Specimen collection, storage, transportation and assaying device

• US 20060029517A1
• Filed: 08/03/2004
• Published: 02/09/2006
• Est. Priority Date: 08/03/2004
• Status: Active Grant

• Current Assignee: Ameditech, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Hartselle R. Lawrence
• Inventors: Hartselle, R. Lawrence
• Granted Patent: US 7,758,815 B2
• Time in Patent Office: Days
• US Class Current: 422/61
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: B01L 2200/141 Preventing contamination, tampering
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/046 Function or devices integrated in the closure
• CPC Class Codes: B01L 2300/0609 Holders integrated in container to position an object
• CPC Class Codes: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/0832 cylindrical, tube shaped
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2400/0478 pistons
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00

Abstract

A tamper-proof, point-of-collection specimen assay apparatus including three selectively connectable and sealable chambers, including a first chamber for receiving a specimen, a second chamber housing a specimen testing device and a specimen transfer site positioned between the first chamber and the second chamber for selectively depositing a portion of the specimen from the first chamber into the second chamber and a third chamber having inlets for depositing another portion of the specimen from the first chamber into the third chamber.

Claims

1. A specimen receptacle comprising,

a first chamber for receiving a specimen,

a second chamber including a specimen testing device, and

a specimen transfer site positioned essentially between the first chamber and the second chamber, the specimen transfer site being adapted and arranged for selectively transferring at least a portion of a specimen between the first chamber and the second chamber.

2. The specimen receptacle according to claim 1 wherein the first chamber and the second chamber are not in fluid communication.

3. The specimen receptacle according to claim 1 wherein the first chamber and the second chamber are in fluid communication.

4. The specimen receptacle according to claim 1 further comprising a means for transferring a predetermined amount of the specimen within the first chamber into the second chamber.

5. The specimen receptacle according to claim 4 wherein the predetermined amount is about 1 ml.

6. The specimen receptacle according to claim 1 wherein the specimen site comprises a passageway extending between the first chamber and the second chamber.

7. The specimen receptacle according to claim 6 further comprising a closure obstructing the passageway.

8. The specimen receptacle according to claim 6 wherein at least a portion of the passageway is constricted to prevent the passage therethough of a specimen from the first chamber to the second chamber when the specimen is under ambient pressure only.

9. The specimen receptacle according to claim 1 wherein the second chamber includes a testing device support chamber in fluid communication with the second chamber and the specimen testing device is at least partially contained within the specimen testing device support chamber.

10. The specimen receptacle according to claim 9 wherein the second chamber includes a floor sloped toward the testing device support chamber.

11. The specimen receptacle according to claim 1 wherein the second chamber includes a floor sloped toward the specimen testing device.

12. The specimen receptacle according to claim 1 further comprising a lid having a top side and a bottom side and being adapted to at least partially enclose the first chamber.

13. The specimen receptacle according to claim 12 wherein the lid includes a hole extending from the top side to the bottom side.

14. The specimen receptacle according to claim 13 further comprising a cap adapted to cover the hole.

15. The specimen receptacle according to claim 12 wherein the lid includes a plunger extending out from the bottom side thereof.

16. The specimen receptacle according to claim 1 wherein the first chamber includes a plunger receiving portion for receiving an end of a plunger.

17. The specimen receptacle according to claim 16 wherein the end of the plunger includes at least one sealing member for engaging a portion of the plunger receiving portion.

18. The specimen receptacle according to claim 16 wherein the specimen transfer site is located within the plunger receiving portion.

19. The specimen receptacle according to claim 17 wherein the at least one sealing member is an O-ring.

20. The specimen receptacle according to claim 1 further comprising a pressure exerting device for increasing a pressure within at least a portion of the first chamber.

21. The specimen receptacle according to claim 20 wherein the pressure exerting device defines a third chamber.

22. The specimen receptacle according to claim 20 wherein the pressure exerting device is connected with a lid.

23. The specimen receptacle according to claim 22 wherein the lid includes an opening in fluid communication with a third chamber defined by the pressure exerting device.

24. The specimen receptacle according to claim 23 further comprising a cap adapted to cover the opening.

25. The specimen receptacle according to claim 23 wherein the lid further includes a second opening in fluid communication with the first chamber.

26. The specimen receptacle according to claim 25 further comprising a cap adapted to cover the second opening.

27. The specimen receptacle according to claim 23 wherein the pressure exerting device is a plunger.

28. The specimen receptacle according to claim 27 wherein the first chamber includes a plunger receiving portion for receiving an end of the plunger.

29. The specimen receptacle according to claim 28 wherein the end of the plunger includes a first sealing member for engaging a portion of the plunger receiving portion.

30. The specimen receptacle according to claim 29 wherein the end of the plunger includes a second sealing member for engaging another portion of the plunger receiving portion.

31. The specimen receptacle according to claim 30 wherein the plunger includes at least one aperture between the first sealing member and the second sealing member.

32. The specimen receptacle according to claim 23 wherein the third chamber includes at least one aperture adapted and arranged for selectively connecting the third chamber with the first chamber.

33. The specimen receptacle according to claim 23 wherein the third chamber includes at least one aperture adapted and arranged for selectively depositing a predetermined amount of a specimen contained within the first chamber into the third chamber.

34. The specimen receptacle according to claim 21 further comprising a means for selectively depositing a predetermined amount of a specimen contained within the first chamber into the third chamber.

35. The specimen receptacle according to claim 1 further comprising a third chamber.

36. The specimen receptacle according to claim 34 wherein the third chamber is selectively connectable with the first chamber.

37. The specimen receptacle according to claim 1 wherein the second chamber further includes a means of detecting moisture.

38. The specimen receptacle according to claim 37 wherein the means of detecting moisture includes moisture paper.

39. A method for specimen collection, analysis, transportation or storage comprising,

providing the specimen receptacle according to claim 1,

depositing a specimen into the first chamber, and

manually causing an amount of the specimen within the first chamber to enter into the second chamber through the specimen transfer site.

40. The method according to claim 39 further comprising manipulating a pressure exerting device for manually causing the amount of specimen within the first chamber to enter into the second chamber.

41. The method according to claim 40 further comprising manually causing a second amount of specimen within the first chamber to enter into a third chamber defined by the pressure exerting device.

42. The method according to claim 41 further comprising selectively preventing fluid communication between the first chamber, the second chamber and the third chamber.

43. A method for specimen collection, analysis, transportation or storage comprising,

providing a specimen receptacle including a first chamber and a second chamber,

depositing a specimen into the first chamber, and

manually causing a first predetermined amount of the specimen within the first chamber to be deposited into the second chamber.

44. The method according to claim 43 wherein the second chamber includes a specimen testing device or an access to the specimen testing device.

45. The method according to claim 44 wherein the predetermined amount of the specimen is about 1 ml.

46. The method according to claim 43 wherein the specimen receptacle includes a third chamber.

47. The method according to claim 46 further comprising manually causing a second predetermined amount of the specimen within the first chamber to be deposited into the third chamber.

48. The method according to claim 47 wherein the second predetermined amount is at least about 15 ml.

49. The method according to claim 47 comprising preventing fluid communication between the second chamber, the third chamber and first chamber.

50. The method according to claim 43 wherein manually causing a first predetermined amount of the specimen within the first chamber to be deposited into the second chamber includes exerting a pressure on the specimen in the first chamber.

51. The method according to claim 43 wherein manually causing the first predetermined amount of the specimen within the first chamber to be deposited into second chamber includes manipulating a plunger into a plunger receiving portion of the second chamber.

52. The method according to claim 51 wherein the plunger is connected with a lid, the lid being adapted to enclose at least part of the first chamber.

53. The method according to claim 47 wherein manually causing the second predetermined amount of the specimen within the first chamber to be deposited into the third chamber includes manipulating a plunger into a plunger receiving portion of the second chamber.

54. The method according to claim 53 wherein the plunger is connected with a lid, the lid being adapted to enclose at least part of the first chamber.

55. The method according to claim 47 wherein manually causing the first predetermined amount of the specimen within the first chamber to be deposited into the second chamber and manually causing the second predetermined amount of the specimen within the first chamber to be deposited into the third chamber includes manipulating a plunger into a plunger receiving portion of the second chamber.

56. The method according to claim 55 wherein the plunger is connected with a lid, the lid being adapted to enclose at least part of the first chamber.

57. The method according to claim 56 wherein the lid includes a first opening for providing access to the first chamber.

58. The method according to claim 57 wherein the lid further includes a second opening for providing access to the third chamber.

59. The method according to claim 43 further comprising viewing a means of detecting moisture located within the second chamber.

60. A receptacle comprising:

a first container defining a first void,

a second container nested with the first container and defining a second void,

a specimen testing device in fluid communication with the first void, and

a specimen transfer site for selectively transferring a specimen between the first void and the second void.

61. The receptacle according to claim 60 wherein the first container includes a floor sloping toward the specimen testing device.

62. The receptacle according to claim 60 wherein the second container includes a conical portion.

63. The receptacle according to claim 60 wherein the second container includes a plunger receiving portion.

64. The receptacle according to claim 63 wherein the plunger receiving portion is centrally located within a bottom of the second container.

65. The receptacle according to claim 64 wherein the bottom slopes toward the plunger receiving portion.

66. The receptacle according to claim 63 wherein the specimen transfer site is located within the plunger receiving portion.

67. The receptacle according to claim 63 further comprising a plunger assembly adapted and arranged to engage the plunger receiving portion.

68. The receptacle according to claim 67 wherein the plunger assembly includes a lid for enclosing at least part of the receptacle.

69. The receptacle according to claim 68 wherein the lid includes a first sealable opening that provides access to the second void.

70. The receptacle according to claim 68 wherein the lid includes a second sealable opening that provides access to a third void defined by the plunger assembly.

71. The receptacle according to claim 67 wherein the plunger assembly includes a lower end having a seal member thereabout adapted and arranged to sealingly engage a wall of the plunger receiving portion.

72. The receptacle according to claim 67 wherein the plunger assembly defines a third void.

73. The receptacle according to claim 72 wherein the plunger assembly includes an aperture for providing fluid communication between the second void and the third void.

74. The receptacle according to claim 73 wherein the plunger assembly includes a first sealing member and a second sealing member, the first and second sealing members being adapted and arranged to sealingly engage a wall of the plunger receiving portion.

75. The receptacle according to claim 74 wherein the aperture of the plunger assembly is positioned between the first sealing member and the second sealing member.

76. The receptacle according to claim 60 wherein the specimen transfer site includes a passageway that is at least partially obstructed by a removable closure or a constriction of the passageway.

77. The receptacle according to claim 60 wherein the first void includes a moisture detection device.

78. The receptacle according to claim 60 wherein second container is locked with the first container.

79. A method of collecting, assaying, transporting or storing a specimen comprising,

providing the receptacle according to claim 60,

depositing a specimen within the second void,

forcing an amount of the specimen from the second void through the specimen transfer site and into the first void.

80. The method according to claim 79 wherein the amount of the specimen is about 1 ml.

81. The method according to claim 79 wherein forcing the amount of the specimen includes inserting a plunger into a plunger receiving portion of the second container.

82. The method according to claim 79 wherein inserting the plunger into the plunger receiving portion prevents fluid communication between the first void and the second void.

83. A method of collecting, assaying, transporting or storing a specimen comprising,

providing the receptacle according to claim 73,

depositing a specimen into the second void,

forcing an amount of the specimen from the second void through the specimen transfer site and into the first void.

84. The method according to claim 83 wherein forcing the amount of the specimen includes inserting the plunger assembly into the plunger receiving portion.

85. The method according to claim 84 wherein inserting the plunger assembly into the plunger receiving portion prevents fluid communication between the first void and the second void.

86. The method according to claim 84 wherein inserting the plunger assembly into the plunger receiving portion prevents fluid communication between the second void and the third void.

87. The method according to claim 84 wherein inserting the plunger assembly into the plunger receiving portion isolates an amount of the specimen within the third void from the second void.

88. A method of collecting, testing, storing or transporting a specimen comprising,

providing a specimen receptacle including at least two selectively connectable chambers, depositing a specimen within a first one of the at least two chambers.

89. The method according to claim 88 further comprising manually causing an amount of the specimen in the first one of the at least two chambers to be deposited into a second one of the at least two chambers.

90. The method according to claim 89 wherein the amount is predetermined.

91. The method according to claim 90 wherein the predetermined amount is about 1 ml.

92. The method according to claim 88 wherein the specimen receptacle further includes a third chamber wherein the third chamber is selectively connectable with the first one of the at least two selectively connectable chambers.

93. The method according to claim 92 further comprising manually causing an amount of the specimen in the first one of the at least two chambers to be deposited into a second one of the at least two chambers.

94. The method according to claim 92 further comprising manually causing an amount of the specimen in the first one of the at least two chambers to enter into the third chamber.

95. The method according to claim 93 wherein the amount is predetermined.

96. The method according to claim 94 wherein the amount is predetermined.

97. The method according to claim 95 wherein the predetermined amount is about 1 ml.

98. The method according to claim 96 wherein the predetermined amount is at least about 15 ml.

99. The method according to claim 92 further comprising manually causing a first amount of the specimen in the first one of the at least two chambers to be deposited into a second one of the at least two chambers and a second amount of the specimen in the first one of the at least two chambers to be deposited into the third chamber.

100. The method according to claim 88 further comprising viewing a moisture detection device located within the first one of the at least two chambers.

101. The method according to claim 89 wherein manually causing the amount of the first specimen in the first one of the at least two chambers to be deposited into the second one of the at least two chambers includes exerting a pressure onto the specimen in the first one of the at least two chambers.

102. The method according to claim 101 wherein the exerting a pressure onto the specimen in the first one of the at least two chambers includes directing a plunger into a plunger receiving portion of the first one of the at least two chambers.

103. The method according to claim 94 wherein manually causing an amount of the specimen in the first one of the at least two chambers includes directing a plunger into a plunger receiving portion of the first one of the at least two chambers.

113. The receptacle according to claim 102 further comprising a means of depositing an amount of a specimen from the second chamber into the third chamber.

114. The receptacle according to claim 113 wherein the amount is predetermined.

115. The receptacle according to claim 114 wherein the predetermined amount is at least about 15 ml.

104. A specimen receptacle comprising,

a first chamber,

a specimen testing device contained within at least a portion of the first chamber, and

a means of evidencing the presence of moisture within the first chamber prior to the introduction of a specimen into the first chamber.

105. The specimen receptacle according to claim 104 wherein the means of evidencing moisture within the first chamber includes a moisture paper.

106. The specimen receptacle according to claim 105 wherein the moisture paper is located about a bottom edge of the specimen testing device.

107. The specimen receptacle according to claim 105 wherein the moisture paper is viewable from outside of the specimen receptacle.

108. The specimen receptacle according to claim 104 further comprising a second chamber selectively connectable with the first chamber.

109. The specimen receptacle according to claim 108 further comprising a means of manually depositing an amount of the specimen from the second chamber into the first chamber.

110. The specimen receptacle according to claim 109 wherein the amount is predetermined.

111. The specimen receptacle according to claim 110 wherein the predetermined amount is about 1 ml.

112. The receptacle according to claim 108 further comprising a third chamber selectively connectable with the first chamber.

116. A method of detecting tampering of a specimen receptacle comprising,

providing within the specimen receptacle a means of evidencing the presence of moisture within the specimen receptacle wherein the moisture is not derived from a specimen.

117. The method according to claim 116 wherein the means of evidencing moisture within the specimen receptacle includes a moisture paper.

118. The method according to claim 116 wherein the means of evidencing moisture within the specimen receptacle is supported by a specimen assay assembly contained within at least a portion of the specimen receptacle.

119. The method according to claim 116 wherein the specimen receptacle includes a first chamber and a second chamber wherein a specimen testing device and the means of evidencing moisture within the specimen receptacle are contained within the first chamber.

120. The method according to claim 119 wherein the first chamber and the second chamber are selectively connectable.

121. The method according to claim 120 further comprising a third chamber being selectively connectable with the second chamber.

122. A specimen receptacle comprising

a first chamber including a specimen testing device and a floor sloped toward the specimen testing device.

123. The specimen receptacle according to claim 122 wherein the specimen testing device includes at least one lateral flow detection device.

124. The specimen receptacle according to claim 122 further comprising a second chamber selectively connectable with the first chamber.

125. The specimen receptacle according to claim 124 further comprising a means of depositing an amount of a specimen contained within the second chamber into the first chamber.

126. The specimen receptacle according to claim 125 wherein the amount is predetermined.

127. The specimen receptacle according to claim 124 further comprising a pressure exerting device for increasing a pressure within at least a portion of the second chamber.

128. The receptacle according to claim 122 wherein the first chamber further includes a moisture detection device.