Multiple port assay device

• US 4,981,786 A
• Filed: 09/04/1987
• Issued: 01/01/1991
• Est. Priority Date: 09/04/1987
• Status: Expired due to Term

• Current Assignee: DADE Behring Beteiligungs GmbH (Siemens AG)
• Original Assignee: Syntec Incorporated (Atos SE)
• Inventors: Dafforn, Geoffrey A., Kurn, Nurith, Ullman, Edwin F., Becker, Martin
• Primary Examiner(s): Nucker, Christine
• Application Number:
  US07/094,176
• Time in Patent Office: 1,215 Days
• Field of Search: 436/514, 436/541, 436/810, 422/55-58, 422/101, 422/102, 435/7, 435/805, 435/810
• US Class Current: 435/7.92
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• 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 33/54388 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 435/81 Packaged device or kit
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

A device is disclosed for conducting an assay. The device comprises a housing, means enclosed in the housing for capturing a first member of a specific binding pair (sbp) in a zone and for allowing liquid to be transported by capillary action away from the zone, first means in the housing for introducing the sample into the device, and second means in the housing other than the first means for introducing a liquid reagent other than the sample into the device. The device of the invention finds use in assay methods for the determination of an analyte in a sample suspected of containing the analyte. Kits for conducting an assay are also disclosed.

Claims

1. A device for conducting an assay, said device comprising:

(a) a housing,

(b) means enclosed in said housing for capturing a first member of a specific binding pair (sbp) in a zone and for allowing liquid to be transported by capillary action away from said zone,

(c) first inlet means in said housing for introducing a sample into the device, and

(d) second inlet means in said housing for introducing liquid reagent other than said sample into the device without also introducing said liquid reagent through said first inlet means.

a portion of said means for capturing being in liquid receiving relationship with said first inlet means and said second inlet means.

2. The device of claim 1 wherein the means for capturing comprises a bibulous material that is immunosorbing or is capable of being rendered immunosorbing.

3. The device of claim 2 wherein said bibulous material has a member of a specific binding pair (sbp) bound thereto.

4. The device of claim 3 wherein said sbp member is an antibody or an antigen.

5. The device of claim 2 wherein a second piece of bibulous material is in liquid receiving relationship with said bibulous material.

6. The device of claim 5 wherein said bibulous material is composed of glass fibers.

7. The device of claim 1 which further includes one or more reagents confined for subsequent release in at least one container enclosed in said housing for conducting an assay method for the determination of an analyte in a sample.

8. The device of claim 7 wherein said reagent or reagents are contained in a water insoluble breakable container.

9. The device of claim 8 wherein said reagent or reagents are in an aqueous medium.

10. The device of claim 9 wherein said medium comprises a member of a signal producing system capable of generating a signal in relation to the amount of an analyte in the sample.

11. The device in claim 7 wherein said reagent or reagents are in an aqueous wash solution.

12. The device of claim 2 wherein said bibulous material has in contact with it a dry, water dispersible, sbp member conjugated to a label.

13. The device of claim 12 wherein said label is selected from the group consisting of catalysts, enzymes, chromogens, radioactive substances, and dispersible particles.

14. The device of claim 1 wherein said first inlet means is an opening in said device.

15. The device of claim 14 wherein said opening is adjacent to said zone.

16. The device of claim 1 wherein said second inlet means is an opening in said device.

17. The device of claim 1 wherein said first inlet means is proximate said second inlet means.

18. The device of claim 1 wherein said means for capturing is a bibulous material capable of entrapping beads coated with an sbp member.

19. The device of claim 1 wherein said means for capturing includes a second sbp member-non-diffusively bound to said zone.

20. The device of claim 7 which further comprises means integral with said housing for releasing said liquid reagent from said container.

21. The device for claim 1 which further includes means for viewing at least a portion of said zone.

22. The device of claim 21 wherein said first inlet means lies between said second inlet means and said viewing means.

48. A method for conducting an immunoassay for an analyte suspected of being in a sample, which method comprises:

(a) introducing a test solution comprising a sample suspected of containing an analyte into the device of claim 1 through said first inlet means to allow said test solution to traverse at least a portion of said zone.

(b) introducing a liquid agent into said device through said second inlet means whereby said agent traverses at least a portion of said zone, and

(c) observing said zone for the presence of a signal in relation to the presence of analyte in said sample.

23. A device for conducting an assay, which device comprises:

a housing,

a first opening in said housing for introducing a sample suspected of containing an analyte into said device,

bibulous material enclosed in said housing, said bibulous material being capable of transporting liquid away from the point of introduction of said sample, and

a second opening in said housing for introducing liquid reagent other than said sample into said device without contacting said bibulous material at said point of introduction with said liquid reagent except by capillary transport,

a portion of said bibulous material being in liquid receiving relationship with said first opening and said second opening.

24. The device of claim 23 wherein the bibulous member has on its surface a member of a specific binding pair (sbp)

25. The method of claim 24 wherein said sbp member is non-diffusively bound to said bibulous member.

26. The device of claim 24 wherein said sbp member is an antigen or antibody.

27. The device of claim 24 wherein said bibulous material is a strip and said sbp member is bound to a portion thereof.

28. The device of claim 23 which further includes a liquid reagent for conducting an assay confined in a breakable container, and means integral and said housing allowing for breaking said container.

29. The device of claim 28 wherein said liquid reagent contains an enzyme substrate.

30. The device of claim 25 wherein said bibulous material has in contact with it a dry water soluble sbp member conjugated to a label.

31. The device of claim 30 wherein said label is selected from the group consisting of catalysts, chromogens, radioactive substances, and dispersible particles.

32. The device of claim 23 which further includes a second bibulous material in liquid receiving relationship with said bibulous material.

33. The device of claim 32 wherein said bibulous material and said second bibulous material are bound together to provide a single unit.

34. The device of claim 23 wherein said bibulous material is a strip with a portion having a pore size different from the remainder of said strip.

35. The device of claim 23 which further includes a window in said housing for viewing at least a portion of said bibulous material.

36. The device of claim 35 wherein said first opening lies between said second opening and said window.

37. The device of claim 23 wherein said second opening is proximate said first opening.

38. The device of claim 23 wherein said liquid reagent is an aqueous medium.

39. The kit for conducting an assay method, said kit comprising in a packaged combination with other assay components the device of claim 23.

50. A method for detecting an antibody in a sample suspected of containing said antibody, which method comprises:

introducing beads of less than about 5μ

diameter coated with antigen complementary with said antibody and said sample into a first opening of the device of claim 28,

introducing an enzyme labeled receptor for immunoglobulin into a second opening of said device

breaking the breakable container of said device to release a liquid reagent containing a substrate or substrate precursor for said enzyme,

incubating for a time sufficient for product to form on the strip of said device opposite said first opening when enzyme is present at said opening, and

comparing the amount of product formed opposite said first opening with the product formed at said second opening or with the product formed with a sample free of said antibody.

51. A method for detecting an antigen in a sample suspected of containing said antigen, which method comprises:

introducing beads of less than about 5μ

diameter coated with antibody complementary with said antigen and said sample into a first opening of the device of claim 28,

introducing an enzyme labeled receptor for said antigen into a second opening of said device

breaking the breakable container of said device to release a liquid reagent containing a substrate or substrate precursor for said enzyme,

incubating for a time sufficient for product to form on the strip of said device opposite said first opening when enzyme is present at said opening, and

comparing the amount of product formed opposite said first opening with the product formed at said second opening or with the product formed with a sample free of said antigen.

52. The method of claim 51 wherein said antigen is a microbial antigen.

40. A device for conducting an immunoassay for an analyte in a sample suspected of containing said analyte, which device comprises:

a housing having means for viewing the interior thereof, first inlet means for introducing a sample therein, and second inlet means for introducing therein an aqueous solution other than said sample, and

a piece of bibulous material enclosed in said housing, said bibulous material having a specific binding pair (sbp) member non-diffusively bound to a situs on said bibulous material, said bibulous material further having a labeled sbp member diffusively deposited on said bibulous material between said means for viewing and said second inlet means.

a portion of said bibulous material being in liquid receiving relationship with said first inlet means and said second inlet means and said situs being in viewing relationship with said means for viewing.

41. The device of claim 40 which further includes a breakable container enclosed in a portion of said housing, said container having confined therein an aqueous medium.

42. The device of claim 40 which further comprises absorbent material enclosed in said housing in liquid receiving relationship with said bibulous material.

43. The device of claim 40 wherein said analyte is a protein and said labeled sbp member is an antibody.

44. In a device for conducting an assay, said device comprising inlet means for introducing a sample containing an analyte into said device and means for transporting liquid away from said inlet means, the improvement which comprises second inlet means other than said inlet means for introducing liquid reagent other than said sample into said device and means for transporting said liquid reagent by capillaRy action away from said second inlet means, a portion of said means for transporting being in liquid receiving relationship with said inlet means and said second inlet means.

45. The device of claim 44 wherein said inlet means and said other means are openings in said device.

46. The device of claim 44 wherein said liquid reagent is an aqueous medium.

47. The device of claim 44 wherein said transporting means is a bibulous material.

49. In a method for conducting an assay for an analyte in a sample suspected of containing said analyte, which method comprises:

introducing a test solution comprising said sample onto a bibulous material in an assay device through inlet means and allowing said test solution to traverse at least a portion of said bibulous material contained in said device,

introducing into said device immediately thereafter a liquid agent to traverse at least a portion of said bibulous material, and

observing said bibulous material for the presence of a signal in relation to the presence of analyte in said sample,

the improvement which comprises introducing said liquid agent into said device at a second inlet means such that said liquid agent does not also enter said device through said first inlet means.