Integrated device for analyte, testing, confirmation, and donor identity verification

• US 7,879,623 B2
• Filed: 02/11/2008
• Issued: 02/01/2011
• Est. Priority Date: 03/31/2006
• Status: Active Grant

• Current Assignee: Sonabank (432804) (Primis Financial Corp.)
• Original Assignee: BiotechPharma LLC
• Inventors: Guirguis, Raouf A.
• Primary Examiner(s): Chin; Christopher L
• Application Number:
  US12/029,418
• Publication Number:
  US 20080194041A1
• Time in Patent Office: 1,086 Days
• Field of Search: 422/56, 422/57, 422/58, 435/287.2, 435/287.7, 435/287.9, 435/805, 435/810, 435/970, 436/169, 436/514, 436/810, 436/815
• US Class Current: 436/514
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: A61B 2010/0006 involving a colour change
• 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 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/815 Test for named compound or class of compounds

Abstract

The present invention provides an apparatus for fluid sample collection and analyte testing, including a sample receiving member and at least one membrane test strip, and optionally a sample retention member, fingerprint acquisition pad, and/or fluid collector. It also provides a fluid collection apparatus having an absorbent material, compression element, and closure element, and optionally a lid that allows the apparatus to be used in conjunction with a fluid container. Also provided are methods of collecting, testing, and retaining a fluid sample and verifying the identity of one or more individuals associated with the sample, such as the test subject, test administrator, and/or witnesses.

Claims

1. An apparatus comprising:

a sample receiving member, having a lockable opening for receiving a fluid sample;

a sample retention member to retain a portion of the fluid sample;

a passage coupling the sample receiving member to the sample retention member to allow a portion of the fluid sample to flow into the sample retention member; and

at least one membrane test strip, in fluid communication with the sample receiving member, to indicate the presence or absence of at least one analyte in the fluid sample.

2. The apparatus of claim 1, further comprising a fluid collector to collect the fluid sample and convey the fluid sample into the sample receiving member.

3. The apparatus of claim 2, wherein the fluid collector comprises:

an absorbent material to absorb the fluid sample;

a compression member operatively associated with the absorbent material; and

a closure member capable of sealing the open end of the sample receiving member when the fluid collector is inserted in the sample receiving member.

4. The apparatus of claim 3, wherein the closure member is capable of creating an airtight seal in the open end of the sample receiving member.

5. The apparatus of claim 3, further comprising means for securing the fluid collector within the sample receiving member after the fluid collector has been inserted into the sample receiving member.

6. The apparatus of claim 5, wherein the means for securing the fluid collector within the sample receiving member comprise at least one annular projection within the sample receiving member.

7. The apparatus of claim 3, wherein the fluid collector further comprises a handle removably attached to the upper surface of the first disk.

8. The apparatus of claim 3, further comprising a saliva-producing substance.

9. The apparatus of claim 8, wherein the saliva-producing substance comprises sugar, salt, acid, or any combination thereof.

10. The apparatus of claim 9, wherein the saliva-producing substance comprises sodium chloride, citric acid, or any combination thereof.

11. The apparatus of claim 1, further comprising a fingerprint acquisition pad.

12. The apparatus of claim 11, wherein the fingerprint acquisition pad is enclosed by a cover attached to the housing.

13. The apparatus of claim 11, wherein the fingerprint acquisition pad is an ink-based fingerprint acquisition pad.

14. The apparatus of claim 13, further comprising a dispenser able to dispense an ink that can elicit a signal in the ink-based fingerprint acquisition pad.

15. The apparatus of claim 11, wherein the fingerprint acquisition pad is an inkless fingerprint acquisition pad.

16. The apparatus of claim 15, further comprising a dispenser able to dispense an activator that can elicit a signal in the inkless fingerprint acquisition pad.

17. The apparatus of claim 15, wherein the inkless fingerprint acquisition pad is an immunoassay-based fingerprint acquisition pad.

18. The apparatus of claim 17, wherein the immunoassay-based fingerprint acquisition pad is in fluid communication with the sample receiving member.

19. The apparatus of claim 18, wherein a channel provides the fluid communication between the sample receiving member and the at least one membrane test strip and the fluid communication between the sample receiving member and the immunoassay-based fingerprint acquisition pad.

20. The apparatus of claim 19, further comprising a dispenser able to dispense a signal-producing agent that can elicit a signal in the immunoassay-based fingerprint acquisition pad.

21. The apparatus of claim 11, wherein the fingerprint acquisition pad is an electronic fingerprint acquisition pad.

22. The apparatus of claim 21, further comprising means for storage of a fingerprint image captured by the fingerprint acquisition pad.

23. The apparatus of claim 21, further comprising means for transmission of the fingerprint image.

24. The apparatus of claim 23, wherein the transmission is a wireless transmission.

25. The apparatus of claim 11, wherein the sample retention member comprises an absorbent material.

26. The apparatus of claim 25, wherein a single channel having multiple openings provides the fluid communication of the sample receiving member with the at least one membrane test strip and the fluid communication of the sample receiving member with the sample retention member.

27. The apparatus of claim 25, wherein the absorbent material is bonded to the fingerprint acquisition pad.

28. The apparatus of claim 11, wherein the sample retention member is a storage container defining a volume for storage of the fluid sample.

29. The apparatus of claim 28, wherein the storage container is bonded to the fingerprint acquisition pad.

30. The apparatus of claim 29, wherein the storage container is removably attached to the apparatus.

31. The apparatus of claim 28, wherein the storage container may be punctured with a needle to access the fluid contained therein.

32. The apparatus of claim 1, wherein at least one channel provides the fluid communication of the sample receiving member with the at least one membrane test strip and at least one channel provide the fluid communication of the sample receiving member with the sample retention member, wherein the at least one channel that provides the fluid communication of the sample receiving member with the at least one membrane test strip has greater flow resistance than the at least one channel that provides the fluid communication of the sample receiving member with the sample retention member, to ensure that a portion of the fluid sample is collected in the sample retention member.

33. The apparatus of claim 1, wherein at least one channel dimensioned to be compatible with a fluid having the viscosity of water provides the fluid communication of the sample receiving member with the at least one membrane test strip and at least one channel dimensioned to be compatible with a fluid having the viscosity of water provides the fluid communication of the sample receiving member with the sample retention member.

34. The apparatus of claim 1, wherein at least one channel dimensioned to be compatible with a fluid having the viscosity of urine provides the fluid communication of the sample receiving member with the at least one membrane test strip and at least one channel dimensioned to be compatible with a fluid having the viscosity of urine provides the fluid communication of the sample receiving member with the sample retention member.

35. The apparatus of claim 1, wherein at least one channel dimensioned to be compatible with a fluid having the viscosity of saliva provides the fluid communication of the sample receiving member with the at least one membrane test strip and at least one channel dimensioned to be compatible with a fluid having the viscosity of saliva provides the fluid communication of the sample receiving member with the sample retention member.

36. The apparatus of claim 1, wherein at least one channel dimensioned to be compatible with a fluid having the viscosity of blood provides the fluid communication of the sample receiving member with the at least one membrane test strip and at least one channel dimensioned to be compatible with a fluid having the viscosity of blood provides the fluid communication of the sample receiving member with the sample retention member.

37. The apparatus of claim 1, wherein each of the at least one membrane test strip includes:

a dye region, disposed at a proximal end of the membrane test strip, including labeled antibodies reactive against one or more of the at least one analyte and at least one labeled control protein;

a control region, disposed at the distal end of the membrane strip, including antibodies reactive against the at least one labeled control protein; and

at least one test region, wherein each of the at least one test region is disposed on the membrane test strip between the dye region and the control region and includes at least one competitor able to bind the antibodies reactive against one or more of the at least one analyte.

38. The apparatus of claim 37, wherein the test region displays a visual indicator when the concentration of an analyte in the fluid sample is below a predetermined threshold.

39. The apparatus of claim 37, wherein the control region displays a visual indicator when the first volume of fluid received from the fluid collector is above a predetermined threshold and proper membrane wicking has occurred.

40. The apparatus of claim 39, wherein the predetermined threshold is 200 microliters.

41. The apparatus of claim 1, wherein each of the at least one membrane test strip includes:

a dye region, disposed at a proximal end of the membrane test strip, including labeled antibodies reactive against one or more of the at least one analyte and at least one labeled control protein;

a control region, disposed at the distal end of the membrane strip, including antibodies reactive against the at least one labeled control protein; and

at least one test region, wherein each of the at least one test region is disposed on the membrane test strip between the dye region and the control region and includes antibodies reactive against one or more of the at least one analyte.

42. The apparatus of claim 41, wherein the test region displays a visual indicator when the concentration of an analyte in the fluid sample is above a predetermined threshold.

43. The apparatus of claim 41, wherein the control region displays a visual indicator when the first volume of fluid received from the fluid collector is above a predetermined threshold and proper membrane wicking has occurred.

44. The apparatus of claim 43, wherein the predetermined threshold is 200 microliters.

45. The apparatus of claim 1, wherein the at least one analyte in the fluid sample is amphetamine, methamphetamine, a cocaine metabolite, an opiate, THC-COOH, phencyclidine, or any combination thereof.

46. The apparatus of claim 45, wherein absence of a visible signal in a test region of the at least one membrane test strip indicates that an analyte is not present above a predetermined threshold concentration in the fluid sample.

47. The apparatus of claim 45, wherein presence of a visible signal in a test region of the at least one membrane test strip indicates that an analyte is present above a predetermined threshold concentration in the fluid sample.

48. An apparatus comprising:

a sample receiving member, having a lockable opening for receiving a fluid sample;

a fluid collector to collect the fluid sample and convey the fluid sample into the sample receiving member, wherein said fluid collector is removably associated with the apparatus and comprises a closure member capable of locking the lockable opening of the sample receiving member;

at least one membrane test strip, in fluid communication with the sample receiving member, to indicate the presence or absence of at least one analyte in the fluid sample, and

a fingerprint acquisition pad.

49. The apparatus of claim 48, further comprising a sample retention member, in fluid communication with the sample receiving member, to retain a portion of the fluid sample.

50. The apparatus of claim 49, wherein the sample retention member comprises an absorbent material.

51. The apparatus of claim 50, wherein the absorbent material is bonded to the fingerprint acquisition pad.

52. The apparatus of claim 48, further comprising a saliva-producing substance.

53. The apparatus of claim 48, wherein the fluid collector comprises:

an absorbent material, to absorb the fluid sample;

a compression member operatively associated with the absorbent material; and

a closure member, capable of sealing the open end of the sample receiving member when the fluid collector is inserted in the sample receiving member.

54. The apparatus of claim 48, wherein the fingerprint acquisition pad is enclosed by a cover attached to the housing.

55. The apparatus of claim 48, wherein the fingerprint acquisition pad is selected from the group consisting of an ink-based fingerprint acquisition pad, an inkless fingerprint acquisition pad, an immunoassay-based fingerprint acquisition pad, and an electronic fingerprint acquisition pad.

56. The apparatus of claim 48, further comprising a dispenser able to dispense an activator that can elicit a signal in the fingerprint acquisition pad.

57. The apparatus of claim 48, wherein each of the at least one membrane test strip includes:

a dye region, disposed at a proximal end of the membrane test strip, including labeled antibodies reactive against one or more of the at least one analyte and at least one labeled control protein;

a control region, disposed at the distal end of the membrane strip, including antibodies reactive against the at least one labeled control protein; and

at least one test region, wherein each of the at least one test region is disposed on the membrane test strip between the dye region and the control region and includes at least one competitor able to bind the antibodies reactive against one or more of the at least one analyte.

58. The apparatus of claim 48, wherein absence of a visible signal in a test region of the at least one membrane test strip indicates that an analyte is not present above a predetermined threshold concentration in the fluid sample.

59. The apparatus of claim 48, wherein each of the at least one membrane test strip includes:

a dye region, disposed at a proximal end of the membrane test strip, including labeled antibodies reactive against one or more of the at least one analyte and at least one labeled control protein;

a control region, disposed at the distal end of the membrane strip, including antibodies reactive against the at least one labeled control protein; and

at least one test region, wherein each of the at least one test region is disposed on the membrane test strip between the dye region and the control region and includes antibodies reactive against one or more of the at least one analyte.

60. The apparatus of claim 48, wherein presence of a visible signal in a test region of the at least one membrane test strip indicates that an analyte is present above a predetermined threshold concentration in the fluid sample.

61. A fluid collection apparatus comprising:

an absorbent material, to absorb a fluid sample;

a compression member operatively associated with the absorbent material; and

a closure member, capable of sealing the open end of a sample receiving member when the fluid collection apparatus is inserted in the sample receiving member.

62. The apparatus of claim 61, further comprising a lid capable of being affixed to a fluid container, wherein the absorbent material is disposed on the inner side of the lid.

63. The apparatus of claim 61, wherein the closure member is capable of creating an airtight seal in the open end of the sample receiving member.

64. The apparatus of claim 61, wherein the fluid collection apparatus further comprises a handle removably attached to the upper surface of the first disk.

65. The apparatus of claim 61, further comprising a saliva-producing substance.

66. The apparatus of claim 65, wherein the saliva-producing substance is selected from the group comprising sugars, salts, acids, and combinations thereof.

67. The apparatus of claim 66, wherein the saliva-producing substance is selected from the group consisting of sodium chloride, citric acid, and combinations thereof.

68. The apparatus of claim 61, further comprising a housing surrounding at least part of the absorbent material.

69. The apparatus of claim 68, wherein the housing defines at least one opening to allow the fluid sample to enter the absorbent material.

70. The apparatus of claim 68, wherein the housing further comprises a porous filter able to strain particulates from the fluid sample.

71. The apparatus of claim 68, wherein the housing is slidably coupled to the compression member.

72. The apparatus of claim 71, further comprising a spring operatively associated with the absorbent material and oriented with the direction in which the absorbent material is compressed, whereby compression of the absorbent material results in compression of the spring.

73. The apparatus of claim 72, wherein the absorbent material is compressed between the compression member and the housing.

74. The apparatus of claim 73, further comprising means for securing the compression member relative to the housing in the position in which the absorbent material is compressed.

75. The apparatus of claim 74, further comprising a lid capable of being affixed to a fluid container, wherein the absorbent material is disposed on the inner side of the lid.

76. An apparatus comprising:

a fluid collector to collect the fluid sample and convey the fluid sample into the sample receiving member, comprising;

an absorbent material, to absorb the fluid sample;

a compression member operatively associated with the absorbent material; and

a closure member, capable of sealing the open end of the sample receiving member when the fluid collector is inserted in the sample receiving member;

a sample receiving member, having an opening for receiving a fluid sample;

a sample retention member, in fluid communication with the sample receiving member, to retain a portion of the fluid sample;

at least one membrane test strip, in fluid communication with the sample receiving member, to indicate the presence or absence of at least one analyte in the fluid sample; and

a fingerprint acquisition pad.

77. A method of testing a fluid sample, comprising:

collecting a fluid sample in an absorbent material;

conveying the absorbent material into a receiving member of an apparatus;

compressing the absorbent material, whereby;

the fluid sample is expelled from the absorbent material into channels within the apparatus;

the fluid sample encounters at least one membrane test strip within the apparatus that visually indicates the presence or absence of each of one or more analytes;

a portion of the fluid sample is retained in a sample retention member of the apparatus;

contacting the finger of an individual associated the test with a fingerprint acquisition pad operatively associated with the apparatus, whereby a fingerprint is collected.