Abstract: The present invention relates to a selectively soluble polymer capable of binding to one or more constituents in a mixture containing various biological materials and the methods of using such a polymer to purify a biomolecule from such a mixture. The polymer is soluble in the mixture under a certain set of process conditions such as pH or temperature and is rendered insoluble and precipitates out of solution upon a change in the process conditions. While in its solubilized state, the polymer is capable of binding to a selected entity within the stream such as impurities (DNA, RNA, host cell protein, endotoxins, etc.) in a cell broth and remains capable of binding to that entity even after the polymer is precipitated out of solution. The precipitate can then be filtered out from the remainder of the stream and the desired biomolecule is recovered and further processed.

Abstract: A method of quantitatively determining the concentration of at least one analyte in a sample. The method may involve adding a portion of the sample to a first analyte assay formulation and to an analyte assay reference formulation to generate a first analyte sample and analyte reference sample, and determining the concentration of the at least one analyte in the sample. The method may additionally or alternatively involve adding a portion of the sample to a second analyte assay formulation, and determining the concentration of the at least one analyte in the sample, or both. The method may be associated with various formulations, kits of parts, systems and computer implemented methods.

Abstract: The present invention relates to reagents for separating proteins from detergent, reagents for detecting proteins in the presence of a detergent, and methods of using the same. The separating reagents contain a cyclic oligomer such as cyclodextrin and a cellulose derivative such as 2-hydroxyethyl cellulose. When used in combination with standard protein-complexing dyes, the reagents allow detection of proteins in electrophoresis gels at nanogram levels.

Abstract: The present invention provides a method for determining the gender of an unborn child by assaying the overall reducing/oxidizing or redox activity 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 earliest being the first day of a missed menstruation. 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 baby gender planning by assaying the overall redox activity of a non-pregnant female's urine or other body fluid. The overall redox activity of a urine sample correlates with the gender specific compatibility of the ovum being released during a particular menstrual cycle. Therefore, assaying the overall redox activity of a non-pregnant female's urine will help a couple conceive a baby having a desired gender.

Abstract: The present invention provides a mouse with liver damage, having a high degree of damage against the mouse's original hepatocytes while having a uPA gene in a heterozygous form, and a method for efficiently preparing the mouse. Specifically, the method for preparing a mouse with liver damage having the uPA gene in a heterozygous form comprises the following steps of: (i) transforming mouse ES cells with a DNA fragment containing a liver-specific promoter/enhancer and cDNA that encodes a urokinase-type plasminogen activator operably linked under the control thereof; (ii) injecting the transformed mouse ES cells obtained in step (i) into a host embryo; (iii) transplanting the host embryo obtained in step (ii) via the injection of the ES cells into the uterus of a surrogate mother mouse, so as to obtain a chimeric mouse; and (iv) crossing the chimeric mice obtained in step (iii), so as to obtain a transgenic mouse in which the DNA fragment is introduced in a heterozygous form.

Abstract: A portable, hand-held glucose testing device includes a housing configured to accommodate a plurality of test sensors in a stacked arrangement and having a wall with an opening defined therein. A plurality of packaged test sensors is stacked in alignment with one another within the housing. Each of the test sensors is packaged within a blister package. The blister package includes a blister package housing and a cover foil overlying a surface of the blister package housing and the test sensor. A drive slide is configured to displace one of the plurality of packaged test sensors out of alignment with other packaged test sensors. A knife mechanism is configured to pierce through the cover foil, and to engage and urge the test sensor to extend through the opening for receiving a sample. A meter contact is configured to engage the test sensor when the test sensor extends through the opening.

Abstract: An analytical device for analysis of chemical or biological samples, a method of using such a device, based on rotation of the device, integrated sample dosing and optical detection, and a system comprising such a device are disclosed. The analytical device comprises a device body having a liquid processing unit. The liquid processing unit comprises a mixing chamber for mixing a sample with a reagent, a sample dosing chamber for delivering a defined volume of the sample to the mixing chamber, and a reagent channel for delivering the reagent to be mixed with the sample, wherein the mixing chamber also serves as a detection chamber.

Abstract: The present invention relates to the optical measurement of blood analytes, such as glycated hemoglobin (HbA1c) and serum albumin as a functional metric of mean blood glucose in the diagnosis of diabetic patients. Non-enhanced Raman spectroscopy is employed as the analytical method for quantitative detection of blood analytes. Using processing techniques, non-enzymatic glycosylation (glycation) of the analytes results in measurable and highly reproducible changes in the acquired spectral data, which enable the accurate measurements and classification of glycated and unglycated analytes.

Abstract: Apparatus and methods are provided for analyzing a medical condition of a user. The apparatus may include a user interface configured to receive user identification information inputted by the user, an analyzer, and a processor all disposed within a common housing. The analyzer is configured to receive a biological specimen from the user and to analyze the biological specimen to generate analysis information. The processor is configured to store and forward the analysis information and to receive prescription information. The apparatus may include a communication unit configured to transmit the user identification information and the analysis information to a doctor at a remote location for review and to receive the prescription information from the doctor. The apparatus then may dispense the prescribed medication or print a medication prescription.

Abstract: The present invention relates to reagents for separating proteins from detergent, reagents for detecting proteins in the presence of a detergent, and methods of using the same. The separating reagents contain a cyclic oligomer such as cyclodextrin and a cellulose derivative such as 2-hydroxyethyl cellulose. When used in combination with standard protein-complexing dyes, the reagents allow detection of proteins in electrophoresis gels at nanogram levels.

Abstract: A urine sample testing apparatus comprises: a urine qualitative measuring section configured to acquire a measurement result for each of a plurality of urine qualitative measurement items; a urine sediment measuring section configured to acquire a measurement result for each of a plurality of urine sediment measurement items; an operation part that is operable by a user to specify a combination of one of the plurality of urine qualitative measurement items and one of the plurality of urine sediment measurement items; an information processing unit configured to determine whether or not a first measurement result of the urine sample obtained by the urine qualitative measuring section and a second measurement result of the urine sample obtained by the urine sediment measuring section have a predetermined relationship with respect to the urine qualitative measurement item and the urine sediment measurement item included in the specified combination.

Abstract: The present invention provides methods for detecting protein in plasma comprising contacting said plasma with a protease capable of digesting said protein into at least one detectable fragment and detecting said at least one detectable fragment using high performance liquid chromatography and mass spectroscopy.

Abstract: Methods and kits for diagnosis and prognosis using biomarkers comprising albumin-bound protein/peptide complex (ABPPC).

Abstract: An object of the present invention is to provide a control material which can be preferably employed in detection of 1,5-anhydro-D-glucitol and glycoalbumin, which are employed as excellent indices for diabetes. The present inventor has found that mannitol which is added to serum or plasma used as control material stabilizes 1,5-anhydro-D-glucitol and glycoalbumin present in the serum or plasma for a long period of time, and that the object can be attained through provision of (1) an agent for stabilizing control material, the agent being composed of mannitol and (2) control material containing mannitol and 1,5-anhydro-D-glucitol.

Abstract: The presently disclosed invention relates to a portable device for detecting one or more urinary proteins based on aggregation-induced emission (AIE) luminogen and quantifying the total urinary proteins in a urine sample in order for monitoring human health, in particular, to a device that utilizes a water-soluble AIE luminogen to detect one or more urinary protein aggregation in order to determine the content of both the target protein and the total urinary proteins in a subject. The device is useful at home or at clinical level for monitoring human health on regular basis.

Abstract: A surface grafted conjugated polyelectrolyte (CPE) is formed by coupling a CPE by a coupling moiety to the surface of a substrate. The substrate can be of any shape and size, and for many uses of the surface grafted CPE, it is advantageous that the substrate is a nanoparticle or microparticle. Surface grafted CPEs are presented that use silica particles as the substrate, where a modified silane coupling agent connects the surface to the CPE by a series of covalent bonds. Two methods of preparing the surface grafted CPEs are presented. One method involves the inclusion of the surface being modified by the coupling agent and condensed with monomers that form the CPE in a grafted state to the substrate. A second method involves the formation of a CPE with terminal groups that are complimentary to functionality that has been placed on the surface of the substrate by reaction with a coupling agent. The surface grafted CPEs are also described for use as biosensors and biocides.

Abstract: The invention provides a method for labeling an analyte comprising a primary amino group, the method comprising: a. a labeling process comprising reacting the analyte with a dialdehyde in the presence of a label, wherein the label bears a charge, and b. an analysis process comprising subjecting the labeled analyte to MS, preferably LC-MS-MS. Herein, preferably, the labeling process comprises reacting an analyte with a dialdehyde, wherein the dialdehyde carries a label bearing a charge, to provide a labeled analyte carrying the charge. The present invention also provides a labeling method to provide a labeled analyte carrying a charge, wherein the labeling method comprises a labeling process comprising reacting an analyte with a dialdehyde, wherein the analyte comprises a primary amino group and wherein the dialdehyde carries a label bearing the charge. The dialdehyde is preferably an aromatic dialdehyde, most preferably an aromatic 1,2- or 1,3-dicarboxaldehyde.

Abstract: The present invention relates to the use of cyclometalated iridium complexes for detecting poly(amino acids) including peptides, polypeptides, and proteins. Poly(amino acids) are detected in solution, in electrophorectic gels, and on solid supports, including blots. The method of the present invention is rapid, highly sensitive, and extremely facile.

Abstract: What is described is a single reference material and method of making useful for calibrating or qualifying instruments that are diagnostic spectroscopically for bilirubin, hemoglobin, and hemoglobin fractions, and, optionally, diagnostic for other blood analytes by sensor means.

Abstract: Provided herein are methods, devices and compositions to conductively or to inductively fix substrates, including tissues, using electromagnetic energy. Also provided is a method of controlling the fixing process via feedback monitoring of a property of the composition and/or of the electromagnetic energy used.

Abstract: Stabilizers for colorants used for detection of enzymatic reactions, having a cyclodextrin and a catalase; reagents including stabilizers; and methods of use of such stabilizers and reagents.

Abstract: Methods and kits for diagnosis and prognosis using biomarkers comprising albumin-bound protein/peptide complex (ABPPC).

Abstract: Methods and devices for diagnosing, monitoring, or determining glomerulonephritis or an associated disorder in a mammal are described. In particular, methods and devices for diagnosing, monitoring, or determining glomerulonephritis or an associated disorder using measured concentrations of a combination of three or more analytes in a test sample taken from the mammal are described.

Abstract: Methods and devices for diagnosing, monitoring, or determining obstructive uropathy or an associated disorder in a mammal are described. In particular, methods and devices for diagnosing, monitoring, or determining obstructive uropathy or an associated disorder using measured concentrations of a combination of three or more analytes in a test sample taken from the mammal are described.

Abstract: The present invention relates to the use of at least one partner for binding to an aldehyde derivative resulting from the peroxidation of lipids in protein-bound form, for instance to 4-hydroxy-2-nonenal, to 4-hydroxy-2-hexenal or to malondialdehyde, for the detection of ischemia-modified albumin (IMA) in a biological sample.

Abstract: Diagnostic devices and methods involve comparison of relative levels of first and second components and/or characteristics of a fluid sample (e.g., saliva), preferably using antibodies arranged to interact with selected components, and colorimetric indicators that are bound or released in proportion to relative concentration or amount of the components or characteristics, as indicative of a health condition such as dehydration state, shock state, stress state, disease state, drug consumption, and drug metabolization. Amylase and IgA may be selected as specific salivary components of interest.

Abstract: A method of modifying protein samples that comprises combining the sample with a peroxycarbonate solution and inserting the sample into a mass spectrometer. The present invention also includes methods of N-terminus characterization.

Abstract: The present invention provides a method of analyzing albumin in a sample solution, which is characterized by pretreating a sample solution before subjecting the sample solution to mass spectrometry or liquid chromatography. The present invention further provides a method of accurately and stably analyzing the amount and ratio of oxidized and reduced albumin in a sample solution, and an albumin standard accurate and controlled quantitative analysis of albumin.

Abstract: The present invention relates to a method of staining proteins in gels and membranes using stain alta.

Abstract: Presented herein are methods, devices and kits for the mass spectrometric immunoassay (MSIA) of proteins present in complex biological fluids or extracts. Pipettor tips containing porous solid supports that are covalently derivatized with affinity ligand and used to extract specific proteins and their variants from various biological fluids. Nonspecifically bound compounds are rinsed from the extraction devices using a series of buffer and water rinses, after which the wild type protein (and/or its variants) are eluted directly onto a target in preparation for analysis such as matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS). Mass spectrometry of the eluted sample then follows with the retained proteins identified via accurate molecular mass determination.

Abstract: A device for biochemical processing and analysis of a measured sample volume of a sample is described. The device is characterised in that it consists of a sealed vessel (1) and that it comprises at least one thin pierceable membrane (2) through which a capillary tube (3) containing said measured sample volume of a sample can pass into said sealed vessel (1). Said sealed vessel (1) further contains at least one biochemically reactive substance (4) and a liquid (6). A method, wherein the device according to the invention is used for analysis, is also described.

Abstract: The present invention relates to phosphate-binding compounds that find use in binding, detecting and isolating phosphorylated target molecules including the subsequent identification of target molecules that interact with phosphorylated target molecules or molecules capable of being phosphorylated. A binding solution is provide that comprises a phosphate-binding compound, an acid and a metal ion wherein the metal ion simultaneously interacts with an exposed phosphate group on a target molecule and the metal chelating moiety of the phosphate-binding compound forming a bridge between the phosphate-binding compound and a phosphorylated target molecule resulting in a ternary complex. The binding solution of the present invention finds use in binding and detecting immobilized and solubilized phosphorylated target molecules, isolation of phosphorylated target molecules from a complex mixture and aiding in proteomic analysis wherein kinase and phosphatase substrates and enzymes can be identified.

Abstract: The present invention provides methods for quantitation of glycated protein in a biological sample using a solid support matrix by making a first bound protein measurement total bound protein under conditions where both glycated and non-glycated protein bind to the support in making a second bound protein measurement under conditions where glycated protein is bound to the support and non-glycated protein is not substantially bound. Diagnostic devices and kits comprising the methods of the present invention are also provided.

Abstract: The invention relates, in part, to methods of using proteomic biomarkers to diagnose preeclampsia. In some aspects the invention, in part, relates to the detection of serpina-1 polypeptide and/or albumin polypeptide in samples from pregnant subjects. Samples from subjects may be compared to control samples to diagnose preeclampsia and/or to determine the onset, progression, or regression of preeclampsia in a subject. The invention also relates, in part, to screening methods to identify agents that can be used to treat preeclampsia and to determine the efficacy of a preeclampsia treatment. The invention, in part, also includes kits that are useful to diagnose and assess preeclampsia in a subject.

Abstract: A method for assessing liver function in an individual, which method comprises determining the level of methylarginine(s) (such as ADMA and/or SDMA) and the ratio of ischemia modified albumin (IMA):albumin ratio (IMAR) in the individual, thereby to assess liver function in the individual.

Abstract: The invention relates to an analysis method which can conduct analysis on low molecular weight compound in a sample containing water-soluble polymer and low molecular weight compound under isocratic conditions without being affected by proteins or the like and in which water-soluble polymer and low molecular weight compound can be separated efficiently and to a column for such an analysis by high performance liquid chromatography, packed with a packing material comprising a crosslinked organic polymer compound obtained by polymerizing glycerin dimethacrylate at 90 mass % or more as starting material, having the exclusion limit molecular weight measured with pullulan of 30000 or less but 3000 or more and having a mass average particle diameter of 0.1 to 100 ?m.

Abstract: This invention provides protein or polypeptide imprinted polymers with integrated emission sites (PIPIES) for detecting the presence of a protein or polypeptide analyte comprising templated sites which are specific for the analyte. At or near the templated sites are selectively placed reporter molecules. A method is also disclosed for the preparation of the PIPIES and the use of these for the detection of analytes.

Abstract: A preparation for the diagnosis of pancreatic exocrine function by determining the amount in which a substance administered to a subject or a degradation product or metabolite thereof migrates into the blood and/or is excreted out of the body, wherein the substance is carried by a carrier and released from the carrier when exposed to the action of a pancreatic exocrine function-related factor.

Abstract: A preparation for the diagnosis of pancreatic exocrine function by determining the amount in which a substance administered to a subject or a degradation product or metabolite thereof migrates into the blood and/or is excreted out of the body, wherein the substance is carried by a carrier and released from the carrier when exposed to the action of a pancreatic exocrine function-related factor.

Abstract: The present invention provides an indicator composition for evaluating cleaning of a medical instrument that includes an extracellular matrix component and hemoglobin, as a contamination model having cleaning profile resembling an actual contaminant adhered to a medical instrument such as a surgical instrument.

Abstract: The present invention provides a method for the detection of early renal disease in animals. The method includes the steps of (a) obtaining a sample from an animal to be tested and (b) determining the amount of albumin in the sample. An amount of albumin in the range of from 10 ?g/ml to about 300 ?g/ml indicates the presence of early renal disease. The present invention also provides antibodies to canine, feline and equine albumin which can be used to detect the presence of early renal disease.

Abstract: Described are determination procedures for fibrinogen and/or fibrinogen-derivatives by matrix-independent turbidimetry. In the FIFTA called procedure the fibrinogen activity is preferably determined in an undiluted sample by addition of thrombin and/or albumin, as well as polybrene if appropriate, in PBS and determination of the increase in absorbance at 405 nm. In the FIATA called procedure the fibrinogen-concentration and/or the concentration of fibrinogen-derivatives is preferably determined by addition of vancomycin and determination of the increase in turbidity at 405 nm. It is standardized by usage of plasma standards of known fibrinogen-activity and/or fibrinogen-concentration.

Abstract: The present invention generally relates to the determination of an analyte concentration (quantitative determination) or whether an analyte threshold level has been passed (qualitative determination) in a biological sample through employment of a disposable analytical microprocessor device. The device can include a batch-specific, self-executable algorithm for the calculation of the analyte concentration.

Abstract: A method of measuring the concentration of a bioactive agent is disclosed.

Abstract: The present invention relates to a technique of measuring a protein based on a degree of coloring in a liquid sample mixed with a protein measurement indicator. In the present invention, information reflecting creatinine concentration in the liquid sample is obtained, and then an influence quantity caused by creatinine to the protein concentration measurement is eliminated based on the information.

Abstract: A diagnostic test and method is provided comprising mixing blood or another biological fluid sample with a test compound and spotting the blood on filter paper for subsequent analysis of the effect of the test compound on the blood. The biological fluid can be a cerebrospinal fluid, a peritoneal fluid, a cyst fluid, an amniotic fluid, a lavage fluid, a saliva, a cell extract or a tissue extract. The compound is chosen among an amino acid, a peptide, a protein, a carbohydrate, an oligosaccharide, a polysaccharide, a glycoprotein, a lipid, a lipoprotein, a glycosaminoglycan, a hormone, a steroid, a vitamin, a low molecular weight synthetic or natural compound which influences the blood to cause an alteration of its composition, e.g., a toxin, allergen, autoantigen, bacterial protein or polysaccharide, viral protein, fungal protein or polysaccharide, parasitic protein or polysaccharide, bacterial lipopolysaccharide or any other compound relevant to diseases.

Abstract: A post-translational modification of a predetermined protein expressed by a cell is detected by specifically detecting an O-acetylation of a serine, threonine or tyrosine residue of the protein as an indication of the post-translational modification. The detection may employ antibodies that specifically bind an O-acetylated protein expressed by the cell, wherein the specific binding is dependent on the presence of an O-acetylated serine, threonine or tyrosine residue in the protein.

Abstract: A compound linked to a solid support (R) through a divalent linker moiety (X) and which is represented by the following formula: is disclosed. In particular, the 1-hydroxybenzotriazole-6-carboxylic acid is directly linked to the support under mild conditions (i.e., in aqueous or organic solvents at neutral pH and at room temperature). The polymer bound 1-hydroxybenzotriazole-6-carboxylic acid can be used for the derivatization of amines as well as for single step amino group modification of proteins, peptides, and amines via acylation or sulfonylation reactions. A flow through device and method for the single step amino group modifications of proteins, peptides, and amines is disclosed. Also disclosed is a flow through device for the detection of amines in a sample. Additionally, a device and method for the detection of amines in a sample using 1-hydroxybenzotriazole-6-carboxylic acid is disclosed. In a preferred embodiment, the device is used to detect the presence of amines in a spoiled meat product.

Abstract: A method is disclosed whereby the concentration of a blood substitute, such as cross-linked hemoglobin, in a serum or plasma specimen is rapidly and accurately identified and quantified. The method further takes the measured concentration of the blood substitute and uses it to correct for its effect, if any, on a measured analyte concentration, e.g., serum/plasma total protein. Further, the method allows for the determination of the concentration of true hemoglobin in the presence of blood substitutes. The method is carried out in respect of samples contained in a primary or secondary labelled tube, or a pipette tip used to dispense serum or plasma in a blood analyzer.

Abstract: The present invention provides methods for determining a ratio of an amount of a glycated form of a protein to a total amount of the protein in a sample containing the glycated protein, the glycosylated protein, or the glycoprotein. The method incorporates lateral flow test strip or vertical flow test strip devices having negatively charged carboxyl or carboxylate groups and hydroxyboryl groups immobilized and interspersed on a solid support matrix. The solid support matrix may include derivatives of cellulose (e.g., carboxy cellulose) derivatized with carboxylic acid (e.g., carboxylate, carboxyl) groups and hydroxyboryl compounds including phenylboronic acid (e.g., phenylborate), aminophenylboronic acid, boric acid (e.g., borate), or other boronic acid (e.g., boronate) compounds. The present invention is usefi.il for monitoring glycation or glycosylation of hemoglobin or albumin for monitoring glycemic control (e.g., glycemia in diabetes).