Immunoassay methods utilizing trapping conjugate

• US 9,891,216 B2
• Filed: 02/25/2015
• Issued: 02/13/2018
• 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:
  US14/631,006
• Publication Number:
  US 20150285799A1
• Time in Patent Office: 1,084 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

Methods 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 method for testing a sample for the presence of a first ligand, comprising:

a) obtaining a test device having a first sorbent strip having a first location for receiving a solution and defining a first migration path, a marker conjugate located on or in said first migration path, said marker conjugate adapted to bind to said first ligand, 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, 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, and 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 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;

b) applying the sample to said second location;

c) after said applying the sample, applying a solution to the first location to cause said marker conjugate to migrate along said first migration path; and

d) inspecting said test site to determine an indication the presence or lack thereof of the first ligand in the sample, 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,

said test device has 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,

said applying the sample comprises depositing the sample through said second opening to said second location,

said applying the solution comprises depositing the solution through said first opening to said first location,

said inspecting comprises inspecting through said window,

said first ligand is a first flu antibody, and

said second ligand is a second flu antibody different than said first flu antibody.

2. A method according to claim 1, wherein:

said first flu antibody is a pandemic flu antibody; and

said second flu antibody is a non-pandemic flu antibody.