Rapid assay device

• US 5,212,065 A
• Filed: 10/25/1990
• Issued: 05/18/1993
• Est. Priority Date: 10/25/1990
• Status: Expired due to Fees

• Current Assignee: KM Laboratories Incorporated, International Diagnostic Systems Corp. (Neogen Corporation)
• Original Assignee: KM Laboratories Incorporated, International Diagnostic Systems Corp. (Neogen Corporation)
• Inventors: Pegg, R. Kevin, Saunders, Mary S.
• Primary Examiner(s): Saunders, David
• Assistant Examiner(s): Chin, Christopher L.
• Application Number:
  US07/603,151
• Time in Patent Office: 936 Days
• Field of Search: 422/56-58, 422/61, 422/102, 422/104, 435/7.9, 435/5, 435/7.32, 436/527, 436/530, 436/531, 436/169, 436/805, 436/808
• US Class Current: 435/7.9
• 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: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/808 Automated or kit

Abstract

A rapid immunoassay device comprising a single porous membrane that serves as both a reagent support and a spent reagent reservoir is disclosed. The immunoassay device directs the flow of sample and reagents within the device in a manner that eliminates both lateral diffusion and backflow of reagents without the necessity of additional external means.

Claims

1. An apparatus for use in immunoassay procedures consisting essentially of:

(A) a housing comprising a reservoir member and a base member, said reservoir member defining a cavity, said base member engaging said reservoir member to enclose said cavity, and having

(i) a first surface on said reservoir member facing away from said cavity and a second surface on said reservoir member facing into said cavity;

(ii) an aperture providing an opening through both of said first and second surfaces,

(iii) a first profile provided on said first surface around said aperture,

(iv) at least one vent hole,

(v) a second profile facing said cavity provided on said second surface around said aperture;

(B) a single porous foam member provided in said cavity, wherein a surface of said foam member is deformable by said second profile to produce a depression that surrounds an area on said surface of said foam member; and

(C) a reagent-binding member provided on said surface of said member, wherein no external means to direct the flow of sample and reagents within said apparatus is required.

2. An apparatus according to claim 1, wherein said first profile is conical.

3. An apparatus according to claim 1, wherein said second profile has a circular cross section.

4. An apparatus according to claim 1, wherein said porous foam member is comprised of a material selected from the group consisting of fibers of cellulose or cellulose derivatives, glass, ceramic and non-cellulose hydrocarbon materials.

5. An apparatus according to claim 1, wherein said reagent-binding member is comprised of Staphylococcal protein A.

6. An apparatus according to claim 1, wherein said reagent-binding member is comprised of Staphylococcal protein G.

7. An apparatus according to claim 1, wherein said reagent-binding member is comprised of latex particles.

8. An apparatus according to claim 5, which further comprises antibodies which specifically bind an analyte selected from the group consisting of antibiotics, mycotoxins, drugs of abuse, hormones, and bacterial antigens, said antibodies being bound to said reagent-binding member.

9. An apparatus according to claim 8, wherein said analyte is a coccidiostat.

10. An apparatus according to claim 8, wherein said analyte is sulfamethazine, gentamicin, aflatoxin, zearalenone, monensin, tylosin, opiates, amphetamines, methamphetamines, cocaine, barbiturates, progesterone, human chorionic gonadotropin, or Pasteurella multocida antigen.

11. A kit for determining an analyte in a sample, comprising an apparatus according to claim 8 and, in a separate container, an antibody which specifically binds said analyte and which is conjugated to an enzyme.

12. A kit according to claim 11, wherein said enzyme is horseradish peroxidase, glucose oxidase, or alkaline phosphatase.

13. A kit for determining an analyte in a sample, comprising an apparatus according to claim 8, and, in a separate container, an analyte as recited in claim 8 conjugated to an enzyme.

14. A kit according to claim 13, wherein said enzyme is horseradish peroxidase, glucose oxidase, or alkaline phosphatase.

15. An apparatus according to claim 6, which further comprises antibodies which specifically bind an analyte selected from the group consisting of antibiotics, mycotoxins, drugs of abuse, hormones, and bacterial antigens, said antibodies being bound to said reagent-binder member.

16. An apparatus according to claim 15, wherein said analyte is a coccidiostat.

17. An apparatus according to claim 15, wherein said analyte is sulfamethazine, gentamicin, aflatoxin, zearalenone, monensin, tylosin, opiates, amphetamines, methamphetamines, cocaine, barbiturates, progesterone, human chorionic gonadotropin, or Pasteurella multocida antigen.

18. A kit for determining an analyte in a sample, comprising an apparatus according to claim 15 and, in a separate container, an antibody which specifically binds said analyte and which is conjugated to an enzyme.

19. A kit according to claim 18, wherein said enzyme is horseradish peroxidase, glucose oxidase, or alkaline phosphatase.

20. A kit for determining an analyte in a sample, comprising an apparatus according to claim 15, and, in a separate container, an analyte as recited in claim 15 conjugated to an enzyme.

21. A kit according to claim 20, wherein said enzyme is horseradish peroxidase, glucose oxidase, or alkaline phosphatase.

22. An apparatus according to claim 7, which further comprises antibodies which specifically bind an analyte selected from the group consisting of antibiotics, mycotoxins, drugs of abuse hormones, and bacterial antigens, said antibodies being bound to said reagent-binding member.

23. An apparatus according to claim 22, wherein said analyte is a coccidiostat.

24. An apparatus according to claim 22, wherein said analyte is sulfamethazine, gentamicin, aflatoxin, zearalenone, monensin, tylosin, opiates, amphetamines, methamphetamines, cocaine, barbiturates, progesterone, human chorionic gonadotropin, or Pasteurella multocida antigen.

25. A kit for determining an analyte in a sample, comprising an apparatus according to claim 22 and, in a separate container, an antibody which specifically binds said analyte and which is conjugated to an enzyme.

26. A kit according to claim 25, wherein said enzyme is horseradish peroxidase, glucose oxidase, or alkaline phosphatase.

27. A kit for determining an analyte in a sample, comprising an apparatus according to claim 22, and, in a separate container, an analyte as recited in claim 22 conjugated to an enzyme.

28. A kit according to claim 27, wherein said enzyme is horseradish peroxidase, glucose oxidase, or alkaline phosphatase.