Sample Collection Cup with Integrated Activatable Sample Analysis System

• US 20090031790A1
• Filed: 08/27/2007
• Published: 02/05/2009
• Est. Priority Date: 11/14/2003
• Status: Active Grant

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Inventors: GUO, Lijiang, TUNG, Hsiaoho, DAI, Jeilin, Wu, Yuzhang
• Granted Patent: US 8,486,353 B2
• Time in Patent Office: Days
• US Class Current: 73/64.560
• 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 2200/141 Preventing contamination, tampering
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/047 Additional chamber, reservoir
• CPC Class Codes: B01L 2300/048 enabling gas exchange, e.g. vents
• 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 2400/0644 rotary valves
• 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: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 33/493 urine

Abstract

Medical and environmental diagnostic devices are described and claimed. Preferred embodiments feature cup (1) within cup configurations wherein one cup is dedicated, for the most part, to sample collection and another cup (2) is dedicated, for the most part, to assay performance. Communication between the cups is afforded by what is believed to be a unique valve assembly (3) and lid (7) tandem.

Claims

1. A device for determining the presence or amount of an analyte in a sample, comprising:

a first cup comprising an interior for holding a liquid sample, a top, one or more sidewalls, and a bottom;

a second cup having a top, one or more sidewalls, and a bottom;

the first cup disposed within the second cup;

at least one reservoir for containing an aliquot of sample located between the first and second cups, the first cup further comprising an aperture venting from the interior of the first cup into the at least one reservoir;

a valve assembly interfacing with the at least one reservoir for regulating communication of the aliquot of sample from the interior of the first cup to the reservoir;

one or more test elements comprising a sample application zone, for determining the presence or amount of an analyte in the liquid sample;

a passageway connecting the at least one reservoir and the sample application zone.

2. The device of claim 1 wherein the first cup is rotatably disposed within the second cup, wherein the first cup has first and second positions within the second cup.

3. The device of claim 2 wherein the valve assembly comprises a valve member that seals the reservoir from liquid communication with the interior of the first cup when the valve member is located in the first position.

4. The device of claim 1 further comprising a lid that comprises at least one key element, and wherein the first cup comprises at least one key hole.

5. The device of claim 4 wherein the at least one key element is inserted into the at least one key hole when the lid is placed onto the first and second cups.

6. The device of claim 5 wherein the first cup has a first position wherein the valve member seals the at least one reservoir from liquid communication with the interior of the first cup, and a second position wherein liquid communication occurs between the reservoir and the interior of the first cup, and between the reservoir and the test elements.

7. The device of claim 1 wherein the one or more test elements are lateral flow detection components.

8. The device of claim 7 wherein the one or more test elements are test strips.

9. The device of claim 8 wherein the one or more test strips produce a calorimetric signal when an analyte of interest is present.

10. The device of claim 1 wherein the valve member is comprised on the bottom of the second cup and can be comprised in a first position wherein the aperture is sealed, and a second position wherein the aperture is open.

11. The device of claim 10 wherein the passageway is open when the first cup is in the second position.

12. The device of claim 9 wherein the first and second positions are located about 90 degrees radially apart.

13. The device of claim 4 wherein the lid is rotatably sealable about the top of the second cup.

14. The device of claim 2 further comprising a seal located at a base of the one or more sealable reservoirs.

15. The device of claim 14 wherein the seal is an O-ring, which seals the reservoir to prevent liquid communication between the reservoir and the test elements when the first cup is in the first position.

16. The device of claim 15 wherein liquid communication occurs between the reservoir and the one or more test elements, through the passageway, when the first cup is in the second position.

17. The device of claim 1 further comprising an access opening.

18. A method of determining the presence or amount of an analyte in a sample comprising:

placing the sample into a device comprising

a first cup comprising an interior for holding a liquid sample, a top, one or more sidewalls, a bottom, and one or more engagement mechanisms;

a second cup having a top, one or more sidewalls, and a bottom, the first cup disposed within the second cup;

at least one reservoir for containing an aliquot of sample located between the first and second cups, the first cup comprising an aperture venting from the interior of the first cup into the at least one reservoir, and being in a first position allowing for liquid communication between the first cup and the reservoir;

a valve assembly interfacing with the at least one reservoir;

one or more test elements for determining the presence or amount of an analyte in the liquid sample;

a passageway between the at least one reservoir and the one or more test elements;

a lid comprising one or more key elements;

placing the lid on the first and second cups and engaging the key elements in the engagement mechanisms;

turning the lid so that the first cup is moved from the a position to a second position, thereby sealing the aperture and preventing fluid flow from the interior of the first cup to the reservoir, and thereby permitting fluid flow from the reservoir to the testing elements through the passageway;

determining the presence or amount of analyte in the sample.

19. The method of claim 18 wherein the valve assembly comprises a valve member that seals the reservoir from liquid communication with the interior of the first cup when the valve member is located in the first position.

20. The method of claim 18 wherein the key elements are comprised on the inside lip of the lid.

21. The method of claim 18 wherein the one or more test elements are lateral flow detection components.

22. The method of claim 21 wherein the one or more detection components are test strips.

23. The method of claim 22 wherein the one or more test strips produce a calorimetric signal when an analyte of interest is present.

24. The method of claim 18 wherein the first and second positions are located about 90 degrees radially apart.

25. The method of claim 24 wherein the lid is rotatably sealable about the top of the first and second cups.

26. The method of claim 18, the device further comprising a seal located at a base of the one or more reservoirs and sealing the reservoir to prevent liquid communication with the passageway when the first cup is in the first position, and the seal being opened when the first cup is turned to the second position thereby allowing liquid communication between the reservoir and the test elements.

27. The method of claim 26 wherein the seal is broken when the first cup is turned to the second position and liquid communication occurs between the reservoir and the test elements through the passageway.

28. A kit including

a device comprising:

a first cup comprising an interior for holding a liquid sample, a top, one or more sidewalls, and a bottom;

a second cup having a top, one or more sidewalls, and a bottom;

the first cup disposed within the second cup;

at least one reservoir located between the first and second cups, the first cup further comprising an aperture venting from the interior of the first cup into the at least one reservoir;

a valve assembly comprised in the at least one reservoir allowing for regulated communication of an aliquot of the sample between the interior of the first cup and the at least one sealable reservoir in the space between the cups;

one or more test elements comprising a sample application zone, for determining the presence or amount of an analyte in the liquid sample;

a passageway connecting the at least one reservoir and the sample application zone; and

instructions for use of the device.