Specimen collection and assay container

• US 8,394,626 B2
• Filed: 06/02/2009
• Issued: 03/12/2013
• Est. Priority Date: 01/04/2003
• Status: Active Grant

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories)
• Original Assignee: Alere Switzerland GmbH (Abbott Laboratories)
• Inventors: Ramsey, James T., Hartselle, Larry
• Primary Examiner(s): Chin, Chris L
• Application Number:
  US12/477,107
• Publication Number:
  US 20100028981A1
• Time in Patent Office: 1,379 Days
• Field of Search: 422/400, 422/401, 422/408, 422/414, 422/420, 422/425, 422/430, 435/6.1, 435/287.1, 435/287.7, 435/287.9, 435/288.4, 435/288.5, 435/810, 435/970, 436/514, 436/524, 436/525, 436/528, 436/530, 436/531, 436/63, 436/169, 436/810, 436/815, 436/816, 436/817, 436/901
• US Class Current: 435/287.1
• 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 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 3/508 rigid containers not provided for above
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

The present invention includes but is not limited to a specimen collection device that includes a chamber capable of collecting a specimen, a specimen passage slot, a reservoir, a reservoir seal, and a test device. A sample or specimen added to the chamber flows through the specimen passage slot into the reservoir. Flow into the reservoir may be limited by the reservoir seal. The test device positioned within the reservoir detects the presence or concentration of an analyte within the sample or specimen.

Claims

1. A specimen collection device, comprising:

a) a chamber, wherein said chamber is capable of collecting a specimen;

b) a test device, wherein said test device is capable of detecting or measuring an analyte;

c) a reservoir, wherein said reservoir is capable of receiving said test device;

d) a specimen passage slot;

wherein said chamber and said reservoir are in direct fluid communication, and further wherein said reservoir is capable of receiving a portion of said specimen from said chamber; and

e) a reservoir seal which, in cooperation with said specimen passage slot, controls fluid access to said reservoir, wherein said reservoir seal seals said reservoir and is operable to prevent excess influx of said specimen into said reservoir upon introduction of said specimen into said chamber.

2. The specimen collection device of claim 1, wherein said chamber comprises a chamber seal.

3. The specimen collection device of claim 2, wherein said chamber seal is a tamper resistant seal or tamper evident seal.

4. The specimen collection device of claim 2, wherein said chamber seal is a screw-lid or a snap-lid.

5. The specimen collection device of claim 2, wherein said chamber seal is leak resistant.

6. The specimen collection device of claim 2, said chamber seal further comprising an O-ring.

7. The specimen collection device of claim 1, wherein said chamber can hold a specimen between about 0.0001 milliliter and about 1,000 milliliters.

8. The specimen collection device of claim 1, wherein said chamber comprises at least one label on a surface on which to record data pertaining to said specimen.

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

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

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

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

13. The specimen collection device of claim 1, wherein said chamber and said reservoir comprise a single unit.

14. The specimen collection device of claim 1, wherein said chamber and said reservoir comprise separate units.

15. The specimen collection device of claim 1, wherein said reservoir is attached to said chamber.

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

17. The specimen collection device of claim 16, wherein said test strip is capable of performing at least one specific binding reaction.

18. The specimen collection device of claim 17 wherein said specific binding reaction comprises an immunoassay.

19. The specimen collection device of claim 16, wherein said test strip is capable of performing an enzymatic reaction.

20. The specimen collection device of claim 16, wherein said test strip is capable of performing a chemical reaction.

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

22. The specimen collection device of claim 21, 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.

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

24. The specimen collection device of claim 1, whereby said reservoir seal seals said test device inside said reservoir.

25. The specimen container of claim 1, wherein said reservoir seal further comprises metal, silicon, glass, ceramic, plastic or a polymer.

26. The specimen container of claim 1, wherein said reservoir seal snugly engages said reservoir.

27. The specimen container of claim 1, wherein said reservoir seal hermetically seals said reservoir.

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

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

30. The specimen collection device of claim 1, wherein said specimen has a volume between about 0.0001 milliliter and about 1,000 milliliters.

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