Abstract: This disclosure provides an antibody array for the analysis of the three-dimensional structure of a protein. It includes the development and production of the antibody array and methods of using the array to analyze the three-dimensional structure of a protein as well as to compare the three-dimensional structure of two proteins, for example, a therapeutic protein and a biosimilar, to determine if the two proteins are similar.

Abstract: Methods for assessing pneumonia in a patient, methods for managing treatment of a patient suspected of having pneumonia, and methods of managing treatment in a patient suffering from pneumonia. The method of assessing pneumonia includes contacting a biological sample with reagents for detection and/or quantification of neutrophil-derived microparticles, determining a level of neutrophil-derived microparticles, and assessing pneumonia if the level is elevated. The method of managing treatment of a patient suspected of having pneumonia includes assessing pneumonia by calculating a concentration of neutrophil-derived microparticles, treating the patient where pneumonia is indicated, and determining treatment response by measuring a post treatment concentration of neutrophil-derived microparticles.

Abstract: This method for detecting a target particle comprises (a) preparing a solution containing a target particle, a luminescent probe that binds to the target particle and a particle for separation and recovery, or containing the target particle bound to the luminescent probe, the luminescent probe and the particle for separation and recovery, and forming a complex composed of the target particle, the luminescent probe and the particle for separation and recovery in the solution, (b) recovering the particle for separation and recovery from the solution by solid-liquid separation treatment after the (a) and preparing a sample solution containing the particle for separation and recovery, and (c) calculating the number of the complex present in the sample solution according to a scanning molecule counting method, wherein the particles for separation and recovery bind to a complex composed of the target particles and the luminescent probe.

Abstract: Test kits and methods for diagnosing and monitoring relative risk of joint injury are provided. The apparatus and methods beneficially permit intervention to reduce the risk of joint injury and/or reduce the damage resulting from joint injury. Methods for monitoring recovery from a joint injury are also provided.

Abstract: Methods and kits for the diagnosis of primary hyperaldosteronism (PHA). In particular, the use of a new diagnostic parameter that is composed of the ratio between the Ang II level, in particular the steady state equilibrium Ang II level, and the aldosterone level in a biological sample, such as e.g. plasma. The ratio of the two measured parameters is used to diagnose PHA in patients and has clear advantages over currently used diagnostic methods.

Abstract: A diagnostic method for the identification of a subject suffering from a primary non-infectious disease having an increased risk of an adverse outcome potentially being induced by the administration of an antibiotic to said subject comprising the determination of the level of Procalcitonin (PCT) or a fragment thereof or a precursor or fragment thereof having a length of at least 12 amino acid residues in a sample of a bodily fluid from said subject and the correlation of the determined level to a potential risk induced by the administration of an antibiotic, as well as a kit for performing the method and methods of treatment based thereon.

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 immobilisation agent and an antibody capture agent and a detectable agent, which can bind to the analyte. The antibody capture agent comprises, at a plurality of sites, a ligand for the immobilisation agent. A complex between the analyte, the antibody capture agent and a detectable agent is formed and immobilised on the solid substrate by binding between the immobilisation agent and the ligand. In some embodiments, the ligand and the immobilisation agent are a binding pair comprising a peptide tag and an anti-peptide tag antibody.

Abstract: Methods, devices, kits and systems for diagnosing inclusion body myositis (IBM) are provided. Methods, devices, kits and systems involves detecting the presence and/or level of autoantibodies that are reactive against at least a ˜43 kilodalton (kDa) protein or ˜43 kDa protein band from a muscle lysate or a mammalian cell lysate, or autoantibodies that are reactive against a cytosolic 5?-nucleotidase 1A protein (NT5C1A), or a cytosolic 5?-nucleotidase 1B protein (NT5C1B), or a NT5C1B isoform thereof, or a peptide fragment thereof, an isolated peptide thereof or a fusion protein comprising an isolated peptide of NT5C1A or NT5C1B. Such autoantibodies are only found in IBM patients and not in patients with other myopathies.

Abstract: The invention provides a multiparametric method of assessing the reaction of a patient's immune system to a test subject. The invention compares a patient sample reacted with a test sample and a third party sample and combines the assessments of the multiple parameters to correlate the test reaction with a clinical event.

Abstract: The present invention provides a kit for determining male fertility including a container system containing a plurality of enzyme-linked antibodies one of each capable of binding to analytes Atp6v0a2, G-CSF, MIP 1?, and MCP-1. The kit further includes suitable packaging and a set of instructions for using the enzyme-linked antibodies with a seminal sample to determine the fertility of the sample.

Abstract: Provided are: a novel test method for rheumatoid arthritis; and a kit for rheumatoid arthritis test, which is used in the novel test method for rheumatoid arthritis. A test method for rheumatoid arthritis according to the present invention is characterized by comprising a step for measuring the amount of talin in the plasma or serum of an animal subject. This measurement is carried out, for example, by an immunological method using an antibody which binds to talin. A kit for rheumatoid arthritis test according to the present invention is used for such a test method and contains, for example, a solid-phase carrier to which an antibody that binds to talin is affixed.

Abstract: Methods and reagents are disclosed for conducting assays. Embodiments of the present methods and reagents are concerned with chemiluminescent reagents for determining the presence and/or amount of an analyte in a sample suspected of containing the analyte. The reagent is non-particulate and comprises a binding partner for the analyte and a chemiluminescent composition comprising an olefinic compound and a metal chelate. In embodiments of an assay, a combination is provided that comprises a sample suspected of containing the analyte, a chemiluminescent reagent as described above and a sensitizer reagent capable of generating singlet oxygen. The combination is subjected to conditions for binding of the analyte to the binding partner for the analyte. The sensitizer is activated and the amount of luminescence generated by the chemiluminescent composition is detected wherein the amount of luminescence is related to the amount of the analyte in the sample.

Abstract: Peptides useful in determining the presence of autoantibodies in patients suffering from rheumatoid arthritis are disclosed.

Abstract: The invention provides methods and kits for diagnosing a growth in a subject by providing a sample of a growth taken from a subject, determining the level of midkine or pleiotrophin in the sample by an immunoassay, and comparing the level of midkine or pleiotrophin determined from the sample with a control. An increased level of midkine or pleiotrophin in the sample as compared to the control is diagnostic of a malignant growth, whereas an equivalent or decreased level of midkine or pleiotrophin in the sample as compared to the control is diagnostic of a benign growth. Growth refers to, for example, papillary thyroid cancer (PTC).

Abstract: The invention provides methods and kits for diagnosing a growth in a subject by providing a sample of a growth taken from a subject, determining the level of midkine or pleiotrophin in the sample by an immunoassay, and comparing the level of midkine or pleiotrophin determined from the sample with a control. An increased level of midkine or pleiotrophin in the sample as compared to the control is diagnostic of a malignant growth, whereas an equivalent or decreased level of midkine or pleiotrophin in the sample as compared to the control is diagnostic of a benign growth.

Abstract: The present invention generally relates to phospho-serine 10 topoisomerase I antibodies and other protein binding moieties, and kits and uses thereof.

Abstract: Compositions and methods for determining post-transfusion survival or toxicity of red blood cells and the suitability of red blood cell units for transfusion by measuring the levels of one or more markers in a red blood cell sample are provided.

Abstract: Antibodies against citrullinated protein antigens (ACPA) have shown their relevance for the diagnosis and possibly pathogenesis in arthritis. Described are means and methods for determining antibodies against homocitrulline-containing proteins or carbamylated proteins/peptides (anti-CarP) for the classification of individuals suffering from, or at risk of suffering from, arthritis.

Abstract: The invention is directed to a method for producing a polypeptide composition comprising: combining a polypeptide with a volatile additive to form a liquid mixture and lyophilizing the liquid mixture to obtain a lyophilized polypeptide composition.

Abstract: The invention provides a multiparametric method of assessing the reaction of a patient's immune system to a test subject. The invention compares a patient sample reacted with a test sample and a third party sample and combines the assessments of the multiple parameters to correlate the test reaction with a clinical event.