Biological Sample Verification for Hematology and Microscopy Devices
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Solution Overview
Problem
Biological analysis devices, such as hematology and microscopy devices, may produce inaccurate information if not properly verified, leading to potential misdiagnosis and adverse health outcomes.
Innovation Solution
A method and system that utilize a quality control sample to verify a hematology device, which is then used to analyze a biological sample to verify its parameters, and subsequently verify a microscopy device using another portion of the same sample.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional verification methods using synthetic quality control samples and fixed cells are used, then the verification process can be standardized, but the accuracy and reliability of device verification deteriorate because these samples do not represent real biological samples
Solution Approach 1:
The patent uses a real biological sample that is consumed during the verification process. The sample is divided into portions for different devices, and each device analyzes a portion, effectively using a disposable real sample instead of reusable synthetic controls. This resolves the contradiction by accepting the 'cost' of sample consumption to gain verification accuracy.
Solution Approach 2:
The real biological sample serves multiple functions: it acts as the verification standard for multiple different devices (hematology device, microscopy device, etc.), replacing the need for device-specific synthetic controls. This universal sample approach improves reliability while managing complexity through centralized sample management.
2Measurement precision
If real biological samples are used for verification, then verification accuracy improves, but the complexity of managing and standardizing the verification process increases
Solution Approach 1:
The real biological sample is segmented into multiple portions, with each portion allocated to a specific device for verification. This segmentation allows each device to receive a standardized portion while the overall sample management remains centralized, reducing the complexity of managing multiple different samples while maintaining measurement precision.
3Productivity
If multiple separate verification processes are used for different devices, then each device can be verified independently, but the overall verification efficiency deteriorates due to redundant steps
Solution Approach 1:
The patent merges multiple verification processes into a unified workflow using a single real biological sample. Instead of running separate verification processes with different synthetic controls for each device, the system combines them into one coordinated process where the same sample type serves all devices, improving efficiency and reducing total verification time.
Data Source
AI summary
The present disclosure is directed to methods and systems for verifying biological analysis devices. The method includes calibrating a hematology device utilizing at least one of a quality control sample or historical patient data, generating diagnostic data associated with a portion of a biological sample with the hematology device, the diagnostic data comprising a first group of attributes associated with the biological sample, identifying whether the first group of attributes is within predetermined parameters, capturing an image of another portion of the biological sample with a microscopy device, identifying a second group of attributes associated with the biological sample based at least in part on the image, and determining one or more verification parameters based on the second group of attributes.