Diagnostic sanitary test strip

• US 20070048878A1
• Filed: 05/16/2006
• Published: 03/01/2007
• Est. Priority Date: 06/10/1997
• Status: Active Grant

• Current Assignee: Nipro Diagnostics, Inc.
• Original Assignee: Home Diagnostics Incorporated
• Inventors: Bell, Douglas, Schneider, Jon, Carroll, Patrick
• Granted Patent: US 7,560,288 B2
• Time in Patent Office: Days
• US Class Current: 436/514
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/815 Test for named compound or class of compounds
• CPC Class Codes: Y10S 436/827 Lectins

Abstract

An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing. The improved test strip comprises no more than two operative layers and: (a) a reaction membrane containing a reagent capable of reacting with the analyte of interest to produce a measurable change in said membrane; (b) an upper support layer defining a sample receiving port for receiving the fluid sample thereat; (c) one or more structures for directing the sample containing the analyte of interest through at least a portion of said reaction membrane; and (d) a lower support layer having a reaction viewing port in vertical alignment with said membrane for displaying said measurable change, said lower support being associated with said upper support to secure said reaction membrane in said test strip.

Claims

1-28. -28. (canceled)

29. A diagnostic test strip for measuring an analyte of interest in a heterogeneous fluid sample, the test strip comprising:

a first support layer having a first interior adhesive surface;

a second support layer having a second interior adhesive surface; and

first and second operative layers supported between the first and second support layers;

wherein the first operative layer includes a material for filtering the fluid sample, and the second operative layer includes a membrane for measuring the analyte of interest, and

wherein the first operative layer is in contact with the first interior adhesive surface of the first support layer, and the second operative layer is in contact with the second interior adhesive surface of the second support layer.

30. The diagnostic test strip of claim 29, wherein the first support layer includes a sample receiving port, and the second support layer includes a reaction viewing port.

31. The diagnostic test strip of claim 30, wherein the first operative layer is in vertical alignment with the sample receiving port, and the second operative layer is in vertical alignment with the reaction viewing port.

32. The diagnostic test strip of claim 29, wherein the first operative layer filters at least one undesirable element from the fluid sample prior to passing the fluid sample to the second operative layer.

33. The diagnostic test strip of claim 29, wherein the material of the first operative layer is a woven fabric including a plurality of mesh openings.

34. The diagnostic test strip of claim 29, wherein the membrane is optically white.

35. The diagnostic test strip of claim 29, wherein at least one of the operative layers is pretreated with a reagent.

36. The diagnostic test strip of claim 35, wherein the reagent produces a glucose oxidase/peroxidase reaction.

37. The diagnostic test strip of claim 29, further comprising:

indicia for indicating a proper orientation for insertion of the test strip in a corresponding meter.

38. The diagnostic test strip of claim 29, wherein the indicia includes at least one arrow on the first support layer to indicate proper direction of insertion.

39. The diagnostic test strip of claim 29, wherein the indicia includes a light absorbing medium on a top surface of the first support layer.

41. The diagnostic test strip of claim 29, wherein the membrane is pretreated with a reagent for reacting with the analyte of interest to produce a measurable change in color for display in a reaction viewing port.

43. A diagnostic test strip for measuring an analyte of interest in a heterogeneous fluid sample, the test strip comprising:

a first support layer including a sample receiving port for receiving the fluid sample;

a second support layer including a reaction viewing port for displaying the measurement;

a first operative layer in vertical alignment with the sample receiving port; and

a second operative layer in vertical alignment with the reaction viewing port;

wherein the first and second operative layers are supported between the first and second support layers, and

wherein the first operative layer is a separating layer for filtering the fluid sample, and the second operative layer is a membrane for measuring the analyte of interest.

40. The diagnostic test strip of claim 42, wherein the light absorbing medium includes a black region proximate to an end portion of the first support layer near a sample receiving port.

42. The diagnostic test strip of claim 44, wherein the measurable change in the reagent corresponds to an amount of the analyte of interest present.

44. The diagnostic test strip of claim 43, wherein the first support layer includes a first interior adhesive surface, and the second support layer includes a second interior adhesive surface.

45. The diagnostic test strip of claim 44, wherein the first operative layer is in contact with the first interior adhesive surface, and the second operative layer is in contact with the second interior adhesive surface.

46. The diagnostic test strip of claim 43, wherein at least one of the operative layers is pretreated with a reagent.

47. The diagnostic test strip of claim 43, wherein the separating layer filters at least one undesirable element from the fluid sample prior to passing the fluid sample to the membrane.

48. The diagnostic test strip of claim 43, wherein the membrane is optically white.

49. The diagnostic test strip of claim 47, wherein the membrane further filters the fluid sample that passes through the separating layer.

50. The diagnostic test strip of claim 43, wherein the membrane is pretreated with a reagent for reacting with the analyte of interest to produce a measurable change in color for display in the reaction viewing port.

51. The diagnostic test strip of claim 50, wherein the measurable change in the reagent corresponds to an amount of the analyte of interest present.

52. A diagnostic test strip for measuring an analyte of interest in a heterogeneous fluid sample, the test strip comprising:

a first support layer;

a second support layer;

a separating layer pretreated with a separating agent; and

a membrane pretreated with a reagent and a conditioning solution to produce a color change in response to the analyte of interest;

wherein the separating layer and the membrane are supported between the first and second support layers.

53. The diagnostic test strip of claim 52, wherein the separating layer removes substantially all red blood cells from the fluid sample.

54. The diagnostic test strip of claim 53, wherein the membrane removes the remaining red blood cells from the fluid sample.

55. The diagnostic test strip of claim 52, wherein the membrane is isotropic.

56. The diagnostic test strip of claim 52, wherein the first support layer includes a sample receiving port, and the second support layer includes a reaction viewing port.

57. The diagnostic test strip of claim 56, wherein the separating layer is in vertical alignment with the sample receiving port, and the membrane is in vertical alignment with the reaction viewing port.

58. The diagnostic test strip of claim 52, wherein the separating layer filters at least one undesirable element from the fluid sample prior to passing the fluid sample to the membrane.

59. The diagnostic test strip of claim 52, wherein the separating layer is a woven fabric including a plurality of mesh openings.

60. The diagnostic test strip of claim 52, wherein the color change in the reagent corresponds to an amount of the analyte of interest present.

61. A diagnostic test strip for measuring an analyte of interest in a heterogeneous fluid sample, the test strip comprising:

a first support layer including a sample receiving port for receiving the fluid sample;

a second support layer including a reaction viewing port for displaying the measurement;

a separating layer pretreated with a separating agent; and

a membrane pretreated with a reagent for reacting with the analyte of interest to produce a measurable change in color for display in the reaction viewing port;

wherein the separating layer and the membrane are supported between the first and second support layers, and

wherein the separating agent filters at least one undesirable element from the fluid sample prior to passing the fluid sample to the membrane.

62. The diagnostic test strip of claim 61, wherein the separating layer includes a plurality of mesh openings.

63. The diagnostic test strip of claim 61, wherein the first support layer includes a first interior adhesive surface, and the second support layer includes a second interior adhesive surface.

64. The diagnostic test strip of claim 63, wherein the separating layer is in contact with the first interior adhesive surface, and the membrane is in contact with the second interior adhesive surface.

65. The diagnostic test strip of claim 61, wherein the separating layer is in vertical alignment with the sample receiving port, and the membrane is in vertical alignment with the reaction viewing port.

66. The diagnostic test strip of claim 61, wherein the measurable change in the reagent corresponds to an amount of the analyte of interest present.