IP Library › Granted Patent US 8,114,612
Granted Patent B2
US 8,114,612 · App. 12/986,893 · Granted Feb 14, 2012

Methods for the assay of troponin I and T and complexes of troponin I and T and selection of antibodies for use in immunoassays

Assignee: Alere San Diego, Inc.
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Quick Facts
Patent No.
US 8,114,612
App. No.
12/986,893
Granted
Feb 14, 2012
Kind
B2
Abstract

Assay systems and specialized antibodies for the detection and quantitation of troponin I and troponin T in body fluids as an indicator of myocardial infarction are disclosed. Troponin I and T exist in various conformations and the ratios of monomeric troponin I and T and the binary and ternary complexes, as well as which form of troponin present in the blood, may be related to the metabolic state of the heart. Disclosed are systems to determine the presence of a troponin form or a group of troponin forms in whole blood, serum or plasma samples. Disclosed is a method for improving the recovery of troponin I or T from a surface used in immunoassays. Also disclosed are antibodies which recognize unbound troponin forms, the forms of troponin in binary complexes, the ternary complex of troponin I, T and C, and the conformations of troponin I having intramolecularly oxidized and reduced cysteines.

Claims (17)

1. A method of increasing assay sensitivity in a cardiac troponin immunoassay, comprising:

contacting an agent to reduce non-specific adsorption of cardiac troponin I in a body fluid sample obtained from a human subject to a substrate of an assay device, wherein said immunoassay uses antibodies, comprising;

(a) a first antibody that specifically binds to uncomplexed cardiac troponin I, wherein said first antibody also specifically binds to cardiac troponin I complexed to troponin T and troponin C; or

(b) another first antibody that specifically binds to cardiac troponin I, uncomplexed to either troponin T or troponin C and a second antibody that specifically binds to cardiac Troponin I, complexed to troponin T and troponin C; or

(c) a combination thereof;

and wherein said immunoassay is configured to provide assay results that are within a factor of two for

(i) cardiac troponin I, uncomplexed to either troponin T or troponin C, at a concentration between 1 and 15 ng/ml; and

(ii) an equivalent concentration of cardiac troponin I in a complex with troponin T and troponin C; and

wherein said agent that reduces non-specific adsorption increases assay sensitivity for troponin I; and

performing said immunoassay in the presence of said agent, thereby increasing assay sensitivity for troponin I in a cardiac troponin assay.

2. The cardiac troponin assay method of claim 1 , wherein the agent that reduces non-specific adsorption of troponin I is melittin.

3. The cardiac troponin assay method of claim 1 , wherein the agent that reduces non-specific adsorption of troponin I is protamine.

4. The cardiac troponin assay method of claim 1 , wherein the agent that reduces non-specific adsorption of troponin I is combination of melittin and protamine.

5. The cardiac troponin assay method of claim 2 or 4 , wherein the melittin is provided at a concentration of between about 0.017 mM to about 0.05 mM.

6. The cardiac troponin assay method of claim 3 or 4 , wherein the protamine is provided at a concentration of between about 0.03 mg/mL to about 0.1 mg/mL.

7. The cardiac troponin assay method of claim 6 wherein assay response is increased by factors of 30% to 400% compared to an assay without an agent that reduces non-specific adsorption.

8. The cardiac troponin assay method of claim 1 , 2 , 3 , 4 or 7 , wherein said substrate is a membrane or latex particle.

Assignments (6)
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 →
CHANGE OF NAME Recorded Sep 13, 2011
From: BIOSITE INCORPORATED
To: ALERE SAN DIEGO, INC.
Reel/Frame 026897/0423 →
SECURITY AGREEMENT Recorded Jul 7, 2011
From: ADVANTAGE DIAGNOSTICS CORPORATION; ALERE MEDICAL INCORPORATED; 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.; ZYCARE INC.; MARTIA HEALTHCARE, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION
Reel/Frame 026557/0287 →
Continuity (6)
Continuation 12554668 · Sep 4, 2009
Continuation 10850954 · May 21, 2004
Continuation 09687051 · Oct 12, 2000
Continuation In Part 08633248 · Apr 18, 1996
Continuation In Part 08423582 · Apr 18, 1995
Related Publication 20110143455A1 · Jun 16, 2011