Test carrier for the determination of an analyte as well as a process for its production

• US 5,451,350 A
• Filed: 05/28/1993
• Issued: 09/19/1995
• Est. Priority Date: 05/29/1992
• Status: Expired due to Fees

• Current Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Zimmer, Volker, Macho, Heinz, Harttig, Herbert, Lerch, Rolf
• Primary Examiner(s): Redding, David A.
• Application Number:
  US08/068,110
• Time in Patent Office: 844 Days
• Field of Search: 422/55-60, 422/61, 422/82.05, 422/82.09, 422/86, 436/164, 436/165, 436/169, 436/805, 436/810, 435/4, 435/291, 435/805, 435/808, 424/7.1, 427/2, 264/23, 264/25, 264/321, 264/325, 264/327
• US Class Current: 264/442
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

An analytical device determines the analytes in a liquid sample. This device includes a layer of flat material which has a sample application area and a detection area thereupon. The detection area includes a reagent for determining the analyte, and the absorbent sample application area and the absorbent detection area are disposed within a liquid impermeable boundary. The layer of flat material also includes an absorbent connector which is disposed such that the sample application area and the detection area are connected by the absorbent connector. The liquid impermeable boundary and the absorbent connector prevents liquid from being transported between the sample application area and the detection area, except through the absorbent connector.

Claims

1. An analytical device for determining an analyte in a liquid sample, said analytical device comprising:

a layer of flat material having at least one absorbent sample application area and at least one absorbent detection area, said at least one absorbent detection area having a reagent for determining the analyte, said absorbent sample application area and said absorbent detection area being disposed within a liquid impermeable boundary, said sample application area not containing all reagents necessary for analyte detection and determination, wherein

said layer of flat material further comprising at least one absorbent connector, said absorbent connector being disposed such that said sample application area and said detection area are connected by said absorbent connector,

wherein said liquid impermeable boundary and said absorbent connector prevent liquid from being transported between said at least one sample application area and said at least one detection area, except through said absorbent connector.

2. An analytical device as recited in claim 1, wherein said at least one absorbent detection area is a plurality of detection areas, each of said plurality of detection areas being connected to said sample application area by a corresponding plurality of said absorbent connectors.

3. An analytical device as recited in claim 2, wherein said at least one sample application area is a plurality of sample application areas.

4. An analytical device as recited in claim 1, wherein said layer of flat material is heat-meltable material wherein said liquid-impermeable boundaries comprise heat treated areas of said heat-meltable material, wherein the heat treatment reduces the absorbency of the heat treated areas.

5. An analytical device as recited in claim 1, wherein said liquid-impermeable boundary comprises a material which is not a same material as the layer of material comprising the absorbent sample application area and the absorbent detection area.

6. An analytical device as recited in claim 1, wherein a surface area of said at least one sample application area is larger than a surface area of said at least one detection area.

7. An analytical device as recited in claim 1, wherein the at least one sample application area and the at least one detection area comprise a fibrous material.

8. An analytical device as recited in claim 1, wherein said at least one sample application area, detection area, and absorbent connector comprise a porous material.

17. An analytical device as recited in claim 1, wherein said layer of flat material has a consistent chemical make-up throughout.

19. An analytical device as recited in claim 1, wherein said sample application area and said detection area are located on a same surface of said layer of flat material.

20. An analytical device as recited in claim 1, wherein said layer of flat material comprises a combination of heat-meltable and non-heat-meltable material, wherein said liquid impermeable boundaries comprise heat treated areas of said combination of heat-meltable and non-heat meltable material, wherein heat treatment reduces absorbance of the heat-treated areas.

62. An analytical device as recited in claim 1, further comprising absorbent functional areas within said liquid impermeable boundary, said absorbent functional areas interrupting said absorbent connector between said sample application area and said detection area.

63. An analytical device as recited in claim 62, wherein said functional areas have a cross-section which is greater than a cross-section of the absorbent connector.

9. A process for manufacturing an analytical device for determining an analyte in a liquid sample, said process comprising the steps of:

providing a layer of flat absorbent first material;

forming at least one absorbent sample application area on said layer of flat first material, said sample application area not containing all reagents necessary for analyte detection and determination;

forming at least one absorbent detection area on said layer of flat first material;

forming at least one absorbent connector connecting said at least one sample application area and said at least one detection area,

wherein said at least one sample application area, said at least one detection area, and said absorbent connector are disposed within a liquid impermeable boundary, said liquid impermeable boundary being formed during said forming steps, and wherein said at least one absorbent detection area includes a reagent for determining the analyte in a liquid sample.

10. A process for manufacturing an analytical device as recited in claim 9, wherein said steps of forming said sample application area, forming said detection area, and forming said absorbent connector comprises heat treatment of portions of said layer of flat first material forming the liquid impermeable boundaries.

11. A process for manufacturing an analytical device as recited in claim 10, wherein said heat treatment is performed with ultrasound.

13. A process for manufacturing an analytical device as recited in claim 9, further comprising the steps of:

providing a heat-deformable second material;

locating said heat-deformable second material under said layer of flat first material, wherein said steps of forming the sample application area, forming the detection area, and forming the absorbent connector are performed by heat-treatment of the heat-deformable second material such that the absorbent flat first material is affected in selected areas so that it is no longer absorbent.

72. A process for manufacturing an analytical device as recited in claim 9, further comprising the step of forming at least one absorbent functional area within said liquid impermeable boundary, said absorbent functional area interrupting said absorbent connector between said sample application area and said detection area.

73. A process for manufacturing an analytical device as recited in claim 72, wherein said absorbent functional area is formed with a cross-section which is larger than a cross-section of the absorbent connector.

12. A process for manufacturing an analytical device for determining an analyte in a liquid sample, said process comprising the steps of:

providing a layer of flat absorbent first material;

forming at least one absorbent sample application area on said layer of flat first material forming at least one absorbent detection area on said layer of flat first material, wherein said first absorbent first material is heat-deformable;

forming at least one absorbent connector connecting said at least one sample application area and said at least one detection area,

wherein said at least one sample application area, said at least one detection area, and said absorbent connector are disposed within a liquid impermeable boundary, said liquid impermeable boundary being formed during said forming steps, and wherein said at least one absorbent detection area includes a reagent for determining the analyte in a liquid sample.

74. A process for manufacturing an analytical device as recited in claim 12, further comprising the step of forming at least one absorbent functional area within said liquid impermeable boundary, said absorbent functional area interrupting said absorbent connector between said sample application area and said detection area.

75. A process for manufacturing an analytical device as recited in claim 74, wherein said absorbent functional area is formed with a cross-section which is larger than a cross-section of the absorbent connector.

14. A process for manufacturing an analytical device for determining an analyte in a liquid sample, said process comprising the steps of:

providing a layer of flat absorbent first material;

forming at least one absorbent sample application area on said layer of flat first material forming at least one absorbent detection area on said layer of flat first material;

forming at least one absorbent connector connecting said at least one sample application area and said at least one detection area,

providing a die having a plurality of elevations and depressions formed therein, wherein said steps of forming the sample application area, forming the detection area, and forming the absorbent connector is performed by contacting the layer of flat first material with said die;

wherein said at least one sample application area, said at least one detection area, and said absorbent connector are disposed within a liquid impermeable boundary, said liquid impermeable boundary being formed during said forming steps, and wherein said at least one absorbent detection area includes a reagent for determining the analyte in a liquid sample.

15. A process for manufacturing an analytical device as recited in claim 14, wherein an outer surface of said die is coated with a non-stick material.

16. A process for manufacturing an analytical device as recited in claim 15, wherein said non-stick material comprises Teflon™

.

76. A process for manufacturing an analytical device as recited in claim 14, further comprising the step of forming at least one absorbent functional area within said liquid impermeable boundary, said absorbent functional area interrupting said absorbent connector between said sample application area and said detection area.

77. A process for manufacturing an analytical device as recited in claim 76, wherein said absorbent functional area is formed with a cross-section which is larger than a cross-section of the absorbent connector.

18. An analytical device for determining an analyte in a liquid sample, said analytical device comprising:

a layer of flat material having at least one absorbent sample application area and at least one absorbent detection area, said at least one absorbent detection area having a reagent for determining the analyte, said absorbent sample application area and said absorbent detection area being disposed within a liquid impermeable boundary, wherein

said layer of flat material further comprising at least one absorbent connector, said absorbent connector being disposed such that said sample application area and said detection area are connected by said absorbent connector,

wherein said liquid impermeable boundary and said absorbent connector prevent liquid from being transported between said at least one sample application area and said at least one detection area, except through said absorbent connector, and wherein said sample application area, said absorbent connector, said detection area, and said liquid impermeable boundary of said layer of flat material comprise the same chemical elements.

64. An analytical device as recited in claim 18, further comprising absorbent functional areas within said liquid impermeable boundary, said absorbent functional areas interrupting said absorbent connector between said sample application area and said detection area.

65. An analytical device as recited in claim 64, wherein said functional areas have a cross-section which is greater than a cross-section of the absorbent connector.

21. An analytical device for determining an analyte in a liquid sample, said analytical device comprising:

a layer of flat material having at least one absorbent sample application area and at least one absorbent detection area, said at least one absorbent detection area having a reagent for determining the analyte, said absorbent sample application area and said absorbent detection area being disposed within a liquid impermeable boundary, wherein

said layer of flat material further comprising at least one absorbent connector, said absorbent connector being disposed such that said sample application area and said detection area are connected by said absorbent connector, said at least one absorbent connector having a cross-section which is less than a cross-section of the sample application area and a cross-section of the detection area,

wherein said liquid impermeable boundary and said absorbent connector prevent liquid from being transported between said at least one sample application area and said at least one detection area, except through said absorbent connector.

22. An analytical device as recited in claim 21, wherein said at least one detection area is a plurality of detection areas, each of said plurality of detection areas being connected to said sample application area by a corresponding plurality of said absorbent connectors.

23. An analytical device as recited in claim 22, wherein said at least one sample application area is a plurality of sample application areas.

24. An analytical device as recited in claim 21, wherein said layer of flat material is heat-meltable material wherein said liquid-impermeable boundaries comprise heat treated areas of said heat-meltable material, wherein the heat treatment reduces the absorbency of the heat treated areas.

25. An analytical device as recited in claim 21, wherein said layer of flat material comprises a combination of heat-meltable and non-heat-meltable material, wherein said liquid impermeable boundaries comprise heat treated areas of said combination of heat-meltable and non-heat-meltable material, wherein heat treatment reduces absorbance of the heat-treated areas.

26. An analytical device as recited in claim 21, wherein said liquid-impermeable boundary comprises a material which is not a same material as the layer of material comprising the absorbent sample application area and the absorbent detection area.

27. An analytical device as recited in claim 21, wherein a surface area of said at least one sample application area is larger than a surface area of said at least one detection area.

28. An analytical device as recited in claim 21, wherein the at least one sample application area and the at least one detection area comprise a fibrous material.

29. An analytical device as recited in claim 21, wherein at least one sample application area, detection area, and absorbent connector comprise a porous material.

30. An analytical device as recited in claim 21, wherein said layer of flat material has a consistent chemical make-up throughout.

31. An analytical device as recited in claim 21, wherein said sample application area and said detection area are located on a same surface of said layer of flat material.

66. An analytical device as recited in claim 21, further comprising absorbent functional areas within said liquid impermeable boundary, said absorbent functional areas interrupting said absorbent connector between said sample application area and said detection area.

67. An analytical device as recited in claim 66, wherein said functional areas have a cross-section which is greater than the cross-section of the absorbent connector.

32. An analytical device for determining an analyte in a liquid sample, said analytical device comprising:

a layer of flat material having at least one absorbent sample application area and at least one absorbent detection area, said at least one absorbent detection area having a reagent for determining the analyte, said absorbent sample application area and said absorbent detection area being disposed within a liquid impermeable boundary, said layer of flat material being heat-meltable material, wherein the liquid-impermeable boundaries comprise heat treated areas of said heat-meltable material, wherein the heat treatment reduces the absorbency of the heat treated areas, wherein

said layer of flat material further comprising at least one absorbent connector, said absorbent connector being disposed such that said sample application area and said detection area are connected by said absorbent connector,

wherein said liquid impermeable boundary and said absorbent connector prevent liquid from being transported between said at least one sample application area and said at least one detection area, except through said absorbent connector.

33. An analytical device as recited in claim 32, wherein said at least one detection area is a plurality of detection areas, each of said plurality of detection areas being connected to said sample application area by a corresponding plurality of said absorbent connectors.

34. An analytical device as recited in claim 33, wherein said at least one sample application area is a plurality of sample application areas.

35. An analytical device as recited in claim 32, wherein said liquid-impermeable boundary comprises a material which is not a same material as the layer of material comprising the absorbent sample application area and the absorbent detection area.

36. An analytical device as recited in claim 32, wherein a surface area of said at least one sample application area is larger than a surface area of said at least one detection area.

37. An analytical device as recited in claim 32, wherein the at least one sample application area and the at least one detection area comprise a fibrous material.

38. An analytical device as recited in claim 32, wherein at least one sample application area, detection area, and absorbent connector comprise a porous material.

39. An analytical device as recited in claim 32, wherein said layer of flat material has a consistent chemical make-up throughout.

40. An analytical device as recited in claim 32, wherein said sample application area and said detection area are located on a same surface of said layer of flat material.

68. An analytical device as recited in claim 32, further comprising absorbent functional areas within said liquid impermeable boundary, said absorbent functional areas interrupting said absorbent connector between said sample application area and said detection area.

69. An analytical device as recited in claim 68, wherein said functional areas have a cross-section which is greater than a cross-section of the absorbent connector.

41. An analytical device for determining an analyte in a liquid sample, said analytical device comprising:

a layer of flat material having at least one absorbent sample application area and at least one absorbent detection area, said at least one absorbent detection area having a reagent for determining the analyte, said absorbent sample application area and said absorbent detection area being disposed within a liquid impermeable boundary, said layer of flat material being formed of a mixture of heat-meltable and non-heat-meltable material, wherein said liquid impermeable boundary comprises heat treated areas of said mixture of heat-meltable and non-heat-meltable material, wherein the heat treatment reduces absorbance of the heat treated areas, wherein

said layer of flat material further comprising at least one absorbent connector, said absorbent connector being disposed such that said sample application area and said detection area are connected by said absorbent connector,

wherein said liquid impermeable boundary and said absorbent connector prevent liquid from being transported between said at least one sample application area and said at least one detection area, except through said absorbent connector.

42. An analytical device as recited in claim 41, wherein said at least one detection area is a plurality of detection areas, each of said plurality of detection areas being connected to said sample application area by a corresponding plurality of said absorbent connectors.

43. An analytical device as recited in claim 42, wherein said at least one sample application area is a plurality of sample application areas.

44. An analytical device as recited in claim 41, wherein said liquid-impermeable boundary comprises a material which is not a same material as the layer of material comprising the absorbent sample application area and the absorbent detection area.

45. An analytical device as recited in claim 41, wherein a surface area of said at least one sample application area is larger than a surface area of said at least one detection area.

46. An analytical device as recited in claim 41, wherein the at least one sample application area and the at least one detection area comprise a fibrous material.

47. An analytical device as recited in claim 41, wherein at least one sample application area, detection area, and absorbent connector comprise a porous material.

48. An analytical device as recited in claim 41, wherein said layer of flat material has a consistent chemical make-up throughout.

49. An analytical device as recited in claim 41, wherein said sample application area and said detection area are located on a same surface of said layer of flat material.

70. An analytical device as recited in claim 41, further comprising absorbent functional areas within said liquid impermeable boundary, said absorbent functional areas interrupting said absorbent connector between said sample application area and said detection area.

71. An analytical device as recited in claim 70, wherein said functional areas have a cross-section which is greater than a cross-section of the absorbent connector.

50. A process for manufacturing an analytical device for determining an analyte in a liquid sample, said process comprising the steps of:

providing a layer of flat absorbent first material;

forming at least one absorbent sample application area on said layer of flat first material;

forming at least one absorbent detection area on said layer of flat first material;

forming at least one absorbent connector connecting said at least one sample application area and said at least one detection area;

providing a heat-deformable second material;

locating said heat-deformable second material under said layer of flat first material, wherein said steps of forming the sample application area, forming the detection area, and forming the absorbent connector are performed by heat-treatment of the heat-deformable second material such that the absorbent flat first material is affected in selected areas so that it is no longer absorbent,

wherein said at least one sample application area, said at least one detection area, and said absorbent connector are disposed within a liquid impermeable boundary, said liquid impermeable boundary being formed during said forming steps, and wherein said at least one absorbent detection area includes a reagent for determining the analyte in a liquid sample.

78. A process for manufacturing an analytical device as recited in claim 50, further comprising the step of forming at least one absorbent functional area within said liquid impermeable boundary, said absorbent functional area interrupting said absorbent connector between said sample application area and said detection area.

79. A process for manufacturing an analytical device as recited in claim 78, wherein said absorbent functional area is formed with a cross-section which is larger than a cross-section of the absorbent connector.

51. A process for manufacturing an analytical device for determining an analyte in a liquid sample, said process comprising the steps of:

providing a layer of flat absorbent first material;

forming at least one absorbent sample application area on said layer of flat first material;

forming at least one absorbent detection area on said layer of flat first material;

forming at least one absorbent connector connecting said at least one sample application area and said at least one detection area, said at least one absorbent connector having a cross-section which is less than a cross-section of the sample application area and a cross-section of the detection area,

wherein said at least one sample application area, said at least one detection area, and said absorbent connector are disposed within a liquid impermeable boundary, said liquid impermeable boundary being formed during said forming steps, and wherein said at least one absorbent detection area includes a reagent for determining the analyte in a liquid sample.

52. A process for manufacturing an analytical device as recited in claim 51, wherein said steps of forming said sample application area, forming said detection area, and forming said absorbent connector comprises heat treatment of portions of said layer of flat first material forming the liquid impermeable boundaries.

53. A process for manufacturing an analytical device as recited in claim 52, wherein said heat treatment is performed with ultrasound.

54. A process for manufacturing an analytical device as recited in claim 51, further comprising the steps of:

providing a heat-deformable second material;

locating said heat-deformable second material under said layer of flat first material, wherein said steps of forming the sample application area, forming the detection area, and forming the absorbent connector are performed by heat-treatment of the heat-deformable second material such that the absorbent flat first material is affected in selected areas so that it is no longer absorbent.

80. A process for manufacturing an analytical device as recited in claim 51, further comprising the step of forming at least one absorbent functional area within said liquid impermeable boundary, said absorbent functional area interrupting said absorbent connector between said sample application area and said detection area.

81. A process for manufacturing an analytical device as recited in claim 80, wherein said absorbent functional area is formed with a cross-section which is larger than the cross-section of the absorbent connector.

55. A process for manufacturing an analytical device for determining an analyte in a liquid sample, said process comprising the steps of:

providing a layer of flat absorbent first material;

forming at least one absorbent sample application area on said layer of flat first material;

forming at least one absorbent detection area on said layer of flat first material;

forming at least one absorbent connector connecting said at least one sample application area and said at least one detection area,

wherein said at least one sample application area, said at least one detection area, and said absorbent connector are disposed within a liquid impermeable boundary, said liquid impermeable boundary being formed during said forming steps, and wherein said at least one absorbent detection area includes a reagent for determining the analyte in a liquid sample, said layer of flat absorbent material being a heat-meltable material wherein said liquid-impermeable boundaries comprise heat treated areas of said heat-meltable material, wherein the heat treatment reduces the absorbency of the heat treated areas.

56. A process for manufacturing an analytical device as recited in claim 55, wherein said steps of forming said sample application area, forming said detection area, and forming said absorbent connector comprises heat treatment of portions of said layer of flat first material forming the liquid impermeable boundaries.

57. A process for manufacturing an analytical device as recited in claim 55, further comprising the steps of:

providing a heat-deformable second material;

locating said heat-deformable second material under said layer of flat first material, wherein said steps of forming the sample application area, forming the detection area, and forming the absorbent connector are performed by heat-treatment of the heat-deformable second material such that the absorbent flat first material is affected in selected areas so that it is no longer absorbent.

82. A process for manufacturing an analytical device as recited in claim 55, further comprising the step of forming at least one absorbent functional area within said liquid impermeable boundary, said absorbent functional area interrupting said absorbent connector between said sample application area and said detection area.

83. A process for manufacturing an analytical device as recited in claim 82, wherein said absorbent functional area is formed with a cross-section which is larger than a cross-section of the absorbent connector.

58. A process for manufacturing an analytical device for determining an analyte in a liquid sample, said process comprising the steps of:

providing a layer of flat absorbent first material;

forming at least one absorbent sample application area on said layer of flat first material;

forming at least one absorbent detection area on said layer of flat first material;

forming at least one absorbent connector connecting said at least one sample application area and said at least one detection area,

wherein said at least one sample application area, said at least one detection area, and said absorbent connector are disposed within a liquid impermeable boundary, said liquid impermeable boundary being formed during said forming steps, and wherein said at least one absorbent detection area includes a reagent for determining the analyte in a liquid sample, and wherein said layer of flat material comprises a mixture of heat-meltable and non-heat-meltable material, wherein said liquid impermeable boundary comprises heat treated areas of said heat-meltable material, wherein the heat treatment reduces absorbance of the heat treated areas.

59. A process for manufacturing an analytical device as recited in claim 58, wherein said steps of forming said sample application area, forming said detection area, and forming said absorbent connector comprises heat treatment of portions of said layer of flat first material forming the liquid impermeable boundaries.

60. A process for manufacturing an analytical device as recited in claim 59, wherein said heat treatment is performed with ultrasound.

61. A process for manufacturing an analytical device as recited in claim 58, further comprising the steps of:

providing a heat-deformable second material;

locating said heat-deformable second material under said layer of flat first material, wherein said steps of forming the sample application area, forming the detection area, and forming the absorbent connector are performed by heat-treatment of the heat-deformable second material such that the absorbent flat first material is affected in selected areas so that it is no longer absorbent.

84. A process for manufacturing an analytical device as recited in claim 58, further comprising the step of forming at least one absorbent functional area within said liquid impermeable boundary, said absorbent functional area interrupting said absorbent connector between said sample application area and said detection area.

85. A process for manufacturing an analytical device as recited in claim 84, wherein said absorbent functional area is formed with a cross-section which is larger than a cross-section of the absorbent connector.