Biofluid Diagnostic Screening System Using Imaging Analysis
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Solution Overview
Problem
There is a need for a consumer-friendly, biofluid-based diagnostic screening system that allows patients to perform tests independently without the direct assistance of a medical service provider, enabling convenient and self-administered medical diagnostics.
Innovation Solution
A biofluid-based diagnostic screening system comprising a lateral flow test strip with a sample pad, a detection zone containing biological components for analyte detection, and an identification code for determining the test type. The system includes a test housing for positioning the test strip and an imaging device for capturing images and calculating analyte concentrations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a traditional laboratory-based biofluid testing system is used, then measurement precision and reliability are improved, but device complexity and ease of operation deteriorate due to requiring medical service provider assistance and laboratory infrastructure
Solution Approach 1:
The system enables patients to independently perform biofluid testing without medical service provider assistance. The imaging device automatically captures images of the test strip, processes the images to determine analyte concentrations, and communicates results to the patient or provider, making the entire testing process self-service oriented
Solution Approach 2:
The patent replaces manual laboratory analysis with an automated imaging-based detection system. The image capture device and image processing algorithms substitute for traditional mechanical and manual laboratory procedures, enabling accurate analyte detection while simplifying operation for patients
2Measurement precision
If traditional laboratory-based testing is used, then measurement precision is improved, but loss of time increases due to patient travel and scheduling requirements for follow-up visits
Solution Approach 1:
Patients can perform monitoring tests at home without scheduling follow-up visits, eliminating travel time and waiting time. The system maintains measurement precision while allowing patients to conduct tests on their own schedule, significantly reducing time loss
Solution Approach 2:
The imaging device and image processing system serve as intermediaries that bridge laboratory-quality testing with home-based convenience. This intermediary technology enables accurate biomarker measurement without requiring physical presence in a laboratory, reducing time loss while maintaining precision
3Ease of operation
If a simplified home-testing system is used, then ease of operation is improved, but measurement precision and reliability deteriorate
Solution Approach 1:
Manual interpretation and subjective assessment are replaced with automated image capture and objective image processing algorithms. This substitution ensures consistent, reliable results while maintaining ease of operation for patients
Solution Approach 2:
The system provides automated feedback through image processing that objectively determines analyte concentrations based on captured images. This feedback mechanism ensures reliable and consistent interpretation of test results, maintaining high reliability while simplifying operation
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
The system enables patients to perform biofluid tests conveniently and accurately, providing analyte concentration values that can be communicated to patients or medical service providers, facilitating timely and informed medical decisions.
Implementation Method 1
a lateral flow test strip providing a rigid backing on which is positioned an at least one sample pad configured for receiving and absorbing a volume of the patient's biofluid, a corresponding at least one detection zone containing an at least one biological component for detecting a presence or absence of an at least one target analyte
Implementation Method 2
an at least one sample pad configured for receiving and absorbing a volume of the patient's biofluid
Implementation Method 3
an imaging device for capturing images and calculating analyte concentrations
Data Source
AI summary
A biofluid-based diagnostic screening system and associated methods are disclosed for screening a volume of biofluid of a patient for an at least one medical condition. In at least one embodiment, the system provides a lateral flow test strip, a test housing sized and configured for removably receiving the test strip therewithin, and a user application residing locally in memory on an imaging device and configured for screening a volume of biofluid of a patient, as deposited on the test strip, for an at least one medical condition.