IP Library › Granted Patent US 7,393,697
Granted Patent B2
US 7,393,697 · App. 10/456,771 · Granted Jul 1, 2008

Diagnostic test for analytes in a sample

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Quick Facts
Patent No.
US 7,393,697
App. No.
10/456,771
Granted
Jul 1, 2008
Kind
B2
Abstract

Diagnostic devices and methods are provided. The diagnostic devices preferably comprise a test strip with a test area. The sample to be analyzed contacts the test area, which comprises a specific binding partner for the analyte of interest. Analyte, if present in the sample, binds to the immobilized binding partner in the test area and is subsequently contacted with a conjugate. The conjugate specifically binds the analyte and provides a visual indication of the presence of the analyte. The devices may be used for the diagnosis of particular diseases or disorders in a patient, such as HIV or hepatitis. They may also be used to determine if an individual is pregnant.

Claims (17)

1. An immunoassay device for determining the presence of an analyte in a liquid sample, comprising:

a buffer receiving member for receiving a buffer solution;

a conjugate pad in moisture conductive communication with the buffer receiving member, said conjugate pad comprising,

a composition comprising a conjugate disposed in dry state, said conjugate comprising a colored particle and a first binder capable of binding the analyte;

a membrane strip in moisture conductive communication with the conjugate pad, the membrane strip comprising a test area located downstream of the conjugate pad, the test area comprising a second binder agent immobilized therein for forming an immobilized complex with the analyte;

a removable porous member for receiving the liquid sample, wherein said porous member is in contact with and located directly above the test area so as to cover the test area; and wherein

the device is configured to provide a flowpath along which the buffer solution flows into the conjugate pad to mobilize the conjugates and form a mixture comprising the buffer and the mobilized conjugates, and along which flowpath the mixture flows into the membrane strip to the test area, wherein the buffer solution of the mixture washes the immobilized complexes in the test area.

2. The device of claim 1 , wherein the analyte is an antibody to immunodeficiency virus (HIV) and the second binder is selected from the group consisting of an antigen to HIV-1 and an antigen to HIV-2.

3. The device of claim 1 , wherein the colored particles are colloidal gold.

4. The device of claim 3 , wherein the first binder is protein A.

5. The device of claim 1 , wherein the analyte is an antibody.

6. The device of claim 1 , wherein the analyte is an antibody to immunodeficiency virus (HIV).

7. The device of claim 1 comprising a control area located downstream of the test area, the control area comprising an immobilized control binding agent that is able to bind the conjugate.

8. The device of claim 1 wherein the membranous strip comprises a nitrocellulose membrane.

9. The device of claim 1 , wherein the porous member forms a lower wall of a container for receiving the liquid sample.

10. The device of claim 9 , wherein the container is removable from the membranous strip to permit visualization of the test area.

11. The device of claim 1 , wherein the porous member is filter paper.

Assignments (4)
RELEASE OF SECURITY INTEREST IN INTELLECTUAL PROPERTY RECORDED AT REEL 036994, FRAME 0192 AND REEL 037115, FRAME 0498 Recorded Oct 5, 2017
From: HEALTHCARE FINANCIAL SOLUTIONS, LLC, AS COLLATERAL AGENT
To: ALERE CONNECT, LLC; ALERE SAN DIEGO, INC. (FKA BIOSITE INC. OR FKA CHOLESTECH CORP. OR FKA HEMOSENSE INC. OR FKA INVERNESS MEDICAL-BIOSTAR INC. OR FKA ISCHEMIA TECHNOLOGIES, INC. OR FKA TWISTDX, INC.); ALERE SCARBOROUGH, INC. (FKA MATRITECH, INC. FKA ADVANTAGE DIAGNOSTICS CORP. OR FKA BINAX, INC. OR FKA MILANO ACQUISITION CORP.); INNOVACON, INC. (FKA APPLIED BIOTECH, INC. OR FKA AMEDITECH INC.); IONIAN TECHNOLOGIES, LLC (FKA IONIAN TECHNOLOGIES, INC.); QUALITY ASSURED SERVICES INC. (FKA ZYCARE INC.); STANDING STONE, LLC; ESCREEN, INC.
Reel/Frame 044213/0258 →
ASSIGNMENT OF IP SECURITY AGREEMENT, PREVIOUSLY RECORDED AT REEL 036994, FRAME 0192 Recorded Nov 16, 2015
From: GENERAL ELECTRIC CAPITAL CORPORATION, AS RETIRING ADMINISTRATIVE AGENT
To: HEALTHCARE FINANCIAL SOLUTIONS, LLC, AS SUCCESSOR ADMINISTRATIVE AGENT
Reel/Frame 037115/0498 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Oct 29, 2015
From: ALERE CONNECT, LLC; ALERE SAN DIEGO, INC. (FKA BIOSITE INC. OR FKA CHOLESTECH CORP. OR FKA HEMOSENSE INC. OR FKA INVERNESS MEDICAL-BIOSTAR INC. OR FKA ISCHEMIA TECHNOLOGIES, INC. OR FKA TWISTDX, INC.); ALERE SCARBOROUGH, INC. (FKA MATRITECH, INC. FKA ADVANTAGE DIAGNOSTICS CORP. OR FKA BINAX, INC. OR FKA MILANO ACQUISITION CORP.); INNOVACON, INC. (FKA APPLIED BIOTECH, INC. OR FKA AMEDITECH INC.); IONIAN TECHNOLOGIES, LLC (FKA IONIAN TECHNOLOGIES, INC.); QUALITY ASSURED SERVICES INC. (FKA ZYCARE INC.); STANDING STONE, LLC; ESCREEN, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS COLLATERAL AGENT
Reel/Frame 036994/0192 →
NOTICE OF RELEASE OF SECURITY INTEREST IN PATENTS RECORDED AT REEL 026557 FRAME 0287 Recorded Jun 23, 2015
From: GENERAL ELECTRIC CAPITAL CORPORATION, AS ADMINISTRATIVE AGENT AND COLLATERAL AGENT
To: ADVANTAGE DIAGNOSTICS CORPORATION; ALERE MEDICAL, INC.; ALERE SAN DIEGO, INC.; ALERE SCARBOROUGH, INC.; AMEDITECH INC.; APPLIED BIOTECH, INC.; BINAX, INC.; BIOSITE INCORPORATED; CHOLESTECH CORPORATION; GENECARE MEDICAL GENETICS CENTER, INC.; HEMOSENSE, INC.; INSTANT TECHNOLOGIES, INC.; INVERNESS MEDICAL - BIOSTAR INC.; ISCHEMIA TECHNOLOGIES, INC.; MATRITECH, INC.; MATRIA HEALTHCARE, INC.; ZYCARE, INC.
Reel/Frame 036011/0581 →