Dual path immunoassay device

• US 8,877,450 B2
• Filed: 08/13/2013
• Issued: 11/04/2014
• Est. Priority Date: 03/11/2005
• Status: Active Grant

• Current Assignee: Chembio Diagnostic Systems Incorporated (Chembio Diagnostics, Inc.)
• Original Assignee: Chembio Diagnostic Systems Incorporated (Chembio Diagnostics, Inc.)
• Inventors: Esfandiari, Javanbakhsh
• Primary Examiner(s): YAKOVLEVA, GALINA M
• Application Number:
  US13/965,829
• Publication Number:
  US 20140045172A1
• Time in Patent Office: 448 Days
• Field of Search: None
• US Class Current: 435/7.1
• CPC Class Codes: G01N 33/538 by sorbent column, particles or resin strip , i.e. sorbent materials
• CPC Class Codes: G01N 33/5695 Mycobacteria
• CPC Class Codes: G01N 33/56988 HIV or HTLV

Abstract

Systems include test cells with sorbent material in a T-shape and defining a first flow path for a solution and a second flow path for a sample, and a test line or test site with immobilized antigens or antibodies or other ligand binding molecules located at the junction of the T. A housing houses the sorbent material and defines a first hole adjacent an end of the first flow path for receiving the solution and a second hole adjacent an end of the second flow path for receiving the sample.

Claims

1. A test device for use with a solution and for determining the presence of a ligand in a liquid sample, the test device comprising:

a) one or more sorbent strips laid out in a “

T”

configuration with a test site located at the junction of the “

T”

, said test site having an immobilized ligand-binding mechanism;

b) a conjugate having a marker located along and supported by a first leg of the “

T”

;

c) a housing surrounding said one or more sorbent strips, said housing defining a first opening adjacent a first end of said first leg of the “

T”

configuration, said first opening adapted to receive the solution to cause said conjugate to laterally migrate over time along said first leg to said test site, and said housing defining a second opening adjacent a first end of a second leg of the “

T”

, said second opening adapted to receive the sample which can laterally migrate over time along said second leg which is perpendicular to said first leg to said test site, and said housing defining a window adjacent said test site through which said test site is viewable.

2. A test device according to claim 1, wherein:

said first opening and said second opening are equidistant said window.

3. A test device according to claim 1, wherein:

said ligand-binding mechanism is an antigen or antibody for said ligand, and said conjugate comprises an antigen or antibody for the ligand and said marker coupled to the antigen or antibody.

4. A test device according to claim 3, wherein:

said marker is a colored marker viewable in the visible spectrum.

5. A test device according to claim 1, wherein:

said one or more sorbent strips includes a control site, and said housing defines a window for viewing said control site.

6. A test device according to claim 1, further comprising:

said solution, wherein said solution comprises a buffer.

7. A test device according to claim 1, wherein:

said immobilized ligand-binding mechanism comprises an HIV antigen or antibody.

8. A test device according to claim 1, wherein:

said test device is for determining the presence of a plurality of different ligands in the liquid sample, and

said test site has a plurality of separate immobilized ligand-binding mechanisms for separately binding to respective of said plurality of different ligands.

9. A test device according to claim 8, wherein:

said plurality of separate immobilized ligand-binding mechanisms includes a tuberculosis antigen and at least one HIV antigen.

10. A test device according to claim 8, wherein:

said plurality of separate immobilized ligand-binding mechanisms includes p24 antibodies and at least one of an HIV1 and an HIV2 antigen.

11. A method for testing a sample for the presence of a ligand, comprising:

a) obtaining solution and a test device having

(i) one or more sorbent strips laid out in a “

T”

configuration with a test site located at the junction of the “

T”

, said test site having an immobilized ligand-binding mechanism;

(ii) a conjugate having a marker located along and supported by a first leg of the “

T”

;

(iii) a housing surrounding said one or more sorbent strips, said housing defining a first opening adjacent a first end of said first leg of the “

T”

configuration, said first opening adapted to receive the solution to cause said conjugate to laterally migrate over time along said first leg to said test site, and said housing defining a second opening adjacent a first end of a second leg of the “

T”

, said second opening adapted to receive the sample which can laterally migrate over time along said second leg which is perpendicular to said first leg to said test site, and said housing defining a window adjacent said test site through which said test site is viewable;

b) applying the sample through the second opening to the second leg;

c) after said applying the sample, applying the solution through the first opening to the first leg; and

d) inspecting said test site through said window to determine an indication of the presence or lack thereof of the ligand in the sample.

12. A method according to claim 11, wherein:

said one or more sorbent strips includes a control site, and said method further comprises inspecting said control site to determine an indication of the validity of testing.

13. A method according to claim 11, wherein:

said test device is for determining the presence of a plurality of different ligands in the liquid sample, and said test site has a plurality of separate immobilized ligand-binding mechanisms for separately binding to respective of said plurality of different ligands, and said inspecting said test site comprises inspecting to determine an indication of the presence or lack thereof of each of said plurality of different ligands.

14. A method according to claim 13, wherein:

said plurality of separate immobilized ligand-binding mechanisms are arranged in a plurality of separate lines, and said inspecting said test site comprises looking for the presence of colored lines.