Specimen collection and assay container

• US 7,560,272 B2
• Filed: 01/04/2003
• Issued: 07/14/2009
• Est. Priority Date: 01/04/2003
• Status: Expired due to Term

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories)
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Inventors: Ramsey, James T., Hartselle, Larry
• Primary Examiner(s): Chin; Christopher L
• Application Number:
  US10/336,204
• Publication Number:
  US 20040132091A1
• Time in Patent Office: 2,383 Days
• Field of Search: 422/56, 422/58, 422/61, 422/68.1, 422/70, 422/102, 435/7.1, 435/286.1, 435/287.7, 435/288.4, 435/288.5, 435/810, 436/165, 436/169
• US Class Current: 435/288.4
• 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 and assay device, comprising:

a sample chamber sized and shaped to receive a liquid sample, and comprising a circumferential chamber side wall having an upper edge, a lower edge, an inner surface and an outer surface, a chamber bottom wall adjoining the lower edge of the chamber side wall, and an opening defined by the upper edge of the chamber side wall;

a lid for sealing the opening;

a test reservoir external to the sample chamber, the test reservoir having a reservoir side wall having an upper edge, a lower edge, and an inner surface, a portion of the reservoir side wall being defined by a common portion of the chamber side wall, a bottom wall contiguous with the chamber bottom wall and adjoining the lower edge of the reservoir side wall, a portion of the inner surface of the reservoir side wall being defined by the outer surface of the common portion of the chamber side wall;

a reservoir seal separate from the lid, the reservoir seal adjoining the upper edge of the reservoir side wall and sealing the test reservoir;

a test device for detecting an analyte, the test device being sealed within the test reservoir; and

a valveless specimen passage slot disposed in the common portion of the chamber side wall adjacent to the chamber bottom wall, and functionally interposed between the sample chamber and the test reservoir for fluid communication between the sample chamber and the test reservoir, whereby upon addition of the sample to the sample chamber, a portion of the sample enters the test reservoir through the specimen passage slot, the portion of the sample entering the test reservoir compresses gases present in the test reservoir, the compression of the gases limiting the amount of sample added to the test reservoir.

2. The specimen collection device of claim 1 wherein the lid is a screw-lid or snap-lid.

3. The specimen collection device of claim 2 wherein the lid is a screw-lid.

4. The specimen collection device of claim 2 wherein the lid is leak resistant.

5. The specimen collection device of claim 2 wherein the lid comprises an O-ring.

6. The specimen collection device of claim 1 wherein the chamber can hold a specimen volume between 0.0001 milliliter and 1000 milliliters.

7. The specimen collection device of claim 1 wherein the chamber and reservoir are comprised of a material selected from the group consisting of:

metal, silicon, glass, ceramic, plastic and a polymer.

8. The specimen collection device of claim 1 wherein the test device comprises at least one test strip.

9. The specimen collection device of claim 8 wherein the test strip comprises reagents for at least one specific binding reaction.

10. The specimen collection device of claim 9 wherein the specific binding reaction comprises an immunoassay.

11. The specimen collection device of claim 8 wherein the test strip comprises reagents for an enzymatic reaction.

12. The specimen collection device of claim 8 wherein the test strip comprises reagents for a chemical reaction.

13. The specimen collection device of claim 1 wherein the analyte 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.

14. The specimen collection device of claim 1 wherein the reservoir seal is comprised of a material selected from the group consisting of:

metal, silicon, glass, ceramic, plastic and a polymer.

15. The specimen collection device of claim 1 wherein the reservoir seal hermetically seals the reservoir.

16. The specimen collection device of claim 1 wherein the reservoir seal is an adhesive seal.

17. The specimen collection device of claim 1 wherein the reservoir seal is a plug seal.

18. The specimen collection device of claim 1 wherein the reservoir seal is thermally welded to the reservoir.

19. The specimen collection device of claim 1 wherein the reservoir seal is removable.

20. The specimen collection device of claim 1 wherein the reservoir seal is non-removable.

21. The specimen collection device of claim 1 wherein the valveless specimen passage slot also lacks a seal.