Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: Provided herein are diagnostic tests, methods of use, and kits for the assessment and management of cardiovascular autoimmune disease and risk of cardiovascular autoimmune disease. Assay methods of the invention can be employed to identify cardiovascular autoimmune disease, or risk thereof, in subjects who have cardiovascular disease, an autoimmune disease, or who are related to an individual with an autoimmune disease; for testing of a subject that exhibits symptoms of cardiovascular disease, as well as of a subject that is apparently healthy and does not yet exhibit symptoms of cardiovascular disease; and for determining whether a subject having, or at risk for, a cardiovascular disease is a candidate for immunosuppressive therapy or immunoabsorption therapy. The invention also provides kits and kit components useful for performing the methods.

Abstract: 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.

Abstract: 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.

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

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: A method of determining the presence, amount or concentration of at least one autoantibody that reacts with neutrophil gelatinase-associated lipocalin (NGAL), alone or in further combination with a method of determining the concentration of NGAL, which methods can further comprise diagnosing, prognosticating, or assessing the efficacy of a therapeutic/prophylactic treatment of a patient and, optionally, modifying the therapeutic/prophylactic treatment of the patient as needed to improve efficacy; a kit comprising at least one component for assaying a test sample for at least one autoantibody that reacts with NGAL and instructions for assaying; a method of isolating an autoantibody that reacts with NGAL; an isolated autoantibody that reacts with NGAL; and a method for determining the reliability of an NGAL assay result.

Abstract: The present disclosure relates to assays and kits for detecting and quantifying damage caused by a parasite in a subject and monitoring the progression of parasitic disease in a subject.

Abstract: The present disclosure relates to isolated human autoantibodies and assays and kits for detecting human autoantibodies reactive with at least one natriuretic peptide or natriuretic peptide fragment in a test sample.

Abstract: The present disclosure relates to isolated human autoantibodies and assays and kits for detecting human autoantibodies reactive with at least one natriuretic peptide or natriuretic peptide fragment in a test sample.

Abstract: 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.

Abstract: 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.

Abstract: The present invention relates to interdependent assays and kits for detecting and at least two analytes of interest in a single test sample.

Abstract: The present invention relates to stabilizing compositions, methods and kits for chemiluminescent assays.

Abstract: The present invention relates to assays and kits for detecting or quantifying iron metalloprotein in test samples.

Abstract: The present invention relates to assays and kits for detecting haloperoxidase activity in test samples.