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Publication Number
US-10408828-B2
Publication Date
2019-09-10
Expiration Date
Abstract
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.
Core Innovation
The invention relates to a method of forming a lateral flow test device that includes forming a test device base as a non-strippable article with a floor, a first vertical wall, a second vertical wall, and a recess having a defined width therebetween. The first vertical wall includes one or more first compression structures and the second vertical wall includes one or more second compression structures, where the first and second compression structures define an undercut portion between the first and second vertical wall. Moldable material is introduced into a first mold assembly to form the test device base, and the test device base is removed from the first mold assembly.
A test strip defines a flow path in which a sample applied to a sample receiving region flows through a porous membrane to an absorbent region. The test strip includes a substantially uncompressible and nonabsorbent base layer carrying a first bibulous material at a proximal end to form the sample receiving region and a second bibulous material at a distal end to form the absorbent region, where the second bibulous material is compressible. The porous membrane is disposed on the base layer between the proximal and distal ends and is fluidly connected to the first bibulous material and the second bibulous material.
The porous membrane comprises one or more test zones, each test zone including one or more reagents configured to bind for detection one or more analyte of interest. The method further includes inserting the test strip into the test device base such that the base layer inserts into the undercut portion, and upon completing the insertion, the second bibulous material is contacted by the first compression structures and the second compression structures.
Claims Coverage
The document provides one independent claim. The inventive features focus on a molded non-strippable base with an undercut defined by first and second vertical walls and compression structures, and on inserting a multi-layer test strip so compression structures contact a compressible bibulous material after insertion, in combination with porous membrane test zones with analyte-binding reagents.
Undercut base with compression structures defined by opposing vertical walls
Forming a test device base as a non-strippable article in which a first vertical wall and a second vertical wall define a recess having a defined width, the first vertical wall includes one or more first compression structures, the second vertical wall includes one or more second compression structures, and the first and second compression structures define an undercut portion between the first vertical wall and second vertical wall.
Multi-layer test strip with uncompressible nonabsorbent base and proximal/distal bibulous materials
Providing a test strip comprising a substantially uncompressible and nonabsorbent base layer, a first bibulous material disposed on the base layer at a proximal end forming a sample receiving region, a second bibulous material disposed on the base layer at a distal end forming an absorbent region with the second bibulous material being compressible, and a porous membrane disposed on the base layer between the proximal and distal ends and fluidly connected to the first bibulous material and the second bibulous material, the test strip defining a flow path from sample receiving region through the porous membrane to the absorbent region.
Porous membrane test zones with analyte-binding reagents
Configuring the porous membrane to comprise one or more test zones, each test zone comprising one or more reagents configured to bind for detection one or more analyte of interest.
Insertion such that undercut receives base layer and compression structures contact compressible bibulous material
Inserting the test strip into the test device base such that the base layer inserts into the undercut portion and, upon completing the insertion, the second bibulous material is contacted by the first compression structures and the second compression structures.
Overall, claim coverage centers on a molded non-strippable base with an undercut defined by opposing vertical walls and compression structures, and on inserting a defined porous-membrane test strip so that the compression structures contact the compressible distal bibulous material after insertion while maintaining a flow path and porous membrane test zones with analyte-binding reagents.
Stated Advantages
Improve strip positioning.
Reduce assay imprecision.
Documented Applications
Lateral flow test device manufacturing and assembly in which a molded rigid housing base retains a laminated test strip, including use of internal features for managing flow and capillary edge pooling and for aligning to an instrument for reading.
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