Device for handling and analysis of a biological sample

• US 7,794,656 B2
• Filed: 04/25/2008
• Issued: 09/14/2010
• Est. Priority Date: 01/23/2006
• Status: Active Grant

• Current Assignee: Quidel Corporation
• Original Assignee: Quidel Corporation
• Inventors: Liang, Greg, Kirby, Kevin J.
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): Wecker; Jennifer
• Application Number:
  US12/150,148
• Publication Number:
  US 20090004058A1
• Time in Patent Office: 872 Days
• Field of Search: 422/68.1
• US Class Current: 422/68.1
• CPC Class Codes: A61B 10/0038 Devices for taking faeces samples; Faecal examination devices anal receptacles A61F5/451
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• 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 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0854 Double walls
• CPC Class Codes: B01L 2400/0644 rotary valves
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• 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 3/5082 Test tubes per se

Abstract

An apparatus for detection of an analyte of interest in a solid, semi-solid, or liquid biological sample, using a lateral flow assay test strip, is described. The apparatus minimizes sample handling and manipulation upon introduction of the sample into a sample-receiving chamber and transfer of the sample to a test chamber containing the assay strip.

Claims

1. An apparatus for analysis of a biological sample, comprising:

a test assembly comprising an inner wall defining a sample-receiving chamber and a median wall that together with the inner wall defines a test chamber, said test chamber containing an assay test strip, and the sample-receiving chamber and the test chamber capable of fluid communication via an opening,

wherein the median wall extends beyond a bottom portion of the inner wall into a base portion, said base portion comprising a gap into which said median wall slidably fits an assay test strip disposed in the test chamber; and

such that said base is movably mounted on the test assembly, the base moveable between a closed position and an open position to achieve movement of a valve dimensioned for engagement with said opening, which controls fluid flow from the sample-receiving chamber, via the opening, to the test chamber,

wherein said base further comprises one or more guide pins that enrage with one or more grooves in the median wall and thereby control the extent of movement of said valve and prevent the base from moving beyond a preselected amount.

2. The apparatus of claim 1, wherein the groove is one or more grooves are dimensioned to achieve movement of the base in a radial direction.

3. The apparatus of claim 1, wherein the one or more grooves are dimensioned to achieve movement of the base in a longitudinal direction.

4. The apparatus of claim 1, wherein the one or more grooves comprise one or more narrowing regions.

5. The apparatus of claim 1, further comprising one or more sub-chambers defined by lateral wall members connecting said inner wall and said median wall.

6. The apparatus of claim 1, further comprising a cap with an integral sampling wand.

7. The apparatus of claim 1, wherein the assay test strip is housed in a strip holder sleeve.

8. The apparatus of claim 7, wherein the strip holder sleeve has a tip adapted to reduce formation of bubbles when in contact with a liquid flowing into the test strip.

9. The apparatus of claim 5, wherein a desiccant is disposed in the one or more sub-chambers.

10. The apparatus of claim 5, wherein an assay test strip is disposed in the one or more sub-chambers.

11. The apparatus of claim 1, wherein the sample is a solid or semi-solid sample.

12. The apparatus of claim 11, wherein the sample is a fecal sample.

13. The apparatus of claim 1, wherein the assay test strip comprises at least one antibody.

14. The apparatus of claim 1, comprising a transparent portion in the test assembly for viewing the assay test strip.

15. A kit of parts comprising the apparatus of claim 1 and instructions for use.

16. A kit of parts comprising the apparatus of claim 1, instructions for use, and a label for affixing to the apparatus.

17. An apparatus for detection of an analyte of interest in a biological sample, comprising:

a test assembly comprising an inner wall defining a sample-receiving chamber and a median wall that together with the inner wall defines a test chamber, the sample-receiving chamber and the test chamber capable of fluid communication via an opening, and an assay test strip assembly comprised of comprising a first assay test strip and a strip holder sleeve;

wherein said median wall extends beyond a bottom portion of said inner wall into a base portion said base portion comprising a gap into which said median wall slidably fits, such that said base is movably mounted on the test assembly, the base moveable between a closed position and an open position to achieve movement of a valve dimensioned for engagement with the said opening which controls fluid flow from the sample-receiving chamber, via the opening, to the test chamber,

wherein said base further comprises one or more guide pins that engage with one or more grooves in the median wall and thereby control the extent of movement of said valve and prevent the base from moving beyond a preselected amount.

18. The apparatus of claim 17, further comprising one or more structures formed on a wall of the test chamber for securing the assay test strip in the test chamber.

19. The apparatus of claim 17, further comprising one or more structures formed on an external surface of the strip holder sleeve for securing the assay test strip in the test chamber.

20. The apparatus of claim 17, further comprising one or more sub-chambers.

21. The apparatus of claim 20, wherein the one or more sub-chambers comprises a desiccant.

22. The apparatus of claim 21, wherein the desiccant is a film desiccant.

23. The apparatus of claim 20, wherein the one or more sub-chambers comprises a second assay test strip, for detection of the same or different analyte of interest.

24. The apparatus of claim 17, further comprising a cap with an integral sampling wand.

25. The apparatus of claim 17, wherein the strip holder sleeve has a tip adapted to reduce formation of bubbles when in contact with a liquid flowing into the test strip.