Sample collection cup with integrated activatable sample analysis system

• US 7,550,112 B2
• Filed: 11/15/2004
• Issued: 06/23/2009
• Est. Priority Date: 11/14/2003
• Status: Expired due to Fees

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories)
• Original Assignee: Oakville Hong Kong Co., Limited
• Inventors: Dai, Jielin, Wu, Yuzhang, Gou, Lijian, Tung, Hsiaoho Edward
• Primary Examiner(s): JARRETT, LORE RAMILLANO
• Application Number:
  US10/990,297
• Publication Number:
  US 20050112024A1
• Time in Patent Office: 1,681 Days
• Field of Search: 422/58, 422/61, 422/102, 436/165, 436/169
• US Class Current: 422/562
• 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 within cup configurations wherein one cup is dedicated, for the most part, to sample collection and another cup 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 and lid 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 rotatably disposed within the second cup and having first and second positions 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 when the first cup is in the first position, and the aperture being closed when the first cup is in the second position;

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, the passageway being closed when the first cup is in the first position and open when the first cup is in the second position; and

a lid that comprises at least one key element, and wherein the first cup comprises at least one key hole.

2. The device of claim 1 wherein the valve assembly seals the reservoir from liquid communication with the interior of the first cup when the valve member is in the first position.

3. The device of claim 1 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.

4. The device of claim 3 wherein when the first cup is in the second position the valve assembly seals the at least one reservoir from liquid communication with the interior of the first cup, and liquid communication occurs between the reservoir and the test elements.

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

6. The device of claim 5 wherein the one or more test elements are test strips.

7. The device of claim 6 wherein the one or more test strips produce a calorimetric signal when an analyte of interest is present.

8. The device of claim 7 wherein the first and second positions are located about 90 degrees radially apart.

9. The device of claim 1 wherein the valve assembly is comprised on the bottom of the second cup.

10. The device of claim 9 wherein the passageway is open when the first cup is in the second position.

11. The device of claim 1 wherein the lid is rotatably sealable about the top of the second cup.

12. The device of claim 1 further comprising a seal located at a base of the at least one reservoir.

13. The device of claim 12 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.

14. The device of claim 13 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.

15. 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 rotatably disposed within the second cup and having first and second positions 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 when the first cup is in the first position, and the aperture being closed when the first cup is in the second position;

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 wherein the valve assembly is comprised on the bottom of the second cup;

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, the passageway being closed when the first cup is in the first position and open when the first cup is in the second position.

16. 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 rotatably disposed within the second cup and having first and second positions 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 when the first cup is in the first position, and the aperture being closed when the first cup is in the second position;

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, the passageway being closed when the first cup is in the first position and open when the first cup is in the second position;

and a seal located at a base of the at least one reservoir.