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: 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: A method for diagnosing rheumatoid arthritis, based on the detection of citrullinated autoantigens in a test sample is disclosed. The method diagnoses rheumatoid arthritis more accurately and rapidly. Also disclosed is a kit for carrying out the method.

Abstract: An object of the present invention is to provide a hydrophilic cellulose derivative fine particle having a small particle size, a dispersion liquid thereof and a dispersion body thereof; and provide a diagnostic reagent composed of the hydrophilic particle, which is excellent in storage stability and does not require excess components, such as an emulsifier or surfactant. The cellulose derivative fine particle of the present invention is a cellulose derivative fine particle comprising a cellulose derivative with a part of hydroxyl groups of cellulose being substituted with a substituent, wherein the average particle diameter is from 9 to 1,000 nm; and the diagnostic reagent of the present invention is a diagnostic reagent obtained by loading a substance differentially interacting with a test object substance on the above-described cellulose derivative fine particle.

Abstract: Assays for detecting antibodies to pharmaceutical preparations, food allergens and environmental allergens are described.

Abstract: Methods of detecting a first species' Ig-CTF in a biological sample comprising exposing the biological sample to a first antibody of a second species that preferentially binds the first species' Ig-CTF or an antigen binding fragment of the antibody, forming a mixture, exposing the mixture to a second antibody or antigen-binding fragment of a third species that preferentially binds the first species' Ig, and detecting the Ig-CTF in the biological sample.

Abstract: A method for the quantitative determination of an analyte in a sample is provided comprising: (a) providing an analyte-specific substance which is able to undergo a reaction which generates a detectable signal when it is contacted with an analyte; (b) providing at least two calibration graphs which have been generated by reacting in each case the same analyte-specific substance with different amounts of in each case the same test analyte for in each case a predetermined reaction time; (c) contacting the analyte-specific substance with a sample which contains the analyte to be detected; (d) measuring the signal at a first predetermined reaction time for which a first calibration graph according to (b) is provided; (c) checking whether the signal measured according to (d) enables a quantitative determination of the analyte with a desired accuracy; (f) (i) quantitatively determining the analyte on the basis of the signal measured according to (d) if the desired accuracy is reached, or (ii) measuring the signal a

Abstract: Methods, devices, and kits for measuring multiple analytes in a sample having a broad range of concentrations using optical diffraction are disclosed. Devices, methods, and kits useful for monitoring and diagnosing diabetes, cardiovascular disease, thyroid disease, hormone-related conditions, and sepsis are also described.

Abstract: Methods for determining an analyte in a sample by immunoassay in a one-step format without performing washing steps are described. The method includes a first analyte-specific receptor that contains at least two binding sites for the analyte, and a second analyte-specific receptor that selectively binds to an aggregate arrangement of at least two analyte molecules bound to the first receptor.

Abstract: Provided is a method for quantifying soluble LR11 in a biological sample such as serum by an immunological means conveniently and accurately without the need of carrying out any complicated separation manipulation. An immunological quantification method for soluble LR11 in a sample derived from a mammal, including a step of treating the sample with at least one surfactant selected from a group consisting of a polyoxyalkylene alkyl ether, a polyoxyalkylene alkyl phenyl ether, an alkyl glycoside, an alkylthio glycoside, an acyl-N-methylglucamide and a salt of cholic acid.

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 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 immobilization agent. A complex between the analyte, the antibody 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: Methods for detection of any antibody utilizing a standardized approach applicable to any antibody which provides highly specific assays specific for individual or multiple antibodies. The methods enable improved pharmacokinetic analysis during development and clinical use of antibody-based therapies as well as determination of diagnostic and/or prognostic factors.

Abstract: The disclosure describes immunoassay methods for measurements of concentrations of related analytes in samples of body fluids from different mammalian species. More particularly, the disclosure describes reagents and methods that may be used for assays of a mammalian antigen across a range of different mammalian species, using immunological reagents based on non-mammalian antibodies the mammalian antigen. In addition, a calibrator or a set of calibrators are described that are assigned with concentration values for the antigen for each of the different mammalian species.

Abstract: Provided herein are monoclonal antibodies with a high binding affinity to isoforms of alpha 1-antitrypsin (A1AT), hybridoma cells producing the same, and their uses in diagnosing and/or detecting endometriosis from a serum sample of a subject suspicious of having endometriosis or a subject under health examination.

Abstract: The invention provides methods and materials for using apatite chromatography supports to dissociate and remove contaminants that are complexed to biological products. The invention further provides materials and methods for dissociating aggregations of target biological molecules or improperly folded target molecules to improve purification of the target molecule.

Abstract: Testicular germline markers and their use for predicting the presence or not of reproductive cells in testis of an infertile or hypo fertile male subject are provided. More particularly, identification of specific protein biomarkers of post-meiotic germ cells in the human seminal plasma was carried out by an integrative genomics approach. It was demonstrated that the presence of such biomarkers could be monitored in the seminal plasma of azoospermic subjects in order to select for a testis biopsy and testicular sperm extraction (TESE) only subjects for which there are high probabilities to find reproductive cells. The results indicate the analysis of seminal plasma is a non-invasive approach for predicting the presence of reproductive cells.

Abstract: The determination method of the present invention includes steps of measuring equol in a biological sample derived from a subject who has ingested soybean isoflavone by an immunological method using S-equol as at least one antigen selected from the group consisting of the standard antigen and the labeled antigen, and determining an equol-producing ability of the subject based on the measured value of equol obtained in the above step.

Abstract: The present disclosure provides methods involving use of BIN1 expression levels, in heart tissue, in evaluating the risk of a poor outcome in a patient diagnosed with congestive heart failure. The methods finds use in evaluating patients who are heart transplant candidates as well as in assessing therapy options and efficacy of treatment in congestive heart failure patients.

Abstract: The present application relates to a novel method of in vitro assay of the molecules of the extracellular matrix synthesized by cells in culture and uses thereof in the form of a kit for in vitro measurement and/or for a method of screening of cosmetic and/or pharmaceutical ingredients.

Abstract: Objective quantitation of the c-Src protein directly in cancer patient tissue can aid in determining the aggressiveness of an individual patient's tumor as well as help make more informed decisions about choice of therapy. However, the c-Src protein is currently analyzed directly in formalin fixed patient tissue only by immunohistochemistry methodology which is at best subjectively semi-quantitative. This invention describes an objective quantitative assay for the c-Src protein using mass spectrometry as the analytical methodology. Specific peptides, experimentally discovered characteristics about the peptides, and experimentally established assay conditions based on those peptide characteristics are provided for use in a mass spectrometry-based Selected Reaction Monitoring (SRM) assay in order to measure relative or absolute quantitative levels of c-Src directly in a protein preparation obtained from a formalin fixed cancer patient tissue sample.