Device for detecting analytes in fluid samples

• US 9,011,770 B2
• Filed: 10/26/2005
• Issued: 04/21/2015
• Est. Priority Date: 10/25/2005
• Status: Active Grant

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories)
• Original Assignee: Alere Switzerland GmbH (Abbott Laboratories)
• Inventors: Wu, Yuzhang, Hu, Haipeng, Dai, Jielin, Gou, Lijian
• Primary Examiner(s): Nagpaul, Jyoti
• Application Number:
  US11/260,496
• Publication Number:
  US 20070092402A1
• Time in Patent Office: 3,464 Days
• US Class Current: 422/63
• 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: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2400/0478 pistons
• 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: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

The present invention provides a device for detecting the presence of an analyte in a liquid sample. The device has an opening for introducing the liquid sample into a first chamber for collecting the liquid sample, and a second chamber connected to the first chamber by a passageway and containing a test element. The device also has a third chamber connected to the second chamber by a channel and containing a movable member having first and second positions. The third chamber is divided by the movable member into first and second zones, and the first zone has a vent hole. The movable member is in contact with at least one wall of the third chamber to prevent gas communication between the first and second zones.

Claims

1. A device for detecting the presence of an analyte in a liquid sample, comprising:

an opening for introducing the liquid sample into a first chamber for collecting the liquid sample;

a second chamber connected to the first chamber by a first passageway and containing a test element;

a third chamber connected to the second chamber by a second passageway and containing a plunger, the plunger comprising a push bar and having first and second positions, the third chamber being divided by the plunger into first and second zones;

the plunger in contact with at least one wall of the third chamber to prevent gas communication between the first and second zones; and

a lid for closing the opening, wherein the lid contacts the push bar and moves the plunger from the first position to the second position when the opening is sealed with the lid, wherein movement of the plunger from the first position to the second position causes a volume of air to be drawn from the second chamber into the second zone of the third chamber via the second passageway, thereby causing a volume of the liquid sample to be drawn from the first chamber through the first passageway into the second chamber to contact the test element, wherein the first zone of the third chamber is fluidly sealed from the second chamber in the second position of the plunger, and wherein the device is fluidly sealed when the opening is sealed with the lid.

2. The device of claim 1 wherein the test element is an assay card containing one or more test strips.

3. The device of claim 1 wherein the plunger contains a seal in contact with at least one wall of the third chamber to prevent gas communication between the first and second zones.

4. The device of claim 1 wherein the third chamber comprises a bottom and a vent hole is situated on the bottom of the third chamber.

5. The device of claim 1 wherein the passageway has a diameter of less than 8 mm.

6. The device of claim 5 wherein the passageway has a diameter of less than about 4 mm.

7. The device of claim 1 wherein the test element comprises at least one test strip.

8. A method for detecting the presence of an analyte in a liquid sample, comprising:

a) introducing a liquid sample into a test device comprising;

an opening for introducing the liquid sample into a first chamber for collecting the liquid sample;

a second chamber connected to the first chamber by a first passageway and containing a test element;

a third chamber connected to the second chamber by a second passageway and containing a plunger, the plunger comprising a push bar and having first and second positions, the third chamber being divided by the plunger into first and second zones;

the plunger in contact with at least one wall of the third chamber to prevent gas communication between the first and second zones; and

a lid for closing the opening, wherein the lid contacts the push bar and moves the plunger from the first position to the second position when the opening is sealed with the lid, and wherein the device is fluidly sealed when the opening is sealed with the lid;

b) causing the movable member to move from the first position to the second position and thereby causing a volume of air to be drawn from the second chamber into the second zone of the third chamber via the second passageway, and thereby causing a volume of the liquid sample to be drawn from the first chamber through the first passageway and into the second chamber to contact the test element, wherein the first zone of the third chamber is fluidly sealed from the second chamber in the second position of the plunger; and

c) detecting the presence of the analyte in the sample.

9. The method of claim 8 wherein the test element comprises at least one test strip.

10. The method of claim 8 wherein depressing the push bar and moving the plunger from the first position to the second position causes a negative air pressure gradient to form in the third chamber and the volume of air to be drawn from the second chamber into the third chamber.

11. The method of claim 10 wherein the movement of the volume of air from the second chamber to the third chamber causes a negative air pressure gradient to form in the second chamber.

12. The method of claim 11 wherein the negative air pressure gradient in the second chamber causes the fluid sample to flow from the first chamber through the passageway to the second chamber, and thereby to contact the test element.

13. The method of claim 8 wherein depressing the push bar and moving the plunger from the first position to the second position causes a volume of air to escape from the first zone through a vent hole.