Lateral flow assay with test strip retainer

• US 10,670,596 B2
• Filed: 08/06/2019
• Issued: 06/02/2020
• 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:
  US16/533,272
• Publication Number:
  US 20200033337A1
• Time in Patent Office: 301 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 lateral flow test device system, comprising:

a test strip, the test strip comprising;

a substantially uncompressible base layer, and

a compressible bibulous material disposed on the base layer for absorbing a fluid sample; and

a base, the base comprising;

a floor,

a first vertical wall extending from the floor, and

a second vertical wall extending from the floor,

wherein a recess configured for receiving the test strip is formed between the first and second vertical walls,

wherein the first vertical wall comprises a first engagement structure and the second vertical wall comprises a second engagement structure and the first and second engagement structures define a space within the recess between the engagement structures and the floor, the space being configured to receive the base layer of the test strip, and

wherein the first and second engagement structures are configured to contact the bibulous material without contacting the base layer when the base layer is received within the space so as to properly position the test strip within the base for testing the fluid sample.

2. The lateral flow test device system of claim 1, wherein the bibulous material is one of a first bibulous material and a second bibulous material disposed on the base layer and wherein a porous membrane disposed on the base layer fluidly connects the first and second bibulous materials such that the test strip defines a lateral flow path wherein a sample applied to the first bibulous material flows through the porous membrane to the second bibulous material.

3. The lateral flow test device system of claim 2, wherein the porous membrane comprises a reagent configured to bind for detection of an analyte of interest in the fluid sample.

4. The lateral flow test device system of claim 2, further comprising a lid configured to mate with the base, wherein the lid comprises a sample receiving aperture configured to overlie the first bibulous material and a test aperture configured to overlie the porous membrane.

5. The lateral flow test device system of claim 4, wherein the first and second engagement structures are configured to contact the second bibulous material.

6. The lateral flow test device system of claim 4, wherein the base and the lid are connected by a hinge.

7. The lateral flow test device system of claim 4, wherein the lid comprises a first rib configured to engage an upper surface of the first bibulous material and a second rib configured to engage an upper surface of the second bibulous material.

8. The lateral flow test device system of claim 2, wherein one or both of the first and second bibulous materials at least partially overlies the porous membrane.

9. The lateral flow test device system of claim 2, wherein the porous membrane is a nitrocellulose membrane laminated to a mylar support film.

10. The lateral flow test device system of claim 2, wherein the first bibulous material is configured to define a predetermined sample volume to be analyzed by the lateral flow test device system.

11. The lateral flow test device system of claim 2, wherein the base further comprises a raised platform vertically elevated above the floor and configured to seat a portion of the base layer of the test strip below the porous membrane and wherein the platform is positioned entirely outside of the recess.

12. The lateral flow test device system of claim 1, wherein the base further comprises a raised platform vertically elevated above the floor and configured to seat the base layer of the test strip.

13. The lateral flow test device system of claim 1, wherein the first engagement structure is offset from the second engagement structure in a longitudinal direction transverse to a vertical direction in which the first and second vertical walls extend.

14. The lateral flow test device system of claim 1, wherein the first and second engagement structures are each rounded in profile.

15. The lateral flow test device system of claim 14, wherein the first and second engagement structures are each in the form of a spherical cap.

16. The lateral flow test device system of claim 1, wherein the first and second engagement structures comprise one or more of ribs, bars, frustums, or protrusions, the protrusions being round on a top side away from the floor and flat on a bottom side near the floor.

17. The lateral flow test device system of claim 1, wherein the lateral flow test device system is configured such that the first and second engagement structures compress the compressible bibulous material when the uncompressible base layer is received within the space.

18. The lateral flow test device system of claim 1, wherein a width of the recess extending between the first and second vertical walls is approximately equal to a width dimension of the base layer.

19. The lateral flow test device system of claim 1, wherein the bibulous material comprises cellulose, nitrocellulose, polyvinylidine fluoride, charge modified nylon, polyethersulfone, porous polyethylene, or glass fiber.

20. The lateral flow test device system of claim 1, wherein the base layer of the test strip comprises polypropylene, polystyrene, or polymethylmethacrylate.