Lateral Flow Test Timing Mechanism for Incubation-Insensitive Readout
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Solution Overview
Problem
Existing lateral flow assay devices read by instruments face issues with timing, as they may be read after excessive incubation, leading to invalid or incorrect results due to superior sensitivity of the instrument detecting signals beyond the desired cut-off value.
Innovation Solution
A system comprising a test device with two populations of detectable particles and an analyzer that uses an optical system to determine a cut-off value, independent of incubation time, by calculating a ratio or transforming signals from these particles to accurately detect the presence or absence of an analyte.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If the test device is read after excessive incubation time, then the instrument's superior sensitivity can detect signals, but the results become invalid or incorrect due to detecting signals beyond the desired cut-off value
Solution Approach 1:
The system uses a timer mechanism that provides feedback to the user about the incubation time elapsed. The timer starts when the sample is applied and stops when the incubation period is complete, allowing the user to know when to read the test result to ensure both sensitivity and validity.
Solution Approach 2:
The test device incorporates an integrated timer that automatically tracks the incubation time without requiring external intervention. The timer is built into the device housing and provides audible or visual signals to indicate when incubation is complete, enabling the device to serve itself in managing the timing criticality.
2Ease of operation
If the user waits longer to read the test result, then more label accumulates at the test and control lines improving visibility, but the results become invalid due to excessive incubation
Solution Approach 1:
The timer provides real-time feedback to the user about how long the sample has been incubating. This feedback mechanism helps the user understand when to read the test result to achieve optimal visibility while avoiding excessive incubation time.
Solution Approach 2:
The timer is activated immediately when the sample is applied to the test device, starting the countdown before the user needs to read the result. This preliminary timing action ensures the user knows the exact moment to read the test for optimal performance.
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 provides accurate and reliable analyte detection by rendering the results insensitive to incubation time, ensuring valid and timely analysis of samples within a 3-10 minute period.
Implementation Method 1
The detectable substance to which the specific binding members are associated may be a fluorescent or luminescent compound
Implementation Method 2
The detectable substance to which the specific binding members are associated may be a fluorescent or luminescent compound
Implementation Method 3
the capillary properties of the strip transports the liquid sample along the strip
Data Source
AI summary
A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device. The test device and apparatus interact to provide a timer feature for determining a test device specific adjustable cut-off value that is used to ascertain whether signal from a test line in the device corresponds to a positive or negative results, irrespective of the time elapsed since placement of sample on the test device. The adjustable cut-off value renders the system relatively insensitive to incubation time of the test device, where if the incubation time is shorter or longer than needed for accuracy of a test result, the analyzer will report an invalid result, thus preventing the reporting of an incorrect (false negative or false positive) result.