Abstract: The present invention relates to methods of diagnosing myasthenia gravis in a subject, by determining an amount of at least one autoantibody that specifically binds one or more autoantigens selected from heat-shock protein 60 (hsp60), heat-shock protein 90, alpha isoform (hsp90?), and heat-shock protein 90, beta isoform (hsp90?). The invention also provides diagnostic kits for identifying a subject having myasthenia gravis.

Abstract: Provided herein are methods and compositions related to diagnosing and treating hormone resistant cancers.

Abstract: Disclosed are compositions and methods related to joint inflammation diseases. Disclosed is the relationship between osteoclasts and inflammatory joint diseases and osteoclast precursor cells.

Abstract: Method for diagnosis of autoimmune diseases of the GSE-type or associated with gluten sensitive enteropathy comprising taking a sample and testing the sample for antibodies against human tissue transglutaminase, tissue-specific transglutaminases, or other transglutaminases.

Abstract: Methods of analyzing the electrophoretic mobility distribution of von Willebrand factor (vWF) multimers include providing a sample medium comprising a plurality vWF multimers. The vWF multimers are electrophoretically separated by electrohoretic mobility in the sample medium by subjecting said sample medium to an electric field to provide separated vWF multimers. The separated vWF multimers in the sample medium are exposed to a light source to produce scattered light. The scattered light is detected, and the electrophoretic mobility distribution of the separated vWF multimers is determined from the detected scattered light.

Abstract: Disclosed is a rapid, non-invasive and highly specific and sensitive diagnostic assay for the identification of individuals with autoimmune chronic urticaria, which makes use of CD203c, and in some embodiments, additional proteins, as a marker for the disease. Test kits for diagnosis of an individual suspected of having autoimmune chronic urticaria are also disclosed. Also disclosed are a method of identifying compounds useful for treating autoimmune chronic urticaria and a method of treating autoimmune chronic urticaria.

Abstract: A diagnostic method of monitoring anti-inflammatory and/or antioxidant actions of therapeutic agents comprises determining the level of at least one systemic marker indicative of inflammation or oxidation in a bodily sample taken from a subject at base line or following administration of the therapeutic agent. The marker includes at least one of MPO activity, MPO mass, select MPO-generated oxidation products, and combinations thereof. The level of the systemic marker is compared with a predetermined value to monitor the anti-inflammatory and/or antioxidant actions of the therapeutic agent.

Abstract: The present invention relates to compositions and methods for cancer diagnostics, including but not limited to, cancer markers. In particular, the present invention provides gene expression profiles associated with prostate cancers. Genes identified as cancer markers using the methods of the present invention find use in the diagnosis and characterization of prostate cancer. In addition, the genes provide targets for cancer drug screens and therapeutic applications.

Abstract: The invention provides a method to efficiently express high levels of a recombinant untagged NT-proBNP for use as a calibrator in NT-proBNP immunoassays.

Abstract: Heart and brain fatty acid binding proteins (H-FABP, B-FABP) are markers for stroke. The invention provides a diagnostic assay for either of these markers, preferably by ELISA using a anti-H-FABP or B-FABP antibody. Since H-FABP is also a marker for acute myocardial infarction (AMI), to distinguish stroke from AMI requires an assay specific to AMI, e.g. using troponin-1 or CK-MB as a marker, also to be carried out.

Abstract: A rapid immunoassay method and apparatus for detecting foot and mouth disease virus are disclosed. The method and test device permit pen-side testing of animals and provide test results within a relatively short time period. In a preferred embodiment, the method and apparatus provide a means for differentiating between FMDV-infected and FMDV-vaccinated animals.

Abstract: More particularly, the present invention relates to a method for the detection of a target, e.g. pathogen in a human body fluid wherein a body fluid sample is collected with a swab member.

Abstract: A method to facilitate recovery troponin I and/or troponin T from a sample comprising addition of troponin C to the sample or to a surface from which the troponin I and/or troponin T are recovered.

Abstract: The present invention provides a method of determining whether an individual is at risk for atherosclerosis, comprising the step of measuring the level of cLDL and/or autoantibody to cLDL in a sample obtained from this individual. The invention further discloses a method of reducing carbamylation in an individual with a monomeric amino acid or other enzymatic or non-enzymatic inhibitors of carbamylation. The instant invention also provides a method to decrease the level of cLDL by direct elimination of cLDL from the blood or plasma of an individual. The invention also provides a method of treating or preventing atherosclerosis in an individual by inhibiting aggregation and/or deposition of cLDL in the individual.

Abstract: Assays for the detection of diabetes and prediabetic status rely on exposing patient serum samples to purified ligand capable of binding autoantibodies specific for a 64kD autoantigen present on pancreatic ?-cells. The purified ligand is usually purified glutamic acid decarboxylase (GAD) or a fragment or analog thereof. Preferably, the assays will detect the presence of antibodies to both lower molecular weight GAD and higher molecular weight GAD since diabetic and prediabetic status may be associated with only one of these two forms. The assays can be performed using conventional protocols, such as radioimmunoassay, enzyme-linked immunosorbent assay, and enzyme assay. Methods for treating diabetes comprise administering pharmaceutical compositions including the purified ligand, particularly when coupled to an immunoglobulin or lymphoid cell to induce tolerance.

Abstract: The present invention relates to a diagnostic method for the detection of small quantities of amniotic fluid in the vagina. More specifically, the invention relates to the detection of PAMG-1 in the vagina using anti-PAMG-1 antibodies.

Abstract: This invention provides methods useful in aiding in the diagnosis of Alzheimer's disease. The methods involve measuring the amount of amyloid-? peptide (x-?41) in the cerebrospinal fluid of a patient. High levels of the peptide generally are inconsistent with a diagnosis of Alzheimer's. Low levels of the peptide are consistent with the disease and, with other tests, can provide a positive diagnosis. Other methods involve measuring the amounts of both A?(x-?41) and tau. Low levels of A?(x-?41) and high levels of tau are a positive indicator of Alzheimer's disease, while high levels of A?(x-?41) and low levels of tau are a negative indication of Alzheimer's disease.

Abstract: Method for the in vitro diagnostic or for the monitoring of a disease involving an inflammatory reaction within a patient, which comprises the steps of: a) providing a biological sample from the patient; b) measuring the amount of selenoprotein P which is contained in the biological sample; c) comparing the amount of selenoprotein P measured at step b) i) with the amount of selenoprotein P which is contained in a biological sample from an individual which is not affected with the disease; or ii) with the amount of selenoprotein P which was contained in a biological sample from the same patient.

Abstract: A biochemical marker for the diagnosis of a central nervous system leukodystrophic genetic disorder, e.g., Childhood Onset Ataxia and Central Nervous System Hypomyelination (CACH)/Vanishing White Matter Disease (VWM) has been discovered herein. Such a marker has been found in the cerebrospinal fluid (CSF) of such patients. A two dimensional gel electrophoresis/mass spectrometry or image analysis of stained transferrin isoforms approach revealed that patients with CACH/VWM have a pronounced deficiency of the basic asialo form of the transferrin compared to the amounts of asialotransferrin normally present in CSF from healthy controls or other CNS disorders. The acidic sialotransferrin isoform is not reduced in these disorders. The transferrin isoform abnormality described in the CSF of patients with CACH/VWM is unique and may be used as a clinical diagnostic biomarker. The rapid (48 hr) and efficient diagnosis of this disorder described herein will have great clinical utility.

Abstract: Method for early differential diagnosis and detection, for prognosis and assessment of the severity and for therapy-accompanying assessment of the course of sepsis and sepsis-like systemic infections, in which, preferably with additional determination of at least one further parameter suitable for sepsis diagnosis, the amount of soluble cytokeratin fragments, in particular of CYFRA 21-1, TPS, TPA and/or sCY1F, in a biological fluid of a patient in whom a sepsis is present or a sepsis is suspected is determined and conclusions with regard to the presence, the expected course, the severity and/or the success of initiated measures for the therapy of the sepsis are drawn from the determined amount of soluble cytokeratin fragments.

Abstract: The present invention in one embodiment is an early detection marker for chronic or acute inflammatory-associated diseases. Chronic diseases may include atherosclerosis, Alzheimer's disease, asthma, rheumatoid arthritis, osteoarthritis, and inflammatory diseases of the bowel such as Crohn's disease, Ulcerative colitis, Irritable bowel syndrome and Inflammatory bowel disease. Acute diseases may include sepsis, acute systemic infections, acute lung injury, and acute respiratory distress syndrome.

Abstract: Biomarkers that are diagnostic of type 1 diabetes, type 2 diabetes and/or diabetic disorder are identified. Detection of different biomarkers of the invention are also diagnostic of the degree of severity of type 1 diabetes, type 2 diabetes and/or diabetic disorder. An analysis includes the parameters of matching for BMI and Tanner stage. Receiver-operator characteristic (ROC) curves were established to assess association of the biomarkers with a disease.

Abstract: Methods and compositions for identifying and treating obesity and obesity-induced metabolic disorders are provided. One aspect provides a method for the evaluation of risk and progression of glucose tolerance, insulin resistance and Type 2 diabetes in mammalian subjects. The method includes measuring the concentration of circulating lipocalin-2 in a subject and comparing the measured level to lipocalin-2 to a reference level. Another aspect provides methods of treating insulin resistance, type 2 diabetes and other related complications by administering to a patient a composition that can reduce the circulating levels of lipocalin-2, for example a lipocalin-2 antagonist.

Abstract: The invention relates to a method of treating Alzheimer's disease in a mammal comprising administering to the mammal an anti-microbial agent having anti-Chlamydia pneumoniae activity. The invention also relates to a method of diagnosing Alzheimer's disease in a mammal comprising measuring the serum anti-Chlamydia pneumoniae antibody titer in a patient suspected of having Alzheimer's disease.

Abstract: Using two types of antibodies, i.e., a first antibody having a higher affinity for a target substance than for a competitive substance and a second antibody having a higher affinity for the competitive substance than for the target substance, a specimen is treated with these two antibodies. Then, the competitive substance in the specimen first binds to the second antibody and thus the ratio of the target substance to the competitive substance in the specimen is enlarged. As a result, the target substance becomes liable to bind to the first antibody and, in its turn, the reactivity of the target substance is elevated compared with the case of using the first antibody alone. Thus, the target substance in the specimen can be accurately assayed while avoiding the effects of the competitive substance contained in the specimen.

Abstract: Disclosed are methods for diagnosing and prognosing Inflammatory Bowel disease or Crohn's disease (CD) by measuring levels of antibodies to glycans in a biological sample.

Abstract: Assay systems and specialized antibodies for the detection and quantitation of troponin I and troponin T in body fluids as an indicator of myocardial infarction. Since troponin I and T exist in various conformations in the blood, the ratios of the monomeric troponin I an T and the binary and ternary complexes, as well as which form of troponin present in the blood, may be related to the metabolic state of the heart. Disclosed is a system to determine the presence of a troponin form or a group of troponin forms in a sample of whole blood, serum or plasma. Disclosed is a stabilized composition of troponin; the stabilized composition can comprise a stabilized composition of troponin I, wherein the troponin I is oxidized, the troponin I can be unbound or the troponin I can be in a complex.

Abstract: The present invention relates to a method of qualifying ovarian cancer status in a subject comprising: (a) measuring at least one biomarker in a sample from the subject and (b) correlating the measurement with ovarian cancer status. The invention further relates to kits for qualifying ovarian cancer status in a subject.

Abstract: A method for food sensitivity panel testing (for sensitivities other than gluten sensitivity) by detecting IgA antibodies in serum is disclosed. A method for testing stool samples for the presence of particular antibodies, which is more sensitive and less invasive than prior art testing methods, is also disclosed for diagnosing immunologic food sensitivities. These methods of diagnosis may be used alone or in combination to further enhance the accuracy of diagnosis.

Abstract: Disclosed are methods for diagnosing Crohn's disease (CD) or anti-phospholipid syndrome by measuring levels of antibodies to glycans in a biological sample.

Abstract: A method for identifying or monitoring SLE in an individual is provided. The method includes quantitating complement component C4d on the surfaces of platelets and comparing the amounts of C4d to reference levels of C4d on platelets of individuals without SLE and/or on platelets of the individual obtained at a different time. Kits for use in the above-described methods are provided along with computer readable media tangibly embodying executable instructions to perform the methods.

Abstract: The invention is related to methods of diagnosing inflammatory diseases or conditions by determining levels of components of the complement pathway on the surface of white blood cells.

Abstract: Methods and compositions are provided for detecting biomolecular interactions. The use of labels is not required and the methods can be performed in a high-throughput manner. The invention also provides optical devices useful as narrow band filters.

Abstract: The present invention is directed to a method identifying a risk for a thrombogenic disorder, to a method for selecting patients with a risk for a thrombogenic disorder, to a method for identifying a pharmaceutical for the therapy or prophylaxis of a thrombogenic disorder as well as to a method for producing a medicament and a diagnostic by employing the TAFI-Ile347 polymorphism.

Abstract: An in vitro method for the detection, determination of severity and monitoring and prognosis of neurodegenerative diseases is disclosed. The presence and/or concentration of the physiologically inactive proadrenomedullin (proADM) partial peptide, in particular, the midregional proADM partial peptide, is determined in a biological fluid of a patient who is suffering from a neurodegenerative disease or is suspected of having such a disease. Conclusions about the presence, course, severity or success of a treatment of the neurodegenerative disease are drawn on the basis of the presence and/or concentration of the specific partial peptide in the biological sample.

Abstract: The present invention provides an assay, suitable for neonatal screening of hemoglobinopathies by quantitatively determining the presence of at least one pair of hemoglobin (Hb) variants, determining the ratio between the signals obtained from each variant; and, based on that ratio, determining whether the tested subject is afflicted or not.

Abstract: Disclosed is a method for diagnosing multiple sclerosis and more particularly to a method for diagnosing multiple sclerosis by measuring levels of antibodies to glycans in a biological sample.

Abstract: Methods are provided for diagnosing and/or characterizing chronic immune disease activity in a subject. In the subject methods, a sample is obtained from a subject suspected of having or known to have a chronic immune disease. The sample is then assayed for the presence of native Stat-1 protein and/or any lower molecular weight fragments of Stat-1 protein present. The assay results are used to diagnose the presence of chronic immune disease activity and/or characterize chronic immune disease activity in the subject, e.g., to confirm an initial chronic immune disease diagnosis, to determine the stage of the disease, to monitor disease progression, to predict disease attacks, and the like. In certain embodiments, the assay results are also used to predict the effectiveness of a particularly treatment protocol, e.g., to determine whether an interferon based treatment protocol will be effective. In addition, methods of Stat-1 based methods of treating chronic immune disease conditions are provided.

Abstract: A specific and sensitive in vitro ELISA assay and diagnostic test kit is disclosed for determining levels of NT-proBNP protein in a variety of bodily fluids, non-limiting examples of which are blood, serum, plasma, urine and the like. The NT-proBNP ELISA assay test employs the sandwich ELISA technique to measure circulating NT-proBNP in human plasma. In order to obtain antibodies with specific binding properties for targeted amino acid sequences within human proBNP, recombinant human proBNP (or rhproBNP) was expressed and purified for use as an immunogen. Polyclonal antibodies (PAb) to specific amino acid sequences were subsequently purified from goat serum by sequential affinity purification. Monoclonal antibodies were raised against specific polypeptides. Recombinant human NT-proBNP (or rhNT-proBNP) was expressed and purified in order to obtain material for use in calibration of a quantitative method for measurement of human NT-proBNP.

Abstract: An individual's risk profile for developing a cardiovascular disorder or for experiencing a cardiovascular event is determined by 1) measuring levels of certain stress-evoked proteins including heat shock proteins (HSPs), cytokines, adhesion molecules, chemokines, and the like, or titers of the antibodies targeted to them, or 2) determining the number of seropositive responses to a group of pathogens that have been associated with the presence of atherosclerosis and/or clinical events related to atherosclerosis. The measured levels are compared with clinically derived standards that define the association of these markers with cardiovascular disease. These markers are independent of traditionally recognized risk factors.

Abstract: The present invention relates to a method for determining the condition of a biological fluid by recording the IR spectrum of a sample of the biological fluid. To this end, the biological fluid can be examined in its native form. The method of the invention is usable, for example, for detecting pathological conditions in organisms.

Abstract: The present invention relates to Nephronophthisis, in particular to the NPHP5 protein (nephrocystin-5) and nucleic acids encoding the NPHP5 protein. The present invention also provides assays for the detection of NPHP5 polymorphisms and mutations associated with disease states.

Abstract: A method for determination of at least one of the lipid species in a biological sample comprising subjecting the sample to lipid extraction to obtain a lipid extract and subjecting the resulting lipid extract to multidimensional electrospray ionization mass spectrometry using either precursor ion or neutral loss scanning (or both) of all naturally occurring aliphatic chains, lipid fragments and precursor ions leading to observed fragments to generate a multidimensional matrix whose contour densities provides structural and quantitative information directly without chromatography. A method for determination of lipid content and/or lipid molecular species composition and quantity directly from lipid extracts of a biological sample comprising subjecting said lipid extract to electrospray ionization multidimensional mass spectrometry by comparisons to standards and algorithms described herein.

Abstract: The present invention concerns an immunological test for determining NT-proBNP comprising at least two antibodies to NT-proBNP, wherein at least one of the antibodies to NT-proBNP is a monoclonal antibody. One of these antibodies is directed at least against parts of the epitope of NT-proBNP comprising the amino acids 38 to 50. In addition, one of these antibodies is directed at least against parts of the epitope of NT-proBNP comprising the amino acids 1 to 37 or 43 to 76. The epitope recognized by the antibodies can slightly overlap.

Abstract: The invention relates to methods of diagnosing early stages of atherosclerosis.

Abstract: A method for determining whether a urine sample has been obtained from a subject suffering from a kidney disorder involving kidney damage. The method is based on determining the level of a proteolytic enzyme in urine from the subject. Sample and optionally comparing this level with a reference value. The proteolytic enzyme preferably is a matrix metalloproteases, in particular MMP-2 or MMP-9. The method is particularly suitable for subjects with a condition or disorder that is associated with an increased risk of kidney disorders, such as diabetes. The method may adavnatageously be applied for early detection of kidney damage, in particular when the subject does not yet show any sign of microalbuminuria. The method may also be applied to a subject undergoing dialysis for determining whether the subject is suffering from remodelling of the peritoneal membrane. Thus, the method is particularly suited for patients undergoing continuous ambulatory peritoneal dialysis.

Abstract: The present invention provides a method of determining whether an individual is at risk for atherosclerosis, comprising the step of: measuring the level of carbamylated LDL in a sample obtained from said individual. Further provided is a method of reducing carbamylation in an individual in need of such reducing, comprising the step of: treating said individual with a monomeric amino acid or another enzymatic or non-enzymatic inhibitor of carbamylation. Also provided is a method of preventing carbamylation in an individual with normal renal function, comprising the step of: treating said individual with a monomeric amino acid. Further provided is a method of treating or preventing atherosclerosis in an individual in need of such reducing, comprising the step of: inhibiting aggregation and/or deposition of carbamylated LDL in said individual.

Abstract: The invention concerns a kit for the detection of protein ESM-1 in a sample, comprising: a) a first antibody specifically binding to the N-terminal region of protein ESM-1 contained between the amino acid in position 20 and the amino acid in position 78 of the amino acid sequence of this protein; and b) a second antibody specifically binding to the C-terminal region contained between the amino acid in position 79 and the amino acid in position 184 of the amino acid sequence of protein ESM-1.

Abstract: A cyclic peptide of the structural formula: or a pharmaceutically acceptable salt thereof, wherein R1, R2, R3, R5, R6, m, n and p are as defined. Further provided are compositions for treatment of sexual dysfunction in mammals, including male sexual dysfunction, such as erectile dysfunction, and female sexual dysfunction, by administration of a cyclic peptide including a C-terminus —OH group. Routes of administration include injection, oral, urethral, vaginal, nasal and mucosal administration.

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.