Specimen collection container

• US 7,300,633 B2
• Filed: 08/02/2002
• Issued: 11/27/2007
• Est. Priority Date: 07/25/2001
• Status: Expired due to Term

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Oakville Hong Kong Co., Limited
• Inventors: Yang, Ying, Guan, Zhumin, Wu, Yuchang, Hudak, Robert Thomas
• Primary Examiner(s): Le; Long V.
• Assistant Examiner(s): Counts; Gary W.
• Application Number:
  US10/211,199
• Publication Number:
  US 20030027359A1
• Time in Patent Office: 1,943 Days
• Field of Search: 422/55, 422/58, 422/68.1, 422102-104, 422/81, 422/82, 435/7.1, 435/286.5, 435/288.5, 436/518, 436/164, 738/643.2, 738/646.3, 738/649.1, 738/647.3
• US Class Current: 422/537
• CPC Class Codes: B01L 2200/141 Preventing contamination, tampering
• CPC Class Codes: B01L 2200/185 Long distance transport, e.g. mailing
• CPC Class Codes: B01L 2300/0627 Sensor or part of a sensor is integrated
• CPC Class Codes: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2400/06 Valves, specific forms thereof
• 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
• CPC Class Codes: G01N 1/18 with provision for splitting samples into portions G01N1/12, G01N1/14 take precedence; fraction-collection apparatus for chromatography B01D15/08
• CPC Class Codes: G01N 2001/007 Devices specially adapted for forensic samples, e.g. tamper-proofing, sample tracking
• CPC Class Codes: G01N 35/1097 characterised by the valves valves in general F16K

Abstract

The present invention recognizes that sample handling devices, particularly those used for testing for substances of abuse, do not allow for a separation of the bulk sample from a sample thereof to be tested. The present invention provides such a device and methods of use. The present invention includes but is not limited to a specimen collection device that includes a chamber such that the chamber is capable of collecting a specimen. The device also includes a reservoir such that the reservoir is capable of receiving a portion of the specimen from the chamber and optionally so that the reservoir is capable of receiving a test device. The device includes a valve including a valve body and a valve plunger functionally interposed between the chamber and the reservoir that is capable of transferring at least a portion of the specimen from the chamber to the reservoir such that the chamber and the reservoir are not in direct fluid communication. The device includes a detachable handle able to engage the valve plunger. The device optionally includes a means for fluidic communication between the chamber, the valve and the reservoir.

Claims

1. A specimen collection device, comprising:

a) a chamber for collecting a specimen;

b) a reservoir for receiving a portion of said specimen from said chamber;

further wherein said reservoir receives a test device;

c) a valve comprising;

i) a valve body;

ii) a valve plunger positioned within said valve body;

iii) at least one O-ring in sealing contact with the inner diameter of the valve body;

d) a valve handle for engaging said valve plunger, said valve handle being detachable from said valve plunger;

wherein

said valve is functionally interposed between said chamber and said reservoir for transferring at least a portion of said specimen from said chamber to said reservoir such that said chamber and said reservoir are not in direct fluid communication;

and further wherein

the valve is limited to unidirectional motion and is inoperable after a first actuation.

2. The specimen collection device of claim 1, wherein the device further comprises a tamper resistant seal or tamper evident seal.

3. The specimen collection device of claim 1, wherein the O-ring provides a leak resistant seal.

4. The specimen collection device of claim 1, comprising a seal that is leak resistant up to 100 pounds per square inch internal pressure.

5. The specimen collection device of claim 1, wherein said chamber holds a specimen between about 0.05 milliliters and about 1,000 milliliters.

6. The specimen collection device of claim 1, wherein said chamber comprises metal, silicon, glass, ceramic, plastic or a polymer.

7. The specimen collection device of claim 1, wherein said chamber is tapered.

8. The specimen collection device of claim 1, wherein said chamber comprises a half elliptical side wall and a substantially rectangular test card wall.

9. The specimen collection device of claim 1, wherein said chamber is triangular.

10. The specimen collection device of claim 1, wherein said reservoir comprises metal, silicon, glass, ceramic, plastic or a polymer.

11. The specimen collection device of claim 1, wherein said reservoir snugly engages said test device.

12. The specimen collection device of claim 1, wherein said specimen is a liquid specimen.

13. The specimen collection device of claim 1, wherein said specimen is a biological specimen.

14. The specimen collection device of claim 1, wherein said specimen is urine, blood or serum.

15. The specimen collection device of claim 1, wherein said valve is substantially cylindrical.

16. The specimen collection device of claim 1, wherein said valve is leak resistant between said chamber and said reservoir.

17. The specimen collection device of claim 1, wherein said valve is leak resistant between said chamber and said reservoir to at least about 0 PSI to at least about 50 PSI pressure on said chamber.

18. The specimen collection device of claim 1, wherein said valve comprises metal, silicon, glass, ceramic, plastic or a polymer.

19. The specimen collection device of claim 1, wherein said reservoir is removable from said chamber.

20. The specimen collection device of claim 1, further comprising at least one test device.

21. The specimen collection device of claim 1, wherein said test device comprises at least one test strip.

22. The specimen collection device of claim 21, wherein said test strip is capable of performing at least one specific binding reaction.

23. The specimen collection device of claim 22, wherein said specific binding reaction comprises an immunoassay.

24. The specimen collection device of claim 21, wherein said test strip is capable of performing an enzymatic reaction.

25. The specimen collection device of claim 21, wherein said test strip is capable of performing a chemical reaction.

26. The specimen collection device of claim 1, wherein said test device is capable of detecting at least one analyte of interest.

27. The specimen collection device of claim 26, wherein said analyte of interest is selected from the group consisting of a drug, a drug of abuse, a hormone, a protein, a nucleic acid molecule, an etiological agent and a specific binding member.

28. The specimen collection device of claim 1, wherein said test device further comprises a wick.

29. The specimen collection device of claim 1, wherein said test device is separate from said specimen collection device.

30. The specimen collection device of claim 1, wherein said chamber, said valve, said reservoir or said test device comprises an adulteration determination device.

31. The specimen collection device of claim 1 further comprising a test card housing able to engage said test device.

32. The specimen collection device of claim 31 wherein said test card housing is permanently affixed to said specimen collection device.

33. The specimen collection device of claim 31 wherein said test card housing is detachable from said specimen collection device.

34. A method of detecting an analyte of interest in a specimen, comprising:

a) providing the specimen collection device of claim 1;

b) placing a specimen into said chamber;

c) actuating said valve to transfer at least a portion of said specimen from said chamber to said reservoir;

d) contacting the transferred portion of said specimen with a test device; and

e) detecting the presence or absence of the analyte of interest in the specimen.

35. The method of claim 34, wherein said specimen is a biological specimen.

36. The method of claim 34, wherein said specimen is provided directly or indirectly from a test subject into said chamber.

37. The method of claim 34, wherein after providing said specimen into said chamber, said chamber is sealed with a tamper resistant or tamper evident seal.

38. The method of claim 34, wherein after the step of placing a specimen into said chamber, a temperature sensing device in communication with the specimen is examined to verify that the specimen has not been adulterated.

39. The method of claim 34, further comprising allowing the portion of specimen to enter the valve.

40. The method of claim 34, wherein said portion of said specimen is at least about one milliliter.

41. The method of claim 34, wherein said valve is actuated such that said portion of said specimen is transferred away from said chamber and delivered into said reservoir.

42. The method of claim 41, wherein said transfer of said portion of said specimen into said reservoir is irreversible.

43. The method of claim 41, wherein said chamber and said reservoir are not in direct fluid communication.

44. The method of claim 34, wherein said test device is an immunoassay test device.

45. The method of claim 44, wherein said immunoassay test device comprises one or more lateral flow test strips.

46. The method of claim 34, wherein after the step of providing a specimen to said collection device an adulterant determination device is examined to verify that the specimen has not been adulterated.

47. The method of claim 34, wherein after said chamber containing said specimen has been sealed, the sealed chamber can be transported to a laboratory facility for confirmation of test results provided by said test device.

48. The method of claim 34, wherein after said chamber containing said specimen has been sealed, the sealed chamber can be transported to a laboratory facility for at least one additional test.

49. The device of claim 1, wherein said valve comprises a compartment for holding an aliquot of specimen and transporting the aliquot from the chamber to the reservoir, the valve having first, second and third positions,

wherein

when the valve is in the first position, the valve compartment is in fluid communication with the chamber and is not in fluid communication with the reservoir;

when the valve is in the second position, the valve compartment is not in fluid communication with the chamber nor the reservoir; and

when the valve is in the third position, the valve compartment is in fluid communication with the reservoir and is not in fluid communication with the chamber.

50. The device of claim 49, wherein the valve does not leak under internal pressure of up to 100 pounds per square inch.

51. The device of claim 1 wherein the valve further comprises two movable sections slidably arrayed in a linear fashion within a cylindrical valve body.

52. The specimen collection device of claim 1 wherein the valve handle is detachable from the valve plunger.