HUMAN NT-PRO B-TYPE NATRIURETIC PEPTIDE ASSAY HAVING REDUCED CROSS-REACTIVITY WITH OTHER PEPTIDE FORMS

• US 20100291709A1
• Filed: 05/13/2009
• Published: 11/18/2010
• Est. Priority Date: 05/13/2009
• Status: Abandoned Application

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Moore, Jeffrey Allen, Konrath, John George
• Application Number:
  US12/465,572
• Publication Number:
  US 20100291709A1
• Time in Patent Office: Days
• US Class Current: 436/518
• CPC Class Codes: C07K 16/26 against hormones ; against hormone releasing or inhibiting factors
• CPC Class Codes: G01N 2333/58 Atrial natriuretic factor complex; Atriopeptin; Atrial natriuretic peptide [ANP]; Brain natriuretic peptide [BNP, proBNP]; Cardionatrin; Cardiodilatin
• CPC Class Codes: G01N 33/74 involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors

Abstract

The present disclosure relates to assays for detecting and/or quantifying the amount of human NT-pro B-type natriuretic peptide or human NT-pro B-type natriuretic peptide fragment in a test sample.

Claims

1. An immunoassay for quantifying the amount of human NT-pro B-type natriuretic peptide (“

human NT-proBNP”

) in a test sample being tested for or suspected of containing human NT-proBNP, the immunoassay having reduced cross-reactivity with any human pro B-type natriuretic peptide (“

human proBNP”

) present in the test sample and comprising the steps of;

(a) contacting at least one capture antibody that binds to human NT-proBNP and that has been immobilized onto a solid phase to produce an immobilized antibody with said test sample to form a first mixture comprising an at least one capture antibody-human NT-proBNP complex, wherein said capture antibody comprises antibody 15F11;

(b) contacting said first mixture comprising the at least one capture antibody-human NT-proBNP complex with at least one detection antibody that binds to human NT-proBNP and that has been conjugated to a detectable label to form a second mixture comprising at least one capture antibody-human NT-proBNP-at least one detection antibody complex, wherein the detection antibody comprises antibody 24E11 or 15C4; and

(c) determining the amount of the at least one capture antibody-human NT-proBNP-at least one detection antibody complex formed in step (b) by detecting the detectable label as a measure of the amount of human NT-proBNP contained in the test sample,

wherein the at least one capture antibody and the at least one detection antibody, when used together, exhibit a cross-reactivity of less than about 1.0% with any human proBNP present in the test sample.

2. The immunoassay of claim 1, wherein the at least one detection antibody is 24E11.

3. The immunoassay of claim 1, wherein the at least one detection antibody is 15C4.

4. An immunoassay for quantifying the amount of human NT-pro B-type natriuretic peptide (“

human NT-proBNP”

) in a test sample being tested for or suspected of containing human NT-proBNP, the immunoassay having reduced cross-reactivity with any human pro B-type natriuretic peptide (“

human proBNP”

) present in the test sample and comprising the steps of;

(a) contacting said test sample with at least one detection antibody that binds to human NT-proBNP and that has been conjugated to a detectable label to form a first mixture comprising an at least one human NT-proBNP-detection antibody complex, wherein the detection antibody comprises antibody 24E11 or 15C4;

(b) contacting said first mixture comprising said at least one human NT-proBNP-detection antibody complex with at least one capture antibody that binds to human NT-proBNP and that has been immobilized on to a solid phase to produce an immobilized antibody to form a second mixture comprising an at least one capture antibody-human NT-proBNP-at least one detection antibody complex, wherein said at least one capture antibody comprises antibody 15F11; and

(c) determining the amount of the at least one capture antibody-human NT-proBNP-at least one detection antibody complex formed in step (b) by detecting the detectable label as a measure of the amount of human NT-proBNP contained in the test sample,

wherein the at least one capture antibody and the at least one detection antibody, when used together, exhibit a cross-reactivity of less than about 1.0% with any human proBNP present in the test sample.

5. The immunoassay of claim 4, wherein the at least one detection antibody is 24E11.

6. The immunoassay of claim 4, wherein the at least one detection antibody is 15C4.

7. An immunoassay for quantifying the amount of human NT-pro B-type natriuretic peptide (“

human NT-proBNP”

) in a test sample being tested for or suspected of containing human NT-proBNP, the immunoassay having reduced cross-reactivity with any human pro B-type natriuretic peptide (“

human proBNP”

) present in the test sample and comprising the steps of;

(a) contacting a test sample with at least one capture antibody that binds to human NT-proBNP and that has been immobilized onto a solid phase to produce an immobilized antibody and with at least one detection antibody that binds to human NT-proBNP and that has been conjugated to a detectable label to form an at least one capture antibody-human NT-proBNP-at least one detection antibody complex, wherein the at least one capture antibody comprises antibody 15F11 and the at least one detection antibody is antibody 24E11 or 15C4; and

(b) determining the amount of the at least one capture antibody-human NT-proBNP—

at least one detection antibody complex formed in step (a) by detecting the detectable label as a measure of the amount of human NT-proBNP contained in the test sample,

wherein the at least one capture antibody and the at least one second antibody conjugated to the detectable label, when used together, exhibit a cross-reactivity of less than about 1.0% with any human proBNP present in the test sample.

8. The immunoassay of claim 7, wherein the at least one detection antibody is 24E11.

9. The immunoassay of claim 7, wherein the at least one detection antibody is 15C4.

10. An immunodiagnostic reagent comprising at least one capture antibody and at least one detection antibody specific for human NT-pro B-type natriuretic peptide (“

human NT-proBNP”

), and that, when used together, exhibit a cross-reactivity of less than about 1.0% with any human pro B-type natriuretic peptide (“

human proBNP”

).

11. The immunodiagnostic reagent of claim 10, wherein the capture antibody is antibody 15F11 and the detection antibody is antibody 24E11 or 15C4.

12. A kit for the detection of human NT-pro B-type natriuretic peptide (“

human NT-proBNP”

) in a test sample, said kit comprising;

(a) instructions for conducting the assay of the test sample; and

(b) an immunodiagnostic reagent that comprises at least one capture antibody and at least one detection antibody specific for human NT-pro B-type natriuretic peptide (“

human NT-proBNP”

), and that, when used together, exhibit a cross-reactivity of less than about 1.0% with any human pro B-type natriuretic peptide (“

human proBNP”

).

13. The kit of claim 12, wherein capture antibody is antibody 15F11 and the detection antibody is antibody 24E11 or 15C4.