Abstract: Provided is a novel kit and assay for free and lipid-bound (exosomal) Hsp70. In particular, an ELISA is described for determining the level of Hsp70 in sample derived from a body fluid of a subject, characterized in that the level of Hsp70 is determined by an anti-Hsp70 antibody.

Abstract: The present invention relates to an in vitro method for diagnosing lupus in a subject, said method comprising the step of detecting in a biological sample obtained from the subject the autoantibody recognizing the protein biomarker THEX1. More, the invention relates to kits and array useful for carrying out diagnosis methods according to the present invention.

Abstract: The present invention relates to method for detecting a free histone protein in a biological sample of a subject, e.g. using an immunoassay or a mass spectrometric assay. It also pertains to a method for the diagnosis, prognosis, risk assessment, risk stratification and/or therapy control of a disease or medical condition, comprising detecting a free histone protein or peptide fragment thereof in a biological sample of a subject, wherein the presence of said free histone protein or fragment thereof is indicative for said disease or medical condition.

Abstract: The present invention is to provide a method of exosome analysis that can analyze exosome in a sample in a simple manner. The method of exosome analysis of the present invention is a method of analyzing exosome in a sample, including: an addition step of adding a first antibody that specifically binds to a first antigen contained in the exosome and a second antibody that specifically binds to a second antigen contained in the exosome to the sample; a reaction step of causing the first antigen to be reacted with the first antibody and the second antigen to be reacted with the second antibody; and a detection step of detecting a reaction between the first antigen and the first antibody and a reaction between the second antigen and the second antibody.

Abstract: Provided is a reagent for assaying a thrombin-antithrombin complex (TAT) in a blood sample from a subject by latex agglutination assay. The reagent includes a polycation. As a result, TAT complexes can be precisely assayed while circumventing the effect of heparin.

Abstract: A primary object of the present invention is to provide a method for conveniently and accurately testing for pulmonary hypertension. To achieve this object, the present invention provides a method for testing for pulmonary hypertension using as an indicator the concentration of selenoprotein P protein in a sample derived from a subject.

Abstract: The present invention concerns a method for the in vitro detection of an increased risk of diabetic nephropathy in a subject suffering from diabetes and being normoalbuminuric. Another aspect of the invention pertains to a method for the in vitro identification of a marker for prediction of diabetic nephropathy. Finally, the invention concerns a kit comprising means for detecting at least two proteins selected from the group consisting of heparan sulfate proteoglycan core protein or fragments thereof, carbonic anhydrase 1, prothrombin or fragments thereof, tetranectin, CD59 glycoprotein, plasma serine protease inhibitor, mannan-binding lectin serine protease 2 or isoforms thereof, antithrombin-III, alpha-1-antitrypsin, collagen alpha-1(I) chain, alpha-enolase, histone H2B type 1-O, glutaminyl-peptide cyclotransferase, protein AMBP and zinc-alpha-2-glycoprotein.

Abstract: A method for measuring TAT complexes in a sample separated from a living body includes measuring TAT by performing latex immunoagglutination reaction under a condition of pH 5.8 to 6.6 using a TAT assay reagent. The TAT assay reagent includes a first antibody bound to a first latex particle, which binds to the antithrombin part of the TAT complex and recognizes the complex, and a second antibody bound to a second latex particle, which binds to the thrombin part of the TAT complex and recognizes the complex.

Abstract: To provide a method for quickly and accurately evaluating a condition of skin dryness and a method for efficiently searching a substance to improve dry skin. A method for evaluating a condition of skin dryness, the method comprising measuring the expression levels of AGR2 and/or AGR3 in skin cells collected from subjects.

Abstract: The present invention relates to a combination product for detecting a target marker simply and with high sensitivity. More specifically, the present invention relates to a combination product for detecting a target marker in a biological sample in combination with a target marker binding molecule which is capable of binding specifically to the target marker in the biological sample, the combination comprising, at least: (a) a first binding agent comprising a first binding molecule which is capable of directly or indirectly binding specifically to the target marker binding molecule, and a labeling substance; (b) a linker molecule which is capable of binding specifically to the first binding agent; and (c) a second binding agent which is capable of binding specifically to the linker molecule, and comprises a second binding molecule and a labeling substance.

Abstract: The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in sepsis patients. In particular, the invention relates to using assays that detect one or more biomarkers selected from the group consisting of Insulin-like growth factor-binding protein 7, Beta-2-glycoprotein 1, Metalloproteinase inhibitor 2, Alpha-1 Antitrypsin, Leukocyte elastase, Serum Amyloid P Component, C-X-C motif chemokine 6, Immunoglobulin A, Immunoglobulin G subclass I, C-C motif chemokine 24, Neutrophil collagenase, Cathepsin D, C-X-C motif chemokine 13, Involucrin, Interleukin-6 receptor subunit beta, Hepatocyte Growth Factor, CXCL-1, -2, -3, Immunoglobulin G subclass II, Metalloproteinase inhibitor 4, C-C motif chemokine 18, Matrilysin, C-X-C motif chemokine 11, and Antileukoproteinase as diagnostic and prognostic biomarker assays of renal injury in the sepsis patient.

Abstract: The invention provides anti-variant Fc-region antibodies which specifically bind to an antibody that has the mutation P329G or the mutations P329G/L234A/L235A or the mutations I253A/H310A/H435A in the Fc-region, and methods of using the same.

Abstract: The present invention relates in essence to an in vitro method for determining the stability, such as the shelf stability; stability over time; shelf life of a composition which comprises or essentially consists of soluble human Fc gamma receptor IIA, MB, IIIA and/or 1 MB, said method comprising the steps of contacting a surface comprising human Fc gamma receptor IIA, MB, IIIA and/or 1 MB with a set amount of aggregated human IgG; contacting said surface comprising human Fc gamma receptor IIA, MB, IIIA and/or 1 MB with a set amount of said composition of soluble human Fc gamma receptor IIA, MB, IIIA and/or 1 MB; determining the amount of aggregated human IgG which is bound to said surface comprising said human Fc gamma receptor IIA, MB, IIIA and/or 1 MB, and comparing the amount of aggregated human IgG which is bound to said surface as determined in step (c) with a reference value and (thereby) determining the stability [shelf stability; stability over time; shelf life] of said composition which comprises or

Abstract: An immunoadsorbent for purifying fumonisin B1, aflatoxin B1, ochratoxin A, zearalenone and sterigmatocystin; a complex affinity column and its preparation method; and a method for detecting the mycotoxins using the same are provided. The immunoadsorbent comprises a solid-phase support, and an anti-fumonisin B1 monoclonal antibody, an anti-aflatoxin B1 monoclonal antibody, an anti-ochratoxin A monoclonal antibody, an anti-zearalenone monoclonal antibody and an anti-sterigmatocystin monoclonal antibody which are coupled to the solid-phase support, wherein the anti-fumonisin B1 monoclonal antibody is secreted by a hybridoma cell strain Fm7A11. The complex affinity column can be used for purification and detection of a fumonisin B1 sample, an aflatoxin B1 sample, an ochratoxin A sample, a zearalenone sample and a sterigmatocystin sample at the same time.

Abstract: Monoclonal and polyclonal antibodies that bind hamster phospholipase B-like 2 are provided. Also provided are methods for detecting and quantifying hamster phospholipase B-like 2, for example, in recombinant polypeptide preparations, as well as kits for carrying out such methods. Methods of screening or selecting host cell lines or recombinant polypeptide-expressing cell lines that express low levels of hamster phospholipase B-like 2 are also provided.

Abstract: The present invention provides an accurate and reliable method to detect acute cardiovascular syndromes or disorders and to detect acute cardiovascular syndromes or disorders at earlier time points such that more aggressive interventions can be used in high risk subjects

Abstract: The present disclosure relates to methods and a kit for diagnosing, prognosing and/or monitoring a gynaecological disease, especially epithelial ovarian cancer, on the basis of altered glycosylation pattern of CA125. More specifically, said altered glycosylation pattern relates to that recognizable by MGL.

Abstract: This disclosure relates to the field of diagnostic methods. A new marker antibody for rheumatoid arthritis, as well as a new method for detecting rheumatoid arthritis, is disclosed herein. Also provided herein are means and methods for predicting whether a subject will develop rheumatoid arthritis. This disclosure is based on the discovery that patients with rheumatoid arthritis have antibodies in their circulation that react specifically with citrullinated antibodies. In one aspect, the disclosure, therefore, relates to an antibody comprising a citrulline residue. In another aspect, the disclosure provides a method for the detection of antibodies specific for rheumatoid arthritis in a sample from a subject, wherein the sample is contacted with a citrullinated antibody and wherein it is determined whether the sample comprises antibodies specifically reactive with the citrullinated antibody.

Abstract: The present invention provides novel compositions and methods for creating quantitative standards to calibrate analytes. These compositions and methods enable the creation of standards and calibrators for analyzing analytes and measuring clinical biomarkers. Also provided are kits comprising the novel compositions for use in assays, for example sandwich immunoassays.

Abstract: The present invention concerns a method for determining the concentration of a protein in a gastrointestinal (GI) tract sample taken from a human or an animal. The present invention is characterized by the feature that a dilution of the sample in the buffered aqueous extraction medium in a range of 1:100 to 1:10,000 is obtained. The present invention leads to a significant improvement of the technical situation, and provides a simple, sensitive and specific determination tool of proteins in GI tract samples. The determination of proteins, e.g. calprotectin, elastases or hemoglobin, in GI tract samples leads to more accurate and reproducible results.