Immunoassay utilizing trapping conjugate

• US 9,885,710 B2
• Filed: 02/25/2015
• Issued: 02/06/2018
• Est. Priority Date: 04/02/2014
• 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): Brown, Melanie Yu
• Application Number:
  US14/631,084
• Publication Number:
  US 20150285795A1
• Time in Patent Office: 1,077 Days
• CPC Class Codes: G01N 2333/11 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: G01N 2333/161 gag-pol, e.g. p55, p24/25, p17/18, p.7, p6, p66/68, p51/52, p31/34, p32, p40
• CPC Class Codes: G01N 2469/10 Detection of antigens from microorganism in sample from host
• CPC Class Codes: G01N 2469/20 Detection of antibodies in sample from host which are directed against antigens from microorganisms
• CPC Class Codes: G01N 33/5306 Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54386 Analytical elements
• 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: G01N 33/56983 Viruses
• CPC Class Codes: G01N 33/56988 HIV or HTLV

Abstract

Test devices are provided for determining the presence of a first ligand in a sample. In some embodiments depletion conjugates are used to deplete the ligands different from but related to the first ligands from the sample. In some embodiments, interim binding agents are used to enhance the test signal.

Claims

1. A test device for determining the presence of a first ligand in a liquid sample, comprising:

a) a first sorbent strip having a first location for receiving a solution and defining a first migration path;

b) a marker conjugate adapted to move along said first migration path and bind to said first ligand;

c) a second sorbent strip distinct from said first sorbent strip and having a second location for receiving the liquid sample and defining a second migration path;

d) depletion molecules located on or in said second migration path wherein said depletion molecules include an immobilized ligand-binding element adapted to bind to second ligands that are different from but related to said first ligand wherein said first ligand is a first flu antibody, and said second ligand is a second flu antibody different than said first flu antibody; and

e) a test site located on or in one at least one of said first sorbent strip and said second sorbent strip, said test site having an immobilized first ligand binding mechanism for said first ligand, and said first and second sorbent strips touching each other at the test site location, wherein said second location is removed from said test site such that sample applied to said second location requires time to migrate to said test site and does not immediately wet said test site.

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

a housing defining a first opening adjacent said first location, a second opening adjacent said second location, and a window adjacent said test site through which said test site is viewable.

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

said ligand binding mechanism of said test site is an antigen or antibody for said first ligand, and said marker conjugate comprises an antigen or antibody for the first ligand and a 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 4, wherein:

said first sorbent strip and said second sorbent strip are arranged in a “

T”

configuration.

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

said depletion molecules comprises a conjugate including an antigen or antibody for the second ligand and particles that are not readily seen by the human eye against a background of said test site.

7. A test device according to claim 6, wherein:

said particles comprise white latex.

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

said first sorbent strip has a first pore size and said second sorbent strip has a second pore size, and said second pore size is larger than said first pore size.

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

at least one of said first sorbent strip and said second sorbent strip includes a control site, and either said window is sized to permit viewing of said control site or a second window is provided in said housing to permit viewing of said control site.

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

buffer solution, wherein said marker conjugate is disposed on or in said first migration path and said buffer solution is adapted to carry said marker conjugate to said test site.

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

a first adhesive backing card underlying or overlying said first sorbent strip, and

a second adhesive backing card underlying or overlying said second sorbent strip, wherein

said first sorbent strip includes a first membrane and a first backing and said second sorbent strip includes a second membrane and a second backing, and said first sorbent strip and said second sorbent strip are arranged such that said first membrane is in contact with said second membrane.