Flow control technique for assay devices

• US 8,124,421 B2
• Filed: 12/15/2010
• Issued: 02/28/2012
• Est. Priority Date: 04/29/2005
• Status: Active Grant

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Feaster, Shawn Ray, Yang, Kaiyuan
• Primary Examiner(s): Mui, Christine T
• Application Number:
  US12/968,366
• Publication Number:
  US 20110097734A1
• Time in Patent Office: 440 Days
• Field of Search: 436/169, 436/518, 422/56, 435/11, 435/7.1, 435/4
• US Class Current: 436/169
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• 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

A method for controlling fluid flow in an assay device that employs a membrane is provided. Specifically, one or more recessed regions are formed in the membrane by applying a solvent treatment thereto. The solvent treatment is selected based on its particular dissolving capacity for the material used to form the membrane. For example, an alcohol-based solvent, such as methanol, may be used as a solvent for nitrocellulose membranes. Upon contact with the solvent treatment, a recessed region is formed that may serve a variety of different functions relating to flow control. In one particular embodiment, the recessed region may function as a metering channel that is capable of delivering a controlled volume of the test sample to a detection zone upon initiation of the assay.

Claims

1. A method for forming a lateral flow assay device for detecting the presence or absence of an analyte within a test sample, the method comprising:

applying a solvent treatment to a membrane, the solvent treatment having a sufficient dissolving capacity for the membrane so that at least one recessed metering channel is formed therein that is configured to receive the test sample;

immobilizing an immunoreactive receptive material on the membrane to form a detection zone, wherein the receptive material is capable of binding to detection probes or conjugates thereof to facilitate detection of an analyte that is suspected to be present within a test sample; and

providing a diluent that is configured to flow laterally from a location upstream from the metering channel until contacting the test sample within the metering channel and facilitating the lateral flow thereof through the pores of the membrane to the detection zone.

2. The method of claim 1, wherein the solvent treatment comprises an active solvent.

3. The method of claim 2, wherein the solvent treatment further comprises a co-solvent selected from the group consisting of active solvents and latent solvents.

4. The method of claim 3, wherein the active solvent is present in the treatment composition in an amount greater than about 50 vol. %.

5. The method of claim 1, wherein the solvent treatment comprises a glycol, glycol ether, ether, alcohol, triglycerides, ketone, ester, amide, nitrile, sulfoxide, or sulfone.

6. The method of claim 1, wherein the solvent treatment comprises acetone, methyl ethyl ketone, methyl isobutyl ketone, ethyl acetate, butyl acetate, methoxy propyl acetate, methyl glycol ether, ethyl glycol ether, isopropyl glycol ether, methanol, or ethanol.

7. The method of claim 1, wherein the solvent treatment comprises methanol.

8. The method of claim 1, wherein the membrane is formed from a polymeric material selected from the group consisting of nitrocellulose, polyether sulfone, polyethylene, nylon, polyvinylidene fluoride, polyester, and polypropylene.

9. The method of claim 1, wherein the membrane is formed from nitrocellulose.

10. The method of claim 1, wherein the solvent treatment is applied by spraying, printing, using a pipette, air brushing, or metering with a dispensing pump.

11. The method of claim 1, wherein the solvent treatment is applied in an amount of from about 0.01 to about 10 microliters per centimeter in width of the membrane.

12. The method of claim 1, wherein the solvent treatment is applied in an amount of from about 0.5 to about 5 microliters per centimeter in width of the membrane.

13. The method of claim 1, wherein a plurality of discrete metering channels are formed in the membrane.

14. The method of claim 1, wherein the metering channel having a width that is the same or substantially equal to the width of the membrane.

15. The method of claim 1, wherein the solvent treatment further comprises a hydrophilic wetting agent, an agglutinating agent, or combinations thereof.

16. The method of claim 1, further comprising providing a bridging member that is configured to be placed over the metering channel.

17. The method of claim 1, wherein the immunoreactive receptive material includes an antibody or antigen.

18. The method of claim 1, further comprising providing the detection probes in fluid communication with the membrane.

19. The method of claim 18, wherein the detection probes are positioned on a conjugate pad that is in contact with the membrane.

20. A lateral flow assay device formed by the method of claim 1.