Specimen collection container

• US 7,270,959 B2
• Filed: 07/25/2001
• Issued: 09/18/2007
• 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: Hudak, Robert Thomas
• Primary Examiner(s): Le; Long V.
• Assistant Examiner(s): Counts; Gary W.
• Application Number:
  US09/915,494
• Publication Number:
  US 20030022392A1
• Time in Patent Office: 2,246 Days
• Field of Search: 422/55, 422/58, 422/68.1, 422/102, 422/103, 422/104, 422/81, 422/82, 435/7.1, 435 792- 794, 435/287.7, 435/287.9, 436/518, 436/164, 436/165, 436/169, 738/643.2, 738/646.3, 738/649.1
• US Class Current: 435/7.1
• 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 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 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 an aliquot of specimen from the chamber and for receiving a test device;

(c) a valve functionally interposed between the chamber and the reservoir and having 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;

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; and

the valve being inoperable after a first actuation.

2. The specimen collection device of claim 1, wherein the device comprises a lid for sealing the chamber.

3. The specimen collection device of claim 2, wherein the lid is a tamper resistant lid or tamper evident lid.

4. The specimen collection device of claim 2, wherein the lid comprises at least one O-ring.

5. The specimen collection device of claim 2, wherein when the chamber is sealed with the lid, the lid does not leak specimen between the chamber and the exterior at an internal pressure of up to 100 pounds per square inch.

6. The specimen collection device of claim 1, wherein the reservoir firmly engages the test device.

7. The specimen collection device of claim 1, wherein the valve is a piston valve.

8. The specimen collection device of claim 1, wherein said valve has at least one valve O-ring.

9. The specimen collection device of claim 1, wherein said valve has two or more O-rings.

10. The specimen collection device of claim 1, wherein the valve does not leak specimen between the chamber and the reservoir at an extcmal pressure of up to 100 pounds per square inch.

11. The specimen collection device of claim 1, wherein the valve includes a handle for actuating the valve, wherein the handle functionally disengages from the valve after the valve is actuated and wherein the valve cannot be actuated with the handle disengaged therefrom.

12. The specimen collection device of claim 1, further comprising at least one test device present in the reservoir.

13. The specimen collection device of claim 12, wherein the test device comprises at least one test strip.

14. The specimen collection device of claim 13, wherein the test strip comprises reagents for performing at least one specific binding reaction.

15. The specimen collection device of claim 13, wherein the test strip comprises reagents for an immunoassay.

16. The specimen collection device of claim 13, wherein the test strip comprises reagents for an enzymatic reaction.

17. The specimen collection device of claim 13, wherein the test strip comprises reagents for a chemical reaction.

18. The specimen collection device of claim 1, wherein the reservoir comprises a port for receiving the test device.

19. The specimen collection device of claim 1, wherein the test device comprises an adulteration determination device.

20. The specimen collection device of claim 1, wherein the specimen is a liquid specimen.

21. The specimen collection device of claim 1, wherein the specimen is a biological specimen.

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

a) collecting a specimen in a test device comprising;

i) a chamber for collecting and holding the specimen;

ii) a reservoir for receiving an aliquot of specimen and having a test device; and

iii) a valve functionally interposed between the chamber and the reservoir and having a compartment for holding the aliquot, and having a first position wherein the compartment is in fluid communication with the chamber, and a second position wherein the compartment is separated from fluid communication with both the chamber and the reservoir, wherein the valve is inoperable after a first actuation;

b) causing an aliquot of specimen to enter the compartment of the valve;

c) actuating the valve;

d) causing the aliquot of specimen to flow out of the compartment and into the reservoir to contact the test device; and

e) detecting the analyte of interest.

23. The method of claim 22 wherein actuation of the valve comprises causing the valve to move from the first to the second position, and then to a third position where the compartment is in liquid communication with the reservoir and is not in liquid communication with the chamber.

24. The specimen collection device of claim 22 wherein the test device comprises a test strip having reagents for detecting the presence of at least one analyte of interest.

25. The method of claim 22 wherein the test device comprises a test strip comprising reagents for conducting an immunoassay.

26. The method of claim 25 wherein after the specimen aliquot contacts the reagents for conducting an immunoassay, visible indicators become present on the test strip indicating the presence or absence of the analyte of interest.

27. The method of claim 22 wherein the specimen is a biological specimen.

28. The method of claim 22 wherein the analyte of interest is selected from the group consisting of:

a drug of abuse, a hormone, a protein, a nucleic acid molecule, an etiological agent and a specific binding member.