Automated Analyzer for Biological Sample Confirmation Testing
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Solution Overview
Problem
Current confirmation testing of biological samples for analytes, such as hepatitis B virus (HBV) surface antigen (HBsAg), is cumbersome, error-prone, and requires significant laboratory resources, including manual preparation steps and intellectually challenging decision-making, which can lead to false results and increased exposure to infectious substances.
Innovation Solution
An automated analyzer system that automates the confirmation testing process, reducing manual handling and decision-making by using a controller to manage fluid transfer, mixing, temperature control, and measurements, allowing for automated selection and execution of workflows, thereby minimizing errors and sample consumption.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual confirmation testing is performed with multiple preparation steps, then testing accuracy can be improved through operator judgment, but operator workload and error probability increase significantly
Solution Approach 1:
The system enables self-service automation where the automated analyzer independently performs confirmation testing without operator intervention. The controller automatically executes workflows, manages fluid transfer, controls temperature, and interprets results, allowing the system to serve itself and eliminating the need for manual operation while maintaining high accuracy
Solution Approach 2:
Manual mechanical operations are replaced with automated mechanical and electronic systems. The automated analyzer uses programmed mechanical fluid transfer, electronic temperature control, and automated data processing to substitute human manual preparation steps, thereby reducing operator workload while preserving testing accuracy
2Adaptability or versatility
If multiple manual preparation steps are required for confirmation testing, then protocol flexibility can be improved, but error probability and time consumption increase
Solution Approach 1:
The system implements dynamic workflow selection where the controller automatically chooses appropriate confirmation testing protocols based on sample characteristics and testing requirements. Multiple predefined workflows can be dynamically selected and executed without manual reconfiguration, providing protocol flexibility while maintaining efficient automated execution that reduces testing time
Solution Approach 2:
Multiple testing workflows are pre-programmed and prepared in advance within the controller. The system has preliminary configurations for different confirmation testing scenarios, allowing automatic selection and execution of appropriate protocols without requiring manual setup during testing, thereby reducing time consumption while maintaining protocol flexibility
3Object-affected harmful factors
If automated analyzer is used for confirmation testing, then operator safety can be improved by reducing exposure to infectious substances, but initial system complexity increases
Solution Approach 1:
The automated analyzer acts as an intermediary between the operator and infectious samples. The system physically handles all sample processing operations including fluid transfer, mixing, and measurement, eliminating direct operator contact with potentially infectious substances. This intermediary function protects operator safety while the automated nature manages system complexity through programmed operations
4Measurement precision
If manual interpretation of confirmation test results is required, then diagnostic accuracy can be improved through operator expertise, but labor time and resource consumption increase
Solution Approach 1:
The system implements automated feedback loops where the controller continuously monitors test parameters, compares results against predefined criteria, and automatically interprets confirmation test outcomes. The system provides real-time feedback on sample classification (reactive, non-reactive, indeterminate) based on measured parameters, maintaining diagnostic accuracy through programmed decision logic while eliminating manual interpretation time and increasing testing throughput
Data Source
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AI summary
One aspect of the present disclosure relates to an automated analyzer system for biological samples includes a sample processing system and a controller configured to receive a selection of one of multiple workflows for determining a presence and/or concentration of an analyte in a biological sample and prompt the automated analyzer system to automatically carry out the selected workflow using the sample processing system and output a result classifying the biological sample.