Abstract: The present invention provides a method for determining the gender of a fetus by assaying the sex hormones, evaluating the overall reducing/oxidizing (redox) activity, and/or evaluating the radical scavenging capacity of the maternal urine or other body fluid. The method can be used to determine fetal gender at any time point during the entire pregnancy. The body fluid may be processed before assaying. Processing may involve aging the body fluid, or purification of various fractions. The methods of the present invention also provide for a means for pre-conception offspring gender planning by assaying the sex hormones, evaluating the overall reducing/oxidizing (redox) activity, and/or evaluating the radical scavenging capacity of the urine or other body fluid from a non-pregnant female. The sex hormone profiles, the overall redox activity, and/or the radical scavenging capacity of a urine sample correlates with the gender specific compatibility of the ovum being released during a particular menstrual cycle.

Abstract: Disclosed are methods of identifying binding moieties that recognize antigens displayed on cells, such as membrane proteins or recombinant proteins that display eptiopes on the surface of cells. Binding moieties capable of binding membrane proteins can be difficult to obtain because these proteins can depend on their native environments for structural integrity. In some methods scFv phage display libraries are panned against whole cells expressing a membrane protein in an emulsion. Certain methods further permit discrimination of binding moieties according to their affinity or avidity for a target. This approach allows rapid identification of cell surface epitope specific antibodies for research, diagnostics, and immunotherapeutics.

Abstract: There is method for detecting the presence or absence of a target analyte in a sample comprising the steps of: allowing an inorganic fluorescent particle to conjugate with a detection biomolecule that is bound to said target analyte, if present in said sample, said target analyte additionally being bound by a capture biomolecule immobilized on or within a nanostructure; and detecting the fluorescence emitted by said inorganic fluorescent particle, said nanostructure being capable of generating a surface plasmon resonance effect when excited by a light source to substantially increase the fluorescence emitted by said inorganic fluorescent particle, wherein the detected fluorescence indicates the presence of said target analyte in said sample.

Abstract: The invention discloses a sample preservation method which comprises the following steps: a) providing a paper substrate comprising ligands, where the ligands comprise charged groups, b) applying a sample comprising at least one analyte and at least one contaminant on the paper substrate, c) drying the sample on the paper substrate and, d) extracting at least part of the paper substrate to provide a solution of the analyte.

Abstract: Embodiments of the methods, compositions, and systems provided herein relate to enzymatic enhancement of immunoassays using photonic sensor arrays.

Abstract: Provided is a method for staining a tissue enabling highly precise staining, by which the expression amount and/or the location of a biological substance in a tissue sample can be detected with a high quantitativity together with detailed information that can be obtained by bright field observation. The tissue staining method of the present invention is a method for staining a tissue, in which both staining that allows bright field observation and fluorescence staining are carried out for the same specific biological substance.

Abstract: The present invention relates in particular to methods of detecting predisposition to or diagnosis and/or prognosis of Charcot-Marie-Tooth disease (CMT) and related disorders. More specifically, the invention relates to development, validation and application of new biomarkers which can be used for detecting the presence or risk of CMT disease and related disorders. In particular, the present invention relates to metabolite, lipid, carbohydrate and proteinaceous biomarkers that can be measured in biological body fluids and easily available extracts of biopsies, which can be used to aid in the detection, prediction of drug treatment and follow-up of this treatment of neurodegenerative disorders, including CMT disease. The present invention also relates to methods for identification of CMT disease subtypes and assessing the responsiveness to treatments and the efficacy of treatments in subjects having CMT or a related disorder.

Abstract: The present invention provides methods for detecting insulin autoantibody. Such methods can be used, for example, to predict susceptibility of and/or diagnose the presence of Type 1 diabetes in a subject. Some aspects of the invention also provide kits adapted for use in such methods. In particular, some aspects of the invention use proinsulin to detect the presence of insulin autoantibody.

Abstract: A substance determining apparatus determines a substance within a fluid where particles, which have attached the substance, are bound to a binding surface. A sensing unit is configured to generate a sensing signal being indicative of at least one of i) a distance between the particles bound on the binding surface and the binding surface, and ii) an in-plane position of the particles bound on the binding surface. A binding discrimination unit is configured to discriminate between different kinds of binding of the particles bound on the binding surface depending on the generated sensing signal. The binding discrimination unit may be a unit for determining the part of the sensing signal being caused by specifically bound particles and for determining the substance based on this determined part of the sensing signal.

Abstract: The invention relates to a screening process for determining a disordered von Willebrand factor (VWF)-GPIb interaction in a patient's sample. This comprises contacting the sample with isolated GPIb.alpha. protein, with VWF protein and with a solid phase associated with an antibody specific for said isolated GPIb.alpha. protein, and determining complex formation.

Abstract: Methods and kits for detecting antibodies (e.g., anti-drug antibodies). Such methods and kits permit the detection of, for example, anti-drug antibodies in human body fluids, such as blood, plasma and serum.

Abstract: Disclosed is an antibody which binds to risperidone, which can be used to detect risperidone in a sample such as in a competitive immunoassay method. The antibody can be used in a lateral flow assay device for point-of-care detection of risperidone, including multiplex detection of aripiprazole, olanzapine, quetiapine, and risperidone in a single lateral flow assay device.

Abstract: Methods, devices, and compositions for assaying therapeutic agents. In one aspect, methods, devices, and compositions for assaying paclitaxel to provide therapeutic drug monitoring guided therapy of paclitaxel.

Abstract: The chromatography method of the present invention includes (a) developing a complex of a test substance and a labeling substance modified with a first binding substance bindable to the test substance, onto an insoluble carrier, (b) causing the complex to be trapped in a reaction site on the insoluble carrier which contains a second binding substance bindable to the test substance or a substance exhibiting binding properties to the first binding substance, (c) washing the insoluble carrier with a washing solution containing at least one of the potassium iodide, urea, and guanidine after the step (b), (d) washing off the washing solution of the step (c) remaining in the insoluble carrier from the insoluble carrier, and (e) amplifying the labeling substance of the complex trapped in the reaction site.

Abstract: Subject matter of the present invention is a method for predicting the risk of getting cancer in a female subject that does not suffer from cancer or alternatively diagnosing cancer in a female subject comprising: determining the level of Pro-Enkephalin or fragments thereof including Leu-Enkephalin and Met-Enkephalin of at least 5 amino acids in a bodily fluid obtained from said female subject; and correlating said level of Pro-Enkephalin or fragments thereof with a risk for getting cancer, wherein a reduced level is predictive for an enhanced risk of getting cancer or alternatively diagnosing cancer wherein an reduced level is correlated with the diagnosis of cancer.

Abstract: Provided are methods and compositions for predicting the development of kidney disease, including acute kidney injury. In certain aspects and embodiments the provided methods and compositions are particularly useful for predicting kidney injury following an event likely to cause kidney injury and/or kidney failure in a patient, such as a cardiac surgery, e.g., a surgery involving a cardiopulmonary bypass (CPB), such as a coronary artery bypass graft surgery. In some embodiments, the higher the urinary hepcidin-to-urinary creatinine ratio (uHep/uCr) at 6-24 hours following initiation of CPB, the lower is the risk for development of AKI determined by RIFLE criteria in the ensuing four to five days. Conversely, the higher the urinary NGAL to urinary creatinine ratio (uNGAL/uCr) at 6-24 hours following initiation of CPB, the higher is the risk of developing CPB-mediated AKI over the same time period.

Abstract: The present invention pertains to the field of cancer prediction. Specifically, it relates to a method for predicting the risk of recurrence of bladder cancer in a subject after treatment of bladder cancer comprising the steps of determining the amount of at least one biomarker selected from the biomarkers shown in Table, and comparing the amount of said at least one biomarker with a reference amount for said at least one biomarker, whereby the risk of recurrence of bladder cancer is to be predicted. The present invention also contemplates a method for identifying a subject being in need of a further bladder cancer therapy. Encompassed are, furthermore, diagnostic devices and kits for carrying out said methods.

Abstract: Methods, devices, reagent, systems and kits for the detection, diagnosis of ovarian cancer as well as for the monitoring of ovarian cancer progression and for monitoring the progress of ovarian cancer treatments using BNP as a biomarker.

Abstract: The present invention, in some embodiments thereof, relates to methods and devices for determining a disease state in a patient. In some embodiments, human serum albumin may be analyzed for associated molecules, wherein the associated molecules are related to a disease such as cancer. Certain aspects of the invention are generally directed to devices and methods for determining a disease state as a function of the three-dimensional structure of a blood protein, human serum albumin (HSA) or its complex with other ligands, e.g., due to binding to disease-specific ligands. HSA interacts with biomolecules associated with a disease presence, and liganded HSA may differentially partition between aqueous phases of a predetermined partitioning system, wherein the partitioning behavior differs between HSA from healthy individuals and HSA from people harboring the predetermined disease, such as breast cancer.

Abstract: Compositions and methods related to diagnosis of ear infections and acute otitis media.