Immunoassay for the detection or quantitation of an analyte

• US 5,236,826 A
• Filed: 12/18/1990
• Issued: 08/17/1993
• Est. Priority Date: 12/10/1985
• Status: Expired due to Term

• Current Assignee: Murex Diagnostics Corporation (Abbott Laboratories)
• Original Assignee: Murex Corporation
• Inventors: Marshall, David L.
• Primary Examiner(s): Nucker, Christine
• Assistant Examiner(s): STUCKER, JEFFREY J
• Application Number:
  US07/630,365
• Time in Patent Office: 973 Days
• Field of Search: 435/7.1, 435/7.92, 422/55, 422/56, 422/58, 436/533, 436/534
• US Class Current: 435/7.92
• CPC Class Codes: G01N 33/538 by sorbent column, particles or resin strip , i.e. sorbent materials
• CPC Class Codes: G01N 33/54306 Solid-phase reaction mechanisms
• CPC Class Codes: G01N 33/54313 the carrier being characterised by its particulate form
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/56927 Chlamydia
• CPC Class Codes: G01N 33/56983 Viruses

Abstract

An immunoassay method for the detection or quantitation of an analyte suspected of being in a solution comprising: (a) combining said specimen, a first binding component, insoluble particles, and second binding component labelled with a signal generating material in a solid phase retention and separation apparatus having a sufficient pore size such that said particles are trapped within said filter yet permitting rapid passage of fluid therethrough in such a manner that an immunological reaction occurs if analyte is present in said specimen, resulting in the formation of an immunocomplex of insolubilized first binding component:analyte:second labelled binding component on or within said filter means; (b) separating bound from unbound material; and (c) determining the presence and/or amount of signal produced which is correlative with the amount of analyte present in the solution.

Claims

1. An immunoassay for the detection or quantitation of an analyte suspected of being present in a specimen solution comprising:

(a) contacting said specimen solution with insoluble particles capable of being suspended in said specimen solution and of binding any said analyte present in said specimen solution,

(b) applying said suspension to a filter means having a pore size, such that said insoluble particles and insoluble complexes of said insoluble particles and said analyte, if any, are trapped within or on said filter means, and unbound material passes therethough

(c) applying a soluble labeling component capable of binding to said analyte, to said insoluble particles and insoluble complexes, if any, on said filter means to form insoluble complexes of said insoluble particles, said analyte, and said labeling component, if any complexes of insoluble particles and analyte are present within or on said filter means, and

(d) determining the presence or amount of signal produced by any said complexes of said insoluble particles, said analyte, and said labeling component as an indicator of the presence and/or amounts of said analyte present in the specimen solution.

2. An immunoassay method for the detection or quantitation of an analyte suspected of being present in a specimen solution comprising:

(a) contacting said specimen solution with insoluble particles capable of binding said analyte and a soluble labeling component capable of binding said analyte to form a suspension of insoluble complexes of said insoluble particles, said analyte, and said labeling component, if any said analyte is present in said solution,

(b) applying said solution to a filter means having a pore size such that said insoluble particles and insoluble complexes, if any, are trapped within or on said filter means and unbound material passes therethrough, and

(c) determining the presence amount of signal produced by any said complexes as an indication of the presence or amount of analyte present in said specimen.

3. An immunoassay method for the detection or quantitation of an analyte suspected of being present in a speciment solution comprising:

(a) applying insoluble particles capable of binding said analyte to a filter means having a pore size such that said insoluble particles are trapped within or on said filter means and unbound material passes therthrough,

(b) contacting said trapped insoluble particles sequentially with said specimen solution and then with a soluble labeling component capable of binding said analyte to form insoluble complexes of said insoluble particles, said analyte, and said labeling component if any said analyte is present in said solution, and

(c) determining the presence or amount of signal produced by any said complexes as an indicator of the presence or amount of analyte present in said specimen solution.