Lateral Flow Assay Device External Data Integration
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Solution Overview
Problem
Current in-vitro diagnostic (IVD) devices are limited in their ability to receive and utilize external data, lack network connectivity for data transmission beyond a local area, and require manual intervention for result storage and analysis, restricting their capability to provide accurate and comprehensive diagnostic information.
Innovation Solution
The system enables IVD devices to connect to public networks, such as cellular networks, to receive and transmit data externally, allowing for the integration of additional information to augment test results, and facilitates automatic data upload and analysis through a centralized server for enhanced diagnostic capabilities and data management.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If IVD devices are configured to report, store, and transmit diagnostic information determined solely from diagnostic tests and manual entry, then device simplicity is maintained, but data accuracy and comprehensiveness deteriorate due to limited data sources and potential manual entry errors
Solution Approach 1:
The patent introduces an intermediary system (centralized server or cloud platform) that receives diagnostic information from the IVD device and combines it with external data sources. This mediator handles the complexity of data integration, allowing the IVD device itself to remain relatively simple while achieving enhanced data accuracy through external information aggregation and validation.
Solution Approach 2:
The system enables the IVD device to access multiple data sources (external databases, electronic health records, laboratory information systems) through standardized communication interfaces. This multi-functionality allows the device to retrieve and utilize diverse data types without requiring separate specialized systems for each data source, improving data comprehensiveness while managing complexity through universal protocols.
2Adaptability or versatility
If IVD devices lack network connectivity, then device simplicity and reliability are maintained, but data transmission capability and remote analysis capability deteriorate
Solution Approach 1:
The patent employs an intermediary server or gateway that manages network communications between IVD devices and external systems. This mediator handles the complexity of network protocols, data formatting, and communication protocols, allowing the IVD device to gain network connectivity capabilities without incorporating complex communication hardware and software directly into the device itself.
Solution Approach 2:
The system extracts network communication functions from the IVD device and places them in a separate external system (server, cloud platform, or gateway). This extraction allows the IVD device to achieve data transmission capability while maintaining its core simplicity, as the complex networking infrastructure is housed externally rather than within the device.
3Productivity
If manual intervention is required for result storage and analysis, then device simplicity is maintained, but productivity and time efficiency deteriorate
Solution Approach 1:
The patent implements self-service automation where the IVD device automatically transmits diagnostic results to external systems, retrieves additional data, and performs preliminary analysis without requiring manual intervention. The system autonomously handles data exchange, storage, and initial processing, significantly improving productivity while maintaining appropriate levels of automation that enhance rather than replace human oversight where needed.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This solution enhances the accuracy and reliability of diagnostic results by incorporating external data and enables remote analysis and storage of test data, improving the effectiveness and utility of IVD devices by allowing them to connect directly to networks for data exchange and aggregation.
Implementation Method 1
the test sample flows along a solid substrate via capillary action
Data Source
AI summary
A system and method for augmenting or adding to the information used by an in-vitro diagnostic or other diagnostic device to generate results of a test is disclosed. A diagnostic device is capable of generating test results based on a sample, such as a sample provided by a patient, and is also capable of receiving additional information to enhance the results providable by the device. For example, an in-vitro diagnostic device is configured to read a lateral flow assay test, and is configured to receive additional diagnostic, network, test identification, or environmental information over a network. Using both the result of the diagnostic test and the additional information, the disclosed device provides more thorough, accurate, and reliable diagnostic information. The results generated by the device may be communicated to an appropriate remote device to enhance the results obtainable by such tests.