LATERAL-FLOW POROUS MEMBRANE ASSAY WITH FLOW RATE CONTROL

• US 20100159599A1
• Filed: 12/18/2008
• Published: 06/24/2010
• Est. Priority Date: 12/18/2008
• Status: Abandoned Application

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Yang, Kaiyuan, Song, Xuedong, Feaster, Shawn R., Takeuchi, James M.
• Application Number:
  US12/338,636
• Publication Number:
  US 20100159599A1
• Time in Patent Office: Days
• US Class Current: 436/39
• CPC Class Codes: A61F 13/42 with wetness indicator or alarm
• CPC Class Codes: G01N 33/54386 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
• CPC Class Codes: Y10T 428/18 Longitudinally sectional layer of three or more sections

Abstract

Various modifications to a porous substrate, such as employed in lateral flow assay devices, to regulate or modify the flow rate and/or flow path pattern of a fluid through the porous substrate is described. The lateral flow assay device has a porous substrate matrix in fluid communication with a flow-rate control zone having a number of flow-rate control devices arranged as features in or on a substrate surface or laminates thereof in a body. The flow-rate control devices may include: a density gradient, porosity gradient, ion affinity gradient, micro-channels, and combinations thereof.

Claims

1. A lateral flow assay device comprising:

a first substrate with a porous matrix adapted for conducting lateral flow, said substrate having;

a sample contact zone and a detection zone as part of a buffer pad,

a feedback zone as part of a wicking pad, and

a flow-rate control zone situated downstream of said detection zone and between said detection zone and said feedback zone, physically separating said detection and feedback zones, within said flow-rate control zone are a number of flow-rate control mechanisms constituting either surface features or laminated substrate layers having a plurality or combination of different flow-rate control mechanisms in a body, such that said flow-rate control zone regulates development of a visual signal in said feedback zone, and

each of said zones is in fluidic communication with each other.

3. The device according to claim 1, wherein said flow-rate control mechanisms are selected from the group consisting of:

a density gradient, filter porosity gradient, ion affinity gradient, micro-channels, and combinations thereof.

4. The device according to claim 3, wherein said micro-channels are arranged in a pattern, oriented either in parallel, orthogonal, on a diagonal to a primary direction of lateral flow, or in combination thereof.

5. The device according to claim 3, wherein said micro-channels have either a constant cross-sectional dimension or alternating regions with either an enlarged or constricted channel cross-sectional dimension.

6. The device according to claim 3, wherein said micro-channels have a cross- sectional dimension of from about 0.01 micron to about 60 microns.

7. The device according to claim 6, wherein said micro-channels have a cross-sectional dimension of from about 1 micron to about 40 microns.

8. The device according to claim 3, wherein said micro-channels encourage mixing of fluids.

9. The device according to claim 1, wherein said flow-rate control zone has a combination of layers of laminated substrates, each with a particular physical or chemical property.

2. (canceled)

10. An assay apparatus to monitor specific gravity of a urine sample, the apparatus comprising:

a lateral flow assay format having a porous matrix in fluid communication with a buffer pad, wicking pad, and a flow-rate control zone situated between and physically separating said buffer pad and wicking pad, said flow-rate control zone regulates an amount of time needed for development and appearance of a visual signal in a observation-feedback zone of said wicking pad until a color transition in a detection zone of said buffer pad attains color stability.

11. The assay apparatus according to claim 10, wherein said flow-rate control zone has a porosity gradient differential relative to said adjacent buffer pad or said wicking pad.

12. The assay apparatus according to claim 10, wherein said flow-rate control zone has a number of flow-control devices selected from either:

a micro-channel pattern design, density gradient, ion gradient, degree of filter porosity, or a combination thereof.

13. The assay apparatus according to claim 10, wherein said flow-rate control zone comprises a combination of layers of laminated substrates, each with a particular physical or chemical property.

14. An absorbent article comprising:

a first substrate with a porous matrix adapted for conducting lateral flow, said substrate having a sample contact zone and a detection zone on a buffer pad, feedback zone on a wicking pad, and a flow-rate control zone situated between and physically separating said detection zone and said feedback zone, wherein each of said zones is in fluidic communication with each other, either directly or indirectly by an adjacent component, said flow- rate control zone having a number of flow-rate control mechanisms as surface features or laminated substrate layers thereof, such devices being at least one of the following;

a density gradient, filter porosity gradient, ion affinity gradient, micro-channels, and combinations thereof.

15. The absorbent article according to claim 14, wherein said absorbent article is one of the following:

diapers, adult incontinence products, feminine hygiene products, or absorbent pads.

16. A method for controlling flow rate and time intervals of fluids in a lateral flow assay device, the method comprising:

providing a substrate with a porous matrix in fluid communication with a flow-rate control zone;

forming a number of flow-rate control devices as features in a substrate surface;

and positioning at least one substrate or a plurality of laminated substrate layers thereof together in said flow-rate control zone, said flow-rate control devices being selected from the group consisting of;

a density gradient, porosity gradient, ion affinity gradient, micro-channels, and combinations thereof.

17. The method according to claim 16, wherein said micro-channels are arranged in a pattern, oriented either in parallel, orthogonal, on a diagonal to a primary direction of lateral flow, or in combination thereof.

18. The method according to claim 16, wherein said micro-channels have either a constant cross-sectional dimension or alternating regions with either an enlarged or constricted channel cross- sectional dimension.

19. The method according to claim 16, wherein said flow-rate control zone has a combination of layers of laminated substrates, each with a particular physical or chemical property.

20. The method according to claim 16, wherein said flow-rate control devices are formed according to at least one of the following processes:

cutting with a die, laser etching, chemical etching, or printing reagents on said substrate surface.

21. A method of monitoring dehydration, the method comprises:

providing a later flow strip with a porous matrix in fluid communication with a buffer pad, wicking pad, and a flow-rate control zone situated between said buffer pad and wicking pad;

introducing a test sample to a sample zone on said buffer pad, allowing said sample to travel through a detection zone to said flow-rate control zone before developing a visual signal in an observation-feedback zone;

controlling the flow rate by means of manipulating porosity, density, or ion affinity gradient in a matrix forming at least part of said flow-rate control zone.