Test device for detecting an analyte in a liquid sample

• US 8,071,394 B2
• Filed: 01/26/2009
• Issued: 12/06/2011
• Est. Priority Date: 07/26/2006
• Status: Active Grant

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Inventors: Wu, Xin, Gao, Fei, Dai, Jielin, Wu, Yinfei
• Primary Examiner(s): Nguyen, Bao Thuy L
• Application Number:
  US12/360,087
• Publication Number:
  US 20090232702A1
• Time in Patent Office: 1,044 Days
• Field of Search: 436/514, 436/518, 435/283.1, 435/287.1, 435/287.2, 435/970, 422/401, 422/425, 422/430
• US Class Current: 436/518
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 435/97 Test strip or test slide

Abstract

The present invention relates to test devices, and in particular devices capable of detecting the presence or absence of an analyte in a sample, such as a liquid sample. Also provided are methods of using such devices for quantitative or qualitative measurement of one or more analytes in a liquid sample.

Claims

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

a test strip defining a flow path, comprising;

a second reagent zone positioned along the flow path, the second reagent zone comprising a first binding agent, the first binding agent being mobilizable by the liquid sample, the first binding agent being capable of binding the analyte to form a first complex;

a first reagent zone located downstream of the second reagent zone along the flow path, the first reagent zone comprising a second binding agent, the second binding agent being mobilizable by the liquid sample, the second binding agent being capable of binding the first complex to form a second complex, the second binding agent comprising a detectable label; and

a test zone located downstream of the first reagent zone along the flow path, the test zone comprising a third binding agent, the third binding agent being immobilized in the test zone, the third binding agent being capable of binding the first or second complex;

wherein the second reagent zone is separable from the first reagent zone, and wherein prior to placing said second reagent zone in fluidic communication with the test strip, the liquid sample has been in contact with the second reagent zone for a period of time sufficient to effect formation of the first complex.

2. The device of claim 1, wherein the third binding agent is capable of binding the second complex via binding to the analyte when the analyte is bound to the first binding agent to form a third binding agent-analyte-first binding agent sandwich.

3. The device of claim 1, wherein the first binding agent comprises an antibody.

4. The device of claim 1, wherein the analyte comprises a drug abuse chemical.

5. The device of claim 4 wherein the drug of abuse chemical is THC or BZO.

6. The device of claim 1, wherein the detectable label is a color particle or a water-soluble dye.

7. The device of claim 1, wherein the second binding agent is capable of binding the first binding agent to form a second complex if analyte is not present in the sample, and wherein the third binding agent is capable of binding the first binding agent.

8. The device of claim 1, wherein at least a portion of the first binding agent is immobilized in the second reagent zone, and at least a portion of the first binding agent being mobilizable by the liquid sample, the first binding agent being capable of binding the analyte to form a first complex, and wherein the third binding agent is capable of binding the second complex.