Assay devices comprising a porous capture membrane in fluid-withdrawing contact with a nonabsorbent capillary network

• US 6,297,060 B1
• Filed: 02/11/1999
• Issued: 10/02/2001
• Est. Priority Date: 03/12/1990
• Status: Expired due to Term

• Current Assignee: BIOSITE INCORPORATED (Abbott Laboratories Incorporated)
• Original Assignee: Biosite Diagnostics Incorporated (Abbott Laboratories Incorporated)
• Inventors: Nowakowski, Mark R., Buechler, Kenneth F., Valkirs, Gunars E., Anderson, Richard R.
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US09/249,321
• Time in Patent Office: 964 Days
• Field of Search: 422/55-58, 422/61, 435/287.1, 435/287.2, 435/287.9, 435/287.7, 435/287.8, 435/805, 435/810, 435/970, 436/169, 436/170, 436/514, 436/518, 436/805, 436/810
• US Class Current: 436/518
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• 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 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 435/975 Kit
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

Devices for use in heterogeneous ligand-receptor assays, having a porous member in contact with a nonabsorbent textured surface, where the surface texturing is such that a capillary network is formed when in fluid communication with the porous member. More particularly, these devices comprise:

(a) a porous member having (i) at least one binding agent capable of immobilizing at least one target ligand on the porous member from a fluid sample in at least one zone and (ii) a means for detecting the presence or amount of said target ligand as a result of the assay process; and

(b) a nonabsorbent member in fluid communication with the porous member, the nonabsorbent member forming at least one capillary with the porous member so that when sample, alone or in combination with other fluids, is added to the porous member, fluid is drawn through the porous member.

Claims

1. A device for performing a heterogeneous assay, comprising:

(a) a porous member having (i) a means for physically entrapping at least one target ligand on said porous member from a fluid sample in at least one zone and (ii) a means for detecting the presence or amount of said target ligand as a result of the assay process; and

(b) a first nonabsorbent member in fluid communication with said porous member, said first nonabsorbent member forming at least one capillary with said porous member so that when sample, alone or in combination with other fluids, is added to said porous member, fluid is drawn through said porous member.

2. A device according to claim 1, wherein said means for physically entrapping at least one target ligand comprises at least one binding agent immobilized in at least one zone of said porous member.

3. A device according to claim 1, wherein said device further comprises a second nonabsorbent member disposed substantially above or around the porous member, the second nonabsorbent member comprising a first fluid opening and a second fluid opening, the first fluid opening providing access to a first region of the porous member, and the second fluid opening providing access to a second region of the porous member.

4. The device according to claim 3, wherein said first fluid opening in said second nonabsorbent member is located above an extremity of the porous member such that fluid introduced into the first fluid opening traverses the porous member.

5. The device of claim 4, wherein the second fluid opening in said second nonabsorbent member is located above a medial portion of the porous member.

6. The device of claim 5, wherein fluid introduced into the second fluid opening flows within, and along an outer surface of, the porous member.

7. The device of claim 4, wherein the extremity of the porous member extends beyond a perimeter of a textured surface of the first nonabsorbent member.

8. The device of claim 7, wherein the extremity of the porous member does not participate in forming the capillary formed by the porous member and the first nonabsorbent member.

9. The device of claim 8, wherein the fluid introduced into the first fluid opening traverses the porous member to a region of the porous member distal to the first fluid opening.

10. The device of claim 9, wherein fluid introduced into the first fluid opening remains substantially confined within the porous member when the volume of fluid introduced into the device is less than or equal to the void volume of the porous member.

11. The device of claim 7, wherein a lower surface of the extremity of the porous member extending beyond the perimeter of the textured surface of the first nonabsorbent member is sealed to prevent fluid passage through the lower surface.

12. The device of claim 3, wherein the first fluid opening is located at an extremity of the first nonabsorbent member, such that fluid introduced into the first fluid opening traverses the extremity of the first nonabsorbent member to contact the first region of the porous member.

13. The device of claim 12, wherein the second fluid opening is located above a medial portion of the porous member.

14. The device of claim 13, wherein fluid introduced into the second fluid opening flows within, and along the outer surface of, the porous member.

15. The device of claim 12, wherein the extremity of the first nonabsorbent member extends beyond a perimeter of the porous member.

16. The device of claim 12, wherein the extremity of the first nonabsorbent member does not participate in forming the capillary formed by the porous member and the first nonabsorbent member.

17. The device of claim 12, wherein the fluid introduced into the first fluid opening flows from the extremity of the first nonabsorbent member to the capillary formed by the porous member and the first nonabsorbent member.

18. A device according to claim 1, wherein said means for physically entrapping at least one target ligand comprises at least one pore for physically said at least one target ligand.