Abbott Laboratories Corporation

Abbott Laboratories D-337/ap6d

Phillip G Mattingly

Maciej B Adamczyk

Roy Jeffrey Brashear

Larry G Bennett

Joan D Tyner

Donald D Johnson

Mary M Perkowitz

Diana E Clarisse

Robert C Doss

Jeffrey R Brashear

Lynn M Codacovi

Christopher J Welch

Steven C Kuemmerle

Theresa L Lane

Suzanne M Delby

James E Dombrowski

R Jeffrey Brashear

Jefffrey R Brashear

William D Garner

The present disclosure describes immunoassays for detecting cardiac troponin-T (cTnT) in a test sample, and in particular immunoassays and kits for detecting cTnT in a test sample suspected of containing substances that may interfere with the determination of cTnT, such as heterophilic endogenous antibodies and autoantibodies to cTnT. The methods use more than one capture phase antibody and more than one detection antibody to improve specificity, and provide for the use of humanized immunoreagents to overcome heterophilic antibody interferences.

Assay for cardiac troponin-T (cTnT)

Assays are disclosed for diagnosing a clinical condition, assessing risk or predicting an outcome as a result of cardiac myocyte damage. Immunoassay methods and kits provide for the assessment of cardiac myocyte damage by determining the presence of multiple cardiac myocyte antigens in a test sample, and combining the multiple determinations in a single assay result.

Assay for diagnosis of cardiac myocyte damage

The present disclosure provides immunoassays and kits for detection or quantification of an analyte of interest in a test sample that potentially contains endogenously produced autoantibodies reactive with the analyte.

Autoantibody enhanced immunoassays and kits

The disclosure provides among other things an assay method that compensates for the presence of endogenous antibodies, e.g., autoantibodies, which might otherwise compromise the measurement of an analyte in a biological sample. In one embodiment, this method entails the use of a two labeled entities: a labeled detection agent and a labeled species-specific antibody, wherein the labeled species-specific antibody is specific for the species from which the biological sample was obtained. Sample analyte is bound by the detection agent and any anti-analyte autoantibodies present in the sample. Analyte bound by autoantibodies is detected via the species-specific antibody, optionally labeled.

Immunoassay of analytes in samples containing endogenous anti-analyte antibodies

The present invention relates to methods of detecting hemoglobin in a test sample. These methods can be used to diagnose a subject suffering from a genetic disorder relating to hemoglobin metabolism, to determine the eligibility of a subject to be a blood donor, to determine the age of a stored blood sample or to identify a hemolyzed plasma sample. The present invention also relates to kits for use in the above described methods.

Methods and kits for detecting hemoglobin in test samples

The invention provides among other things methods and kits based on assaying for cardiac troponin autoantibodies, either in conjunction with an assay for cardiac troponin and/or as an independent indicator of cardiac pathology, such as myocarditis, cardiomyopathy, and/or ischemic heart disease. Assay methods of the invention can be employed among other things to identify cardiac pathology, or risk thereof, in subjects who have an autoimmune disease or who are related to an individual with an autoimmune disease. In particular embodiments, the invention also provides a method of determining whether a subject having, or at risk for, a cardiac pathology is a candidate for immunosuppressive therapy or immunoabsorption therapy. The invention also provides kits and kit components that are useful for performing the methods of the invention.

Assay for cardiac troponin autoantibodies

The present invention relates to methods and kits for detecting an analyte in a test sample using acridinium-9-carboxylate aryl esters.

Acridinium phenyl esters useful in the analysis of biological

A method of assessing whether or not erythrocytes are suitable for transfusion into a recipient comprising (i) assaying a sample of erythrocytes for free choline, and (ii) comparing the level of free choline in the sample with the level of free choline deemed suitable for transfusion therapies; and a kit for use in such a method comprising at least one reagent for assaying the sample, instructions for conducting the assaying of the sample, and guidelines for assessing the suitability of the erythrocytes for transfusion.

Measuring free choline to determine suitability of erythrocytes for transfusion

Acridinium sulfonylamides and isomers, such as phenanthridinium sulfonylamides, may be employed in applications including chemiluminmescent immunoassays. Methods for synthesis of these compounds include contacting an amine with a sulfonylhalide to form a sulfonamide and acylating with an activated carboxylic acid of an acridine or isomer thereof. The N-sulfonyl-9-acridinium carboxamide and isomers may be conjugated to antigens, haptens, antibodies, and nucleic acids for use in chemiluminescent assays.

Chemiluminescent acridinium salts

5(6)-methyl substituted fluorescein derivatives and a process for producing 5(6)-methyl substituted derivatives. Also provided are methods for these utilizing these derivatives as indicator reagents in assays for analytes, indicator reagents which comprise specific binding members attached to these derivatives and test kits which contain these derivatives.

5(6)-methyl substituted fluorescein derivatives

Immunoassay methods and reagents for the specific quantification of thyroxine in a test sample are disclosed employing antibodies prepared with thyroxine derivatives of the formula: ##STR1## wherein P is an immunogenic carrier material and X is a linking moiety. The present invention also describes the synthesis of unique labelled reagent of the formula: ##STR2## wherein Q is a detectable moiety and W is a linking moiety, preferably fluorescein or a fluorescein derivative.

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Grayslake, IL, United States of America

Phillip G Mattingly