Abstract: A process for the depletion or removal of endotoxins from preparations containing active ingredients designated for therapeutical use which are obtained from natural sources by genetic engineering and/or biotechnology by treatment with chromatographic material wherein said natural sources are lysed, the fractions obtained are optionally centrifuged, filtrated or treated with affinity chromatographic methods; said fractions are preincubated with an aqueous salt solution and detergents, treated with anion exchange material and then washed with another salt solution, and the active ingredients are eluted from the anion exchanger, followed by further purification in a per se known manner.

Abstract: It is an object of the present invention to provide a method for measuring the interaction between a physiologically active substance immobilized on the surface of a substrate and a test substance, wherein the influence of negative signals intermittently generated due to desorption of the physiologically active substance as a ligand from the surface of the substrate upon the measured value that indicates the binding amount of a test substance as an analyte can be eliminated. The present invention provides a method for measuring the interaction between a physiologically active substance immobilized on the surface of a substrate and a test substance, wherein a calibration curve is produced by using baseline values obtained by repeatedly measuring a single type of solution, and the measurement value of said test substance is calibrated by said calibration curve, so as to obtain the interaction signals of said test substance.

Abstract: The pumps (Pn) are operated to transport individual reagent streams into the chip in a non-pulsatile, laminar flow regime at low flow rates permitting lows grading from 0 to as little as 5 nl/min with a precision of 0.1 nl/min. In the chip (MFC), the reagent streams are merged and the reagents mixed to form a reaction product. The reaction product can be measured at one or more detection points defined in the chip. Concentration gradients are continuously varied by continuously varying the flow rates respectively produced by the pumps according to predetermined flow velocity profiles.

Abstract: Compositions, reagents, kits, systems, system components, and methods for performing assays. More particularly, the invention relates to the use of novel combinations of reagents to provide improved assay performance.

Abstract: Methods of improving microfluidic assays are disclosed. Assays can be improved (better signal to noise ratio) by using sessile drop evaporation as an analyte concentration step (enhanced signal) and repeated passes of wash droplets as a means to reduce non-specific binding (noise reduction). In addition multiple massively parallel analyses improve the statistical precision of the analyses.

Abstract: Methods of prevention and correction of white blood cell interferences to the measurements of mean cell volume (MCV), red blood cell concentration (RBC) and hematocrit (Hct) of a blood sample are disclosed. The interference to MCV can be prevented by identifying a valley between the red blood cell and white blood cell modes on the red blood cell distribution histogram, defining a red blood cell region using the valley and calculating MCV within the defined region. Alternatively, a curve fit of the white blood cell population on the red blood cell distribution histogram can be used to exclude the white blood cells. RBC can be corrected by subtracting the white blood cell concentration obtained from the analysis of a second aliquot sample, when the white blood cell concentration (WBC) exceeds a predetermined criterion. Hct of the blood sample can be calculated using the obtained MCV and RBC.

Abstract: Red blood cells from a vertebrate are treated to make them effective components of a hematology control, allowing the control to be used for detecting all blood cell components, including white blood cells and platelets. The treatment includes the use of a fixative under limited conditions of concentration and exposure time, and the resulting red blood cells are stable but lysable in a hematology instrument and have a reduced tendency to form particulates.

Abstract: Compositions and methods for detecting carbonyl functional groups on polypeptides are disclosed.

Abstract: A method for classifying leukocytes in animal blood is described. In the method, a measurement sample is prepared by mixing a canine or feline blood sample with a lysing reagent. Erythrocytes are lysed and leukocytes are shrunk in the measurement sample. The data correlated with the size of leukocytes in the measurement sample are measured. The leukocytes, on the basis of the measured data, are classified into a first group containing lymphocytes, a second group containing neutrophils and monocytes and a third group containing eosinophils.

Abstract: Tissue mimicking materials for elastography phantoms have elastic, ultrasound, and magnetic resonance characteristics that are characteristic of human soft tissues and well suited for the calibration and performance assessment of elastography imaging systems. In one embodiment, the material is formed from a base material containing an oil dispersed within a gel matrix and at least one inclusion formed from a gel. In another embodiment, the material is formed from a gel-forming material suffused throughout an open-cell reticulated mesh matrix.

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: A polarization validation microplate for validating fluorescence polarization readers includes a microplate housing and one or more sealed fluorescence polarization samples in the housing positioned for reading by a fluorescence polarization reader.

Abstract: A lytic reagent composition and methods for differential analysis of leukocytes are disclosed. In embodiments, the analysis may utilize optical measurements in flow cytometry based hematology analyzers. The reagent system includes an anionic surfactant in a hypotonic solution, an inorganic buffer to maintain the pH in a range from about 6 to about 10, and optionally a leukocyte stabilizer. The reagent system is used to lyse red blood cells and stabilize the leukocytes to enable multi-part differentiation of leukocytes in a near physiologic pH environment on a flow cytometry based hematology analyzer using axial light loss, light scatter intensity, high-numerical aperture side scatter, and time-of-flight measurements.

Abstract: Disclosed are various preferred embodiments for dynamic transfer of information from a test sensor to an analyte medical test device. Exemplary embodiments include various containers, systems and 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: According to the present invention, precipitation of a reactive substance-bound microparticle can be prevented in a dispersion liquid, to make a concentration of the reactive substance-bound microparticle uniform in the dispersion liquid. The present invention provides a method of preventing precipitation of a reactive substance-bound microparticle. The method includes coexisting at least one selected from the group consisting of polyanion or its salt, dextran, cyclodextrin, polyethylene glycol, and glycerol, with the microparticle in a dispersion liquid.

Abstract: The invention includes fusion polypeptides including a first fluorescent protein, e.g., a FRET donor protein, a second fluorescent protein, e.g., a FRET acceptor protein, and, linked to at least one of the fluorescent (e.g., FRET donor or FRET acceptor) proteins, an Fc-region of an immunoglobulin. The polypeptide can be immobilized with respect to a surface via the Fc-region even in the absence of antibodies to either the FRET donor protein or FRET acceptor protein, and can be used as a calibration standard for fluorescence resonance energy transfer includes a polypeptide.

Abstract: A reference solution is provided, which comprises, in a liquid phase, at least one of a first compound and a second compound which are mutually convertible into each other, and at least one catalyst, which catalyzes the conversion between the first compound and the second compound.

Abstract: A microchannel chip and a dilution method using the same capable of continuously diluting the diverse concentrations of solution by one time fluid injection using the microfluid technology are provided. The microchannels are formed in a plastic chip using the microfluid technology, and a width, a sectional area, or a length of the microchannel is regulated so that the flow rate of a diluted solution (e.g., buffer solution) and a sample (e.g., chemicals or medicament) is controlled. The diluted solution and the specimen are mixed in the mixing channel according to the flow rate, thereby diluting the sample. Such a diluted solution is mixed again with a diluted solution, carrying out the dilution. With the repeated dilution processes, continuously diluted solution is obtained.

Abstract: Method and system providing calibration of light detected from biological samples with a correction factor including components for each of a plurality of spectrally distinguishable species and/or for each well and/or for each filter.

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 present invention provides a series of systems, devices, and methods relating to the determination of explosives, such as peroxides or peroxide precursors, and other species. Embodiments of the invention may allow a sample suspected of containing an explosive (e.g., a peroxide) or other species to interact with a reactant, wherein the sample may react and cause light emission from the reactant. Advantages of the present invention may include the simplification of devices for determination of peroxide-based explosives, wherein the devices are portable and, in some cases, disposable. Other advantages may include relative ease of fabrication and operation.

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: Analysing fluid samples for target biological or chemical species comprising a detector unit with a body incorporating a SAW sensor (29) for said target species, in a microfluidic channel (27) and a reader unit adapted to receive the detector unit. The reader unit includes electrical contacts with said SAW sensor and a processor to analyse the sensor signals to determine if the target is present. The detector unit includes a storage reservoir (23) for the calibrating and sample solutions arranged so that the fluid flows through the microfluidic channel over the SAW sensor to a storage reservoir. The sensor is calibrated by using a first liquid having a known quantity of a form of the target species to provide a first frequency change and then a sample solution to be measured and measuring a second frequency change and using the first and second measurements to calibrate the sensor and determine the quantity of the target in the sample solution.

Abstract: The present invention relates generally to methods for reducing the complexity of a sample. More specifically, the present invention relates to proteomics, the measurement of the protein levels in biological samples, and analysis of proteins in a sample using antibodies that recognize small epitopes.

Abstract: The present invention relates to a standard calibration set comprising at least three calibration standards that consist of a molded article made of a thermoplastic polymer which contains the elements Cd, Cr, Pb, Hg and Br, with the Cr:Pb:Hg:Br:Cd ratio being different in each of the three calibration standards, and to a method for manufacturing said calibration standards and their use in X-ray fluorescence analysis.

Abstract: The present invention provides a reference solution for use in instruments that determine hematocrit levels in biological samples by measuring the resistance and/or conductivity of the biological samples. A reference solution according to the invention achieves conductivities representative of known hematocrit levels in blood, while maintaining tolerable levels of interference with the measurement of other analytes in the reference solution.

Abstract: Improvements in FISH staining employing a microscope slide holder which allows for batch processing of slides in the hybridization process.

Abstract: A method for calibrating an analysis instrument, e.g., a gas chromatograph, for water analysis that includes four steps. The first step is to continuously remove water from a liquid that contains water to produce a liquid containing a reduced amount of water such as by membrane pervaporation. The second step is to analyze the liquid containing a reduced amount of water for water by a reference water analysis method such as by Karl Fischer titration. The third step is to analyze the stream of liquid containing a reduced amount of water using the instrument to be calibrated, e.g., a gas chromatograph having a helium photoionization pulse discharge detector. The fourth step is to calibrate the instrument using the analysis of the second step. In a related embodiment, a system for normal phase chromatography.

Abstract: Immunoassay reagents, methods and test kits for the specific quantification of vancomycin in a test sample are disclosed. The reagent comprises antibodies prepared with immunogens of FIG. 6 wherein P is an immunogenic carrier material and X is a linking moiety. Also described is the synthesis of labeled reagents of FIG. 8 wherein Q is a detectable moiety, preferably fluorescein or a fluorescein derivative, and X is a linking moiety.

Abstract: A reagent for classifying leucocytes, including: a) at least one of surfactant selected from a cationic surfactant, an amphoteric surfactant, and the combination thereof; b) an organic compound having phenyl or heterocyclic group, wherein when the surfactant is a cationic surfactant, the organic compound is an organic compound having an anionic group; when the surfactant is an amphoteric surfactant or a combination of amphotheric and cationic surfactant, the organic compound is an organic compound having an anionic or cationic group; c) a buffer for adjusting pH.

Abstract: An apparatus for normalizing a PCR instrument, can comprise a microplate comprising at least 6,000 wells and a system of dyes at known concentrations in a plurality of the at least 6,000 wells. A method for normalizing a system can comprise (a) providing a microplate comprising at least 6,000 wells and a system of dyes; (b) exciting at least one dye; (c) detecting an emission output for the at least one dye; (d) determining if the emission output is in an acceptable range; and (e) adjusting the system so that the emission output is in the acceptable range.

Abstract: The present invention relates to a reagent for classifying leukocytes including (a) at least one surfactant capable of lysing erythrocytes and partly damaging the cell membrane of leukocytes, (b) at least one organic compound bearing an anionic group capable of binding to the cationic component present in the leukocytes to provide morphological differences between the leukocytes, and (c) a buffer for adjusting pH to 2˜8. Also disclosed is a method for classifying leukocytes into four groups.

Abstract: A medical test kit includes a glucose testing composition, a protein testing composition, a bilirubin testing composition, a bilinogen testing composition, an amylase testing composition, a blood testing composition, a calcium testing composition, a nitrite testing composition, a ketone testing composition and a pH testing composition. The medical test kit also includes a plurality of corresponding indicative spectra to each of its units such that a health condition of a user can easily be interpreted. Furthermore, an interactive reference chart is provided for guiding a user for the use of the kit. The kit is suitable for use for the public and is capable of encouraging self health care of society.

Abstract: Methods and devices are described for monitoring a therapeutic effect in a red blood cell-related disease by detecting the size of a reticulocyte using a full-automatic blood cell counting device.

Abstract: Substrate comprising a discrete first layer comprising a first surface, an opposing second surface and a polymeric first material, wherein the first layer has a thickness of from about 1 micron to about 1000 microns and a hardness of from about 10 to about 80 on the Shore A scale; a discrete second layer comprising a first surface, an opposing second surface, and a second material, wherein the second layer has a hardness of from about 1 to about 70 on the Shore OOO scale and a thickness of from about 0.001 cm to about 2.

Abstract: A method of using a reference control for measurement of immature granulocytes on a blood analyzer is disclosed. The method includes analyzing a reference control that contains an immature granulocyte component made of processed red blood cells for simulating immature granulocytes and a mature white blood cell component for simulating white blood cells of a blood sample on a blood analyzer adapted for measurement of immature granulocytes, and reporting the immature granulocyte component and the mature white blood cell component of the reference control.

Abstract: Provided is a novel system and apparatus for producing primary standard gas mixtures. The system includes providing a gas permeation device having a constant diffusion rate into a temperature controlled enclosure; connecting a supply source of a component to the permeation device; routing the component from the gas permeation device to a product container until a desired amount of said component in the product container is reached; and supplying a balance of purified gas to the product container to obtain a known concentration of component in the primary standard gas mixture.

Abstract: The present invention relates to a hematology instrument system that discriminates platelets from red blood cells, debris and other particles within a blood sample. The instrument system uses an optical trigger and collects data at optical sensor locations relative to a flow cell-illuminating laser beam's optical axis. An axial sensor measures axial light loss due to a particle in the flow cell's illumination aperture. In addition, the instrument system can include an RF unit generates electrical parameters, such as DC and RF parameters, within the flow cell. Blood specimens can be prepared with and without a sphering agent.

Abstract: The present invention is directed toward a stable calibrator and/or control, kit and process for using in a glucose monitoring instrumentation. Principally, the instant invention teaches a glycolyzed red blood cell component which has been treated with a glycolysis stabilizing effective amount of at least one non-crosslinking aldehyde compound which may be added to fresh plasma along with an amount of glucose to form a simulated whole blood glucose control product, effective for maintaining a particular and essentially stable glucose concentration over a period of time sufficient for accurate measurement and calibration of a glucose measuring instrument.

Abstract: The present invention pertains to a method for verifying usability of a test element on the basis of the relation of at least one control parameter measurable from the blank test field of a test element to a standard value for the at least one control parameter. In one embodiment, the method comprises determining the deviation between a first ratio calculated from a blank-field reference value measured for the control parameter and a first standard value, and a second ratio calculated from a blank-field control value and the first standard value, and rejecting a test element if the deviation is not within a predetermined tolerance range for the deviation.

Abstract: A device containing one or more aqueous solutions comprising a fluorochrome in varying concentrations is used to quantitatively measure the fluorescence data collected from one or more tissues. Examples for making and using such a device during angiography to quantitatively measure the fluorescence data collected from a patient's eye is provided.

Abstract: A method of calibrating the zero point of an apparatus which is used to determine the quantity of silica contained in a silica solution sample to be analysed, using a colorometric method. The colorometric method used by the apparatus consists of successively introducing the following components into the sample: a molybdate solution, a developer and a reagent. In order to determine the zero point, the developer is first introduced into the sample of silica solution to be analyzed, a first measurement is taken, followed by addition of the molybdate solution and the reducing agent to the sample, where a second measurement is take and the zero point is calculated.

Abstract: Compositions and methods for reducing the rate of loss of oxygen from a solution and increasing the effective life span of oxygen-containing calibration solutions.

Abstract: A compound represented by the following formula (I) or (II): wherein, in the formula (I), R1, R2, R3, and R4 independently represent methyl group or ethyl group; and in the formula (II), R5, R6, R7, and R8 independently represent methyl group or ethyl group and X— represents an anion, and a reagent for measurement of nitric oxide which comprises said compound.

Abstract: An article and method for high throughput and a high content investigation of compound interactions with live tissue or its substitutes under controlled conditions during compound absorption and related processes. In some variations of the illustrative embodiment, the article is a multi-chamber enclosure having at least two chambers separated by a membrane. Membranes can be prepared from live epithelial tissue or from an artificial material with or without attached cells from cell-line cultures. Each chamber is advantageously connected to a fluidic-control system by tubes that pass through a feed fitting. In addition to coupling the chambers with the fluidic-control system, the feed fitting, which is spring-biased, provides a sealing force to seal the enclosure. In some variations, one or more multi-chamber enclosures are installed in a mother chamber, which provides controlled environmental conditions.

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.

Abstract: A reference control composition containing a nucleated red blood cell component and the method of making are disclosed. The reference control composition includes a nucleated red blood cell component made of fixed non-nucleated blood cells and a suspension medium. The non-nucleated blood cell has a natural cell size substantially similar to a size of nucleus of said nucleated red blood cell of said blood sample. The nucleated red blood cell component can be made of equine, ovine, bovine, feline, canine, or porcine red blood cells; and it is substantially free of nucleic acid. The reference control composition can further include a white blood cell component, a red blood cell component, a platelet component, a reticulocyte component, or combinations thereof. Further disclosed are the methods of using the reference control composition for measurement of nucleated red blood cells on a blood analyzer.

Abstract: A method for discriminating and quantifying platelets within an analyzed blood sample involves initially diluting the blood sample with a ghosting reagent that causes a change in the index of refraction of the red blood cells. Owing to the change in the index of refraction, light scattered from the ghosted red blood cells will be substantially reduced relative to light scattered from platelets. This results in locations of platelets within a scatterplot of the analyzed blood sample to fall within a region distinguishable from those containing normal red blood cells, fragmented red blood cells, and microcytic red blood cells.

Abstract: An optically clear, fluorescent acrylic adapted for use as a calibration material. In particular, the fluorescent acrylic cartridge may used as a calibration tool for a microarray reader, such as, the Nanogen NC400® microarray system.