DEVICE FOR HANDLING AND ANALYSIS OF A BIOLOGICAL SAMPLE

• US 20090215159A1
• Filed: 02/20/2009
• Published: 08/27/2009
• Est. Priority Date: 01/23/2006
• Status: Abandoned Application

• Current Assignee: Quidel Corporation
• Original Assignee: Quidel Corporation
• Inventors: Kirby, Kevin J.
• Application Number:
  US12/390,303
• Publication Number:
  US 20090215159A1
• Time in Patent Office: Days
• US Class Current: 435/287.200
• 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: A61B 2010/0003 including means for analysis by an unskilled person
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0609 Holders integrated in container to position an object
• CPC Class Codes: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0854 Double walls
• CPC Class Codes: B01L 2300/105 using desiccants
• 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
• CPC Class Codes: B01L 3/545 for laboratory containers

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, the sample-receiving chamber and the test chamber capable of fluid communication via an opening,

a desiccant member disposed within said test chamber;

an assay test strip disposed in the test chamber; and

a base 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 opening.

2. The apparatus of claim 1, wherein said desiccant member is formed of a desiccant material selected from the group consisting of a molecular sieve, alumina, bauxite, anhydrous calcium sulfate, water-absorbing clays, silica gel and zeolite.

3. The desiccant of claim 2, wherein said desiccant member is in the form of a molded piece or a film.

4. The desiccant of claim 1, wherein the desiccant member cradles the sample-receiving chamber.

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

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

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

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

9. 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, the sample-receiving chamber and the test chamber capable of fluid communication via an opening,

a strip holder sleeve disposed in the test chamber;

an assay test strip disposed in the strip holder sleeve;

a base 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 opening.

10. The apparatus of claim 9, wherein the strip holder sleeve has a curved outer surface.

11. The apparatus of claim 9, wherein the strip holder sleeve is transparent.

12. The apparatus of claim 9, wherein the strip holder sleeve has protrusions for securing assay test strips.

13. The apparatus of claim 9, wherein the inner surface of said strip holder sleeve has a plurality of elevated features and depressed features relative to said inner surface of the sleeve, and wherein one or more of said plurality of elevated features is in direct contact with said assay test strip.

14. The apparatus of claim 9, wherein said assay test strip has a plurality of raised pads.

15. The apparatus of claim 9, further comprising a cap with an integral sampling wand.

16. The apparatus of claim 9, wherein the assay test strip comprises at least one antibody.

17. A kit of parts comprising the apparatus of claim 9 and instructions for use.

18. A kit of parts comprising the apparatus of claim 9, instructions for use, and a label for affixing to the apparatus.