. By using a database of stored measurement data, the system can generate control standards for any test item regardless of testing frequency, making the quality control process universally applicable.
Solution Approach 2:
The database acts as an intermediary between physical control samples and quality control decision-making. Instead of requiring physical control samples for every test, the system uses stored measurement data from the database to evaluate current measurement results, enabling quality control for test items without commercially available control samples.
3Measurement precision
If control graphs are generated using external tools like Excel, then quality control analysis can be performed, but user expertise is required and operation complexity increases
Solution Approach 1:
The measurement apparatus performs quality control analysis automatically using its own built-in processing unit and database. The system retrieves stored control data, compares current measurements against historical data, and determines whether quality control standards are met without requiring external tools or user intervention in the analysis process.
Solution Approach 2:
The system merges the quality control database, data processing capabilities, and analysis functions into the measurement apparatus itself. This integration eliminates the need for separate external tools like Excel and combines measurement and quality control functions into a single unified system.
Data Source
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AI summary
Disclosed is a measurement apparatus that includes: a measurement unit configured to measure a control sample for quality control; a display unit; and a processing unit configured to cause the display unit to display an input screen for setting an evaluation criterion used in the quality control, and, in the measurement apparatus, the processing unit causes the display unit to display a quality control result of a test item, based on the evaluation criterion and a measurement result of the control sample.