Lateral Flow Test Strip Retainer Using Housing Undercuts
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Solution Overview
Problem
Lateral flow assay devices face challenges in maintaining the test strip in position within the device, leading to unpredictable flow paths and reduced sensitivity due to aberrant liquid movement, which contributes to assay imprecision.
Innovation Solution
The use of an undercut feature in the housing base to retain the test strip, engaging the bibulous material through compression and friction, ensuring accurate positioning and stable flow through the device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If pressure bars are used to maintain test strip position, then test strip positioning is improved, but device complexity increases
Solution Approach 1:
The patent removes the separate pressure bar component from the device design. Instead of using pressure bars to maintain test strip positioning, the invention integrates the positioning function directly into the housing structure through molded retention features, thereby eliminating the need for separate pressure bar components while maintaining positioning precision
Solution Approach 2:
The patent combines the positioning function with the housing structure by integrating retention features directly into the molded housing. The housing now serves dual purposes: providing structural support and actively retaining the test strip through built-in features such as recesses, channels, or protrusions, eliminating the need for separate positioning components
2Device complexity
If test strip positioning is not maintained, then device complexity is reduced, but measurement precision deteriorates
Solution Approach 1:
The patent incorporates retention features directly into the molded housing structure during manufacturing. These features are pre-formed as integral parts of the housing, ensuring that the test strip is properly positioned and secured before the device is even assembled or used, thereby preventing positioning drift that would compromise assay precision
Solution Approach 2:
The housing structure provides self-retention capabilities through integrated features such as recesses, channels, or protrusions that automatically hold the test strip in the correct position. The device structure itself serves the dual function of both housing and positioning, eliminating the need for additional positioning mechanisms
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 retention of the test strip, reducing coefficient of variation (CV) to less than 10% and improving assay sensitivity by controlling fluid flow effectively.
Implementation Method 1
One or more features in the housing base which create the undercut are configured to engage the bibulous lateral flow material by compression
Implementation Method 2
One or more features in the housing base which create the undercut are configured to engage the bibulous lateral flow material by compression and/or friction
Implementation Method 3
The sample flows along the lateral flow matrix, and one or more analyte components to be detected in the sample react with at least one reagent
Data Source
AI summary
It is an object of the present invention to provide improved methods and compositions for manufacture and use of lateral flow test devices. In particular, the present invention provides a molding method which provides one or more features in the housing base configured to retain the test strip within the base. These features are provided as undercuts in the housing base. The test strip is configured as a bibulous lateral flow material disposed on a substantially non-compressible base layer, and the base layer is positioned within the undercut in order to retain the test strip in the housing base. Optionally, one or more features in the housing base which create the undercut are configured to engage the bibulous lateral flow material by compression and/or friction, thereby increasing the ability of the base to maintaining the test strip in its proper position within the device.