Testing Instrument Quality Control with IQC-PBRTQC Alarm Verification
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Solution Overview
Problem
Current internal quality control (IQC) methods in medical laboratories are costly, discontinuous, and prone to matrix effects, while patient-based real-time quality control (PBRTQC) lacks unified standards, leading to underutilization and false alarms.
Innovation Solution
A method integrating IQC and PBRTQC by using quality control materials to simulate biological samples, combining first and second monitoring indicators to verify alarm reliability, reducing false alarms and clinical risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional IQC monitoring using quality control materials is performed, then quality control can be implemented, but it is discontinuous, costly, and prone to matrix effects
Solution Approach 1:
The patent merges traditional IQC monitoring with PBRTQC by integrating quality control material testing results with patient sample testing results into a unified monitoring system. This combination allows continuous quality control without requiring separate discontinuous IQC procedures, reducing overall system complexity while maintaining reliability.
Solution Approach 2:
The testing instrument is made multi-functional by enabling it to perform both patient sample testing and quality control material testing through the same analytical workflow. This universality eliminates the need for separate quality control processes, reducing operational complexity while ensuring continuous monitoring.
2Productivity
If PBRTQC is implemented using patient samples, then real-time continuous monitoring is achieved with no matrix effect, but false alarms increase and lack unified standards
Solution Approach 1:
The patent implements feedback by using quality control material testing results to validate and adjust the alarm thresholds and monitoring parameters of the PBRTQC system. The quality control data provides feedback on system performance, allowing optimization of alarm accuracy while maintaining continuous monitoring efficiency.
Solution Approach 2:
The system performs preliminary quality control assessment using quality control materials before relying solely on patient sample-based monitoring. This preliminary action establishes baseline parameters and validates the system, reducing false alarms while maintaining continuous monitoring capabilities.
3Reliability
If quality control materials are used for IQC, then monitoring can be performed, but additional costs for materials, reagents, and human resources are incurred
Solution Approach 1:
The testing instrument performs dual functions by using the same reagents and analytical processes for both patient sample testing and quality control material testing. This eliminates the need for separate quality control reagent sets and reduces overall material consumption while maintaining reliability.
Solution Approach 2:
The system uses patient samples themselves for quality control monitoring purposes, allowing the system to self-validate without requiring additional external quality control materials. This self-service approach reduces material consumption while maintaining continuous monitoring capability.
Data Source
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AI summary
Embodiments of the disclosure relate to a method for quality control of a testing instrument, a sample testing system, a device, and a computer-readable storage medium. The method includes: obtaining a quality control test result of a quality control material that simulates a biological sample, and obtaining a first monitoring indicator based on the quality control test result; determining whether the testing instrument is out of control based on the first monitoring indicator, outputting a first alarm prompt when the testing instrument is out of control, obtaining actual test results of a plurality of actual biological samples tested by the testing instrument for the target item, and inputting the actual test results into a patient-based real-time quality control (PBRTQC)-based quality control model to obtain second monitoring indicators; and determining whether the first alarm prompt is reliable based on the second monitoring indicators. This reduces an IQC false alarm probability.