Depositing a binder on a solid support

• US 5,073,340 A
• Filed: 07/06/1990
• Issued: 12/17/1991
• Est. Priority Date: 10/08/1987
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Bloomster, Timothy G., Covington, Gloria J.
• Primary Examiner(s): Johnston, Jill
• Application Number:
  US07/549,670
• Time in Patent Office: 529 Days
• Field of Search: 422/56-58, 436/169, 435/7, 435/805, 427/2
• US Class Current: 422/404
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing

Abstract

A test device for use in determining analyte wherein binder is supported on a solid support in admixture with a marker whereby the presence and location of binder on the support can be determined prior to the assay. A control for the assay may also be applied to the support in admixture with a label.

Claims

1. A test device for use in detecting the presence of an analyte, comprising:

a casing having an aperture;

a solid support comprising an upper surface and contained in said casing;

a test area on the upper surface of said support and positioned in registry with said aperture;

a binder for said analyte attached to said test area;

a detectable chromogen marker attached to said binder, related to the presence or absence of the binder which does not interfere with said assay; and

a background area on the upper surface of said support without binder and detectable marker;

wherein;

said marker causes the binder to be distinguishable from said support so that, before the device is used in said assay the device is examined to confirm that binder is present in said test area.

2. A test device for use in an assay for detecting the presence of an analyte, comprising:

a solid support comprising an upper surface and a lower surface;

a test area on the upper surface of said support;

a binder for the analyte attached to said test area;

a detectable marker attached to said binder which is related to the presence or absence of the binder, and does not interfere with said assay; and

a background area on the upper surface of said support without binder and detectable marker;

a control area on the upper surface of said support;

an assay control attached to said control area; and

a detectable label attached to said assay control which is distinguishable and does not interfere with the assay or with the detectable marker;

wherein;

the detectable marker causes the binder to be distinguishable from said support so that, before the device is used in said assay the device is examined to confirm that binder is present in said test area; and

said label causes the assay control to be distinguishable from said support so that before the device is used in said assay the device is examined to confirm that assay control is present on said support.

3. The test device of claim 2 wherein the assay control is a positive analyte control.

4. The test device of claim 3 wherein said control area is attached to said test area.

5. The test device of claim 2 wherein the label is a chromogen.

6. The test device of claim 5 wherein the solid support is nitrocellulose.

7. A process for producing a test device suitable for detecting the presence of an analyte, comprising:

providing a solid support comprising an upper surface;

contacting said upper surface with a binder for said analyte;

contacting said binder with a detectable marker related to the presence or absence of the binder which does not interfere with said assay;

detecting the marker to confirm that binder is present in said device; and

placing the support in a casing including an aperture with the test area in registry with the aperture.

8. The process of claim 7 further comprising:

contacting said upper surface with a mixture of an assay control; and

contacting said assay control with a detectable label;

wherein;

said control area is distinguishable from said test area and said support, and said label is related to the presence or absence of said assay control.

9. The process of claim 8 wherein said control area is attached to said test area.

10. The process of claim 8 wherein the marker is a fluorescent material and the label is a different fluorescent material.

11. The process of claim 7 wherein the marker is a chromogen.

12. The process of claim 7 wherein the marker is a fluorescent dye.

13. The process of claim 7 wherein the support is nitrocellulose.