Rapid test apparatus

• US 7,871,568 B2
• Filed: 01/22/2007
• Issued: 01/18/2011
• Est. Priority Date: 01/23/2006
• Status: Active Grant

• Current Assignee: Quidel Corporation
• Original Assignee: Quidel Corporation
• Inventors: Liang, Yahong, Liang, Greg
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): Hammond; Charles
• Application Number:
  US11/625,813
• Publication Number:
  US 20070275475A1
• Time in Patent Office: 1,457 Days
• Field of Search: 422/58
• US Class Current: 422/408
• CPC Class Codes: A61B 10/0038 Devices for taking faeces samples; Faecal examination devices anal receptacles A61F5/451
• 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
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

Provided herein are methods and devices for rapid testing of solid, semi-solid, or liquid specimens, such as stool, blood, urine, saliva, or swab specimens of the cervix, urethra, nostril, and throat, and for environmental testing.

Claims

1. A device for testing a specimen, comprising

a. a test assembly, comprising a sample receiving chamber and a test chamber, wherein

said test chamber comprises an upper end, a lower end, an exterior wall, and a septum wall, said septum wall having a top section that connects to the exterior wall and a bottom section that is separate from the exterior wall,

said sample receiving chamber is on the interior of said septum wall,

said sample receiving chamber comprises a bottom hole, which places the sample receiving chamber in fluid communication with the test chamber, and

said lower end of said test chamber comprises an opening;

b. at least one reagent member within the test chamber; and

c. a base capable of being coupled to the opening at the lower end of the test chamber, said base comprising;

a handle, an insert section having a thread which engages said opening, and a plug which is effective to seal said hole;

wherein, when said base is inserted into the lower end of said test chamber, said sample receiving chamber is sealed from said test chamber, and when said base is loosened, said sample receiving chamber is open to said test chamber.

2. The device of claim 1, wherein said base further comprises an o-ring encircling said plug.

3. The device of claim 1, wherein said test assembly further comprises a cap to cover the upper end of said test assembly.

4. The device of claim 3, wherein said cap further comprises a sampler pin.

5. The device of claim 1, wherein said sample receiving chamber further comprises a buffer.

6. The device of claim 1, wherein said reagent member comprises a wick section and a test area comprising an assay reagent.

7. The device of claim 1, wherein said base further comprises an o-ring encircling said insert section.

8. The device of claim 1, comprising at least 2 reagent members.

9. The device of claim 1, comprising from 3-5 reagent members.

10. The device of claim 1, wherein said specimen is solid, semi-solid, or liquid.

12. A kit comprising a device of claim 1 or claim 11 comprising instructions and further comprising a sample buffer.

11. A device for testing a specimen, comprising

a. a test assembly comprising an interior wall and an exterior wall that join together at a neck area, forming a test chamber between said interior and exterior walls and a sample receiving chamber within said interior wall,

and a first breakable seal which seals a lower end opening of the interior wall, such that said sample receiving chamber is sealed from said test chamber;

b. a reagent member contained within the test chamber;

c. a bottom part, comprising a hole sealed with a second breakable seal, which part is sized to fit a lower end opening of the exterior wall of said test assembly; and

d. a pincap comprising a rod;

wherein, when said bottom part is fitted into said lower end opening of the exterior wall, and said pincap is inserted into said hole of said bottom part, said rod breaks said breakable seals, causing said sample receiving chamber to be open to said test chamber.