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: A method is disclosed for obtaining an antibody or antibody fragment to a conformational epitope specific for misfolded inactive human parathyroid hormone and fragments thereof. The method includes the steps of a) immunizing an animal with an immunogen which comprises oxidized parathyroid hormone or an oxidized fragment of parathyroid hormone, or both; and b) recovering an antibody, antibody fragments, or single chain antibody. The complementary determining region of the recovered antibody, antibody fragment or single chain antibody is capable of specifically recognizing a conformational epitope (antigenic determinant) which is present on oxidized parathyroid hormone and fragments thereof only but not regular bioactive human parathyroid hormone.

Abstract: A method of characterizing the protein O-GlcNAcylation site-specificity of an antibody. A method of detecting or quantitating the expression of site-specific O-GlcNAcylated proteins expressed in cells and biological samples. A method of diagnosing cancer in a host based on the cellular expression of site-specific O-GlcNAcylated proteins. A method of screening anti-cancer compounds according to their ability to increase a level O-GlcNAcylation of oncogene or tumor suppressor proteins. Methods of treating cancer in an animal host by administering compounds that increase a level of O-GlcNAcylated c-myc or p53 in cancer cells. A method of distinguishing subclasses of pancreatic cancer according to the sensitivity of pancreatic cancer cells to an imidazole derivative, and a method of personalized pancreatic cancer treatment delivered according to the sensitivity subclasses.

Abstract: The present invention is in the field of coagulation diagnostics and relates to methods for detecting modulators of GPIb-thrombin interaction in a sample. To this end, the sample is contacted with isolated mutated GPIb? protein and thrombin, and the formation of a complex between mutated GPIb? protein and thrombin is determined.

Abstract: Methods for the quantification of influenza HA proteins and anti-influenza antibodies for the fields of vaccine-related protein quantification, potency determination, and efficacy evaluation are provided. According to the technology, quantification is achieved by providing capture agents attached to an array in a series of decreasing concentrations. Serial dilutions of a reference material also may be introduced. The reference material within each solution binds to the capture agents on the array and is labeled with a label agent capable of producing a detectable signal used to construct a calibration curve. A target material of unknown concentration is introduced to a separate identical array, and the target material binds to the capture agents and also is labeled by a label agent to produce a detectable signal. The calibration curve based on the reference material is then utilized to determine the concentration of the target material without the need to perform replicate experiments.

Abstract: Methods for reduction of aggregate levels in antibody and other protein preparations through treatment with low concentrations of electropositive organic additives (e.g., ethacridine, chlorhexidine, or polyethylenimine) in combination with ureides (e.g., urea, uric acid, or allantoin) or organic modulators (e.g., nonionic organic polymers, surfactants, organic solvent or ureides). Some aspects of the invention relate to methods for reducing the level of aggregates in conjunction with clarification of cell culture harvest. It further relates to the integration of these capabilities with other purification methods to achieve the desired level of final purification.

Abstract: Provided is a method for increasing the specificity of an antibody-based test to help in the diagnosis of autoimmune diseases by contacting a subject's sample with a blocking antigen prior to testing that is capable of binding to any interfering antibody present in the sample. More specifically, a method for increasing specificity of an antibody-based autoimmune disease assay comprising the steps of providing a sample from a subject, contacting the sample with a DFS70 derived antigen, reacting the sample with an autoimmune disease target and detecting antibodies to the autoimmune disease target is disclosed.

Abstract: A method of determining the stage (gestation) of a pregnancy—comprising the steps of quantifying the amount of the hormone hPL or a fragment thereof in a body fluid sample derived from a human female selected from a blood, plasma, serum and/or urine sample, and establishing the stage of pregnancy corresponding thereto. The disclosure also extends to a device adapted to detect the levels/amount of hPL or a fragment thereof in a body fluid sample, derived from a human female, selected from a blood, plasma, serum and/or urine sample, for establishing the stage of pregnancy.

Abstract: The present invention provides a method and a solid state device for identifying the presence of urothelial cancer in a patient comprising assigning the subject to a sub-population according to smoking habits, measuring the level of each biomarker of a panel of biomarkers in one or more samples obtained from the subject; and correlating the measured levels of the panel of biomarkers with the likelihood of the subject having urothelial cancer such that the subject can be classified as having urothelial cancer or as being a control.

Abstract: The purpose of the present invention is to develop: a method for selectively separating a glycoprotein derived from the central nervous system from a body fluid or a central nervous system cell; and a method for searching for an index marker for central nervous system diseases, which utilizes the aforementioned method. A protein derived from the central nervous system, which occurs in a trace amount in a body fluid or a central nervous system cell, can be selectively enriched by a two-stage separation procedure comprising removing a glycoprotein having sialic acid at a non-reducing terminal thereof from the body fluid or the central nervous system cell and then separating a glycoprotein having N-acetylglucosamine at a non-reducing terminal thereof.

Abstract: The present invention provides methods of diagnosing and monitoring systemic lupus erythematosus.

Abstract: It has been demonstrated that the urinary level of HBP increases in individuals that have a urinary tract infection. Accordingly, the urinary level of HBP in an individual can be used to determine whether or not an individual has a urinary tract infection.

Abstract: The present invention provides a method for detection of a basic peptide by mixing a sample suspected to contain the basic peptide and a reagent containing denatured albumin and detecting turbidness due to a complex of the basic peptide and denatured albumin.

Abstract: Certain embodiments of the invention are directed to a photothermal immunoassay employing a thermometer or colorimetric detection method for sensitive quantitative readout based on the photothermal effect provided by a detection reagent.

Abstract: Monoclonal antibodies, which can be produced in vitro, against cardiac epitopes of the human My-C are produced by generating myeloma cell clones that produce such specific antibodies having epitope specificity. These monoclonal antibodies allow, among other things, the creation of an enzyme-linked immunosorbent assay (ELISA) for the specific, cross-reactivity-free quantitative determination of My-C in serum, plasma, whole blood or other body fluid. Specifically, a hybridoma cell clone producing a monoclonal antibody that detects and binds a cardiac epitope in the My-C is provided, which has no cross-reactivity with respect to the myosin-binding proteins of the skeletal muscles. The hybridoma cell line can be obtained by fusing myeloma cells with spleen cells of a test animal, in particular a mouse, immunized against recombinant My-C.

Abstract: The present invention provides antibodies and antigen-binding fragments thereof that bind to the antibody pembrolizumab (pembrolizumab). These antibodies are useful, for example, for use as positive controls in assays for detecting the presence of anti-drug antibodies in a sample, e.g., the blood of a patient who has been administered pembrolizumab.

Abstract: Provided include a human IgE antibody that binds to a sweat allergy antigen protein and a human high-affinity IgE receptor but does not induce degranulation in a reaction with the sweat allergy antigen protein, and a composition for treatment or diagnosis of sweat allergy comprising the same.

Abstract: Monoclonal antibodies, which can be produced in vitro, against cardiac epitopes of the human My-C are produced by generating myeloma cell clones that produce such specific antibodies having epitope specificity. These monoclonal antibodies allow, among other things, the creation of an enzyme-linked immunosorbent assay (ELISA) for the specific, cross-reactivity-free quantitative determination of My-C in serum, plasma, whole blood or other body fluid. Specifically, a hybridoma cell clone producing a monoclonal antibody that detects and binds a cardiac epitope in the My-C is produced, which has no cross-reactivity with respect to the myosin-binding proteins of the skeletal muscles. The hybridoma cell line can be obtained by fusing myeloma cells with spleen cells of a test animal, in particular a mouse, immunized against recombinant My-C.

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: Antibodies, and antigen-binding fragments, which specifically bind to argininosuccinate synthase, and related compositions, kits, and methods of use, which are useful as companion diagnostics to identify suitable subjects for arginine deprivation or depletion therapies such as ADI-PEG 20 and other arginine deiminase (ADI) polypeptide-based therapies.