Non-instrumented assay with quantitative and qualitative results

• US 6,194,220 B1
• Filed: 09/25/1996
• Issued: 02/27/2001
• Est. Priority Date: 09/25/1996
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: McFarland, Edward Charles, Malick, Adrien Paul
• Primary Examiner(s): Housel, James
• Assistant Examiner(s): NELSON, BRETT L
• Application Number:
  US08/719,220
• Time in Patent Office: 1,616 Days
• Field of Search: 436/514, 436/539, 436/807, 436/518, 435/4, 435/7.1
• US Class Current: 436/514
• 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

Abstract

The present invention is directed to non-instrumented assays giving quantitative and/or qualitative results. In one embodiment, the present invention is directed to a process and kit determining analyte in a sample wherein the solid support has a contact zone and binder distributed and immobilized throughout the solid support. A sample and a tracer are added to the contact zone and a visible zone is obtained. In another embodiment, the present invention is directed to a process and test wherein the solid support has two contact zones and the binder is not immobilized on the solid support. In this embodiment, the binder is mobile and is added to the second contact zone. At the same time, sample and a tracer are added to the first contact zone. A visible zone is obtained.

Claims

1. A process for determining the presence, absence or amount of an analyte in a sample in which there is provided a solid support having a first and second contact zone, wherein said first contact zone is located at the front end of the solid support and said second contact zone is located at the distal end of the solid support wherein the process comprises:

a) contacting said first contact zone with a sample containing analyte;

b) contacting said first contact zone with tracer wherein said tracer is comprised of analyte labeled with a directly visible label or analyte analog labeled with a directly visible label, without the need for further treatment to said tracer;

c) contacting said second contact zone with a specific binding member for the analyte wherein said specific binding member is attached to a directly visible label;

d) obtaining a directly visible zone of tracer comprising complexes of analyte-specific binding member-label or analyte analog-specific binding member-label; and

e) determining the presence, absence or amount of said analyte as a function of the location of said visible zone in the solid support, without the need for instrumentation to determine said directly visible zone of tracer.

2. The process of claim 1 wherein sample and tracer are sequentially contacted with the first contact zone.

3. The process of claim 1 wherein the sample and tracer are simultaneously contacted with the first contact zone.

4. The process of claim 1 wherein said label is a non-soluble particulate sac including a visible dye.

5. The process of claim 4 wherein the sac is a liposome.

6. The process of claim 1 wherein the solid support is comprised of nitrocellulose.

7. The process of claim 1 wherein the specific binding member is an antibody.

8. The process of claim 1 wherein the analyte is digoxin.

9. The process of claim 1 wherein said label is a non-soluble particulate colored polymeric bead.