Abstract: The present invention relates to analyte detection test systems, including test systems for the oral detection of analytes in saliva. The present invention also provides compositions and methods for storing multiple assay tests and compositions and methods for measuring the concentration of analytes in a sample.

Abstract: Use of pregnancy-associated plasma protein-A as a marker for inflammatory conditions, and in particular, for acute coronary syndromes is described.

Abstract: The invention provides glycated peptides and glycated fragments and glycated variants thereof, antibodies and aptamers which bind thereto, compositions and kits comprising the same, related conjugates, and a database comprising data indicating the concentration of glycated peptides present in diabetic and non-diabetic persons. The invention also provides a method of monitoring glycemic control, a method of treating or preventing diabetes, a method of preventing a complication of diabetes, a method of monitoring the status of diabetes, a method of determining the efficacy of a diabetes treatment, as well as methods of detecting diabetes or a predisposition thereto.

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: Disclosed are processes to increase the relative abundance of a molecule that is present in a test sample at relatively low abundance. The process includes fractionating a sample and immunizing hosts with the fractions. The antibodies produced from the fractionated test sample are directed primarily to molecules that are in relatively high abundance in the test sample fractions. These antibodies are then contacted with the test sample or a test sample to immuno-deplete relatively high abundance molecules from the sample to form a first depleted sample. These steps can be repeated a reiterative process of immuno-subtraction to produce second and third depleted samples where the relative abundance of the “low abundance” molecule is increased.

Abstract: Methods and compositions are provided for detection of biological substances in nasal specimen.

Abstract: A method for high spatial resolution stochastic examination of a biological sample structure labeled with a labeling substance is described. The method comprises providing a biological sample structure; choosing such a labeling substance that has molecules present in a first state and in a second state, and the first and second states differ from one another in at least one photophysical property such that there is sufficient probability that one portion of the molecules of the substance will be in the first state and another portion of the molecules will be in the second state and within which labeling substance a change of the state of the molecules can occur spontaneously between the two states in both directions; and labeling the biological sample structure with the substance.

Abstract: A method is described for enriching procaryotic DNA, said method including the steps of contacting at least one procaryotic DNA with at least one protein or polypeptide which is capable of specifically binding to non-methylated CpG motifs, and separating the protein/polypeptide-DNA complex. Moreover, the application relates to a kit for carrying out said method.

Abstract: A system for the detection of molecular associations, the system comprising: i) a first agent, comprising a first interacting group coupled to a first reporter component; ii) a second agent, comprising a second interacting group coupled to a second reporter component; iii) a third agent, comprising a third interacting group; iv) a modulator; and v) a detector; wherein proximity of the first and second reporter components generates a signal capable of detection by the detector; and wherein the modulator modulates the association of the second interacting group with the third interacting group; such that monitoring the signal generated by proximity of the first and second reporter components by the detector constitutes monitoring the association of the first and third agents.

Abstract: The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects. In particular, the invention relates to methods and compositions selected to monitor cardiorenal syndrome using assays that detect NGAL, preferably together with assays that detect natriuretic peptides such as BNP. Such methods and compositions can provide early indications of a deterioration in cardiorenal syndrome status, including prognosis regarding mortality and worsening renal function.

Abstract: The invention relates to a method for the diagnosis, and/or risk stratification, and/or outcome prognosis of cardiac insufficiency for NYHA I patients, wherein a determination of the proANP marker, NT-proANP marker, or fragments or partial peptides thereof is carried out parallel to a determination of BNP, proBNP, and/or NT-proBNP on patients to be examined.

Abstract: The invention provides methods of screening a mammalian subject to determine if the subject is at risk to develop or is suffering from, cardiovascular disease. In one embodiment, the method comprises detecting a measurable feature of at least two biomarkers in an HDL subfraction, or in a complex containing apoA-I or apoA-II isolated from a biological sample obtained from the subject, wherein the at least two biomarkers are selected from the group consisting of apoA-I, apoA-II, apoB-100, Lp(a), apoC-I, and apoC-III, combinations or portions and/or derivatives thereof, and comparing the measurable features of the at least two biomarkers from the biological sample to a reference standard, wherein a difference in the measurable features of the at least two biomarkers from the biological sample and the reference standard is indicative of the presence or risk of cardiovascular disease in the subject.

Abstract: Provided are rapid and sensitive cell-free assay methods for detecting and/or measuring specific bimolecular or higher order interactions via reassembly of a split monomeric reporter protein, and methods of detecting or identifying modulators of such interactions by the effect on the signal provided by the reassembled split reporter protein. This methodology is adaptable to protein-protein, protein-peptide, protein-nucleic acid, protein-methylated or nonmethylated nucleic acid and other small or large molecule ligands and binding proteins.

Abstract: Methods and kits for the quantitation of cellular DNA and cell numbers are provided. Passive element uptake, element-labeled DNA intercalators, and element labeled affinity reagents are used to quantify DNA and cells. The DNA and the cells are analyzed by elemental analysis, including ICP-MS. The methods and kits provide a fast and accurate analysis of cellular DNA and cell numbers.

Abstract: Disclosed are systems and methods for developing diagnostic tests (e.g., detection, screening, monitoring, and prognostic tests) based on biomarker information from legacy clinical sample sets, for which only small sample volumes (e.g., about 0.05 to about 1.0 mL or less per sample) are typically available. For example, biomarkers (e.g., about 10, 50, 100, 150, 200, 300, or more) may be detected in the clinical samples through the use of single molecule detection and each biomarker may be detected in an assay that includes about 1 ?L or less of a legacy clinical sample.

Abstract: Provided herein are, inter alia, methods for identifying a candidate compound for treating the toxic effects of compounds or molecules that bind to albumin in a subject. The methods include identifying test compounds that inhibit the binding between FcRn and albumin.

Abstract: The present invention relates, e.g., to a method for pre-processing a sample for mass spectral analysis, comprising cleaving proteins in the sample to peptides and immunodepleting highly abundant and/or well-ionizing and/or proteotypic peptides from the sample. Also described are methods for identifying well-ionizing peptides for use in this and other methods; analytic (diagnostic) methods using antibodies against highly ionizable peptides from a protein target of interest; and compositions kits and devices comprising antibodies of the invention.

Abstract: The invention relates to the detection and quantitation of cyclodextrins and cyclodextrin derivatives in solutions comprising a protein. The invention further relates to methods of evaluating pharmaceutical preparations for the presence of residual cyclodextrins.

Abstract: The present invention relates to the field of immunology and hyperproliferative diseases. More specifically, the present invention relates to a method of detecting and monitoring therapeutic antibody:antigen complex, soluble antigen and soluble therapeutic antibody, wherein a patient has undergone at least one course of immunotherapy. Yet further, levels of therapeutic antibody:antigen complexes, soluble antigens or soluble therapeutic antibodies may be measured and used to stage or monitor a hyperproliferative disease.

Abstract: The present invention relates to use of ?-2-microglobulin (B2M or ?2M) and C-reactive protein (CRP) levels as biomarkers of peripheral artery disease and/or atherosclerosis.