Disposable immunodiagnostic test system

• US 8,475,735 B2
• Filed: 05/01/2007
• Issued: 07/02/2013
• Est. Priority Date: 11/01/2004
• Status: Expired due to Fees

• Current Assignee: Ian Robertson Marshall, Janet Eland-Greenhalgh, Uma Mahesh Babu
• Original Assignee: Ian Robertson Marshall, Janet Eland-Greenhalgh, Uma Mahesh Babu
• Inventors: Babu, Uma Mahesh, Marshall, Ian Robertson, Eland-Greenhalgh, Janet
• Primary Examiner(s): MERKLING, SALLY ANNE
• Application Number:
  US11/743,058
• Publication Number:
  US 20070202542A1
• Time in Patent Office: 2,254 Days
• Field of Search: None
• US Class Current: 422/420
• CPC Class Codes: G01N 33/54391 based on vertical flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387

Abstract

A disposable immunodiagnostic test system tests for marker proteins in a sample and includes intimately contacting passage, protein, and absorbent layers. The passage layer is non-porous and has an aperture therethrough. The protein layer is porous, has combinable proteins immobilized thereon, and enables passage of the sample therethrough. The protein layer has an active surface aligned with the passage layer aperture. The sample is introduced onto the protein layer through the passage layer aperture. In positive results, the marker proteins are bound to the combinable proteins and immobilized relative to the protein layer. In negative results, the sample passes through the protein layer, and is absorbed by the absorbent layer. A housing may also be provided, as may a wash structure. The system may be constructed of combustible materials that produce non-toxic by-products upon incineration, preferably enabling ecologically responsible disposal after diagnostic use of the system.

Claims

1. A disposable immunodiagnostic test system for testing for the presence of a plurality of marker proteins in a liquid sample, said test system comprising:

a passage layer comprised of a first material having a substantially non-porous structure that is configured so as to define at least one aperture therethrough;

a protein layer comprised of a second material that is configured to enable immobilization of a first and a second combinable protein thereon, the protein layer having a substantially porous structure enabling a portion of said liquid sample to pass therethrough; and

an absorbent layer comprised of a third material that enables absorption of at least a portion of said liquid sample, the absorbent layer being in intimate contacting relation with the protein layer;

wherein the at least one aperture of the passage layer is configured to receive the liquid sample; and

wherein the protein layer comprises an active surface area that is aligned with the at least one aperture of the passage layer so as to be viewable through the at least one aperture, the active surface area comprising a plurality of first test areas arranged in at first ring having a first diameter, and a plurality of second test areas arranged in a second ring having a second diameter, the second diameter being larger than the first diameter, with at least one of the first and second combinable proteins being immobilized in the first test area and at least the other one of the first and second combinable proteins being immobilized in the second test area for binding of said marker proteins with said first and second combinable proteins when the liquid sample comprises such marker proteins.

2. The disposable immunodiagnostic test system of claim 1, wherein the active surface area additionally comprises a control area.

3. The disposable immunodiagnostic test system of claim 2, wherein the control area is disposed at the center of the first ring comprising the plurality of first test areas.

4. The disposable immunodiagnostic test system of claim 1, wherein each of the first material, the second material, and the third material is respectively constructed from one or more different combustible materials, each of the combustible materials respectively being one that produces non-toxic by-products upon incineration.

5. A test system according to claim 1, further comprising a reagent, wherein when at least one of the plurality of marker proteins binds to at least one of the first and second combinable proteins, the reagent is bound to the marker proteins that are immobilized on the active surface.

6. A test system according to claim 5, wherein the reagent comprises a visually tagging substance that provides a colored indicium of the binding of the at least one of the plurality of marker proteins to at least one of the first and second combinable proteins and the immobilization of at least one of the first and second combinable proteins to the protein layer.

7. A test system according to claim 6, wherein said visually tagging substance comprises dyed latex beads.

8. A test system according to claim 6, wherein said visually tagging substance comprises a colloidal gold conjugate substance.

9. A test system according to claim 6, wherein said visually tagging substance comprises a colloidal carbon conjugate substance.

10. A test system according to claim 5, wherein said reagent comprises a protein enzyme conjugate substance, with said test system further comprising an enzyme substrate substance that is operatively bound to said protein enzyme conjugate substance when at least one of the plurality of marker proteins binds to at least one of the first and second combinable proteins.

11. A test system according to claim 10, wherein when at least one of the plurality of marker proteins binds to at least one of the first and second combinable proteins, said enzyme substrate substance displays a colored indicium.

12. A test system according to claim 1, wherein, when at least one of the plurality of marker proteins binds to at least one of the first and second combinable proteins, a portion of said liquid sample passes substantially through said protein layer.

13. A test system according to claim 1, further comprising at least one sealant substantially juxtaposed between said passage layer and said protein layer, and between said protein layer and said absorbent layer.

14. A test system according to claim 1, wherein the portion of the active surface area that is visible through the at least one aperture further comprises a procedural control surface area;

and wherein said procedural control surface area is adapted to display a control reading both when at least one of the plurality of marker proteins binds to at least one of the first and second combinable proteins, and when no marker proteins bind to any of the second combinable proteins, so as to operatively confirm that said test system has been used properly.

15. A test system according to claim 14, wherein said procedural control surface area is further adapted to confirm that said test system has been handled and stored properly.

16. A test system according to claim 14, wherein said passage layer is between about 0.2 mm and about 10 mm in thickness.

17. A test system according to claim 16, wherein said passage layer is between about 2 mm and about 4 mm in thickness.

18. A test system according to claim 14, wherein said first material comprises a densely packed paper material.

19. A test system according to claim 18, wherein said paper material is a cardboard material.

20. A test system according to claim 14, wherein said first material comprises a tree bark material.

21. A test system according to claim 14, wherein said first material comprises a packed leaf material.

22. A test system according to claim 14, wherein said protein layer is no greater than about 5 mm in thickness.

23. A test system according to claim 22, wherein said protein layer is between about 0.5 mm and about 2 mm in thickness.

24. A test system according to claim 14, wherein said second material is configured to define pores therethrough, with each of said pores having a pore diameter between about 0.1 microns and about 25 microns.

25. A test system according to claim 24, wherein said pore diameter is between about 0.4 microns and about 2.0 microns.

26. A test system according to claim 14, wherein said second material comprises a nitrocellulose material.

27. A test system according to claim 14, wherein said second material comprises an acetate material.

28. A test system according to claim 14, wherein said second material comprises a nylon material.

29. A test system according to claim 14, wherein said absorbent layer is between about 1 mm and about 50 mm in thickness.

30. A test system according to claim 14, wherein said third material comprises a sponge material.

31. A test system according to claim 30, wherein said sponge material comprises a paper towel material.

32. A test system according to claim 30, wherein said sponge material comprises an acetate material.

33. A test system according to claim 14, further comprising a housing substantially encapsulating said passage layer, said protein layer, and said absorbent layer, with a lower housing portion of said housing being in intimate contacting relation with said absorbent layer and an upper housing portion of said housing being in intimate contacting relation with said passage layer, with said upper housing portion being shaped so as to define at least one housing aperture therethrough, with said housing aperture being substantially aligned in operative fluid communicating relation with said at least one aperture of said passage layer.

34. A test system according to claim 33, wherein said housing is constructed of said at least one combustible material.

35. A test system according to claim 34, wherein said housing is comprised of a housing material having a substantially non-porous housing structure.

36. A test system according to claim 35, wherein each of said upper housing portion and said lower housing portion has said substantially non-porous housing structure.

37. A test system according to claim 33, wherein at least one sealant is substantially juxtaposed between said upper housing portion and said passage layer, and between said lower housing portion and said absorbent layer.

38. A test system according to claim 33, wherein said visible portion of said active surface area is viewable through said housing aperture.

39. A test system according to claim 33, wherein at least one labeling indicium is marked on at least one of an exterior surface portion of said passage layer and an exterior surface portion of said housing.

40. A test system according to claim 39, wherein said labeling indicium is marked on said housing.

41. A test system according to claim 40, wherein said exterior surface portion is provided on said upper housing portion.

42. A test system according to claim 39, wherein said labeling indicium comprises a barcode indicium.

43. A test system according to claim 39, wherein said labeling indicium comprises a text indicium.

44. A test system according to claim 33, wherein said upper housing layer and said lower housing layer are each between about 0.1 mm and about 3 mm in thickness.

45. A test system according to claim 44, wherein said upper housing layer and said lower housing layer are each between about 0.2 mm and about 0.4 mm in thickness.

46. A test system according to claim 1, wherein said combinable proteins comprise proteins adapted to be bound to fungal marker proteins.

47. A test system according to claim 1, wherein said combinable proteins comprise proteins adapted to be bound to viral marker proteins.

48. A test system according to claim 1, wherein said combinable proteins comprise proteins adapted to be bound to bacterial marker proteins.

49. A test system according to claim 1, wherein said combinable proteins comprise proteins adapted to be bound to vector-induced marker proteins.

50. A test system according to claim 1, wherein said combinable proteins comprise proteins adapted to be bound to plant marker proteins.

51. A test system according to claim 14, wherein said visible portion of said active surface area comprises a supplemental first surface area;

and wherein in an operative configuration in which at least a portion of the liquid sample passes through the protein layer, said first combinable proteins are immobilized on each of said first test surface area and said supplemental first test surface area.

52. A test system according to claim 51, wherein a higher concentration of said first combinable proteins are immobilized on said supplemental first test surface area relative to a concentration of said combinable proteins on said first test surface area.

53. A test system according to claim 51, wherein said first test surface area and said supplemental first test surface area together notionally define a substantially planar first test ring, with each of said first test surface area and said supplemental first test surface area notionally situated therewithin.

54. A test system according to claim 53, wherein said first test ring substantially circumscribes said procedural control surface area.

55. A test system according to claim 1, wherein said visible portion of said active surface area further comprises a supplemental first test surface area and a supplemental second test surface area;

and wherein in an operative configuration in which at least a portion of the liquid sample passes through the protein layer, said first combinable proteins are immobilized on each of said first test surface area and said supplemental first test surface area, and said second combinable proteins are immobilized on each of said second test surface area and said supplemental second test surface area.

56. A test system according to claim 55, wherein said first test surface area and said supplemental first test surface area together notionally define a substantially planar first test ring, with each of said first test surface area and said supplemental first test surface area notionally situated therewithin;

wherein said second test surface area and said supplemental second test surface area together notionally define a substantially planar second test ring, with each of said second test surface area and said supplemental second test surface area notionally situated therewithin; and

wherein said second test ring substantially circumscribes said first test ring.

57. A test system according to claim 1, wherein said second test surface area comprises a mimicry surface area, wherein said second combinable proteins comprise native proteins biosynthesizable by substantially healthy cells in at least one of said liquid sample and a species furnishing substantially healthy cells;

wherein in an operative configuration in which at least a portion of the liquid sample passes through the protein layer, said native proteins are immobilized on said mimicry surface area, such that in said positive result configuration, at least one of said plurality of said marker proteins are bound to said native proteins and immobilized relative to said protein layer.

58. A test system according to claim 33, wherein said passage layer comprises at least two apertures, and wherein an upper surface of said passage layer is configured so as to define a concave portion in which the upper surface of the passage layer has a concave curvature, wherein the concave portion is substantially adjacent to said at least two apertures and substantially aligned with said housing aperture.

59. A test system according to claim 14, wherein an upper surface of said protein layer is configured so as to define a concave portion in which the upper surface of the passage layer has a concave curvature, with said concave portion being substantially adjacent to said visible portion of said active surface area and being substantially aligned with said aperture of said passage layer.