DISPOSABLE IMMUNODIAGNOSTIC TEST SYSTEM

• US 20070202542A1
• Filed: 05/01/2007
• Published: 08/30/2007
• Est. Priority Date: 11/01/2004
• Status: Active Grant

• Current Assignee: Ian Marshall, Janet Eland-Greenhalgh, Uma Babu
• Original Assignee: Ian Marshall, Janet Eland-Greenhalgh, Uma Babu
• Inventors: Eland-Greenhalgh, Janet, Marshall, Ian, Babu, Uma
• Granted Patent: US 8,475,735 B2
• Time in Patent Office: Days
• US Class Current: 435/7.100
• 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) a substantially planar passage layer comprised of a first material having a substantially non-porous structure that is shaped so as to define at least one aperture therethrough;

b) a protein layer comprised of a second material that is adapted to enable, in an operative configuration, immobilization of a first and a second combinable protein thereon, with said protein layer having a substantially porous structure enabling a portion of said liquid sample to pass substantially therethrough, and with said protein layer in intimate contacting relation with said passage layer so as to define an active surface area on said protein layer that is substantially adjacent to, and substantially aligned with, said aperture of said passage layer; and

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

wherein, in said operative configuration, said liquid sample is introduced onto said protein layer through said at least one aperture of said passage layer, such that in a positive result configuration, at least a first marker protein of said plurality of said marker proteins is bound to said combinable proteins and immobilized relative to said protein layer, and such that-in a negative result configuration, at least a portion of said liquid sample passes substantially through said protein layer without affixing to any of said combinable proteins immobilized thereon;

wherein at least a visible portion of said active surface area is viewable through said aperture of said passage layer;

wherein said visible portion of said active surface area comprises a first test surface area;

wherein in said operative configuration, said first combinable proteins are immobilized on said first test surface area;

wherein said visible portion of said active surface area further comprises a second test surface area;

wherein in said operative configuration, said second combinable proteins are immobilized on said second test surface area; and

wherein each of said first material, said second material, and said third material is respectively constructed from one or more different combustible materials, with each of said combustible materials respectively being one that produces non-toxic by-products upon incineration.

2. A test system according to claim 1, further comprising a reagent, wherein, in said positive result configuration, said reagent is bound to said marker proteins that are immobilized relative to said protein layer.

3. A test system according to claim 2, wherein said reagent comprises a visually tagging substance that provides a colored indicium of said positive result configuration.

4. A test system according to claim 3, wherein said visually tagging substance comprises dyed latex beads.

5. A test system according to claim 3, wherein said visually tagging substance comprises a colloidal gold conjugate substance.

6. A test system according to claim 3, wherein said visually tagging substance comprises a colloidal carbon conjugate substance.

7. A test system according to claim 2, 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 in said positive result configuration.

8. A test system according to claim 7, wherein in said positive result configuration, said enzyme substrate substance displays a colored indicium.

9. A test system according to claim 1, wherein, in said positive result configuration, a portion of said liquid sample passes substantially through said protein layer.

10. 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.

11. A test system according to claim 1, wherein said visible portion of said active surface area further comprises a procedural control surface area;

and wherein said procedural control surface area is adapted to display a control reading both in said positive result configuration and in said negative result configuration so as to operatively confirm that said test system has been used properly.

12. A test system according to claim 11, wherein said procedural control surface area is further adapted to confirm that said test system has been handled and stored properly.

13. A test system according to claim 11, wherein said passage layer is between about 0.2 mm and about 10 mm in thickness.

14. A test system according to claim 13, wherein said passage layer is between about 2 mm and about 4 mm in thickness.

15. A test system according to claim 11, wherein said first material comprises a densely packed paper material.

16. A test system according to claim 15, wherein said paper material is a cardboard material.

17. A test system according to claim 11, wherein said first material comprises a tree bark material.

18. A test system according to claim 11, wherein said first material comprises a packed leaf material.

19. A test system according to claim 11, wherein said protein layer is no greater than about 5 mm in thickness.

20. A test system according to claim 19, wherein said protein layer is between about 0.5 mm and about 2 mm in thickness.

21. A test system according to claim 11, wherein said second material is shaped so as to define pores therethrough, with each of said pores having a pore diameter between about 0.1 microns and about 25 microns.

22. A test system according to claim 21, wherein said pore diameter is between about 0.4 microns and about 2.0 microns.

23. A test system according to claim 11, wherein said second material comprises a nitrocellulose material.

24. A test system according to claim 11, wherein said second material comprises an acetate material.

25. A test system according to claim 11, wherein said second material comprises a nylon material.

26. A test system according to claim 11, wherein said absorbent layer is between about 1 mm and about 50 mm in thickness.

27. A test system according to claim 11, wherein said third material comprises a sponge material.

28. A test system according to claim 27, wherein said sponge material comprises a paper towel material.

29. A test system according to claim 27, wherein said sponge material comprises an acetate material.

30. A test system according to claim 11, 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.

31. A test system according to claim 30, wherein said housing is constructed of said at least one combustible material.

32. A test system according to claim 31, wherein said housing is comprised of a housing material having a substantially non-porous housing structure.

33. A test system according to claim 32, wherein each of said upper housing portion and said lower housing portion has said substantially non-porous housing structure.

34. A test system according to claim 30, 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.

35. A test system according to claim 30, wherein said visible portion of said active surface area is viewable through said housing aperture.

36. A test system according to claim 30, 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.

37. A test system according to claim 36, wherein said labeling indicium is marked on said housing.

38. A test system according to claim 37, wherein said exterior surface portion is provided on said upper housing portion.

39. A test system according to claim 36, wherein said labeling indicium comprises a barcode indicium.

40. A test system according to claim 36, wherein said labeling indicium comprises a text indicium.

41. A test system according to claim 30, wherein said upper housing layer and said lower housing layer are each between about 0.1 mm and about 3 mm in thickness.

42. A test system according to claim 41, wherein said upper housing layer and said lower housing layer are each between about 0.2 mm and about 0.4 mm in thickness.

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

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

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

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

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

48. A test system according to claim 11, wherein said visible portion of said active surface area comprises a supplemental first surface area;

and wherein in said operative configuration, said first combinable proteins are immobilized on each of said first test surface area and said supplemental first test surface area.

49. A test system according to claim 48, wherein a substantially 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.

50. A test system according to claim 48, 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.

51. A test system according to claim 50, wherein said first test ring substantially circumscribes said procedural control surface area.

52. 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 said operative configuration, 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.

53. A test system according to claim 52, 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.

54. 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 same;

wherein in said operative configuration, 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.

55. A test system according to claim 30, wherein said at least one aperture of said passage layer comprises at least two apertures, and wherein an upper surface of said passage layer is shaped so as to define a concave portion substantially adjacent to said at least two apertures and substantially aligned with said housing aperture.

56. A test system according to claim 11, wherein an upper surface of said protein layer is shaped so as to define a concave portion, with said concave portion substantially adjacent to said visible portion of said active surface area and substantially aligned with said aperture of said passage layer.

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

a) a substantially planar passage layer having a substantially non-porous structure that defines at least one aperture therethrough;

b) a protein layer with combinable proteins operatively immobilized thereon, said protein layer having a substantially porous structure that operatively enables a liquid portion of the sample to pass therethrough, said protein layer being in intimate contacting relation with said passage layer, wherein an active surface area of said protein layer is adjacent to, and aligned with, said aperture of said passage layer;

c) an absorbent layer operatively enabling absorption of at least the liquid portion of the sample, said absorbent layer being in intimate contacting relation with said protein layer; and

d) a wash structure on at least one upper outer surface of the test system;

wherein the wash structure is substantially aligned with said at least one aperture of said passage layer;

wherein, in said operative configuration, said sample is combined with a suitable wash solution proximal to the wash structure to form a combined liquid sample which is then caused to flow from the wash structure to the test aperture, such that said combined liquid sample is introduced onto said protein layer through said at least one aperture of said passage layer;

wherein in a positive result configuration, said marker proteins are bound to said combinable proteins and immobilized relative to said protein layer; and

wherein in a negative result configuration, at least a portion of said combined liquid sample passes substantially through said protein layer.

58. A test system according to claim 57, further comprising a housing that substantially encapsulates said passage layer, said protein layer, and said absorbent layer, said housing having a substantially non-porous structure;

wherein an upper portion of said housing defines at least one housing aperture that is substantially aligned with, and interposed between, the wash structure and said at least one aperture of said passage layer; and

wherein said wash structure is substantially adjacent to said housing aperture.

59. A test system according to claim 58, wherein said housing is in intimate contacting relation both with said absorbent layer and with said passage layer.

60. A test system according to claim 58, wherein said upper outer surface is a housing surface.

61. A test system according to claim 57, wherein the wash structure on the at least one upper outer surface is pre-formed therein.

62. A test system according to claim 57, wherein the wash structure on the at least one upper outer surface is selectively formable therein.

63. A test system according to claim 57, wherein the wash structure on the at least one upper outer surface is secured thereto.

64. A test system according to claim 57, wherein the wash structure on the at least one upper outer surface is selectively securable thereto.

65. A test system according to claim 57, wherein said upper outer surface is a passage layer surface.

66. A test system according to claim 57, wherein said forming of said combined liquid sample, by combination of said sample with said wash solution, takes place on said wash structure.

67. A test system according to claim 57, wherein said forming of said combined liquid sample, by combination of said sample with said wash solution, takes place in said wash structure.

68. A test system according to claim 57, wherein said combined liquid sample is caused to flow from said wash structure to the aperture in the passage layer under the influence of gravity.

69. A test system according to claim 57, wherein said wash structure comprises a mixing bowl substantially adjacent to said at least one aperture in the passage layer;

wherein, in said operative configuration, said combined liquid sample is caused to flow from the bowl to the aperture in the passage layer, under the influence of gravity, by inclining the test system.

70. A test system according to claim 69, wherein one or more channels are provided on said upper outer surface, with each of said channels running at least part-way between said mixing bowl and the aperture in the passage layer;

and wherein said combined liquid sample flows from the bowl to the test aperture substantially within said channels.

71. A test system according to claim 70, wherein the channels on the upper outer surface are pre-formed therein.

72. A test system according to claim 70, wherein the channels on the upper outer surface are selectively formable therein.

73. A test system according to claim 70, wherein said at least one channel comprises a plurality of channels, each running at least part-way between said mixing bowl and the aperture in the passage layer.

74. A test system according to claim 73, wherein said combined liquid sample in each one of said plurality of channels traverses substantially the same distance between said mixing bowl and the aperture in the passage layer as said combined liquid sample in each other one of said plurality of channels.

75. A test system according to claim 70, wherein one or more of said mixing bowl and said channels is selectively formable by depressing at least one frangible area on said upper outer surface.

76. A test system according to claim 75, wherein said upper outer surface is marked with at least one local indicium to indicate the location of said frangible area.

77. A test system according to claim 69, wherein said upper outer surface of the test kit is marked with at least one instructional indicium to suggest proper use of the mixing bowl, in order, before use of the aperture in the passage layer.

78. A test system according to claim 69, wherein said mixing bowl is sized to accommodate a volume of said combined liquid sample at least about as large as the volume of said combined liquid sample capable of being accommodated within said aperture in the passage layer.

79. A test system according to claim 57, wherein said wash structure comprises a wash tablet in substantially overlying relation above said at least one aperture in the passage layer;

wherein, in said operative configuration, said combined liquid sample is caused to flow, from the wash tablet to the aperture in the passage layer, by a wicking effect.

80. A test system according to claim 79, wherein said wash solution is introduced into said tablet before said sample.

81. A test system according to claim 80, wherein said tablet is saturated with said wash solution before said sample is introduced into said tablet.

82. A test system according claim 79, wherein said wash tablet is constructed at least in part from a material selected from the group consisting of glass fiber materials, other synthetic fiber materials, paper materials, and sponge materials of sufficient porosity.

83. A test system according claim 82, wherein said material comprises one of said glass fiber materials, namely, a spun fiberglass material.

84. A test system according claim 82, wherein said material comprises one of said other synthetic fiber materials, namely, nylon.

85. A test system according claim 82, wherein said material comprises one or more of said paper materials, with said paper materials being selected from the group consisting of cellular acetate materials, loose cardboard materials, and paper towels.

86. A test system according to claim 79, wherein said wash tablet is constructed at least in part from a first material that is operatively impregnated with a second material that is adapted to bind to selected contaminant portions of said sample whilst allowing substantially unimpeded passage of said marker proteins and of a remainder of said sample therethrough.

87. A test system according to claim 86, wherein said second material comprises a lectin.

88. A test system according to claim 86, wherein said selected contaminant portions, to which said second material is adapted to be bound, comprise cellular portions of said sample.

89. A test system according to claim 86, wherein said selected contaminant portions, to which said second material is adapted to be bound, comprise lipid portions of said sample.

90. A test system according to claim 86, wherein said selected contaminant portions, to which said second material is adapted to be bound, comprise particulate portions of said sample.

91. A test system according to claim 79, wherein said wash tablet is removably secured to said upper outer surface by securing means.

92. A test system according to claim 91, wherein said securing means is selected from the group consisting of tape and adhesives.

93. A test system according to claim 92, wherein said securing means comprises said tape, with said tape being applied over top of said wash tablet.

94. A test system according to claim 91, wherein said securing means is applied substantially adjacent to a peripheral portion of said wash tablet.

95. A test system according to claim 94, wherein said peripheral portion is selected from the group consisting of the corners and the edges of said wash tablet.

96. A test system according claim 79, wherein after said combined liquid sample is introduced onto said protein layer, said wash tablet is peeled back from said aperture in said passage layer to reveal one of said positive result configuration and said negative result configuration.

97. A test system according to claim 57, wherein a substantial entirety of said test system is constructed of one or more combustible materials that produce non-toxic by-products upon incineration.

98. A test system according to claim 57, wherein at least one of said passage layer, said protein layer, said absorbent layer, and said wash structure is constructed of a densely packed paper material.

99. A test system according to claim 58, wherein at least one of said passage layer, said protein layer, said absorbent layer, said wash structure, and said housing is constructed of a densely packed paper material.