Analyte detection device including a hydrophobic barrier for improved fluid flow

• US 5,354,692 A
• Filed: 09/08/1992
• Issued: 10/11/1994
• Est. Priority Date: 09/08/1992
• Status: Expired due to Fees

• Current Assignee: Quidel Corporation
• Original Assignee: Pacific Biotech, Inc. (Quidel Corporation)
• Inventors: Liu, Ping, Newton, Michael, Yang, Hsin M.
• Primary Examiner(s): Scheiner, Toni R.
• Assistant Examiner(s): Chin, Christopher L.
• Application Number:
  US07/941,667
• Time in Patent Office: 763 Days
• Field of Search: 422/55-58, 435/805, 435/970, 436/514, 436/518, 436/527, 436/530, 436/531, 436/169, 436/170, 436/805, 436/810
• US Class Current: 436/514
• 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: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

An immunochromatographic assay device for the detection of an analyte in a liquid sample, the device including a housing that contains an opening for the application of the liquid sample and multiple liquid permeable materials located in the housing that are adapted to receive, treat and facilitate the movement of the sample through the housing; preferably, a first liquid permeable material is adapted to receive the liquid sample; a second liquid permeable material is positioned under the first liquid permeable material; a third liquid permeable material is positioned above the second liquid material; means are provided to prevent liquid communication between the first and third liquid permeable materials; a wicking material, in fluid contact with the third liquid permeable material receives the sample; and reagents are positioned in the housing that display the results of the immunoassay.

Claims

1. An immunochromatographic assay device for detection of an analyte comprising:

a housing having an opening for introduction of a liquid sample;

first liquid permeable material in said housing under said opening to receive a liquid sample introduced through said opening and defining a sample receiving zone;

second liquid permeable material in said housing under said first liquid permeable material in fluid contact with said first liquid permeable material to receive sample from said first liquid permeable material, said second liquid permeable material being absorbent and defining a sample transport zone;

third liquid permeable material in said housing adjacent said first liquid permeable material and in fluid contact with said second permeable material to receive sample from said second liquid permeable material, said third liquid permeable located on top of said second liquid permeable material;

a barrier comprising a hydrophobic material interposed between said first and third liquid permeable materials to prevent direct transfer of sample from said first liquid permeable material to said third liquid permeable material;

an elongated sheet of wicking material in fluid contact with said third liquid permeable material in fluid contact with said third liquid permeable material to receive sample therefrom, wherein said elongated sheet of wicking material supports an immobilized capture molecule for said analyte; and

a detecting reagent located in one of said liquid permeable materials to detect the presence of bound analyte in said elongated sheet of wicking material.

2. The assay device of claim 1, wherein said first and third liquid permeable materials and said hydrophobic material are physically joined together into an integral sheet which is separate from said second liquid permeable material.

3. The assay device of claim 1, wherein said first liquid permeable material is porous thermoplastic polymer.

4. The assay device of claim 3, wherein said third liquid permeable material is porous thermoplastic polymer.

5. The assay device of claim 4, wherein said porous thermoplastic polymer is high density polyethylene.

6. The assay device of claim 4, wherein said first liquid permeable material has a pore size that is smaller than the pore size of said third liquid permeable material.

7. The assay device of claim 1, wherein said first liquid permeable material has a pore size of not greater than about 300 microns and acts to filter said sample.

8. The assay device of claim 1, further comprising an absorbent material in fluid contact with an end of said wicking material which is distal from the end of said wicking material which is in fluid contact with said third liquid permeable material.

9. The assay device of claim 1, wherein said first liquid permeable material has a sufficient pore size to filter said liquid sample or contains a reagent to pretreat said liquid sample.

12. The assay device of claim 9, wherein said liquid sample is pretreated with immobilized antibody in said first liquid permeable material from an animal immunized with a control fluid sample from a human, said control fluid sample comprising a negative control specimen, wherein said control fluid sample does not contain said analyte, said control fluid sample thereby testing negative in an assay performed with said immunochromatographic assay device.

10. An immunocromatographic assay device for detection of an analyte in a liquid sample comprising a housing, a sample receiving zone in said housing, an elongated sheet of wicking material in fluid communication with said sample receiving zone, wherein said elongated sheet of wicking material supports an immobilized capture molecule for said analyte, and a detecting reagent located in said sample receiving zone to detect the presence of bound analyte in said elongated sheet of wicking material, said sample receiving zone comprising a sample treatment pad having a first liquid permeable material for receiving the liquid sample, a second liquid permeable material in fluid communication with said first liquid permeable material in order to receive sample from said first liquid permeable material, and a third liquid permeable material in fluid communication with said second liquid permeable material and adjacent said first liquid permeable material, wherein a barrier comprising a hydrophobic material is interposed between said first and third liquid permeable materials to prevent direct transfer of sample from said first liquid permeable material to said third liquid permeable material.

11. The assay device of claim 10, wherein said first liquid permeable material has a sufficient pore size to filter said liquid sample or contains a reagent to pretreat said liquid sample.

13. The assay device of claim 10, wherein said liquid permeable material is a porous thermoplastic polymer.

14. The assay device of claim 10, wherein said hydrophobic means is polypropylene hot melt adhesive.

15. The assay device of claim 10, wherein said hydrophobic means is a liquid-impermeable thermoplastic polymer.

16. The assay device of claim 10, wherein a further improvement comprises means for preventing flooding in said assay device.

17. The assay device of claim 16, wherein said means for preventing flooding is a divider that controls the flow of liquid from said liquid permeable materials to said wicking material.

18. The assay device of claim 17, wherein said means for preventing flooding flow includes a depression adjacent to said divider to collect liquid pooling in the housing.

19. The assay device of claim 10, wherein said housing additionally comprises at least two support rails extending in the direction of fluid flow for supporting said wicking material, said support rails defining at least one recess between said support rails wherein excess liquid can pool.

20. The assay device of claim 10, wherein said third liquid permeable material has a sufficient pore size to filter said liquid sample or contains a reagent to pretreat said liquid sample.

21. A sample treatment pad for use in an immunochromatographic assay device comprising at least

a first liquid permeable material;

a second liquid permeable material in fluid contact with said first liquid permeable material in order to receive sample from said first liquid permeable material, said second liquid permeable material being absorbent and defining a sample transport zone;

a third liquid permeable material adjacent said first liquid permeable material and in fluid contact with said second liquid permeable material in order to receive sample from said second liquid permeable material; and

a barrier comprising a hydrophobic material interposed between said first and third liquid permeable materials to prevent direct transfer of sample from said first liquid permeable material to said third liquid permeable material.

22. The sample treatment pad of claim 21, wherein at least one of said liquid permeable materials is a porous thermoplastic polymer.

23. The sample treatment pad of claim 21, wherein said hydrophobic barrier is polypropylene, silicone, or rubber.

24. The sample treatment pad of claim 21, wherein said hydrophobic barrier is high density polyethylene.

25. The sample treatment pad of claim 21, wherein at least one of said liquid permeable materials is a glass fiber pad.