Abstract: A cavitational ultrasound (e.g., Histotripsy) gel phantom and cavitational ultrasound testing system are provided that may include any of a number of features. One feature of the phantom and system is that it can allow for instant visual feedback on the efficacy and dosage of a Histotripsy transducer. The changes in the gel phantom can be visualized with the naked eye without having to wait for histology. The changes in the gel phantom can also be visualized with a camera, with ultrasound imaging, or with microscopy. In various embodiments, the phantom includes indicators such as carbon particles, dye-encapsulated beads, and red blood cells. Methods associated with use of the cavitational ultrasound gel phantom and testing system are also covered.

Abstract: The present invention provides methods and kits for assessing the state of oocyte maturation in a female mammal based on the level of PAPP-A found in the female's bodily fluid sample.

Abstract: A system and method for a flow cytometer system including a prepared sample fluid with reference beads; an interrogation zone that analyzes the prepared sample fluid; a peristaltic pump system that draws the sample fluid through the interrogation zone; and a processor that monitors a measured volume of sample fluid sampled by the peristaltic pump system and an expected sample volume based on data generated by the analysis of the sample fluid. A system and method is additionally described using an alternative volume sensing fluidic system.

Abstract: The method of the invention pertains to determining signal transduction activity in a tissue section by immunohistochemistry techniques. The expression level of the receptor of interest is determined as well as the expression levels of one or more effector molecules of the receptor signal transduction pathway. Furthermore a combined ratio of expression levels of effector molecules in subcellular compartments with the receptor expression was found to have prognostic significance.

Abstract: Embodiments of the invention provide to apparatuses and media used in drug elution studies and methods for making and using them. One embodiment of the invention is a drug elution method that can be used for in-vitro studies of a matrix impregnated with a compound such as a drug blended polymer matrix. Such methods and materials can be used for example to assess and control the manufacturing process variability of drug eluting implantable devices such as cardiac leads.

Abstract: Glucose measured in blood samples is distinguished from glucose measured in the control solutions used to test the optical instruments which make such measurements. The control solutions contain a labeling substance recognized by the optical instrument to distinguish glucose measurements made of control solutions from those made of blood samples.

Abstract: A cassette for preparing a sample is disclosed herein. The cassette includes a housing, which encloses the structures and the processes used to prepare the sample.

Abstract: A method for separating and purifying the active hematinic species (AHS) present in iron-saccharidic compositions, including AHS such as sodium ferric gluconate complex, ferric hydroxide-sucrose complex and ferric saccharate complex and others of similar form and function. The method separates the AHS from one or more excipients and, preferably, lyophilizes the separated AHS. Separation of the AHS permits its analytical quantification, further concentration, purification and/or lyophilization as well as preparation of new and useful products and pharmaceutical compositions, including those useful for the treatment of humans and animals.

Abstract: A sample analyzer is provided. The sample analyzer includes a reagent container holder, a measurement unit, and an information processing unit configured to perform operations including controlling the measurement unit to start the successive measurement of the plurality of samples, determining whether to switch from the first reagent container to the second reagent container while performing the successive measurement by using the reagent contained in the first reagent container, controlling the measurement unit to suspend a start of aspiration of a next sample, to measure a quality control measurement sample prepared from the reagent contained in the second reagent container, when determined to switch from the first reagent container to the second reagent container, and controlling the measurement unit to start the aspiration of the next sample when an analysis result of the quality control measurement sample meets a predetermined condition.

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 liquid for ejection includes a bio-specimen, and at least one kind of first compounds expressed by Formula (1), wherein, in Formula (1), m?8, and 8?n?18.

Abstract: The formulations, systems, and methods disclosed herein permit automated preparation of specimens (e.g., biological specimens) for examination. The formulations can include a cytological fixative solution including Azure B, a surfactant, methanol, and ethylene glycol. The disclosed formulations, systems, and methods provide fast, efficient, and highly uniform specimen processing using minimal quantities of fluids. The methods include at least a fixing phase for fixing a specimen to a substrate such as a microscope slide, a staining phase for staining the specimen, and a rinsing phase for rinsing the specimen. One or more of the fixing, staining, and rinsing phases include one or more agitation phases for distributing reagents evenly and uniformly across the specimen. The systems can be implemented as a standalone device or as a component in a larger system for preparing and examining specimens.

Abstract: Methods and systems for preparation of calibrant infusion fluid sources are disclosed. In one embodiment, a precise volume of glucose is injected into a saline-solution filled calibrant infusion fluid source proximate in time to conducting a calibration procedure. The glucose concentration in the calibrant infusion fluid source is subsequently calculated based on the measured weight of the saline-solution, as determined prior to glucose injection, and the volume of glucose injected. This method provides a highly accurate and convenient manner for use in a hospital environment, for example, with an intravenous blood glucose sensor system. In another embodiment, a premixed calibrant infusion fluid source is provided that includes saline solution and a predetermined concentration of glucose. In such embodiments, shelf life problems related to water evaporation are mitigated by hermetically covering or otherwise hermetically containing the calibrant infusion fluid source up until the point of use.

Abstract: An exemplary embodiment may be directed to a fluorescence polarization assay that screens compounds or agents for their affinity to hematopoietic prostaglandin D synthase (H-PGDS) based on their ability to displace a fluorophore-containing detection analyte bound to an enzyme comprising the primary amino acid sequence of H-PGDS. Another exemplary embodiment utilizes an enzyme having a maltose binding protein amino-acid sequence fused with an N-terminus of the enzyme.

Abstract: The present invention provides a method of testing the ability of a test compound to bind to and optionally modulate the activity of a protein of the JMJD2 subfamily of Jumonji proteins. The method comprises incubating a test compound with a protein of the JMJD2 subfamily of Jumonji proteins, a co-factor of said protein and, optionally, a substrate for demethylation. The method of the invention can be used for screening large numbers of compounds to identify a group of compounds that are candidate compounds for clinical use for treatment of certain cancers especially prostate cancers. Other compounds that do not have activity in the screening assays can be eliminated from further consideration as candidate compounds. The method of the invention therefore has utility in the pharmaceutical industry.

Abstract: The present invention reagents and methods for setting up an instruments having a multiplicity of detector channels for analyzing a multiplicity of fluorescent dyes. The present invention is particularly applicable in the field of flow cytometry.

Abstract: The invention relates to a method for calibrating and/or adjusting an analytical device for chemical substances. A predetermined concentration of a chemical substance in a reference liquid is measured by mixing the reference liquid with a reagent for producing a color change, followed by irradiating with light of a predetermined wavelength. Based on the absorption of the light by the reference liquid, a concentration is determined, which is compared with the predetermined concentration of the reference liquid. In the case of which a calibrating and/or adjusting associated with the measurement process is possible without long interruptions of the measurement process, the predetermined concentration of the reference liquid is gained by mixing at least two standard, which contain different concentrations of the chemical substance.

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 copolypmers 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: The invention relates to a method for detecting endotoxins in a sample.

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 method for the calibration of a device for measuring the total organic carbon content (TOC) of an aqueous solution by measuring resistivity. The method includes the following steps, in the presence of a reference TOC analyzer: (a) producing a calibration point by a measurement carried out on ultrapure water by the device and the 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 the device and the analyzer, in order to establish a correlation between the values measured by the device and the analyzer; and (c) calibrating the device by at least one algorithm, based on the measurements carried out in the previous step.

Abstract: The present invention pertains to pharmaceutical compositions which comprise a botulinum neurotoxin from Clostridium botulinum, the neurotoxin being free of the complexing proteins naturally present in the botulinum neurotoxin complex or being chemically modified or being modified by genetic manipulation. Moreover the pharmaceutical compositions of the instant invention have good stability and are advantageously formulated free of human serum albumin.

Abstract: Embodiments of the invention provide to apparatuses and media used in drug elution studies and methods for making and using them. One embodiment of the invention is a drug elution method that can be used for in-vitro studies of a matrix impregnated with a compound such as a drug blended polymer matrix. Such methods and materials can be used for example to assess and control the manufacturing process variability of drug eluting implantable devices such as cardiac leads.

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 method of the invention pertains to determining the signal transduction activity in a tissue section by immunohistochemistry techniques. The expression level of the receptor of interest is determined as well as the expression levels of one or more effector molecules of the receptor signal transduction pathway. Furthermore a combined ratio of expression levels of effector molecules in subcellular compartments with the receptor expression was found to have prognostic significance.

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: An activated partial thromboplastin time measuring reagent, including a first reagent containing a phospholipid and an activator and a second reagent containing a herparin neutralizer and a calcium salt is disclosed. An activated partial thromboplastin time measuring method, and a determination method for determining a presence or absence of a blood coagulation inhibitor are also disclosed.

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 container for use in processing a biopsy sample. Biopsy sample and materials are received within a sample processing area of the container. A semi-permeable barrier is positioned at a downstream portion of the sample processing area and prevents the prevent passage of the biopsy sample. A cap is positioned at the downstream side of the barrier, and holds fluids within the container.

Abstract: A calibration device and method of using the device to calibrate an analytical instrument capable of reading a photoluminescent oxygen probe. The device includes at least (a) a first mass of an oxygen sensitive photoluminescent dye retained within a hermetically sealed space so as to isolate the dye from environmental oxygen, and in fluid communication with an activated metal-air battery whereby any oxygen permeating into the hermetically sealed space is quickly consumed by the battery, and (b) a second mass of an oxygen sensitive photoluminescent dye in fluid communication with an environmental concentration of oxygen.

Abstract: An automatic analyzer for performing analysis of a precision control sample in response to an external factor to alleviate the burden on the operator and perform precision control at appropriate timing, thereby allowing automatic maintenance of the measurement precision. Analysis of a precision control sample is performed by creating an analysis request for the internally held precision control sample and then transferring the precision control sample in response to an external factor occurring, when a calibrator is inputted in the analyzer, the number of remaining reagents under analysis satisfies a predetermined condition (becomes zero or falls below a specified value), the date changes, a specified time runs out, the operator is changed, the number of analyzed samples exceeds a specified value, a specified time period has elapsed, a new reagent is registered, and a measurement failure is detected.

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: 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: At least one embodiment of a stabilizing system includes a stabilizing agent present in an amount or concentration sufficient to completely or substantially prevent or reduce degradation or inactivation of a glycosylated hemoglobin (HbA1c) in a body fluid and a detection agent capable of detecting the HbA1c.

Abstract: A bio-threat simulant that includes a carrier and DNA encapsulated in the carrier. Also a method of making a simulant including the steps of providing a carrier and encapsulating DNA in the carrier to produce the bio-threat simulant.

Abstract: A method for analyzing platelet is described. In the method, a measurement sample is prepared by mixing a sample and a dye for staining platelet. The dye is selected from the group consisting of Capri blue, Nile blue and brilliant cresyl blue. By irradiating cells in the measurement sample with light, scattered light and fluorescence emitted from the cells is measured. The platelet is detected on the basis of the scattered light and the fluorescence. A reagent kite and a reagent are also described.

Abstract: A lunar dust simulant containing nanophase iron and a method for making the same. Process (1) comprises a mixture of ferric chloride, fluorinated carbon powder, and glass beads, treating the mixture to produce nanophase iron, wherein the resulting lunar dust simulant contains ?-iron nanoparticles, Fe2O3, and Fe3O4. Process (2) comprises a mixture of a material of mixed-metal oxides that contain iron and carbon black, treating the mixture to produce nanophase iron, wherein the resulting lunar dust simulant contains ?-iron nanoparticles and Fe3O4.

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 sample analyzer is disclosed that includes a first measurement unit for measuring a sample, a second measurement unit for measuring a sample, and an information processing unit for acquiring a first analysis result based on a result of the measurement by the first measurement unit and a second analysis result based on a result of the measurement by the second measurement unit. The information processing unit is configured to correct the first analysis result based on a first correction value, correct the second analysis result based on a second correction value, update the first correction value, and update the second correction value. A calibration method of a sample analyzer is also disclosed.

Abstract: A calibration card and method of using the card to calibrate an analytical instrument capable of reading a photoluminescent oxygen probe. The card includes at least (a) a first mass of an oxygen sensitive photoluminescent dye retained within a hermetically sealed space so as to isolate the dye from environmental oxygen, and in fluid communication with an activated metal-air battery whereby any oxygen permeating into the hermetically sealed space is quickly consumed by the battery, and (b) a second mass of an oxygen sensitive photoluminescent dye in fluid communication with the environment whereby the second mass of photoluminescent dye is exposed to an environmental concentration of oxygen.

Abstract: The present invention relates to the field of the distinction between bacterial meningitis and viral meningitis. It relates in particular to an in vitro method for detecting the presence of bacterial meningitis, which comprises determining the concentration of procalcitonin present in a test blood sample and of proteins present in a test cerebrospinal fluid sample, and comparing the concentrations thus determined to the concentration of procalcitonin and of proteins present in a reference sample or to a reference value. It also relates to a kit comprising means for detecting procalcitonin and proteins in the cerebrospinal fluid, and to the use thereof for the production of a diagnostic tool for bacterial meningitis.

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: 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: A method of correction of particle interference to hemoglobin measurement of a blood sample on a hematology analyzer is provided. The method includes mixing an aliquot of a blood sample with a lytic reagent to lyse red blood cells and forming a sample mixture; measuring absorbance of the sample mixture at a predetermined wavelength of a hemoglobin chromogen formed in the sample mixture, and obtaining an apparent hemoglobin concentration of the blood sample using obtained absorbance; measuring concentration and size of cellular particles remaining in the sample mixture; removing contribution of the cellular particles to the apparent hemoglobin concentration using the concentration and the size of the cellular particles to obtain a corrected hemoglobin concentration of the blood sample; and reporting the corrected hemoglobin concentration of the blood sample.

Abstract: The invention relates to methods of isolating white blood cells (WBCs) from a sample, e.g., whole blood, using magnetic particles that specifically bind to WBCs and a series of specific steps and conditions. The methods can include one or more of decreasing the viscosity of the sample prior to WBC isolation, agitating the sample at specified frequencies, and/or using a sample container arranged such that all of the sample is placed in close proximity (e.g., within 5, 2, 1, or 0.5 mm) to the source of the magnetic field. The new methods provide for isolation of WBC preparations with high yield, purity, and viability. The methods are designed for compatibility with automation protocols for rapid processing of multiple samples.

Abstract: Fluorescently labeled microsphere calibration and quality control particles for use in establishing standardized fluorescence detector setup, monitoring daily QC of flow cytometers and quantitative calibration of the fluorescence detectors in traceable units of measure (molecules equivalent soluble fluorescence; MESF).

Abstract: The present invention provides methods and software applications for quantifying a target in an experimental sample by collecting and processing initial signal data from the experimental sample and at least two standard control samples containing known target copy numbers. In this regards, the present invention allows the quantification of target copy number in the experimental sample.

Abstract: The invention provides among other things methods and kits based on assaying for cardiac troponin autoantibodies, either in conjunction with an assay for cardiac troponin and/or as an independent indicator of cardiac pathology, such as myocarditis, cardiomyopathy, and/or ischemic heart disease. Assay methods of the invention can be employed among other things to identify cardiac pathology, or risk thereof, in subjects who have an autoimmune disease or who are related to an individual with an autoimmune disease. In particular embodiments, the invention also provides a method of determining whether a subject having, or at risk for, a cardiac pathology is a candidate for immunosuppressive therapy or immunoabsorption therapy. The invention also provides kits and kit components that are useful for performing the methods of the invention.

Abstract: The present invention provides a simple method for the stabilization of a peptide in a biological sample and a reagent for the stabilization, a simple method for the preservation of a biological sample comprising a peptide and a reagent for the preservation, and a method for the accurate measurement of a peptide in a biological sample and a reagent for the measurement. Addition of a saccharide to a biological sample enables the stabilization of a peptide in the biological sample, the preservation of the biological sample comprising a peptide in a stable condition and the accurate measurement of a peptide in the biological sample. As the present invention can stabilize a peptide in a biological sample collected in the clinical examination, the peptide as a marker in the biological sample can be measured accurately in the clinical examination.

Abstract: Provided is a simulant material for simulating hazardous materials, including a quantity of at least one explosive material and at least one inert material. The simulant material is a non-explosive material and is in the form of a homogenous, flexible and non-particulated material. Also provided is a method for manufacturing such a simulant material.