Abstract: The present invention relates generally to methods for enantiomeric separation of complex chemical mixtures using micelles of surfactant molecules that have a sulfate or sulfonate head group, a chiral selector, a linker, and a hydrophobic tail. Also provided are micelle compositions with sulfate or sulfonated head groups, methods of manufacture, and applications thereof. In particular, the micelles of the present invention provide an efficient enantiomeric separation and detection techniques for use in capillary electrophoresis and capillary electrophoresis with mass spectrometry.

Abstract: A parallel processing system for processing samples is described. In one embodiment, the parallel processing system includes an instrument interface parallel controller to control a tray motor driving system, a close-loop heater control and detection system, a magnetic particle transfer system, a reagent release system, a reagent pre-mix pumping system and a wash buffer pumping system.

Abstract: A reagent for four-part differentiation of white blood cells is provided. In one embodiment the reagent has an osmolality below 50 mOsm/kg H2O. A method for differentiating white blood cells using the reagent is also provided. The disclosure provides for a rapid lysis of red blood cells and four-part differentiation of white blood cells. The reagent may be simple in components and a surfactant is not necessary, but optional. A wide range of pH values may be suitable for the reagent.

Abstract: The present invention provides multicolor reagent formulations containing in a single container both fluorescently labeled detection reagents and single-color compensation control reagents, wherein the compensation control reagents consist of reagent-capture particles bound to a fluorescently labeled detection reagent included in the multicolor reagent formulation. The multicolor reagent formulations of the present invention simplify manufacture and commercial distribution of multicolor reagent kits.

Abstract: Provided are methods for measuring renin activity in a plasma sample using mass spectrometry. The methods generally involve ionizing purified angiotensin 1 from the sample and detecting the amount of angiotensin 1 ions generated. The amount of detected angiotensin 1 ions are then related to the amount of angiotensin 1 generated in the sample, which in turn is related to renin activity in the sample.

Abstract: Methods and reagents are disclosed for conducting assays. Embodiments of the present methods and reagents are concerned with a solid support such as, for example, a particle. The support includes a chemiluminescent composition that includes a metal chelate. The present inventors observed that, when such support such as, e.g., particles, were employed in assays for the determination of an analyte, stability of signal output by the chemiluminescent composition associated with the particle was unacceptably reduced as compared to particles including other chemiluminescent compositions. In accordance with embodiments of the present invention, the stability of signal output from such particles is enhanced by including in a medium that contains the particles a sufficient amount of one or more stabilizing agents, which may be a chelating agent and/or a metal chelate such as, for example, the metal chelate that is associated with the particle.

Abstract: A synthetic urine solution is described. The synthetic urine solution is a shelf stable, food grade composition formed of water having a pH between 3 and 10. A thickening agent is dissolved within the water to form a solution having a specific gravity between 1.025 g/cm3 and 1.225 g/cm3. To provide a realistic appearance and odor, a coloring agent and urea are dissolved within the solution. Finally, to provide a shelf stable product, a preservative is also dissolved within the solution.

Abstract: A biosensor system determines analyte concentration from an output signal generated by an oxidation/reduction reaction of the analyte. The biosensor system adjusts a correlation for determining analyte concentrations from output signals at one temperature to determining analyte concentrations from output signals at other temperatures. The temperature-adjusted correlation between analyte concentrations and output signals at a reference temperature may be used to determine analyte concentrations from output signals at a sample temperature.

Abstract: A reagent for classification of leukocytes includes (a) at least two cationic surfactants; (b) at least one organic compound bearing a hydrophobic group and an anionic group; (c) a buffer for adjusting pH into a range of approximately 2-8. Also disclosed is a method for classifying leukocytes with the reagent. With the reagent and method, erythrocytes are lysed rapidly and classification of leukocytes into five groups is achieved in the same channel. The reaction may be carried out at approximately between 10-40° C. and scattered light signals may be detected at two angles for measuring the classification of leukocytes into five groups.

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 present invention provides for novel analogs of fresh human platelets for use in hematological instrument. Methods for preparing such analogs are also described.

Abstract: The present invention relates, in general, to methods for detecting and quantitating plasma-derived protein and recombinant protein in a sample based on the difference in protein glycosylation, when the plasma protein and the recombinant protein are essentially the same protein.

Abstract: A chemical sensor that utilizes localized surface Plasmon resonance including a substrate, metal-containing particles and dielectric particles, wherein the metal-containing particles and the dielectric particles are disposed on the substrate, is used as a chemical sensor element. Thereby, a chemical sensor element having a sufficient detecting sensitivity when localized surface Plasmon resonance is utilized, and a method for the fabrication thereof, can be provided.

Abstract: Described are a urine pretreatment agent, a urine pretreatment method, and a urinary protein quantitation method which reduce or cancel the influences of urine pH variations, cancel the influences of precipitates of urinary inorganic salts, and solubilize membrane proteins. The urine pretreatment agent for urinary protein quantitation, includes a buffer, a chelating agent, and a surfactant; the urine pretreatment method includes a step of mixing 10 to 1000 parts by mass of the urine pretreatment agent of the present invention with 100 parts by mass of urine; and the urinary protein quantitation method includes steps of: mixing 10 to 1000 parts by mass of the urine pretreatment agent with 100 parts by mass of urine; and then measuring the protein concentration.

Abstract: Embodiments provide expanded ability to communicate calibration information to diagnostic systems for determining a characteristic of a test sample. An example system for determining a characteristic of a test sample includes: a test sensor for receiving a test sample; a sensor meter responsive to the test sensor, the sensor meter determining a characteristic of the test sample received on the test sensor; and a calibration element including electrical contacts readable by the sensor meter. The electrical contacts are configurable in one of a plurality of patterns that communicates, to the sensor meter, information relating to the determination of the characteristic of the test sample. The plurality of patterns include two or more of the electrical contacts that are electrically isolated from any other electrical contacts. The sensor meter determines at least partially the information from the electrical contacts by determining a combination of values corresponding to the isolated electrical contacts.

Abstract: The invention relates to quality control of analytical assays, particularly NAT assays of blood samples containing nucleic acids. A control panel containing quantified amounts of substances known to interfere with an analytical assay is used and compared with a reference sample in the analytical assay. A comparison of the assay results interference panel validates the assay and can serve as a periodic quality control check for the analytical assay as well as related methods and protocols. The use of the control panel of the invention can also determine whether interfering substances are present and establish under what conditions the analytical assay reliable.

Abstract: A calibration tool for use in combination with a photoluminescent oxygen-sensitive working probe and an analytical instrument capable of reading the working probe. The calibration tool is effective for achieving two-point calibration of the analytical instrument, and includes at least first and second solid state compositions having different sensitivities to oxygen. The first composition is an oxygen-sensitive photoluminescent dye that is the same as that in the working probe, embedded within an oxygen-permeable carrier matrix that is the same as that in the working probe. The second composition is an oxygen-sensitive photoluminescent dye that is the same as that in the first composition, embedded within a carrier matrix that is different from that in the first composition. The oxygen sensitivity of the second composition is less than the oxygen sensitivity of the first composition.

Abstract: Methods for normalizing output from an instrument employing a reference standard or non-fluorescing substance disposed within at least one of a plurality of reaction chambers. The method comprises collecting and analyzing a signal associated with the reference standard or non-fluorescing substance to determine a normalizing bias. The normalizing bias is then applied to the data signal collected from a remainder of the plurality of reaction chambers.

Abstract: A lancet integrated test element tape includes a plurality of lancet integrated test elements. The lancet integrated test elements each include a lancet configured to form an incision in tissue and a test element configured to analyze body fluid from the incision in the tissue. A cartridge includes a supply compartment configured to store an unused section of the tape. The tape is folded within the supply compartment to limit damage to the lancet integrated test elements. The cartridge can further include a waste compartment in which a used section of the tape is stored. An indexing mechanism moves the tape between the supply and waste compartments.

Abstract: Implementations of the present invention describe an apparatus for generating calibration factors for a spectral detector instrument. The calibration factors are derived from a calibration plate containing one or more spectral species in each well of the calibration plate. Each well is then exposed to an excitation source that causes the one or more spectral species in each of the wells to fluoresce. The signal response is measured and associated with each spectral species at each different well position in the calibration plate. Next, the measured signal response from each spectral species at each well position in the calibration plate is compared with a predetermined signal response for each spectral species. The results of this comparison can be used to determine a calibration factor for each well and spectral species to compensate for the difference between the measured signal response and the predetermined signal response.

Abstract: Control and calibration solutions are described that provide control and calibration data that is recognized by a test meter allowing the meter to segregate the control and calibration data from regular test data. Recognition and segregation of the control and calibration data can occur automatically with no additional input from the meter's user. Methods for use of the solutions are also provided.

Abstract: A control solution packet for calibrating a bodily fluid sampling device includes a container, a control solution pressurized within the container, and a membrane for covering and sealing the container. The control solution can be pressurized before or during calibration so as to ensure the appropriate amount of control solution is delivered to the bodily fluid sampling device. The control solution is manufactured to have a viscosity that controls delivery of the control solution to the device. The membrane is permeable by a piercing device of the bodily fluid sampling device and seals around the piercing device during calibration. In another aspect, the container is in the form of a capsule or dosing attachment that contains the control solution along with a sponge-like material.

Abstract: A microfluidic system comprising a 1st reaction zone, a 2nd reaction zone, a reagent delivery channel configured to deliver one or more reagents to the 1st reaction zone, a waste channel to remove waste from the 2nd reaction zone, a 1st sample delivery channel configured to deliver a sample to the 1st reaction zone and a 2nd sample delivery channel configured to deliver a sample to the 2nd reaction zone; wherein the microfluidic system comprises a means for retaining one or more reagents in each reaction zone; and wherein the 1st reaction zone and 2nd reaction zone are connected in series by a reaction zone channel.

Abstract: A system and method to automatically implement quality control of a clinical diagnostic process are disclosed. Upon generation of an internal error flag, a confirmation rule automatically checks a questionable patient statistic alert by testing a quality control specimen, applying event-related quality control rules to the results of that test, and provides an alert to the operator only upon a confirmed patient signal. The automatic quality control process thus eliminates the uncertainty of operator reaction to an alert signal and implements the quality control run automatically, without operator intervention.

Abstract: Methods of defining a standard for a traditional medicine are provided. A method can comprise obtaining at least two samples of the traditional medicine that have been authenticated by qualitative profiling as representing a control positive; quantitatively profiling each of the at least two samples using at least two physicochemical analyses; blending the at least two samples to form the standard; and creating a quantitative profile for the standard using at least two physicochemical analyses, wherein the quantitative profile for the standard defines the standard. Methods of certifying a test sample of a traditional medicine are also provided. A method can comprise creating a quantitative profile for the test sample using at least two physicochemical analyses; providing a standard; and comparing the quantitative profile for the standard to the quantitative profile for the test sample. A certified traditional medicine comprises a traditional medicine certified by these methods.

Abstract: Configurations herein include a novel process and apparatus for generating and maintaining sulfur trioxide gas. The generation system and process operate to provide sulfur trioxide calibration gas for calibrating sulfur trioxide detection devices. The system and process provides a known, concentration of sulfur trioxide gas via a heated catalyst, which enables accurate calibration of measurement equipment. The system functions in part by controlling temperature, amount of moisture, residence time, catalyst selection, diluting generated sulfur trioxide and by locating the sulfur trioxide generator at a point of injection of a sulfur trioxide detection system.

Abstract: A system and method of characterizing an at least partially hydrophobic sample. The method includes providing an ethanolic solution of ethanol and sodium hydrogen cyanamide, adding a first portion of the ethanolic solution to a sample to produce a reagent-sample mixture, performing infrared spectroscopic testing of the reagent-sample mixture to generate mixture absorption data representing at least one absorption characteristic of the reagent-sample mixture, and generating acidity data for the sample based on the mixture data.

Abstract: The present invention is directed to methods and kits for the determining the presence or absence of ergot alkaloids in sample which use chromatographic instrumentation and columns operating at a pressure of 4,000 to 15,000 psi and columns with 1-3 micron particle size to produce results by mass spectroscopy in approximately four minutes.

Abstract: A method is described for preparing a mixture for quality control of 0.1 g glycine tablets for sublingual application. The mixture for quality control includes a 100:0.5 ratio of ethanol to porphyrized tablets, each tablet containing 0.1 g microcapsules of non-agglomerated crystals of amino-acetic acid covered with a polymeric film of water-soluble methylcellulose, each tablet further containing 0.001 g of magnesium stearate. The process for preparing the mixture includes dissolution of the tablet in ethanol for 20 minutes and is carried out at a temperature of 40° C. in an apparatus using a paddle rotation speed of 200 revolutions per minute. After the mixture is dissolved, it is allowed to stand for 10 minutes at room temperature, and then a light transmission coefficient is measured at 700±2 nm for a 10 mm thick layer of the mixture. A transmission value within the limits of 90% to 100% compared with 50% ethanol corresponds to the proper quality.

Abstract: Use of busulfan amide as stabilized standards in immunoassays for quantifying the amount of busulfan in samples of human biological fluids, methods for carrying out said immunoassay and kits for use in said immunoassay.

Abstract: A lab on a valve analytical system includes a rotary sample preparation assembly having a stator and a rotor. The rotor includes a plurality of integral syringe pumps which can be aligned with passages formed within the stator. The stator passages can be connected with fluid inlet connector which connect the sample preparation assembly with fluid sources, and fluid outlet connectors which connect the sample preparation assembly with one or more wet chemical analytical devices. Some embodiments can include a mixer and optical sensor connected with the fluid outlets. One or more drive motors can be used to control simultaneous actuation of one or more of the syringe pumps, thereby providing for simultaneous delivery of metered volumes of fluid.

Abstract: The invention relates to a method for the calibration of a device for measuring the total organic carbon content (TOC) of an aqueous solution by measuring resistivity, comprising the following steps, in the presence of a reference TOO analyzer: (a) Producing a calibration point by a measurement carried out on ultrapure water by said device and said analyzer, (b) Producing a plurality of calibration points, each calibration point corresponding to a measurement of the resistivity of a solution having a given content of photo-oxidizable compound, by said device and said analyzer, in order to establish a correlation between the values measured by said device and said analyzer; and (c) Calibrating said device by at least one algorithm, based on the measurements carried out in the previous step.

Abstract: A test element, for example in the form of an immunological test strip functioning according to the sandwich principle, for the fluorophoric detection of one or more analytes in a sample comprising an analyte detection zone and a combined control and calibration zone. The combined control and calibration zone include a fluorophore and binding partners for the specific binding of reagents labelled with a fluorophore. Furthermore, the invention concerns a method for calibrating an analyte-specific measurement signal, a method for determining the concentration of an analyte in a sample and the use of the test element for calibrating a signal generated in the analyte detection zone of a test element.

Abstract: A test system comprises a sensor container and a testing device. The sensor container has a base and a lid. The container encloses test sensors therein. The container includes a calibration label attached thereto. The label includes electrical contacts located thereon. The electrical contacts encode calibration information onto the calibration label. The testing device has an auto-calibration feature externally located thereon. The testing device is adapted to determine the analyte concentration in a fluid sample. The auto-calibration feature includes calibration elements that communicate with the electrical contacts on the calibration label. The testing device is adapted to determine the calibration information encoded on the calibration label in response to the calibration elements engaging the electrical contacts. The encoded calibration information is determined without inserting the sensor container or the calibration label into the testing device.

Abstract: Congeneric, halogenated, fluorinated aromatic compounds where A and B are each phenyl radicals, L=oxygen atom, sulfur atom or alkylene radical and p=0 or 1; processes for their preparation and their use.

Abstract: A readhead for a photometric diagnostic instrument includes a holder configured for receiving reagent sample media therein. The sample media has a plurality of test areas configured to react with, and change color, according to an amount of an analyte in a sample. The holder is sized and shaped for forming an indexed fit with the sample media. One or more light sources are configured to emit light onto the test areas. First and second polarized light filters are respectively disposed between the light sources and the test areas, and between the test areas and one or more light detectors, so that the light detectors receive diffuse, non-specular reflections of the light from the test areas, while substantially preventing the light detectors from receiving specular reflections of the light.

Abstract: Provided are a method for preparing a standard sample in which a uniform dispersion of a predetermined concentration of red phosphorus is guaranteed even in a very small amount, and an analytical method for quantitatively determining red phosphorus contained in a resin by pyrolysis-GC/MS, in which the standard sample is used. The method for producing a standard sample for quantitatively determining red phosphorus contained in a resin includes the steps of preparing a red-phosphorus-containing compound by weighing a predetermined amount of red phosphorus and uniformly mixing the red phosphorus in a resin; decreasing the number of particles having a maximum diameter of 5 ?m or more to 1/20 or less of the number of particles having a maximum diameter of 1 ?m or more and less than 5 ?m by pulverizing the red-phosphorus-containing compound; and obtaining a standard sample by weighing about 0.05 to 10 mg, preferably about 0.1 to 0.5 mg of the pulverized red-phosphorus-containing compound.

Abstract: A system for checking measurement results is provided with a urine qualitative analyzer for measuring the specific gravity of a urine, urinary particle analyzer for measuring urine conductivity, and a computer. The urine specific gravity measured by the urine qualitative analyzer, and the urine conductivity measured by the urinary particle analyzer are respectively transmitted to the computer. The correlative relationship between urine specific gravity and urine conductivity is stored in the memory of the computer, and the computer determines whether or not the received urine specific gravity and conductivity match the correlative relationship, and this determination result is output.

Abstract: The invention concerns a method for differentiating and counting cellular components present in a biological fluid sample comprising a primary cytological analysis step typically implemented by a flow cytometry equipment (1) to obtain a set of primary results enabling the set of cellular components of the sample to be differentiated and counted in different populations; and a complementary step of cytological analysis of a particular type of cellular components, based on an identified cellular peculiarity, to obtain complementary results enabling at least one cell population or subpopulation of the sample to be differentiated and counted for identification of said cellular peculiarity. The invention is applicable in particular to hematological analyses.

Abstract: The present invention pertains to a mass spectrometry method for analysing the presence or absence of at least one target analyte in a complex sample, comprising at least the following steps: a) Using a sample carrier suitable for mass spectrometry comprising a pre-applied microcrystalline MALDI matrix spot which is at least partially encompassed by a hydrophobic region; b) Applying a complex sample such that it becomes located on said microcrystalline MALDI matrix spot; c) washing said sample on said microcrystalline MALDI matrix spot; d) analysing said sample for the presence or absence of at least one target analyte via mass spectrometry. The method is in particular suitable for quantitatively analysing target analytes such as hepcidin and other peptides, drug compounds and metabolites in body fluids.

Abstract: An automated standards sampling apparatus (50) and method for using such, apparatus are described. The apparatus can be integrated with a liquid analyzer to form a compact, integrated liquid analysis unit. When used in combination with a specially adapted vial se of standard liquids, the apparatus provides a system for automated, substantially error-free periodic calibration and accuracy verification for an online TOC analyzer (52). The automated standards sampling apparatus of this invention facilitates the easy introduction of known concentrations of standard solutions and “grab” samples into online TOC analyzers to satisfy regulatory compliance, calibration, and validation requirements.

Abstract: A molecule identification and quantitation method is provided wherein a mass tag is conjugated to an analyte and the signature ion of the mass tag remains attached to the analyte after tandem mass spectrometry fragmentation (MS-MS or MS2). Rather than losing the signature ion, a mass-balance part of the structure can be lost as a charge neutral group under tandem mass spectrometry fragmentation. The signature ion can be used for quantitation and, upon further fragmentation, can also provide ion-signals characteristic of the analyte and useful in identifying the analyte. In some embodiments, the ion-signals generated from a third mass spectrometry fragmentation (MS3) can be compared with a known mass spectrum, for example, from a look-up table, from a library, or from a database, to provide an unambiguous identification of the analyte.

Abstract: The invention provides a calibrating method for use in a method of determining the quantity of an analyte labeled with an accelerator mass spectrometry (AMS) isotope in a test sample. The samples can include, for example, urine, faeces, plasma or blood. The analyte can be, for example, a drug or metabolite of a drug.

Abstract: Method for the automatic analysis of a blood sample in which: an analysis solution containing the blood sample, a diluent, and at least one compound to lyze the erythrocytes; at least one compound to stabilize the haemoglobin in the form of a chromogenic complex, is formed in a single dilution and analysis tank, the haemoglobin level is measured in this analysis solution by spectrophotometry in the tank after the lysis of the erythrocytes; and an appropriate quantity of this analysis solution is taken from the tank on which a leucocytic differentiation is carried out by an optical elements characterized in that the analysis solution also contains at least one compound to protect the leucocytes, allowing the distinguishing of at least four main leucocyte sub-populations. A haematological analysis apparatus for the implementation of such a method is disclosed.

Abstract: A device includes a sensor array and a processor is automatically calibrated. The sensor array collects data from a pattern using at least one of a capacitive measurement and a radio frequency measurement. The pattern is included on a calibration storage device. The processor receives the data from the sensor array and calibrates the device in accordance with the data.

Abstract: Provided are a method for preparing a standard sample in which a uniform dispersion of a predetermined concentration of red phosphorus is guaranteed even in a very small amount, and an analytical method for quantitatively determining red phosphorus contained in a resin by pyrolysis-GC/MS, in which the standard sample is used. The method for producing a standard sample for quantitatively determining red phosphorus contained in a resin includes the steps of preparing a red-phosphorus-containing compound by weighing a predetermined amount of red phosphorus and uniformly mixing the red phosphorus in a resin; decreasing the number of particles having a maximum diameter of 5 ?M or more to 1/20 or less of the number of particles having a maximum diameter of 1 ?m or more and less than 5 ?m by pulverizing the red-phosphorus-containing compound; and obtaining a standard sample by weighing about 0.05 to 10 mg, preferably about 0.1 to 0.5 mg of the pulverized red-phosphorus-containing compound.

Abstract: A biosensor has an underfill detection system that determines whether a sample of a biological fluid is large enough for an analysis of one or more analytes. The underfill detection system applies an excitation signal to the sample, which generates an output signal in response to the excitation signal. The underfill detection system switches the amplitude of the excitation signal. The transition of the excitation signal to a different amplitude changes the output signal when the sample is not large enough for an accurate and/or precise analysis. The underfill detection system measures and compares the output signal with one or more underfill thresholds to determine whether an underfill condition exists.

Abstract: The invention involves obtaining signatures of species (including chemical, biological, or biochemical molecules) and/or signatures of interactions between species and using them to characterize species, characterize interactions, and/or identify species that could be useful in a variety of settings. Signatures can be obtained using aqueous multi-phase partitioning and can be used to predict molecular interactions for applications such as drug discovery. A plurality of aqueous multi-phase partitioning arrangements can define an overall system providing an information-intensive signature, maximizing precision and sensitivity.

Abstract: The present invention relates to the field of dissolution measurement and, more particularly to methods for reproducible dissolution testing of pharmaceutical products such as allergen vaccines.

Abstract: A standard calibration set having at least three calibration standards. Each standard is 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. Further disclosed is a method for manufacturing the calibration standards and their use in X-ray fluorescence analysis.