Fluid sample analysis device with sealable sample storage reservoir

• US 20050202568A1
• Filed: 11/15/2004
• Published: 09/15/2005
• Est. Priority Date: 11/14/2003
• Status: Abandoned Application

• Current Assignee: ACON Biotech Company Limited (Abbott Laboratories), Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Inventors: Yang, Ying, Dai, Jielin, Wu, Yuzhang, Tung, Hsiaoho Edward
• Application Number:
  US10/989,624
• Publication Number:
  US 20050202568A1
• Time in Patent Office: Days
• US Class Current: 436/169
• 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 seal, and a test compartment containing test elements. The devices also contain a reservoir for preserving an aliquot of sample for later confirmation testing. When the plunger is lowered into the sample collection well, an aliquot of sample is sealed in the reservoir. 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. 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 test compartment containing at least one test element;

a sample collection well situated in the port and comprising an upper chamber, an expression plate, a lower chamber, and a sample outlet;

a reservoir within or below the lower chamber for storing fluid sample for confirmation testing;

a plunger comprised within the sample collection well, the plunger having a raised position and a lower position;

a seal that fits sealably over the reservoir when the plunger is located in the lower position;

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 plunger further comprises one or more plunger arms extending upward from the direction of the base.

3. The device of claim 2 wherein the one or more plunger arms extend upward inside the sample collection well and beside the expression plate.

4. The device of claim 3, wherein the portion of the cap interacts with the plunger arms to move the plunger from the raised position to the lower position when the cap is applied to the sample collection well.

5. The device of claim 1 wherein the reservoir is an indentation located in the base of the sample collection well.

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

7. The device of claim 6 wherein when the plunger is in the raised position the test compartment and lower chamber are in fluid communication, and when the screw threads are fully engaged the plunger is in the lower position, and the test compartment and the lower chamber are not in fluid communication.

8. The device of claim 1 wherein the sample outlet provides for fluid communication between the lower chamber and the test compartment.

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

10. The device of claim 9 wherein the test strip comprises specific binding molecules immobilized on the test strip.

11. The device of claim 9 wherein the test strip comprises a chemical test.

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

13. The device of claim 12 wherein the fluid sample is saliva.

14. The test device of claim 1 wherein the analyte of interest 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.

15. The test device of claim 14, wherein the analyte is a drug, and the drug is a drug of abuse.

16. A kit comprising:

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 test compartment containing at least one test element;

a sample collection well, situated in the port and comprising an upper chamber, an expression plate, a lower chamber, and a sample outlet;

a reservoir within or below the lower chamber for storing a fluid sample for confirmation testing;

a plunger comprised within the sample collection well, the plunger having a raised position and a lower position, and having a seal at the lower end that fits sealably over the indentation when the plunger is located in the lower position;

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.

17. The kit of claim 16, wherein the sample applicator comprises an absorbent member and a handle.

18. The kit of claim 17 wherein the absorbent member is a sponge or a foam.

19. The kit of claim 17 wherein the absorbent member is treated with a solution that stimulates salivation in a test subject.

20. The kit of claim 17 further comprising instructions for using the device to determine the presence of an analyte in saliva.

21. A method of detecting an analyte suspected of being present in a liquid sample, comprising

applying a liquid sample suspected of containing the analyte to a sample applicator;

applying the liquid sample to a test device by wringing the sample applicator into the test device, where the test device comprises;

a casing, comprising a port for a sample collection well

a test compartment containing at least one test element;

a sample collection well, situated in the port and comprising an upper chamber, an expression plate, a lower chamber, and a sample outlet;

a reservoir within or below the lower chamber for storing a fluid sample for confirmation testing;

a plunger comprised within the sample collection well, the plunger having a raised position and a lower position, and having a seal at the lower end that fits sealably over the reservoir when the plunger is located in the lower position;

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

determining if the analyte is present in the sample.

22. The method of claim 21 wherein sample is applied to the sample applicator by placing the sample applicator into the mouth of a test subject.

23. The method of claim 21 wherein the sample applicator is filled with saliva.

24. The method of claim 23 wherein liquid sample is applied to the test device by pressing the sample applicator against the expression plate of the device, and wringing the sample applicator out so that liquid sample flows into the bottom chamber of the sample collection well.

25. The method of claim 21 wherein the cap and the sample collection well comprise complementary engaging screw threads.

26. The method of claim 25 further comprising fully engaging the screw threads of the cap and sample collection well, and thereby lowering the plunger to the lower position and sealing an aliquot of sample in the reservoir.

27. The method of claim 21 further comprising placing the cap on the sample collection well, lowering the plunger to the lower position, and sealing an aliquot of sample in the reservoir.

28. The method of claim 21 wherein the test element is a test strip.

29. The method of claim 28 wherein the test strip contains reagents for detecting the presence of a drug of abuse.