Abstract: Methods, compositions, and kits for labeling tetracysteine-tagged proteins with biarsenical fluorophores with increased specificity, including compositions, methods and kits particularly adapted for labeling of tetracysteine-tagged proteins to be resolved within an electrophoresis gel.

Abstract: Method as well a kit for the performance of the method for the investigation of biological samples from a mammal for at least one component, wherein the method includes the following steps: (a) Administering at least one marker substance to a mammal; (b) Waiting for a length of time which is sufficient for the at least one marker substance to reach the location of sample removal; (c) Removing a biological sample from the mammal; (d) Investigating the biological sample for the presence and/or amount of at least one marker substance or a derivative thereof; and, if the at least one marker substance or the derivative thereof is detectable in the biological sample; (e) Investigating the biological sample for an analyte.

Abstract: A method for identifying a biological analyte that is affected by a stressor is disclosed in which two substantially identical biological samples are provided, with a first sample being a control sample and a second sample being an experimental sample. The control sample is grown with a nutrient having an isotope of a first atom, whereas the experimental sample is grown with a nutrient having a second isotope of the first atom. The experimental sample is grown with a stressing agent and regimen. The samples are admixed, and the formed composite is mass spectroscopically assayed for analyte peaks. The ratio of first isotope to second isotope is determined for the peaks, as is a sample median isotopic ratio. The ratio for assayed analyte peaks is compared with the median ratio. An analyte whose isotopic ratio significantly deviates from the median ratio is an analyte affected by the stressing agent.

Abstract: The invention provides methods, compositions, kits, and systems for the sensitive detection of cardiac troponin, Such methods, compositions, kits, and systems are useful in diagnosis, prognosis, and determination of methods of treatment in conditions that involve release of cardiac troponin.

Abstract: The present teachings provide methods for the development of a mass spectrometric based assay for a protein in a sample using parent-daughter ion transition monitoring (PDITM). In various aspects, the present teachings provide methods for developing a mass spectrometric based assay for a protein in a sample without the use of a standard for the protein. In various embodiments, the sample comprises proteolytic fragments of a protein which is present in low abundance in the physiological fluid from which it is derived.

Abstract: Methods of using halogenated peptides as internal standards for liquid chromatography-mass spectrometry, and novel halogenated peptides useful for the same, are disclosed. In particular, methods of using halogenated peptides as internal standards in proteomic analyses, as well as methods of using halogenated peptides to conduct quality control assessments of and/or to calibrate liquid chromatography-mass spectrometry systems are disclosed.

Abstract: An object of the present invention is to quantitate with good accuracy, furthermore, quantitate absolutely, one or a plurality of biological molecules in a sample such as a tissue, a biological fluid, a cell, a cell organ or protein complex. By adding a metabolically isotope labeled biological molecule as an internal standard substance and measuring with a mass spectrometer, quantitating with good accuracy one or a plurality of target molecules in a sample has become possible. In addition, by performing waveform separation processing during mass analysis, a highly accurate quantitative analysis method of mass analysis is provided.

Abstract: Heart and brain fatty acid binding proteins (H-FABP, B-FABP) are markers for stroke. The invention provides a diagnostic assay for either of these markers, preferably by ELISA using a anti-H-FABP or B-FABP antibody. Since H-FABP is also a marker for acute myocardial infarction (AMI), to distinguish stroke from AMI requires an assay specific to AMI, e.g. using troponin-1 or CK-MB as a marker, also to be carried out.

Abstract: Provided is a method of assaying for an analyte, which method comprises: a) combining a test sample, which may comprise the analyte, with a calibration sample comprising at least two different aliquots of the analyte, each aliquot having a known quantity of the analyte, wherein the sample and each aliquot are differentially labeled with one or more isobaric mass labels each with a mass spectrometrically distinct mass marker group, such that the test sample and each aliquot of the calibration sample can be distinguished by mass spectrometry; b) determining by mass spectrometry the quantity of the analyte in the test sample and the quantity of the analyte in each aliquot in the calibration sample, and calibrating the quantity of the analyte in the test sample against the known and determined quantities of the analytes in the aliquots in the calibration sample.

Abstract: Alkylated interleukin-18 (IL-18), compositions comprising alkylated IL-18, kits comprising such compositions, methods of alkylating IL-18, and methods of using compositions comprising alkylated IL-18.

Abstract: A urine analysis system includes a urinary particle analyzer and a computer. The urinary particle analyzer has a measuring unit that measures a cast concentration from the urine and an electric conductivity sensor that measures the electric conductivity of the urine. The computer has a function of correcting the cast concentration measured by the measuring unit on the basis of the electric conductivity of the urine measured by the electric conductivity sensor and a function of outputting the corrected cast concentration.

Abstract: The present invention provides a method of determining whether an individual is at risk for atherosclerosis, comprising the step of measuring the level of cLDL and/or autoantibody to cLDL in a sample obtained from this individual. The invention further discloses a method of reducing carbamylation in an individual with a monomeric amino acid or other enzymatic or non-enzymatic inhibitors of carbamylation. The instant invention also provides a method to decrease the level of cLDL by direct elimination of cLDL from the blood or plasma of an individual. The invention also provides a method of treating or preventing atherosclerosis in an individual by inhibiting aggregation and/or deposition of cLDL in the individual.

Abstract: The present disclosure relates, according to some embodiments, to a method of stabilizing a molecule (e.g., a biomolecule) in a bodily fluid comprising: (1) providing a stabilizing solution comprising: (a) an amount of a divalent metal chelator selected from the group consisting of ethylenediaminetetraacetic acid (EDTA), (ethylenebis(oxyethylenenitrilo))tetraacetic acid (EGTA), and 1,2-bis(2-aminophenoxy)ethane-N,N,N?,N?-tetraacetic acid (BAPTA) and salts thereof in the range of from about 0.001 M to about 2 M; and (b) an amount of at least one chelator enhancing component selected from the group consisting of lithium chloride, guanidinium chloride, guanidinium thiocyanate, sodium salicylate, sodium perchlorate, and sodium thiocyanate in the range of from about 0.1 M to about 10 M; and (2) adding the stabilizing solution to the bodily fluid, thus stabilizing the molecule.

Abstract: Methods and compositions for delivering pharmaceutical agents into cells, in particular urothelial cells of the bladder, are provided. In the methods and compositions of the invention, a solubilized cholesterol composition is used to facilitate delivery of pharmaceutical agents. Preferably, the cholesterol is solubilized by a cyclodextrin (e.g., methyl-?-cyclodextrin) and the pharmaceutical agent comprises a polynucleotide and either a cationic lipid, a cationic polymer or a dendrimer. Improved methods for transfecting polynucleotides into cells thus are also provided, using cationic lipids, cationic polymers or dendrimers and solubilized cholesterol, wherein the transfection efficiency is enhanced compared to use of cationic lipids, cationic polymers or dendrimers alone.

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: Disclosed are high throughput assay systems and methods for identifying agents that alter the level of expression of proteins in mammalian cells, particularly integral membrane proteins.

Abstract: The present invention relates to methods for making stable test samples that can be used in ligand-binding assays for measuring natriuretic peptides.

Abstract: The invention provides methods for determining the concentration of polypeptides. The methods generally comprise labeling a polypeptide with a metal label such as colloidal gold and quantifiably detecting the polypeptide-metal complex; the methods are improvements over other quantification assays that use colloidal gold. The invention further provides kits for practicing the methods.

Abstract: An assay technique for label-free, highly parallel, qualitative and quantitative detection of specific cell populations in a sample and for assessing cell functional status, cell-cell interactions and cellular responses to drugs, environmental toxins, bacteria, viruses and other factors that may affect cell function.

Abstract: Provided is caspofungin free of caspofungin impurity A, methods for preparation thereof and isolation of caspofungin impurity A.

Abstract: The present invention provides processes for determining the molecular weight of glatiramer acetate and other copolymers. The present invention further provides a plurality of molecular weight markers for determining the molecular weight of glatiramer acetate and other copolymers which display linear relationships between molar ellipticity and molecular weight, and between retention time and the log of the molecular weight. The molecular weight markers also optimally demonstrate biological activity similar to glatiramer acetate or corresponding copolymers and can be used for treating or preventing various immune diseases. In addition, the subject invention provides pharmaceutical compositions for the treatment of immune diseases comprising a polypeptide having an identified molecular weight and an amino acid composition corresponding to glatiramer acetate or a terpolymer.

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: The invention provides a method for creating a standard for multiple analytes comprising treating a portion of a sample to substantially remove analytes of interest to produce a series of specifically deficient samples; and determining and mixing an appropriate amount of the series of specifically deficient samples to create a standard. The analyte may be any substance to be measured.

Abstract: A method having clinically sufficient degree of diagnostic accuracy for detecting the presence of coronary artery disease in a human patient from the general population and for distinguishing between the stages of the disease in that patient is disclosed. The stages are, first, the non-acute stage, which is either asymptomatic coronary artery disease or stable angina, second, the acute stage known as unstable angina, and, third, the acute stage known as acute myocardial infarction. The diseased state (as opposed to the non-diseased state) is indicated by the clinically significant presence of a first marker in a sample from the patient. The presence of one of the two acute stages, unstable angina or acute myocardial infarction, is indicated by the clinically significant presence of a second marker in a sample from the patient. The presence of the more severe acute stage known as acute myocardial infarction is indicated by the clinically significant presence of a third marker in a sample from the patient.

Abstract: The present invention relates to methods of detecting the presence of detergent- or urea-insoluble amyloid-like fibrils or protein aggregates on filters. Preferably, said fibrils or aggregates are indicative of a disease, preferably of a neurodegenerative disease such as Alzheimer's disease or Huntington's disease. In addition, the present invention relates to inhibitors identified by the method of the invention, to pharmaceutical compositions comprising said inhibitors and to diagnostic compositions useful for the investigation of said amyloid-like fibrils or aggregates.

Abstract: The present invention relates to a reference material for assaying D-dimer, comprising a fibrin degradation product, wherein no less than 70% of a total peak area has the molecular weight of no less than 500,000 in a molecular weight distribution of the fibrin degradation product, measured by gel filtration chromatography.

Abstract: Methods of assessing the effect of a drug on long term memory and for screening a pharmaceutical agent for its ability to modulate long term memory are disclosed.

Abstract: The present invention relates to the qualitative and quantitative validation of marker indices, especially for medical diagnosis and particularly for the determination of the growth fraction in a sample with antibodies against the Ki-67 protein. Diagnostic kit for the quantification of a cell fraction labeled by a marker for in vitro diagnosis, characterized in that a pseudo-tissue is used for the intra- and inter-assay standardization of the marker index.

Abstract: The present invention provides a cellular whole-blood D-dimer composition for use with diagnostic test procedures for D-dimer, and a method of its preparation. The composition comprises human erythrocytes and processed plasma to which D-dimer, and stabilizers, and optionally antimicrobial agents, are added and can be used as a standard and control for D-dimer testing.

Abstract: The present invention relates to glycosylated mammalian NGAL, and methods of using said glycosylated mammalian NGAL.

Abstract: The present invention is based, in part, on the discovery that galectin-1 (Gal1) plays a role in immune disorders, including Hodgkin lymphoma, anaplastic large cell lymphoma, or MLL+ pre B-cell ALL. Accordingly, the invention relates to compositions, kits, and methods for diagnosing, prognosing, and monitoring immune disorders, e.g., Hodgkin lymphoma, anaplastic large cell lymphoma, or MLL+ pre B-cell ALL.

Abstract: The present invention provides antibodies against glycosylated proBNP and NT-proBNP. The antibodies are suitable for precise immunodetection of both of the proteins in human blood. The glycosylated forms of proBNP and NT-proBNP may be utilized as an antigen for antibody generation as well as a calibrator or immunological standard in different types of immunoassays. The invention thus also relates to a stable standard or calibrator pro-Brain Natriuretic Peptide (proBNP) preparation for use in a method for detecting BNP immunoreactivity in a sample, the preparation comprising glycosylated proBNP or a fragment thereof. In addition, the present invention is directed to an assay for precisely detecting the NT-proBNP circulating in a patient's blood, wherein the level of glycosylation of the proBNP molecule is exploited. Therapeutic applications are also contemplated.

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 an assay, suitable for neonatal screening of hemoglobinopathies by quantitatively determining the presence of at least one pair of hemoglobin (Hb) variants, determining the ratio between the signals obtained from each variant; and, based on that ratio, determining whether the tested subject is afflicted or not.

Abstract: In the serum, PSP94 occurs as a free form or is associated with a carrier protein. PSP94 in its bound form has been quantified in the blood of prostate cancer patients and these measurements have shown utility as evaluation or prognosis of prostate cancer. Diagnostic assays, methods, and kits for detecting a free form of PSP94, and reagents such as antibodies able to bind to a free form of PSP94 are disclosed herein.

Abstract: A gel filtration standard suitable for use as molecular weight markers for gel filtration chromatography for a mobile phase with denaturant. In one embodiment, the gel filtration standard comprises ovalbumin, myoglobin, and vitamin B12. In another embodiment, the gel filtration standard comprises phosphorylase b, ovalbumin, and myoglobin along with a reducing agent, such as, for example, dithiothreitol to reduce the multiple peaks of phosphorylase b to a single peak. In a third embodiment, the gel filtration standard comprises phosphorylase b, ovalbumin, myoglobin, and vitamin B12. The benefits of the gel filtration standards described herein include acceptable resolution values and usefulness in system suitability testing. The combination of markers can be used in day-to-day testing for system suitability in the denatured condition for GPC-HPLC analysis for many proteins.

Abstract: Standard reference materials and related methods are described for quality testing and calibration of instruments used for the qualitative and quantitative determination of hemoglobin and glycated hemoglobin as well as other analytes of interest in animal tissue samples. The reference solutions of the disclosure utilize a synthetic cruor in combination with an Hb peptide chain.

Abstract: Pre-labeled protein standards useful in electrophoresis that have sharp, consistent separation characteristics that are substantially the same as those of their unlabeled counterparts are provided. The invention provides pre-labeled protein standard sets that include a plurality of labeled proteins that are labeled on a first amino acid, in which side reactions of the label with amino acids not targeted for labeling are reduced.

Abstract: The invention relates to a method for the non-invasive selection of single living cells under gentle conditions from mixtures of cells or cell cultures with respect to a specific production performance. To this end, the concentration of substances produced by the individual cells which become enriched at the cell membrane, such as reporter gene products (GFP) or specifically secreted products, such as antibodies, is determined by fluorescence-microscopic detection methods.

Abstract: The present invention provides a hemoglobin molecule (Hb) having six ± one PEG chains, wherein two of said PEG chains are bound to Cys-93 (?) of Hb, and the remaining PEG chains are bound to thiol groups introduced on ?-NH2 of Hb. The present invention also provides a process for preparing a modified hemoglobin molecule (Hb), comprising the steps of: (a) reacting Hb with 8-15 fold excess of iminothiolane to form thiolated Hb; and (b) reacting the thiolated Hb with 16-30 fold excess of PEG functionalized with a maleimide moiety, to form the modified Hb.

Abstract: The invention relates to the detection and determination of erythrocytopathies and hemoglobinopathies. The invention provides a method for distinguishing between subsets of red blood cells in a sample involving contacting the sample with at least a first marker reagent reactive with a first component of a red blood cell and with at least a second marker reagent reactive with a second component of a red blood cell and determining the reactivity of the marker reagents with the cells.

Abstract: The present invention provides a method of determining whether an individual is at risk for atherosclerosis, comprising the step of: measuring the level of carbamylated LDL in a sample obtained from said individual. Further provided is a method of reducing carbamylation in an individual in need of such reducing, comprising the step of: treating said individual with a monomeric amino acid or another enzymatic or non-enzymatic inhibitor of carbamylation. Also provided is a method of preventing carbamylation in an individual with normal renal function, comprising the step of: treating said individual with a monomeric amino acid. Further provided is a method of treating or preventing atherosclerosis in an individual in need of such reducing, comprising the step of: inhibiting aggregation and/or deposition of carbamylated LDL in said individual.

Abstract: The invention is in the field of coagulation diagnosis and relates to a liquid, buffer-based D-dimer composition, which additionally contains fibrinogen and which is suitable as a standard material for control or calibration purposes for D-dimer test procedures.

Abstract: Methods are provided for diagnosing and/or characterizing chronic immune disease activity in a subject. In the subject methods, a sample is obtained from a subject suspected of having or known to have a chronic immune disease. The sample is then assayed for the presence of low molecular actin fragments. The assay results are used to diagnose the presence of chronic immune disease activity and/or characterize chronic immune disease activity in the subject, e.g. to confirm an initial chronic immune disease diagnosis, to determine the stage of the disease, to monitor disease progression, to predict disease attacks, and the like. Also provided by the subject invention are kits for practicing the methods.

Abstract: The present invention relates to a stable liquid calibrator or control for use in ligand-binding assays wherein the calibrator or control comprises at least one human synthetic natriuretic peptide and has a pH of from about 4.0 to about 6.5 and remains stable when stored at temperatures of from about 2 to about 8°C. for a period of about twelve months.

Abstract: A self-calibrated, magnetic binding assay (e.g., sandwich, competitive, etc.) for detecting the presence or quantity of an analyte residing in a test sample is provided. The magnetic binding assay includes detection probes capable of generating a detection signal (e.g., fluorescent non-magnetic particles) and calibration probes capable of generating calibration signal (e.g., fluorescent magnetic particles). The amount of the analyte within the test sample is proportional to the intensity of the detection signal calibrated by the intensity of the calibration signal.

Abstract: The invention relates generally to standard sets of proteins, polypeptides, or peptides, and methods of using the standard sets to standardize laboratories, laboratory procedures, or laboratory equipment, and to certify laboratories and laboratory technicians. In certain aspects, the invention relates to standard sets of proteins, polypeptides, or peptides, that may be used in mass spectrometry.

Abstract: The invention contemplates a method for recognition of proteins and other biological molecules by imaging morphology, size and distribution of crystalline and amorphous dry residues in droplets (further referred to as “crystallization pattern”) containing predetermined amount of certain crystal-forming organic compounds (reporters) to which protein to be analyzed is added. It has been shown that changes in the crystallization patterns of a number of amino-acids can be used as a “signature” of a protein added. It was also found that both the character of changer in the crystallization patter and the fact of such changes can be used as recognition elements in analysis of protein molecules.

Abstract: Standard reference materials and related methods are described for quality testing and calibration of instruments used for the qualitative and quantitative determination of hemoglobin and glycated hemoglobin as well as other analytes of interest in animal tissue samples. The reference solutions of the disclosure utilize a synthetic cruor in combination with an Hb peptide chain.

Abstract: Disclosed are cellular hemoglobin A1c (Hb A1c) normal and abnormal (high) controls for use in detecting Hb A1c levels. The present invention also relates to methods for generating cellular Hb A1c controls using red blood cells and methods for using the cellular controls. The present invention encompasses several methods for the preparation of Hb A1c cellular controls including: (1) a boronate method where the glycation occurs non-specifically; (2) a stabilized diabetic blood method where the glycation occurs specifically on Hb A1c, and (3) the glycation of normal blood method that is achieved by controlling conditions such that glycation occurs predominantly on Hb A1c. These methods produce cellular Hb A1c controls with desirable stability and that can be detected on a variety of instruments.