Rapid Test Apparatus

• US 20070275475A1
• Filed: 01/22/2007
• Published: 11/29/2007
• Est. Priority Date: 01/23/2006
• Status: Active Grant

• Current Assignee: Quidel Corporation
• Original Assignee: Quidel Corporation
• Inventors: Liang, Greg
• Granted Patent: US 7,871,568 B2
• Time in Patent Office: Days
• US Class Current: 436/165
• 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 bends away from the exterior wall, forming said sample receiving chamber on the interior of said septum wall, wherein said bottom section of said septum wall comprises a hole;

b. at least one reagent member; and

c. a base, comprising a handle, an insert section having thread, and a plug wherein when said base is inserted into said test assembly, 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.

13. A method for detecting an analyte in a specimen, comprising

a. adding sample buffer to the sample receiving chamber of the device of claim 1, wherein the test chamber of said device comprises at least one reagent member for testing for the presence of said analyte;

b. obtaining a specimen;

c. introducing all or part of said specimen into the sample buffer;

d. loosening said base, allowing said buffer to flow into said test chamber;

and detecting the presence of said analyte by reading the results on said at least one reagent member.

15. The method of claims 13 or 14, wherein said reagent member detects analytes in fecal occult blood, and said sample is fecal matter.

18. A kit comprising a device of claims 1, 11, or 12.

19. The kit of claim 18, further comprising instructions.

20. The kit of claim 18, further comprising a sample buffer.

11. 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 exterior wall and a septum wall, said septum wall having a top section that connects to the exterior wall and a bottom section that bends away from the exterior wall, forming said sample receiving chamber on the interior of said septum wall, wherein said bottom section of said septum wall comprises a hole, wherein said hole is sealed with a breakable seal;

b. a reagent member;

c. a bottom part comprising an upper end, a lower end comprising a hole sealed with a breakable seal, and a sidewall that fits into the interior of the lower end of the test assembly; and

d. a pincap, comprising a rod that fits into the hole in the bottom part;

wherein when said pincap is inserted into said bottom part, said rod breaks said breakable seals causing sample receiving chamber to be open to said test chamber.

14. A method for detecting an analyte in a specimen, comprising

a. adding sample buffer to the sample receiving chamber of the device of claim 11, wherein the test chamber of said device comprises at least one reagent member for testing for the presence of said analyte;

b. obtaining a specimen;

c. introducing all or part of said specimen into the sample buffer;

d. inserting said pincap into said bottom part, breaking said seals allowing said buffer to flow into said test chamber; and

detecting the presence of said analyte by reading the results on said at least one reagent member.

12. A device for testing a specimen, comprising

a. a test assembly comprising 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 bends away from the exterior wall, separating said test assembly into an upper section and a lower section, and forming a reagent member receptacle between said septum and said exterior wall, connecting to said lower section;

wherein said bottom section of said septum comprises a hole;

b. at least one reagent member in said reagent member receptacle; and

c. a bottom part that fits to the lower end of said test assembly, comprising a vent hole, and a porous plug that fills in said vent hole.

16. A method for detecting an analyte in a specimen, comprising

a. adding a liquid specimen, or buffer comprising a solid or semi-solid sample to the upper section of a device of claim 12;

b. allowing a portion of said liquid or buffer to flow into said reagent member receptacle, contacting said at least one reagent member;

c. and detecting the presence of said analyte by reading the results on said at least one reagent member.

17. The method of claim 16, wherein said liquid specimen is urine.