Assay Device Sample Detection Feedback
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Solution Overview
Problem
Current assay devices, such as lateral flow assay devices, often fail to provide users with immediate feedback on whether a sufficient sample has been applied, leading to incorrect test results and user frustration, especially during urine sampling where controlling the sample volume is challenging.
Innovation Solution
Incorporating a sample detection element, such as a pair of electrodes, into the assay device that provides feedback to the user during the sampling event by detecting fluid at a specific point along the assay flow path, ensuring sufficient sample is applied without requiring the user to remove the wick from the urine stream.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a lateral flow assay device is used without additional monitoring means, then the device structure remains simple and easy to manufacture, but the user cannot receive immediate feedback on sample sufficiency leading to potential test failure
Solution Approach 1:
The patent incorporates a monitoring means that detects sample flow and provides immediate feedback to the user through visual indicators (such as LED lights or display screens) showing whether sufficient sample has been applied. This feedback mechanism ensures the user knows when to stop sampling, preventing both insufficient and excessive sampling, thereby improving test reliability without requiring complex manual monitoring procedures
Solution Approach 2:
The device automatically monitors sample flow and determines when sufficient sample has been applied without requiring user intervention or manual assessment. The monitoring means self-regulates the sampling process by providing automatic feedback, allowing the device to serve itself in determining sampling adequacy rather than relying on user judgment
2Loss of information
If the user manually monitors sample application, then feedback can be provided, but the user must remove the wick from the urine stream to check sample volume which interrupts the sampling process
Solution Approach 1:
The monitoring means continuously detects sample flow throughout the sampling process and provides ongoing feedback to the user via visual indicators without requiring the user to remove the wick from the urine stream. This allows real-time information about sample sufficiency to be conveyed while sampling continues uninterrupted
Solution Approach 2:
The monitoring means acts as an intermediary between the sampling process and the user, translating the physical act of sampling into visual feedback signals. This intermediary device communicates sample status information without requiring direct user observation of the sampling process, eliminating the need to remove the wick
3Productivity
If no monitoring means is included, then manufacturing cost and device complexity remain low, but insufficient sampling occurs leading to wasted test devices
Solution Approach 1:
The monitoring means provides immediate feedback to users about sample sufficiency, enabling them to stop sampling at the appropriate moment. This prevents wasted test devices caused by insufficient sampling while not requiring excessive complexity in the monitoring system
Solution Approach 2:
The device automatically determines when sufficient sample has been applied through its monitoring means, eliminating the need for user judgment or manual assessment. This self-service approach maximizes test device utilization by ensuring adequate sampling without requiring complex user instructions or manual monitoring
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 solution ensures that users receive immediate feedback on sample sufficiency, reducing the likelihood of incorrect test results and user error, particularly during midstream urine sampling, by indicating when a sufficient amount of sample has been applied, thus improving the reliability of the testing process.
Implementation Method 1
a sample detection element (13) that is in contact with the assay flow path, located upstream of the analyte detection zone (30) and is adapted to detect fluid at a particular point along the assay flow path
Data Source
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AI summary
The present invention provides an assay device for detecting an analyte in a fluid sample, comprising: a sample receiving member (1), which is fluidically connected to at least two components (2, 3) defining an assay flow path, at least one of which is a detection member (3) comprising an analyte detection zone (31); and a sample detection element (13) adapted to detect fluid at a particular point along the assay flow path. The present invention also provides the use of the assay device of the invention for indicating sample sufficiency when the assay device is exposed to a fluid sample and for indicating to a user after sampling that the device has failed due to insufficient sampling, and a method of alerting a user to the fact that a sufficient sample has been applied to an assay device of the invention.