Lateral flow assay with test strip retainer

• US 10,408,828 B2
• Filed: 02/25/2014
• Issued: 09/10/2019
• Est. Priority Date: 02/26/2013
• Status: Active Grant

• Current Assignee: Astute Medical, Inc. (Compagnie Merieux Alliance SAS)
• Original Assignee: Astute Medical, Inc. (Compagnie Merieux Alliance SAS)
• Inventors: Anderberg, Joseph, Van Bosch, John
• Primary Examiner(s): White, Dennis
• Application Number:
  US14/770,451
• Publication Number:
  US 20160011188A1
• Time in Patent Office: 2,023 Days
• CPC Class Codes: B01L 2200/12 Specific details about manufacturing devices
• CPC Class Codes: B01L 2300/043 Hinged closures
• CPC Class Codes: B01L 2300/0609 Holders integrated in container to position an object
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: B29C 2045/4492 preventing damage or deformation of undercut articles during ejection
• CPC Class Codes: B29C 45/44 for undercut articles
• CPC Class Codes: B29C 45/4407 by flexible movement of undercut portions of the articles
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387

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.

Claims

1. A method of forming a lateral flow test device, comprising:

providing a first mold assembly which forms a test device base as a non-strippable article, the test device base comprising on a floor thereof a first vertical wall and a second vertical wall forming a recess having a defined width therebetween, the first vertical wall comprising one or more first compression structures and the second vertical wall comprising one or more second compression structures, wherein the first and second compression structures define an undercut portion between the first vertical wall and second vertical wall;

introducing a moldable material into the first mold assembly to form the test device base;

removing the test device base from the first mold assembly;

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 thereof and forming a sample receiving region,

a second bibulous material disposed on the base layer at a distal end thereof and forming an absorbent region, wherein the second bibulous material is compressible, and

a porous membrane disposed on the base layer between the proximal and distal ends thereof and fluidly connected to the first bibulous material and the second bibulous material,

the test strip defining a flow path wherein a sample applied to the sample receiving region flows through the porous membrane to the absorbent region, wherein the porous membrane comprises one or more test zones, each test zone comprising one or more reagents configured to bind for detection one or more analyte of interest; and

inserting the test strip into the test device base such that the base layer inserts into the undercut portion and such that upon completing the insertion the second bibulous material is contacted by the first compression structures and the second compression structures.

2. A method according to claim 1, further comprising providing a second mold assembly which forms a test device lid comprising a sample receiving aperture and a test aperture;

introducing a moldable material into the second mold assembly to form the test device lid;

removing the test device lid from the second mold assembly; and

mating the test device lid to the test device base such that the sample receiving aperture overlies the first bibulous material and the test aperture overlies the one or more test zones.

3. A method according to claim 2, wherein the first mold assembly and the second mold assembly are configured as a single assembly, wherein the test device base and the test device lid are formed as a unitary part.

4. A method according to claim 3, wherein the test device base and the test device lid are formed as a unitary part connected by a hinge configured to allow the test device lid to mate to the test device base.

5. The method according to claim 2, wherein the first mold assembly further forms a raised platform portion of the test device base configured to underlie the base layer between the proximal and distal ends thereof and to support the test strip without contacting the porous membrane.

6. The method according to claim 2, wherein the second mold assembly further forms one or more first ribs and one or more second ribs in the in the test device lid, the first ribs configured to engage the upper surface of the first bibulous material, and the second ribs configured to engage the upper surface of the second bibulous material.

7. The method according to claim 2, wherein the first compression structures are offset from the second compression structures.

8. The method according to claim 2, wherein the first compression structures and the second compression structures are rounded in profile.

9. The method according to claim 8, wherein the first compression structures and the second compression structures are in the form of a spherical cap.