Abbott Laboratories Corporation

Abbott Laboratories D-337/ap6d

Maciej B Adamczyk

Phillip G Mattingly

Donald D Johnson

Roy Jeffrey Brashear

Mary M Perkowitz

Joan D Tyner

Diana E Clarisse

Jeffrey R Fishpaugh

John A Walling

Yon-Yih Chen

Bryan D James

Charles A Harrington

Robert E Hruska

Daryl E Hartter

Sharon G Artrip

David A Betebenner

Christopher Bieniarz

Michael D Fiechtner

Kenward S Vaughan

Robert C Doss

Mohamed Shipchandler

Christine H Zeitvogel

Hossein A Ghanbari

Jeffrey R Brashear

Robert E Dubler

Jonathan Grote

Elaine Marie Brate

Sharon G Artip

Jefffrey R Brashear

Sushil D Rege

Patrick J Jonas

Jane Ann Nelson

Luis A Cantarero

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

Immunoassay reagents, methods and test kits for the specific quantification of vancomycin in a test sample are disclosed. The reagent comprises antibodies prepared with immunogens of FIG. wherein P is an immunogenic carrier material and X is a linking moiety. Also described is the synthesis of labeled reagents of FIG. wherein Q is a detectable moiety, preferably fluorescein or a fluorescein derivative, and X is a linking moiety.

Reagents and methods for the detection and quantification of vancomycin in biological fluids

The present invention is directed to a fluorescence polarization immunoassay for barbiturates, to the various components needed for preparing and carrying out such an assay, and to methods of making these components. Specifically, tracers, immunogens and antibodies are disclosed, as well as methods for preparing them and a reagent kit containing them. The tracers and the immunogens are made from substituted barbiturate compounds. A fluorescein moiety is included in the tracer, while a poly(amino acid) forms a part of the immunogen. The assay is conducted by measuring the degree of polarization retention of plane&mdash;polarized light that has been passed through a sample containing antiserum and tracer.

Barbiturate assay, tracers, immunogens, antibodies and kit

The present invention discloses novel immunogens, antibodies prepared from such immunogens, and labeled reagents useful in immunoassays for the detection and quantification of testosterone in a test sample. Also disclosed are immunoassays using these reagents and methods for synthesizing these reagents. The immunoassays are preferably microparticle enzyme immunoassays (MEIAs) and fluorescence polarization immunoassays (FPIAs). Further disclosed are novel starting materials for making the above novel immunogens and labeled reagents. Methods for making the novel immunogens and labeled reagents from the novel starting materials are also disclosed.

Reagents and methods for the detection and quantification of

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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Lindenhurst, IL, United States of America

Maciej B Adamczyk