Abstract: An object of the present invention is to provide a method for increasing the sensitivity of an immunoassay system. In order to achieve the object, the present inventors have discovered that the sensitivity of an immunoassay system can be increased by pretreating urine and thus have completed the present invention.

Abstract: The present invention includes a method of detecting ultraviolet radiation (UVR)-induced skin damage in a mammal. The present invention also includes a method of identifying a mammal at risk of developing UVR-induced skin damage, photoaging, or photocarcinogenesis. The present invention further includes a method of inhibiting UVR-induced skin damage in a mammal at risk of developing UVR-induced skin damage. The present invention also includes a method of reducing the level of Syk kinase in the skin of a mammal. The present invention further includes methods of treating or diagnosing a disease associated with a change of Syk kinase expression in the skin in a mammal.

Abstract: A liquid reagent of a stabilized thyroid hormone-immobilized carrier, by which a thyroid hormone can be measured easily in a short time and at low cost, is provided. The liquid reagent of a thyroid hormone-immobilized carrier according to the present invention includes: a thyroid hormone-immobilized carrier; and a solvent, and a pH of the solvent containing the thyroid hormone-immobilized carrier is in a range from 8.7 to 11.5. The detection of a thyroid hormone using the liquid reagent of the present invention can be carried out by competitively binding a thyroid hormone in a sample and the thyroid hormone-immobilized carrier in the liquid reagent with an anti-thyroid hormone antibody and detecting a composite of the thyroid hormone-immobilized carrier and the anti-thyroid hormone antibody.

Abstract: The present invention discloses a novel device and methods thereof with utility application in the high-throughput detection, screening and disease management of cervical disease. The “multiwell” device of the present invention consists of a solid support featuring multiple well-separated areas, each accommodating a patient sample, leading to simultaneous evaluation of patient samples. The methods of the present invention comprise conventional cytological staining, cervical Pap staining, and immunochemical staining using antibodies or combination of antibodies which are capable of binding to biomarkers that are overexpressed in cancer including in cervical carcinoma and dysplasia, as compared to normal controls. The device and methods of the present invention can be practiced in either manual or automated mode, and applied to any biological fluid or cell suspension from any biological specimen in view of a variety of cell biology assays, and in view of detection and screening of cervical and other diseases.

Abstract: The present invention provides a reagent for assaying D-dimer which includes carriers sensitized to first and second monoclonal antibodies which react with D-dimer, but have different reactivity to D-dimer in which the first monoclonal antibody reacts with high- and low-molecular fractions of D-dimer, the second monoclonal antibody reacts with the high-molecular fraction, but reactivity of the second monoclonal antibody with the low-molecular fraction is different from that of the first monoclonal antibody and a kit of reagent for assaying D-dimer.

Abstract: Disclosed are novel biomarkers and methods related to diagnostic tests for the detection and characterization of inflammatory bowel diseases, such as Crohn's disease and ulcerative colitis. In particular, the instant invention relates to novel biomarkers and methods of using such biomarkers to predict disease behavior and severity, to differentiate among disease types, and to optimize selection of treatment options in individuals suspected of having an inflammatory bowel disease.

Abstract: Subject of the present invention is an in vitro method for therapy follow-up in septic patients wherein the concentration of mature ADM 1-52 and/or mature ADM 1-52-Gly in a sample of bodily fluid of said septic patient is determined using an assay comprising two binders that bind to two different regions within the region of mature adrenomedullin and/or adrenomedullin-Gly that is aminoacid 21-52-amid SEQ ID No. 1 or aminoacid 21-52-Gly SEQ ID No. 2 wherein each of said regions comprises at least 4 or 5 amino acids. Subject of the present invention are further assays and calibration methods.

Abstract: A point of care diagnostic test, device and disposables for determining a patient risk for oral cancer in the same visit that a sample is collected.

Abstract: A method identifies atypical antibodies in blood or blood product manufacturing processes that may produce false positives in quality control testing on intermediate or final products.

Abstract: A marker useful in diagnosing surgical site infections is provided. In the method of the present invention for detecting surgical site infections, sCD14-ST in a sample is measured.

Abstract: Some aspects of this disclosure provide methods and reagents for the detection of apolipoproteins in a sample, for example, a sample obtained from a human subject. Some aspects of this disclosure provide protocols and reagents for the quantification of lipoproteins and lipoprotein particle populations comprising specific combinations of non-integral apolipoproteins and integral apolipoproteins, which is useful, inter alia, for the detection of diseases such as cardiovascular disease as well as an assessment of the risk of an individual to develop a disease.

Abstract: The invention provides methods, compositions, kits, and systems for the sensitive detection of cardiac troponin, Such methods, compositions, kits, and systems are useful in diagnosis, prognosis, and determination of methods of treatment in conditions that involve release of cardiac troponin.

Abstract: Methods for detecting acute kidney injury in an individual comprise (a) contacting a body fluid sample from the individual with an assay device including neutrophil gelatinase-associated lipocalin (NGAL) antibody and a detectable label, to allow complexing of NGAL protein in the sample with NGAL antibody, and determining an amount of complex formed between NGAL protein from the sample and NGAL antibody in the assay device using the detectable label, wherein NGAL antibody in the device has binding capacity with more than two NGAL protein epitopes, and wherein the amount of the formed complex represents a level of acute kidney injury. Methods for determining an origin of NGAL protein in a sample from an individual include the step of determining relative amounts of monomeric, dimeric and heterodimeric forms of NGAL protein in the sample and allow improved diagnosis and therefore better targeted treatment.

Abstract: The present disclosure provides methods and/or kits for detecting an analyte in a sample. Some embodiments provide a method for detecting a non-nucleic acid analyte in a sample using a solid substrate comprising a bound immobilization agent and an capture agent and a detectable agent, which can bind to the analyte. The capture agent comprises, at a plurality of sites, a ligand for the immobilization agent. A complex between the analyte, the capture agent and a detectable agent is formed and immobilized on the solid substrate by binding between the immobilization agent and the ligand. In some embodiments, the ligand and the immobilization agent are a binding pair comprising a peptide tag and an anti-peptide tag antibody.

Abstract: A method for diagnosing a risk for preterm delivery or miscarriage in a pregnant woman and preventing preterm delivery or miscarriage in the pregnant woman who has been determined to have the risk is provided. The method includes measuring plasminogen activator inhibitor-1 activity or level in plasma isolated from a pregnant woman. The method also includes determining that the pregnant woman has a risk for preterm delivery or miscarriage when the activity or the level is lower than that in the plasma of a normal pregnant woman. The method also includes administering plasminogen activator inhibitor-1 to the pregnant woman who has been determined to have the risk. A kit for the diagnosis of the degree of risk for preterm delivery or miscarriage also is provided. A pharmaceutical composition for the prevention of preterm delivery or miscarriage, comprising plasminogen activator inhibitor-1, also is provided.

Abstract: This invention relates to methods of analysis, and in particular to methods for the preliminary fractionation of samples in which low abundance molecules of interest, for example proteins, polysaccharides or fatty acids, are present together with more abundant molecules of little or no interest. In particular, the invention relates to methods of depletion of high abundance proteins from biological samples. Products and kits for use in the method are also disclosed, and form part of the invention. In one aspect, the invention provides a method of depleting a high-abundance molecule from a biological sample, comprising the steps of a) subjecting the sample to affinity depletion using an affinity support with high affinity for a high abundance molecule, and/or b) immunodepletion using an affinity support coupled to an antibody directed against whole or previously fractionated plasma or serum.

Abstract: Methods for determining the presence of heparin/platelet factor 4 antibodies in a sample suspected to contain heparin/platelet factor 4 antibodies are provided, along with apparatus suitable for performing the methods. The method depends upon a color visualization indicating the presence or absence of heparin/platelet factor 4 antibodies in the sample. Preferred methods comprise contacting the sample with particles being complexed to platelet factor 4 (PF4) and which particle-complexed PF4 reacts specifically with heparin/platelet factor 4 antibodies, passing the sample/particle mixture through a filter, and then analyzing the color of the filtrate. The presence of heparin/platelet factor 4 antibodies in the sample is established where the color of the filtrate is substantially different from the color of the receptor-bearing particles.

Abstract: Immunoassays and methods for detecting and quantifying biological levels of intact fibroblast growth factor (FGF)-23, as well as the N-terminal and C-terminal fragments thereof in a biological sample. The relative amounts or ratios of FGF-23 relative the N-terminal and C-terminal fragments can also be determined. The systems and methods deploy antibodies that are specific to antigenic regions formed upon either the N-terminal or C-terminal regions of FGF-23 and are systematically applied such that intact FGF-23 and the fragments thereof can be detected and quantified. In certain embodiments, dissimilar labels conjugated to tracer antibodies or labeled antibodies specific to N-terminal and/or C-terminal tracer antibodies are utilized to facilitate detection and quantification of both whole length FGF-23 and any fragments thereof.

Abstract: The purpose of the present invention is to provide: a biomarker specific to lymphocytic infundibuloneurohypophysitis; and use applications of the biomarker. Provided are: a biomarker comprising an anti-rabphilin 3a antibody; and a test method using the biomarker.

Abstract: A method for the diagnosis and/or therapy control of systemic sclerosis is disclosed wherein soluble CD90 is detected in body fluids. By measuring the concentration of soluble CD90 certain forms of diseases can be differentiated by applying the ex vivo method.