Immunoassay devices and materials

• US 6,027,943 A
• Filed: 11/14/1997
• Issued: 02/22/2000
• Est. Priority Date: 12/18/1989
• Status: Expired due to Fees

• Current Assignee: PBM-Selfcare LLC (Abbott Laboratories Incorporated)
• Original Assignee: Princeton Biomeditech Corporation
• Inventors: Kang, Jemo, Oh, Young Ho, Youn, Byungwoo
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US08/970,425
• Time in Patent Office: 830 Days
• Field of Search: 422/56-58, 422/61, 435/7.92-7.95, 435/287.1, 435/287.2, 435/287.7, 435/287.9, 435/970, 435/805, 435/810, 436/164, 436/169, 436/514, 436/518, 436/524, 436/529, 436/530, 436/805, 436/810
• US Class Current: 436/518
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/54389 with bidirectional or multidirectional lateral flow, e.g. wherein the sample flows from a single, common sample application point into multiple strips, lanes or zones
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

An immunochemical assay device comprising a base member, an array disposed on the base member, and at least one assay indicia zone. The array comprises (i) a reservoir pad to receive sample liquid, (ii) a wicking membrane, and (iii) at least one filter zone interposed between the wicking membrane and the reservoir pad. The filter zone being operable to permit passage of any specific immunocomplex to the wicking membrane while impeding passage of larger components.

Claims

1. An immunochemical assay device comprising:

a base member;

an array disposed on said base member, said array comprising;

(i) a reservoir pad having sufficient porosity and volume to receive and contain a liquid;

(ii) a wicking membrane disposed distally to said reservoir pad, said wicking membrane having sufficient porosity and volume to absorb a substantial proportion of the sample received in said reservoir pad; and

(iii) at least one first filter zone which is separate and distinct from said reservoir pad and wicking membrane, and interposed between and contiguous with said wicking membrane and said reservoir pad, said first filter zone having impregnated therein one or more labelled immunochemical components capable of binding to or competing with one or more analytes of interest in said sample to form one or more immuno-complexes;

(iv) at least one second filter zone which is separate and distinct from said reservoir pad, said wicking membrane and said first filter zone, and contiguous with said wicking membrane, and said first filter zone, said second filter zone having sufficient porosity and volume to receive and containing a liquid sample on which the assay is to be performed;

at least one additional immobilized immunochemical component disposed in at least one assay indicia zone of said wicking membrane downstream of said reservoir pad and defining assay indicia.

2. The assay device according to claim 1 wherein said one or more analytes is selected from a group consisting of an antibody, an antigen, and a hapten.

3. The assay device according to claim 1 wherein said one or more labelled immunochemical components is selected from the group consisting of an antibody, an antigen and a hapten.

4. The assay device according to claim 1 wherein said assay device comprises competition assay or a sandwich assay.

5. The assay device of claim 1 wherein said immobilized component is selected from the group consisting of an antibody, an antigen and a hapten.

6. The immunochemical assay device of claim 1 wherein said one or more labelled immunochemical components comprises finely particulate carbon black and one or more immunological ligands or ligand binding molecules covalently linked to a linking reagent, said carbon black being pretreated with dextran and said linking reagent being absorbed on the surface of said dextran-treated carbon black, and wherein the linking reagent is fluorescein isothiocyanate.

7. The assay device of claim 1 or 6 wherein said at least one filter pad is pretreated with reagents to enhance the sensitivity of the assay device.

8. The assay device of claim 7 wherein said reagents are selected from the group consisting of buffers, detergents, and anticoagulants.

9. The assay device according to claim 1 wherein said immobilized component is an antibody and said labelled immunochemical component is a hapten.

10. The assay device according to claim 1 wherein said immobilized component is an antigen and said labelled immunochemical component is an antibody.