Mobile Clinical Lab Testing with Minimal Sample Volume
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Solution Overview
Problem
The traditional paper-based laboratory testing process is slow and cumbersome, requiring patients to wait days or weeks for results and involving unnecessary steps such as venipuncture and manual handling of blood samples.
Innovation Solution
A system that enables clinical laboratory testing using minimal sample volumes, allowing for mobile scheduling of appointments, variable test menus based on location, and eligibility confirmation before testing, utilizing a network of servers and devices for efficient sample collection and analysis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional paper-based laboratory testing process is used, then comprehensive blood analysis can be performed, but the process is slow and requires patients to wait days or weeks for results
Solution Approach 1:
The system segments the traditional centralized laboratory process into distributed point-of-care testing units. Each device performs specific analyte measurements independently, allowing parallel processing of multiple tests across different locations, thereby reducing overall turnaround time while maintaining comprehensive analysis capability
Solution Approach 2:
The patent introduces a network infrastructure and data management system as an intermediary between point-of-care devices and central laboratories. This intermediary enables real-time data transmission, result aggregation, and coordination, allowing fast local testing while maintaining integration with comprehensive laboratory capabilities
2Quantity of substance
If traditional venipuncture and manual handling process is used, then adequate blood samples can be collected, but the process is cumbersome and complex
Solution Approach 1:
The system extracts the blood collection and analysis process from the centralized laboratory setting and brings it to the point of care. Minimal blood samples (as little as 100 microliters) are collected using simplified devices, eliminating the need for complex venipuncture procedures and manual handling while maintaining adequate sample volume for testing
Solution Approach 2:
The point-of-care devices are designed to be user-friendly and require minimal training, allowing patients or healthcare providers to perform blood collection and testing themselves. The devices automatically handle sample processing, reducing manual intervention and simplifying the overall process while ensuring adequate sample collection
3Measurement precision
If traditional laboratory infrastructure is used, then accurate test results can be obtained, but the system is slow and burdened by various limitations
Solution Approach 1:
The system transitions from static, batch-processing laboratory operations to dynamic, real-time point-of-care testing. Devices can immediately process samples and provide results, adapting to urgent clinical needs while maintaining accuracy through validated testing methodologies and quality control measures
Solution Approach 2:
The patent replaces manual mechanical processes (venipuncture, manual sample handling, physical transport of samples) with automated electronic systems. Blood samples are collected via simplified methods and analyzed by automated point-of-care devices, with results electronically transmitted, eliminating bottlenecks and improving efficiency while maintaining accuracy through consistent, repeatable processes
Data Source
AI summary
Systems, methods, and devices are provided for clinical laboratory testing using less than 1 mL of sample collected from a subject. Some embodiments collect between 1 mL and about 10 uL of sample from a subject. A method is also provided for analyte testing, wherein a mobile computing device may be used for laboratory test requests and for handling of the analyte testing process.