Abstract: The method of the invention provides novel compounds, termed acid-labile isotope-coded extractants (ALICE), for quantitative mass spectrometric analysis of protein mixtures. The compounds contain a thiol-reactive group that is used to capture cysteine-containing peptides from all peptide mixtures, an acid-labile linker, and a non-biological polymer. One of the two acid-labile linkers is isotopically labeled and therefore enables the direct quantitation of peptides/proteins through mass spectrometric analysis. Because no functional proteins are required to capture peptides, a higher percentage of organic solvent can be used to solubilize the peptides, particularly hydrophobic peptides, through the binding, washing and eluting steps, thus permitting much better recover of peptides. Moreover, since the peptides are covalently linked to the non-biological polymer (ALICE), more stringent washing is allowed in order to completely remove non-specifically bound species.

Abstract: The invention relates to a formed tablet calibration standard-reagent for calibrating Karl Fischer reactions for determining water content in a substance, the reagent containing a first component, namely sodium tartrate dihydrate, and a second component, namely magnesium stearate. The invention further relates to a method for determining the water content of a substance using a Karl Fischer analysis. The invention further relates to a formed tablet calibration standard-reagent kit that includes a sealed package containing a formed tablet calibration standard-reagent for a Karl Fischer reaction.

Abstract: A hematology reference control containing an immature granulocyte component and the method of making are disclosed. The reference control includes an immature granulocyte component made of processed blood cells for simulating human immature granulocytes, and a suspension medium suitable for delivering the component to a blood analyzer for measurement of immature granulocytes. The immature granulocyte component can be made of processed avian, reptile or fish red blood cells, or human immature granulocytes produced in vitro. The reference control further includes a white blood cell component which includes white blood cell sub-components for simulating white blood subpopulations. Further disclosed is the method of using the reference control for measurement of immature granulocytes on a blood analyzer.

Abstract: A synthetic urine formulation, a kit including the synthetic urine formulation and a method of preparing synthetic urine are described. The urine formulation includes urine components in dried form, concentrated form or normal concentration and a compound that, when added to water, increases the temperature of the water (a “heat activator”). When the urine components are present in dried form, the synthetic urine can be provided in one or two parts. When present in concentrated form or in normal concentration, the heat activator must be provided separately. Lithium chloride is a preferred heat activator. The components can be provided in kit form, including a measuring cup with a fill line, the powdered, concentrated or normal concentration synthetic urine components, and the heat activator. Optionally, but preferably, the kit also includes a temperature measuring device to ensure that the appropriate temperature is reached.

Abstract: The invention features a method of determining whether one or more members of an analyte family are present in a sample. The method makes use of a test zone binder, e.g., a receptor that can bind one or a plurality of analytes within an analyte family, the analytes family defined by similar structural binding sites. Members of an analyte family can have different detection level requirements and, therefore, additional analyte binders can be employed to adjust test sensitivity for a subset of the analytes in the analyte family individually, so that each analyte can be detected only if it is present in the sample above a predetermined threshold.

Abstract: The present invention provides a microfluidic device for synthesizing an array of compounds and methods for using the same. In particular, the microfluidic device of the present invention comprises a solid support base, an elastomeric layer attached to the solid support, and a plurality of flow channels located within the interface between the solid support and the elastomeric layer. In addition, the solid support comprises a functional group for forming a bond with a reactive reagent. In some embodiments, the microfluidic device further comprises a second plurality of flow channels that intersect the first plurality of flow channels. A plurality of control channels are also present in the microfluidic devices of the present invention. The control channels can be actuated to regulate flow of fluids within the flow channel(s).

Abstract: A method for assessing aspirin resistance and relative risk of a cardiovascular event in a patient taking aspirin is provided. The concentration of 11-dehydro-thromboxane B2 in a urine sample is measured and compared to a set of standardized quartile concentrations. A concentration of urinary 11-dehydro-thromboxane B2 that falls within the second, third, or fourth quartile is indicative of aspirin resistance and an elevated risk of a recurrent cardiovascular event.

Abstract: The present invention provides processes for determining the molecular weight of glatiramer acetate and other copolymers using molecular weight markers. 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.

Abstract: A pretreatment kit and a pretreatment kit for saliva in identification and quantitative determination of mutans streptococci by immunochromatography utilizing an antigen-antibody reaction, which can remove aggregation caused by mucin and chain formation of mutans streptococci in saliva in a simple operation and can efficiently flow out a complex of a labeled antibody and mutans streptococci from a porous membrane retaining the labeled antibody, contains (A) a 0.01 to 10 mol/L aqueous solution of sodium hydroxide, (B) a 0.01 to 3 mol/L aqueous solution of tartaric acid and/or citric acid, and (C) a nonionic surface active agent and/or an amphoteric surface active agent, in which the component (C) is mixed with the components (A) and/or (B), or is provided separately, and at least one substance selected from the particular metallic salts is contained in at least one of the components (A), (B) and (C) in an amount of 5 to 25% by weight.

Abstract: Systems and methods configured to guide and manage laboratory analytical process control operations. A Biometric quality control (QC) process application is configured to monitor bias and imprecision for each test, characterize patient population data distributions and compare, contrast, and correlate changes in patient data distributions to any change in QC data populations. The Biometric QC process monitors the analytical process using data collected from repetitive testing of quality control materials and patient data (test results). The QC process identifies the optimal combination of, for example, frequency of QC testing, number of QCs tested, and QC rules applied in order to minimize the expected number of unacceptable patient results produced due to any out-of-control error condition that might occur.

Abstract: The present invention relates to a formed tablet calibration standard-reagent for Karl Fischer reactions to determine the water content of substances, such as pharmaceuticals, food stuffs, and oils.

Abstract: A method and system are provided for creating a mercury halide standard, and for using that standard to test a mercury analyzer system. Gaseous elemental mercury of a known concentration from a gas cylinder and a halogen donor are fed to a reaction chamber where they react to form mercury halide. The mercury halide is fed to a mercury analyzer system where it is converted to reform gaseous elemental mercury which is then measured by a mercury analyzer. By comparing either the amount of elemental mercury supplied to the reaction chamber or the amount of mercury halide formed in the reaction chamber with the amount of elemental mercury converted from the mercury halide, the ability of the mercury analyzer system to convert mercury halide to gaseous elemental mercury can be evaluated.

Abstract: The invention relates to a transparent or translucent colored cosmetic composition for making up the skin, lips and superficial body growths comprising a transparent or translucent cosmetic base and at least one coloring agent in an amount such that the transmission of a 10 ?m layer of the final composition, measured at the wavelength of the maximum of one of the absorption peaks of the coloring agent, is between 20% and 80%.

Abstract: A water-soluble reference standard is useful for immunoassays of a lipophilic drugs. The reference standard is a compound of formula (I): G-(L)n—Y;??(I) where G is a lipophilic drug; L is a linker which is an alkyl group or heteroalkyl group containing from 1 to 20 carbon atoms; n is 0 or 1; and Y is a water-solubilizing group such as —SO3?, —NR—SO3?, —P(?O)(OH)(O?), or —O—P(?O)(OH)(O?); where R is H or an alkyl group of 1 to 10 carbon atoms.

Abstract: Methods, compositions and kits are disclosed. The compositions are light emitting and comprise a polymeric matrix having dissolved therein a photoactive compound. The composition has the characteristic that, after activation of the photoactive compound, the rate of decrease in the intensity of light emission at any time during a 20-fold decrease in the intensity is proportional to the intensity of the light emission. In one embodiment the polymeric matrix is comprised of particles of about 20 nm to about 100 ?m in diameter to which is bound a specific binding pair member. The particles generally comprise a polymeric matrix having dissolved therein about 1 to about 20% by weight of a dopant. The compositions may be used in methods for determining an analyte. A combination is provided comprising (1) a medium suspected of containing the analyte, (2) and the aforementioned composition. The photoactive substance is activated and the effect of the activating on the optical properties of the combination is detected.

Abstract: The invention discloses methods, compositions and kits for stabilizing a solubilized phenyl phosphate, preferably paranitrophenyl phosphate (PNPP), using charcoal. Also disclosed are methods, compositions and kits for recycling solubilized phenyl phosphate, preferably PNPP, that has an absorbance of less than 0.1 when measured at 405 nm due to non-enzymatic hydrolysis.

Abstract: An artificial test soil is composed of particulate, hair, and fiber components, wherein the particulate component consists of mineral, food, and plant materials, so chosen and proportioned as to correlate to a typical soil found in the home. The test soil may be used to test cleaning products by application of a known amount thereof to a surface, cleaning the surface, and determination of the amount of soil removed from the surface.

Abstract: A method of determining the gender of a bird in ovo comprises detecting the presence or absence of an elevated level of a sex-related hormone in the extra-embryonic fluid of the bird egg, and then determining the gender of the bird within the egg from the presence of an elevated level of a sex-related hormone therein. In particular embodiments, the sex-related hormone is an estrogen. In other representative embodiments, the invention provides methods in which the extra-embryonic fluid is allantoic fluid. In other illustrative embodiments, the method can be carried out on chicken eggs prior to or during transfer of the eggs from incubator to hatcher.

Abstract: Reference control compositions and the method of use are disclosed for measurement of nucleated red blood cells, which includes one set of synthetic spherical particles having a mean particle diameter ranging from 6.2 ?m to 6.8 ?m and a refractive index from 1.58 to 1.62 monodispersed in an aqueous suspension medium. The synthetic spherical particles have optical properties simulating optical properties of nucleated red blood cells as measured by optical measurements. The reference control composition can further include a second set of the synthetic spherical particles having optical properties simulating optical properties of white blood cells. Further disclosed is a reference control system which includes a series of reference control compositions, each having an amount of one type of synthetic spherical particles which have optical properties simulating the optical properties of nucleated red blood cells having a specific cell maturity.

Abstract: An NMR buffer is particularly useful for biomolecules that require a certain amount of salt in the buffer solution. A primary buffer component and a titrating component are selected based on low ion mobility. These selections allow for a lower conductivity buffer without reducing the salt content. As such, a higher sensitivity experiment results.

Abstract: This disclosure relates to CryoArrays, which permit the analysis of samples (such as protein, nucleic acid, virus, or cell samples) in arrays that are prepared at low temperatures. Because CryoArrays are constructed as a block of substantially columnar samples, the block can be sliced to provide a plurality of identical or substantially identical individual arrays. The individual arrays can be used for parallel analysis of the same array feature set, for instance with different probes or under different conditions. Also provided are methods of making CryoArrays, devices for making CryoArrays, and kits.

Abstract: A transport/preservation system has been found which provides safe, effective transport for patient specimens and bodily fluids, and functions as a preservative for biological reagents, therapeutics, and personal care products. The transport/preservative formulations can also be used as safe, effective sanitizers on surfaces, equipment, and appliances. The transport preservation formulation includes a biguanide and one or more other antimicrobial agents, which is cidal to microorganisms when present in a sample or on a surface to be sanitized.

Abstract: A method for separating and purifying the active hematinic species present in iron-saccharidic complexes including sodium ferric gluconate complex in sucrose, ferric hydroxide-sucrose complex and ferric saccharate complex and others of similar form and function, based on separation of the iron-saccharidic complex from one or more excipients and, preferably, lyophilization. Separation of the iron-saccharidic complex permits its analytical quantification; further concentration or purification as a new and useful product; preparation of redesigned formulations for new and useful pharmaceuticals; and/or lyophilization.

Abstract: The present invention quickly resolves troubles in an analyzer and performs effective external quality control management. An analyzer (2) and a control device (1) are connected by a network (3). Error data and sample data taken from assay of a quality control substance are transmitted from the control device (1) to the analyzer (2). The analyzer (2) is made to be remotely operable from the control device (1) and when troubles arise repair from the control device (1) is possible. The control device (1) tallies sample data, and provides the tally results to a Web page. The analyzer (2) accesses the Web page using a WWW browser, and can perform external quality control in real time.

Abstract: An artificial mixture which simulates human feces and its method of use for fecal occult blood testing as a control material or for proficiency testing are disclosed.

Abstract: A method and system for calibrating molecular arrays to a reference molecular array, and for subsequently calibrating the molecular arrays to maintain a constant signal-intensity-to-label-concentration ratio. In the first step of the two-step calibration method, a reference array coated with the fluorophore or chromophore used to label probe molecules is employed, while in the second step of the two-step method, a reference array coated with a stable dye is employed.

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.

Abstract: Controls and standards for assays and method for manufacturing the controls and standards is described. The controls or standards comprise a porous carrier material which has quantitatively reversibly absorbed and dried thereon an analyte for the control or standard wherein the analyte is not degraded over time while it is absorbed to the porous carrier material. Preferably, the controls and standards are provided as a control strip (10) in which the porous carrier material (20) is adhered to the distal end (16) of a support member (12). To quantitatively elute the analyte from the carrier to a solvent for an assay, the carrier is contacted to the same solvent used for the samples in the assay. After the analyte has been eluted, the carrier is discarded and the assay is performed. The controls and standards are useful for assays which detect bacteria, fungi, viruses, and proteins.

Abstract: A method for measuring immature granulocytes in a blood sample is described. The method includes the steps of lysing red blood cells of a blood sample with a lytic reagent, analyzing the sample mixture by DC impedance measurement, determining immature granulocytes from obtained DC histogram, and reporting immature granulocytes in the blood sample. The method further includes measuring nucleated red blood cells in the blood sample.

Abstract: Disclosed are hazardous chemical simulant compositions that can be used to simulate hazardous chemicals and methods for using hazardous chemical simulants. The compositions can include a phosphor, which emits visible light in the presence of ultraviolet light. The methods of using hazardous chemical simulants includes exposing a hazardous chemical simulant to special lighting conditions so that its location can be easily detected.

Abstract: A stabilization reagent composition, particularly desirable for stabilizing blood samples containing platelets, contains reactants that generate multiple species of formaldehyde-ammonium complexes; at least one inhibitor of phosphatase enzymatic activity; and at least one inhibitor of protease enzymatic activity. Blood samples and other tissues are stabilized by this composition. Such stabilized samples are produced by methods for stabilizing the tissue by contacting the sample with the composition.

Abstract: A method and system for predicting the content level of components in materials based on the response of the materials to near infrared radiation. One embodiment comprises electronically receiving a near infrared reflectance spectrum of a material from a customer, predicting the content level of a component in the material based on the spectrum, and electronically reporting the prediction to the customer. Another embodiment includes the exchange of the customer request and prediction report on a Web site or by electronic mail. Other embodiments include the prediction reports, and uses of the predictions, for example in quality control and toxicity evaluation.

Abstract: The method of the invention provides novel compounds, termed acid-labile isotope-coded extractants (ALICE), for quantitative mass spectrometric analysis of protein mixtures. The compounds contain a thiol-reactive group that is used to capture cysteine-containing peptides from all peptide mixtures, an acid-labile linker, and a non-biological polymer. One of the two acid-labile linkers is isotopically labeled and therefore enables the direct quantitation of peptides/proteins through mass spectrometric analysis. Because no functional proteins are required to capture peptides, a higher percentage of organic solvent can be used to solubilize the peptides, particularly hydrophobic peptides, through the binding, washing and eluting steps, thus permitting much better recovery of peptides. Moreover, since the peptides are covalently linked to the non-biological polymer (ALICE), more stringent washing is allowed in order to completely remove non-specifically bound species.

Abstract: An aqueous control solution is disclosed for use with a spectrophotometer or photometric test strip that includes a predetermined amount of an analyte, a hydrophobic reference dye and a surfactant. In one embodiment, the aqueous control solution is applied to a photometric test strip having a chemical that oxidizes glucose and consequently forms hydrogen peroxide which reacts with an indicator dye that is also present on the strip. In this embodiment, the control solution includes a predetermined amount of glucose, an infrared reference dye, sodium dodecyl sulfate, and the indicator dye, such as sulforhodamine B.

Abstract: The present invention includes devices, systems and methods for containing and using liquid solutions. The devices include liquid containment structures and packages of such liquid containment structures for containing single doses of a liquid solution for subsequent use. The systems include at least one subject containment structure or package of containment structures and the liquid solution for which they are intended to contain. The liquid solutions may comprise any type of agent, reagent or control solution. The subject methods involve the use of the liquid containment structures and packages thereof as well as methods of providing a control solution for use to evaluate a system's performance.

Abstract: A reader for a sterilization indicator having sterilizing agent sensitive indicia is described. The indicator allows a sterilization cycle to be monitored without the need for a user to subjectively distinguish between color, quality or intensity of display patterns.

Abstract: A method and apparatus for fractionation of charged macro-molecules such as DNA is provided. DNA solution is loaded into a matrix including an array of obstacles. An alternating electric field having two different fields at different orientations is applied. The alternating electric field is asymmetric in that one field is stronger in duration or intensity than the other field, or is otherwise asymmetric. The DNA molecules are thereby fractionated according to site and are driven to a far side of the matrix where the fractionated DNA is recovered. The fractionating electric field can be used to load and recover the DNA to operate the process continuously.

Abstract: The present invention relates to a method for detecting biopolymers in a matrix, which includes contacting the matrix with a sensitizing reagent including on one or more optionally substituted heteroaromatic compounds; contacting the matrix with one or more reduceable metal salts to stain the biopolymer; and detecting the stained biopolymer. The invention also relates to compositions for carrying out the invention and compositions made according to the invention. The invention also relates to kits for carrying out the methods of the invention.

Abstract: Blood cells of interest are readily distinguishable from other blood cells and look-a-like particles found in a blood sample by their back-scatter signature. A preferred method for differentiating platelets in a blood sample is to irradiate the cells and particles, one at a time, with a beam of radiation, and to detect back-scattered (reflected) radiation using a plurality of optical fibers to transmit the back-scattered radiation to a high-gain photodetector, e.g. a photomultiplier tube. Preferably, the back-scatter signal so obtained is combined with a second signal representing, for example, either the level of forward-scatter within a prescribed, relatively narrow angular range, or the level of side-scattered radiation, or the level of attenuation of the cell-irradiating beam caused by the presence of the irradiated cell or particle in the beam, or the electrical impedance of the irradiated cell or particle, to differentiate the cells of interest.

Abstract: A lytic reagent composition and the method of use for differential analysis of leukocytes using flow cytometry are disclosed. The lytic reagent composition includes a short chain alkyl oxyethanol, such as 2-methoxyethanol, 2-ethoxyethanol, 2-propoxyethanol, or 2-isopropoxyethanol, in a sufficient amount to preserve leukocytes; a non-lysing nonionic surfactant as a debris solublizer; and an inorganic buffer to maintain pH of the lytic reagent composition in a range from 9.1 to 10.7. The lytic reagent composition is used to lyse red blood cells and preserve leukocytes, as well as used as the sheath reagent for the focus flow measurement. The lytic reagent composition, when used on a flow cytometric analyzer with multiple angle light scatter and light absorbance measurements, enables differentiation of leukocytes into five subpopulations.

Abstract: The invention relates to synthetic biepitope compounds which can be used as standards in immunoassays, for the assay of troponin I, method for preparing them, compositions and kits containing such compounds as well as the immunoassay methods using such compounds.

Abstract: A method of microdissection which involves forming an image field of cells of the tissue sample utilizing a microscope, identifying at least one zone of cells of interest from the image field of cells which at least one zone of cells of interest includes different types of cells than adjacent zones of cells, and extracting the at least one zone of cells of interest from the tissue sample. The extraction is achieved by contacting the tissue sample with a transfer surface that can be selectively activated so that regions thereof adhere to the zone of cells of interest to be extracted. The transfer surface includes a selectively activatable adhesive layer which provides, for example, chemical or electrostatic adherence to the selected regions of the tissue sample. After the transfer surface is activated, the transfer surface and tissue sample are separated.

Abstract: Automated staining equipment that can mix reagents is used to spray a Romanowsky stain onto slide mounted specimens which are then briefly centrifuged. The centrifugation step removes excess stain leaving only a thin film. Depending on the time of the centrifugation step, most of the organic solvent and part of the water in the stain are evaporated by airflow through the equipment. This greatly accelerates the staining reaction and preserves water soluble structures such as the granules in basophilic leukocytes. For optimal performance, this staining procedure requires a thiazin-eosin stain with about 90% to about 40% organic solvent, such as methanol, and only about 10% to about 60% water. This is a unique staining reagent in Romanowsky staining.

Abstract: The present invention provides reagents for use in an automated environment for cell conditioning of biological samples wherein the cells or tissues are predisposed for access by reagent molecules for histochemical and cytochemical staining procedures. The components of the reagents are optimized to facilitate molecular access to cells and cell constituents within the biological sample. The present invention also provides reagents for use in an automated environment for removing or etching embedding media by exposing a biological sample to be stained in histochemical or cytochemical procedures without the dependence on organic solvents. The components of the reagents are optimized to facilitate removal or etching of the embedding media from the biological sample.

Abstract: A method to determine an engrafting cell dose of hematopoietic stem cell transplant units from transplant sources having nucleated cells selected from the group consisting of cord blood, bone marrow, peripheral blood comprising the steps of subjecting the source to a substantially complete erythrocyte lysis, measuring in a cell counter a signal corresponding selectively to white blood cells, assessing essentially quantitatively nucleated red blood cell (NRBC) count as part of the total nucleated cell (NC) count, and determining the number of white blood cells (WBCs) as transplant relevant cells.

Abstract: The invention relates to an assay for testing oxidative stress of a subject by measurement of oxidants in biological fluids such as urine, plasma, bioreactor medium and respiratory aspirants. There is provided a method of determining oxidative stress in a mammalian subject. The method comprises: obtaining a sample of a biological fluid from the subject; mixing the biological fluid with a ferrous reaction reagent; incubating the biological fluid and the reaction reagent; and detecting a colored reaction product. There is further provided a ferrous reaction reagent suitable for use in assaying oxidative stress, said reaction reagent comprising 2-deoxyglucose, TBA, EDTA, and ferrous sulfate, and being substantially free of ascorbic acid.

Abstract: A control serum for a dry process is provided that does not show misfit in measurement values by the dry process and a wet process. The above-mentioned control serum is obtained by freezing or freeze-drying a control serum without dialysis.

Abstract: The invention provides a method and an arrangement for filtering or pre-processing most any type of multivariate data exemplified by NIR or NMR spectra measured on samples in order to remove systematic noise such as base-line variation and multiplicative scatter effects. This is accomplished by differentiating the spectra to first or second derivatives, by Multiplicative Signal Correction (MSC), or by similar filtering methods. The pre-processing may, however, also remove information from the spectra, as well as other multiple measurement arrays, regarding (Y) (the response variables). Provided is a variant of PLS that can be used to achieve a signal correction that is as close to orthogonal as possible to a given (y) vector or (Y) matrix. Hence, ensuring that the signal correction removes as little information as possible regarding (Y). A filter according to the present invention is named Orthogonal Partial Least Squares (OPLS).

Abstract: A method and system are provided for creating a mercury halide standard, and for using that standard to test a mercury analyzer system. Gaseous elemental mercury of a known concentration from a gas cylinder and a halogen donor are fed to a reaction chamber where they react to form mercury halide. The mercury halide is fed to a mercury analyzer system where it is converted to reform gaseous elemental mercury which is then measured by a mercury analyzer. By comparing either the amount of elemental mercury supplied to the reaction chamber or the amount of mercury halide formed in the reaction chamber with the amount of elemental mercury converted from the mercury halide, the ability of the mercury analyzer system to convert mercury halide to gaseous elemental mercury can be evaluated.

Abstract: In connection with a fluidic medical diagnostic device that permits measurement of the coagulation time of blood, software, methods and associated devices for quality control are provided. The fluidic device preferably includes a test strip with one end having a sample port for introducing a sample and a bladder at the other end for drawing the sample to a measurement area. A channel carries sample from the sample port to an assay measurement area and first and second control measurement areas. Preferably a stop junction, between the measurement areas and bladder, halts the sample flow for measurement. If results from measurements taken for each control fall within a predetermined zone or defined limits, the assay measurement is qualified. If not, an error is registered and the test strip is counted as unfit.