Rapid sample analysis storage devices and methods of use

• US 7,544,324 B2
• Filed: 11/15/2004
• Issued: 06/09/2009
• Est. Priority Date: 11/14/2003
• Status: Active Grant

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Oakville Hong Kong Co., Limited
• Inventors: Yang, Ying, Dai, Jielin, Wu, Yuzhang, Tung, Hsiaoho Edward
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): JARRETT, LORE RAMILLANO
• Application Number:
  US10/990,324
• Publication Number:
  US 20050180882A1
• Time in Patent Office: 1,667 Days
• Field of Search: 422/56, 422/64, 422/72, 422/102, 436/165
• US Class Current: 422/504
• 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 provides test devices for detecting an analyte suspected of being present in a liquid sample. The devices contain a reservoir compartment, a test compartment, and a port for a sample collection well. The devices also have a rotatable sample collection well located in the port. The device has an upper chamber for insertion of a sample applicator, an expression plate for wringing out the sample applicator and applying sample to the device, a lower chamber, and an aliquot outlet and a reservoir outlet for the movement of sample through the device. The device also contains test elements for detecting the analyte of interest. By rotating the sample collection well, the operator is able to direct distribution of collected sample in the device. Methods of using the devices and kits containing the devices are also provided.

Claims

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

a casing comprising a sealable reservoir compartment, a test compartment, and a port, wherein at least one test element is comprised within the test compartment;

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

wherein

the rotatable sample collection well has a first position where fluid communication is provided through the reservoir outlet between the rotatable sample collection well and the reservoir compartment of the casing and wherein the aliquot outlet is closed; and

the rotatable sample collection well has a second position where fluid communication is provided through the aliquot outlet between the rotatable sample collection well and the test compartment and wherein the reservoir outlet is closed.

2. The device of claim 1, wherein the lower chamber comprises an area between the bottom of the rotatable sample collection well and the expression plate.

3. The device of claim 2 wherein the aliquot outlet and the reservoir outlet are situated on the bottom of the rotatable sample collection well.

4. The device of claim 3 wherein the rotatable sample collection well further comprises an aliquot seal, for sealing of the aliquot reservoir when the rotatable sample collection well is located in the first position.

5. The test device of claim 4 wherein the port comprises a guide slot, and the rotatable sample collection well comprises a guide pin extending from its outer surface and movably located within the guide slot, for directing rotation of the rotatable sample collection well from the first position to the second position.

6. The device of claim 5 wherein the guide slot is substantially parallel to the longitudinal axis of the test element.

7. The test device of claim 1 wherein the expression plate comprises openings through which fluid sample can flow from the upper chamber to the lower chamber.

8. The test device of claim, 1 the casing further comprising a window for observation of the test element.

9. The test device of claim, 1 wherein the casing further comprises a sealable reservoir orifice for extracting liquid sample from the reservoir compartment.

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

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

12. The device of claim 10 wherein the test strip further comprises a chemical test.

13. The test device of claim 1 wherein the sample is a bodily fluid or derived from a tissue or a bodily fluid.

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

15. The test device of claim 14 wherein the sample further comprises saliva.

16. The test device of claim 1 wherein the analyte is an infectious agent or indicative of an infected state.

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

18. The test device of claim 1, wherein the analyte is a drug of abuse.

19. The test device of claim 1 wherein the rotatable sample collection well is comprised of two or more parts, a first part containing the upper chamber and the expression plate, and a second part containing the lower chamber.