Abstract: Methods are provided for screening for the necessity for further diagnosis of one or more diseases or conditions in a subject, which methods are based on the discovery that abnormal levels of selected analytes in a sample fluid from a subject can be correlated with specific diseases or conditions. Further provided are criteria, and methods for the determine thereof, for selected analytes with respect to selected diseases or conditions. Thus, a variety of diseases or conditions can be screened in a rapid, cost-effective composite assay. The methods are useful for screening of newborn humans for a variety of diseases and conditions, whereby additional diagnostic procedures need only be conducted for those diseases or conditions indicated by the methods of the invention.

Abstract: Provided are methods for the detection and diagnosis of galactosemia. The methods are based on the discovery that abnormal levels of selected analytes in sample fluid, typically blood samples, of patients who are at risk are supportive of a diagnosis of galactosemia. At least two new biomarkers for galactosemia are thus disclosed, Eotaxin and MCP-1. Altogether the concentrations these markers, individually, or in combinations with any of Alpha-2 Macroglobulin, Apolipoprotein H, Cancer Antigen 125, Leptin, TNF RII, Alpha-Fetoprotein, IgM, MIP-1 alpha, Ferritin, and IgE provide a sensitive and selective picture of the patient's condition, namely, whether the patient is suffering from galactosemia. Kits containing reagents to assist in the analysis of fluid samples are also described.

Abstract: Provided are methods for the detection and diagnosis of sickle cell. The methods are based on the discovery that abnormal levels of selected analytes in sample fluid, typically blood samples, of patients who are at risk are supportive of a diagnosis of sickle cell. At least two new biomarkers for sickle cell are thus disclosed, Eotaxin and Monocyte Chemotactic Protein-1. Altogether the concentrations of eleven analytes provide a sensitive and selective picture of the patient's condition, namely, whether the patient is suffering from sickle cell. Other important biomarkers for sickle cell are described, including but not limited to IL-12p40, SHBG, MMP-9, Adiponectin, Haptoglobin, FGF basic, IgM, Growth Hormone, Factor VII. Kits containing reagents to assist in the analysis of fluid samples are also described.

Abstract: Provided are methods for the detection and diagnosis of Hypothyroidism. The methods are based on the discovery that altered levels of selected analytes in sample fluid, typically blood samples, of patients are supportive of a diagnosis of Hypothyroidism. At least twenty-four new biomarkers for hypothyroidism are thus disclosed (singly or in any combination), Thyroid Stimulating Hormone, Interleukin-12p40, Tumor Necrosis Factor Alpha, Tissue Factor, Interleukin-15, Insulin, Immunoglobulin E, Growth Stimulating Hormone, Calcitonin, Prostate-Specific Antigen, Interleukin-4, Granulocyte Macrophage Colony Stimulating Factor, Matrix Metalloproteinase 9, Lymphotactin, Fatty Acid Binding Protein, Alpha Fetoprotein, Alpha-2 Macroglobulin, Serum Glutamic Oxaloacetic Transaminase, Matrix Metalloproteinase 3, Cancer Antigen 125, Mumps Antibody, Double Stranded DNA Antibody, Proliferating Cell Nuclear Antigen Antibody, Smith Antibody, or Herpes Simplex Virus 1 Glycoprotein D Antibody.

Abstract: The invention relates to methods of characterizing autoimmune diseases by detecting and measuring at least one analyte using multiplexed assay systems. According to one embodiment, a target is detected and measured by different bead sets having different reactants. According to another approach the ratio of self-antigen to autoantibody is measured by exposing a sample suspected of containing self-antigen and autoantibody to a bead set associated with monoclonal antibody specific for the self-antigen and a bead set associated with the self-antigen.

Abstract: Provided are methods for the detection and diagnosis of acute coronary syndrome or ACS. The methods are based on the discovery that abnormal levels of selected analytes in sample fluid, typically blood samples, of patients who are at risk are supportive of a diagnosis of ACS. At least two new biomarkers for ACS are thus disclosed, MMP-3 and SGOT. Altogether the concentrations of twelve analytes provide a sensitive and selective picture of the patient's condition, namely, whether the patient is suffering a heart attack.

Abstract: A method for the multiplexed diagnosis of a plurality of different biomolecules in a fluid sample substantially simultaneously is provided. In accordance with a method of the invention, a substantial fraction of biomolecules in a fluid sample are complexed with a universal label and a secondary labeling reagent. Flow cytometric measurements may be used to identify and quantify, in real-time, by detecting the secondary reagent and universal label present in any of said complexes. The inventive technology enables the simultaneous, and automated, detection and interpretation of multiple biomolecules while also reducing the cost of performing diagnostic and genetic assays.

Abstract: A biochemical image is derived from specimens, preferably obtained from a statistically relevant sample of a subject population sharing a common characteristic. The biochemical images for one or more conditions present in the subject population and/or one or more test subjects are determined and made available for computer implemented diagnostic evaluations and medical research. In addition to using the information for general research purposes, information from the images may be used to classify diseases and disease states.

Abstract: Internal standards and controls are provided for detecting and/or compensating for sources of measurement error in multiplexed diagnostic and genetic assays. The internal standards include subsets of particles comprising ligand binding partner specific for analytes of interest, each subset having a different known amount of ligand binding partner. Internal controls include subsets of particles comprising ligand binding partner chosen to provide information relating to high-dose hook effects, dilutional linearity, interfering assay factors, or sample or reagent omission.