Rapid sample collection and analysis device and methods of use

• US 7,837,939 B2
• Filed: 08/20/2007
• Issued: 11/23/2010
• Est. Priority Date: 11/14/2003
• Status: Active Grant

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Inventors: Yang, Ying, Dai, Jeilin, Tung, Hsiaoho E., Wu, Yuzhang
• Primary Examiner(s): BROWN, MELANIE YU
• Application Number:
  US11/894,108
• Publication Number:
  US 20090117665A1
• Time in Patent Office: 1,191 Days
• Field of Search: 422/58, 422/50, 422/55, 422/61, 422/68.1, 436/518, 436/164, 436/165, 435/283.1, 435/287.1, 435/288.7
• US Class Current: 422/410
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• 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 2010/0074 Vaginal or cervical secretions
• CPC Class Codes: A61B 2010/0077 Cerebrospinal fluid
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0644 rotary valves
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: G01N 33/48714 for determining substances foreign to the organism, e.g. drugs or heavy metals drugs by chemical analysis G01N33/94

Abstract

The present invention is directed to devices and methods for determining the presence of analyte in a fluid sample. The devices utilize a sample collection well, an expression plate for expressing sample into the sample collection well, a plunger that drives a lance, and a test compartment containing test elements. The devices also preserve an aliquot of fluid sample in a reservoir for later confirmation testing. When the plunger is lowered into the sample collection well, a lance on the device punctures a frangible material that covers a sample outlet. When the sample outlet is thus opened, fluid sample flows from the sample collection cup to the test compartment. In one embodiment the plunger is lowered as a cap is applied to the device. The devices are useful for detecting the presence of analyte in a wide variety of fluid samples, such as saliva, oral fluids, and more. The invention also provides methods of using the devices, and kits containing the devices.

Claims

1. A test device for detecting an analyte suspected of being present in a fluid sample, comprising:

a casing, comprising a port for a sample collection well;

a sample collection well situated in the port, the sample well comprising an expression plate and a plunger, the plunger having a raised position and a lower position, the sample collection well further comprising a lower chamber when the plunger is in the raised position;

an upper chamber for storage of a confirmation sample;

a test compartment containing at least one test element;

a sample outlet sealed by a frangible material and providing liquid communication between the sample collection well and the test compartment when the sample outlet is open;

a lance for piercing the frangible material; and

a cap for the sample collection well, wherein a portion of the cap interacts with the plunger to move the plunger from the raised position to the lower position when the cap is applied to the sample collection well.

2. The device of claim 1 wherein the lance is carried on the plunger.

3. The test device of claim 1, wherein the expression plate divides the upper chamber from the lower chamber, and comprises an aperture for flow of liquid sample from the upper chamber to the lower chamber.

4. The device of claim 1 wherein the lance is downwardly-projecting and is perpendicularly aligned with the outlet for breaking the frangible material.

5. The device of claim 1 wherein the sample collection well and cap further comprise complementary engaging screw threads.

6. The device of claim 1 wherein the cap comprises a downward projection that interacts with the plunger when the cap is applied to the sample collection well.

7. The device of claim 6 wherein the expression plate comprises an opening through which the projection passes to interact with the plunger.

8. The device of claim 1 wherein the lower chamber is absent when the plunger is in the lower position.

9. The device of claim 1 wherein the frangible material is selected from the group consisting of paper, wax-coated paper, plastic-coated paper, plastic film, a thin plastic sheet, adhesive tape, foil, waxed foil and plastic-coated foil.

10. The device of claim 1 wherein the test element is a test strip.

11. The device of claim 1 wherein the test strip comprises specific binding molecules immobilized on the test strip.

12. The device of claim 1 the test strip further comprising a chemical test.

13. The device of claim 1 wherein the fluid sample is selected from the group consisting of oral fluid, blood, serum, plasma, urine, feces, spinal fluid, vaginal swabs, mucus, and tissue.

14. The device of claim 13 wherein the fluid sample is saliva.

15. The device of claim 1 wherein the analyte is selected from the group consisting of a drug, a hormone, a protein, a nucleic acid molecule, an etiological agent and a specific binding pair member.

16. The device of claim 15 wherein the analyte is a drug of abuse.

17. The device of claim 2 wherein the upper and lower chambers are present when the plunger is in the raised position, and the lower chamber is not present when the plunger is in the lower position.

18. A kit comprising:

a device comprising

a casing, comprising a port for a sample collection well;

a sample collection well situated in the port, the sample collection well comprising an expression plate and a plunger, the plunger having a raised position and a lower position, the sample collection well further comprising a lower chamber when the plunger is in the raised position;

an upper chamber for storage of a confirmation sample;

a test compartment containing at least one test element;

a sample outlet sealed by a frangible material and providing liquid communication between the sample collection well and the test compartment when the sample outlet is open;

a lance for piercing the frangible material;

a cap for the sample collection well, wherein a portion of the cap interacts with the plunger to move the plunger from the raised position to the lower position when the cap is applied to the sample collection well; and

a sample applicator.

19. The kit of claim 18 wherein the lance is carried on the plunger.

20. The kit of claim 19 wherein the sample applicator further comprises an absorbent member and a handle.

21. The kit of claim 20 wherein the absorbent member comprises a sponge.

22. The kit of claim 20 wherein the absorbent member comprises a foam.

23. The kit of claim 20 wherein the absorbent member comprises a solution that stimulates salivation in a test subject.