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: A method and a solid phase calibrant are provided suitable for use by untrained personnel to calibrate an analytical instrument under field conditions away from a laboratory. Filter discs or other suitable substrates are impregnated, by the process of adsorption, with solutions of known concentrations of analytes and chromatographic phase materials, such as polymers, in suitable solvents. The substrate material is selected to be chemically inert and to not negatively interact with the analytes, the calibration process, or the analytical instrumentation. The polymers cause the analyte to adhere to the substrate until the solution is desorbed by heating, so that the impregnated substrates form stable calibration solutions in solid phase which can be easily and reliably stored, transported, and used by operators with minimal training. The substrate is preferably contained in a card holder which can be easily inserted into and preferably mate with an inlet for the analytical instrument.

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 disclosed. The fluidic device preferably comprises 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.

Abstract: A biochemical sensor apparatus having an optical radiation source, a sensor array, and a photodetector array is disclosed. Each sensor of the sensor array includes fluorophores for fluorescence (generating response radiation) when mixed with analytes of interest and exposed to stimulus radiation. An array of photodetectors, such as a CMOS imaging array is used to detect the response radiation. The detected response radiation is converted to digital values and the digital values used to analyze various properties of the analytes present in the sensors.

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 disclosed. The fluidic device preferably comprises 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.

Abstract: A collection container and method for collecting a predetermined volume of a biological sample, and particularly a whole blood sample, includes at least one gene induction blocking agent in an amount effective to stabilize and inhibit gene induction. The gene induction blocking agent is able to stabilize nucleic acids in the biological sample at the point of collection to block ex vivo gene induction in the sample when stored at room temperature. The stabilizing agents include cationic compounds, detergents, particularly cationic detergents, chaotropic salts, ribonuclease inhibitors, chelating agents, organic solvents, organic reducing reagents, and mixtures thereof. The biological sample is collected directly from the animal and immediately mixed with the gene induction blocking agent without any intermediate processing or handling.

Abstract: The invention, relates to a method for producing standard gases (CO and H2) for determining the isotope relationships of oxygen and/or hydrogen, in particular during on-line operation, with a sample being decomposed in a (hot) reactor (11) to produce CO and/or H2, and these components being fed to a mass spectrometer (15), and with the mass spectrometer also the gases obtained from the sample. The invention also relates to an apparatus for providing standard gases. The method according to the invention provides for the standard gases in the reactor (11) to be formed by decomposition, and for initial products which are suitable for this purpose to be fed to the reactor.

Abstract: A low formaldehyde containing aqueous blood diluent contains an effective amount of ethylenediamine tetraacetic acid, ethylenediamine tetraacetic acid derivative, or combinations thereof; an effective amount of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one; and an effective amount of 5-bromo-5-nitro-1,3-dioxane. Advantageously, less than about 1 parts per million of formaldehyde is produced in this multipurpose diluent. A method of analyzing a blood sample containing blood cells is conducted by forming a diluted blood sample by mixing a blood sample containing blood cells with this diluent and analyzing the diluted blood sample to determine a physical parameter of the blood cells.

Abstract: This invention relates to a method for establishing and using a decision marker by which positive samples can be discriminated from negative samples. The method employs the analysis of multiple samples from confirmed positive and negative samples. A fluorescence channel is selected so that the desired sensitivity and specificity are achieved. A microparticle having this fluorescence channel then is made and is used in conjunction with a fluorescence marker which is specific for the population of interest.

Abstract: An aqueous control liquid is provided that contains glucose at a known concentration and cyclodextrin. A method is also provided that binds a wetting agent from a region of a test element that comes into contact with a sample. The method includes contacting the region with a control liquid that has a substance selected from the group of cyclodextrin derivatives and dispersed materials having a specific surface of 100 m2/g to over 1000 m2/g. A method for controlling the function of a measuring system having test strips and a measuring instrument for the determination of glucose in liquid samples is provided that includes contacting the test strip with a control liquid containing glucose at a known concentration and at least one substance selected from the group consisting of cyclodextrins and cyclodextrin derivatives and detecting a signal caused by the glucose contained in the control liquid.

Abstract: Fluorescing reference material is used for calibration purposes for improving the measurement accuracy of sensors, especially biosensors, which use fluorescence radiation for determination of signals, the sensors each comprising a waveguide having at least one wave propagation surface as assay, a reactant being supported on the reactant comprising a species of molecule and being bound to an analytical material within a test medium, the waveguide transmitting an output emission radiation signal when it receives a radiation access signal.

Abstract: The present invention provides a method of monitoring calibration of a spectrophotometric apparatus that comprises one or more calibration algorithms for one or more analytes. This method comprises measuring absorbance of a quality control material with the apparatus to obtain a measurement, where the quality control material exhibits an absorbance spectra characterized as having a negative slope for a continuous spectral segment from about 5 nm to about 200 nm in length, and where the spectral segment includes a principal calibration wavelength for the one or more analytes. The method then involves calculating one or more concentration values from the measurement using the one or more calibration algorithms, followed by comparing the one or more concentration values with an assigned value given to the quality control material for each of the one or more analytes, and determining if there is a violation of a pre-established quality control rule.

Abstract: Compositions, methods, devices and kits for use in the calibration of coagulation tests. The control compositions comprise particles capable of aggregating in plasma and calcium ions which, when mixed with plasma, simulate the behavior of whole blood in a coagulation test. The methods comprise providing calcium ions and particles capable of aggregating in plasma, combining the particles and calcium ions with plasma to form a control composition, and applying the control composition to a coagulation test. The devices comprise a container having at least two compartments, with one compartment including particles that promote or induce aggregation of a protein or proteins in plasma, and the other compartment includes a solution of calcium ions. The kits comprise a control composition comprising a container of calcium ions, a container of particles capable of inducing aggregation of proteins in plasma, and one or more coagulation test devices.

Abstract: A method and device for fluorimetric determination of a biological, chemical or physical parameter of a sample utilize at least two different luminescent materials, the first of which is sensitive to the parameter, at least with respect to luminescence intensity, and the second of which is insensitive to the parameter, at least with respect to luminescence intensity and decay time. The luminescent materials have different decay times. The time- or phase behaviour of the resulting luminescence response is used to form a reference value for determination of a parameter.

Abstract: A collection container and method for collecting a predetermined volume of a biological sample, and particularly a whole blood sample, includes an effective amount of at least one stabilizing agent. The stabilizing agent is able to stabilize nucleic acids in the biological sample at the point of collection to prevent enzymatic degradation of the nucleic acids. The stabilizing agents include cationic compounds, detergents, particularly cationic detergents, chaotropic salts, ribonuclease inhibitors, chelating agents, and mixtures thereof.

Abstract: A method of using a chemical array reader, chemical array readers, and computer program products for use with a chemical array reader. The chemical array reader may include a holder to mount an array and hold the array at a reading position. A light system illuminates a mounted array when at a reading position. A detection system having a focal plane, to detect light from different regions across the array emitted in response to the illumination, when at the reading position, and which generates a resulting signal for each of the regions across the array. An autofocus system which detects and reduces offset between the different regions of an array at the reading position and a determined position of the focal plane.

Abstract: A wearable periodic self-calibrating body analyte monitoring system based on the principles of microdialysis for measurement of a body analyte is disclosed. In a preferred embodiment, the system is designed to measure glucose, and can be held on the body with a skin adhesive for comfort. The system may be combined with an insulin delivery system to create an artificial pancreas.

Abstract: The calibration fluid is composed of a biocompatible electrolyte that, at 37° C., exhibits a concentration of bicarbonate ions that lies in the normal physiological range of the concentration of the bicarbonate ions of the blood, exhibits a pH value that lies within a pH value range within 2 through 13 containing the value 7.41 and has a specific ionic strength. In order to enable a calibration of the sensor with a higher precision compared to a known calibration fluid of this type both in vivo as well as in vitro, the ionic strength of the fluid at 37° C. is selected such that it lies in the normal physiological range of the ionic strength of the blood.

Abstract: A method of making a molecularly imprinted porous structure makes use of a surfactant analog of the molecule to be imprinted that has the imprint molecule portion serving as the surfactant headgroup. The surfactant analog is allowed to self-assemble in a mixture to create at least one supramolecular structure having exposed imprint groups. The imprinted porous structure is formed by adding reactive monomers to the mixture and allowing the monomers to polymerize, with the supramolecular structure serving as a template. The resulting solid structure has a shape that is complementary to the shape of the supramolecular structure and has cavities that are the mirror image of the imprint group. Similarly, molecularly imprinted particles may be made by using the surfactant to create a water-in-oil microemulsion wherein the imprint groups are exposed to the water phase.

Abstract: A method and apparatus for automatically selecting test types for an analytical meter system based on the insertion into the meter of a test element. The test element can be an analytical element, formed by a test strip with a fluid such as blood applied thereto; a control element, formed by a test strip with control fluid applied thereto; or a standard element, or a standard strip exhibiting known optical properties. By inserting the test element into the analytical meter system, optical properties are measured and the existence of relationships between the measurements are ascertained. Based on the existence or nonexistence of certain relationships, the proper test can be automatically selected by the meter without the need for user interaction. Advantageously, the results of the test can be classified and stored according to test type.

Abstract: Methods of forming a density gradient by applying a centrifugal field to a solution of one or more metal ion chelate complexes are disclosed. The density gradients are self-forming equilibrium gradients and are useful for separating biological particles by ultracentrifugation. Also disclosed are methods of separating biological particles according to their density. Also disclosed are density gradients of lipoprotein particles and one or more metal ion chelate complexes, wherein the lipoprotein particles are partitioned along the density gradient according to their particle density.

Abstract: The present invention provides a method of monitoring calibration of a spectrophotometric apparatus that comprises one or more than one calibration algorithm for one or more than one analyte. This method comprises measuring absorbance of a quality control material with the apparatus to obtain a measurement, where the quality control material exhibits an absorbance spectra characterized as having a negative slope for a continuous spectral segment from about 5 nm to about 400 nm in length, or a wavelength there between, and where the spectral segment includes a principal calibration wavelength for the one or more than one analyte. The method then involves calculating one or more than one concentration values from the measurement using the one or more than one calibration algorithms, followed by comparing the one or more than one concentration values with an assigned value given to the quality control material for each of the one or more than one analytes.

Abstract: A method of making a molecularly imprinted porous structure makes use of a surfactant analog of the molecule to be imprinted that has the imprint molecule portion serving as the surfactant headgroup. The surfactant analog is allowed to self-assemble in a mixture to create at least one supramolecular structure having exposed imprint groups. The imprinted porous structure is formed by adding reactive monomers to the mixture and allowing the monomers to polymerize, with the supramolecular structure serving as a template. The resulting solid structure has a shape that is complementary to the shape of the supramolecular structure and has cavities that are the mirror image of the imprint group. Similarly, molecularly imprinted particles may be made by using the surfactant to create a water-in-oil microemulsion wherein the imprint groups are exposed to the water phase.

Abstract: A method for molecular imprinting polymers with large biomolecules. The imprinted polymer composite is made by the interfacial polymerization of a monomer in the presence of the print molecule and host polymer. Since polymerization occurs at the interface between an organic solvent and an aqueous solution, the print molecule can be disposed in the phase that allows the print molecule to remain in its native configuration. The choice of the host polymer and the monomer to be polymerized can be varied to enhance the specificity of the composite toward the biomolecule that is selected to be imprinted.

Abstract: Chemical indicator inks for steam-formaldehyde sterilization processes. The chemical indicator ink contains at least one primary organic dye selected from the group consisting of Congo red, Benzo purpurin B, Chicago sky blue 6B, Direct red 75, Evans blue, Naphthol blue black, Nitro red, and combinations thereof. The organic dye undergoes an irreversible color change when exposed to formaldehyde vapor in the presence of steam, but will not change color when exposed to other sterilization processes. The chemical indicator ink can further contain at least one secondary organic dye which does not undergo a color change when exposed to formaldehyde vapor in the presence of steam.

Abstract: The invention provides a class of samples that model the human body. This family of samples is based upon emulsions of oil in water with lecithin acting as the emulsifier. These solutions that have varying particle sizes may be spiked with basis set components (albumin, urea and glucose) to simulate skin tissues further. The family of samples is such that other organic compounds such as collagen, elastin, globulin and bilirubin may be added, as can salts such as Na+, K+ and Cl−. Layers of varying thickness with known index of refraction and particle size distributions may be generated using simple crosslinking reagents, such as collagen (gelatin). The resulting samples are flexible in each analyte's concentration and match the skin layers of the body in terms of the samples reduced scattering and absorption coefficients, &mgr;′s and &mgr;a. This family of samples is provided for use in the medical field where lasers and spectroscopy based analyzers are used in treatment of the body.

Abstract: Compositions for stabilizing polypeptides or antigens are described. These compositions are useful for stabilizing polypeptides or antigens stored in aqueous formulations. Such formulations can be used for various analytical or other methods.

Abstract: A chemical construct for use with solution phase chemistry comprises a reversible attachment unit and one or more attribute conferring units. Such units may include separation attribute conferring units, identification attribute conferring units, and quantitation attribute conferring units.

Abstract: The present invention provides a method for preparing cells for use in a hematology blood control. The preparation steps, namely the use of cross-linking agents such as aldehydes, involve a step-wise process starting with very low concentrations of a cross-linking agent. Successive fixations involve an increase in the concentration of cross-linking agent.

Abstract: An improved control for a hematology analyzer. In one embodiment, blood cells are treated for permitting the cells to simulate nucleated red blood cells for detection or analysis by the hematology analyzer.

Abstract: An improved control for a hematology analyzer. In one embodiment, blood cells are treated for permitting the cells to simulate nucleated red blood cells for detection or analysis by the hematology analyzer.

Abstract: Blood clot analysis instrumentation used to evaluate platelet function and clot structure by monitoring force development during clot retraction or upon application of a known amount of force can have a calibration check automatically performed by using a top member with a known amount of mass which is detachable from the instrumentation, and preferably is a disposable component. The calibration check is performed by monitoring force or displacement on a holding member with and without the top member attached. If the difference measured is within a preferred tolerance range, then the instrumentation can be deemed to be within the specifications deemed best suited for the instrument. The top member may also be modified to allow for mixing reagents with the clot, thereby avoiding the need to pre-mix blood with reagents before measurement.

Abstract: A lytic reagent composition for measuring nucleated blood cells in a blood sample is described. The lytic reagent composition contains a quaternary ammonium surfactant, an ethoxylated phenol, and an ethoxylated alcohol. When mixed with a blood sample, the lytic reagent composition lyses red blood cells and enables a differentiation of nucleated red blood cells from other cell types by DC impedance measurement. The lytic reagent composition can further contain an organic ligand for determining total hemoglobin concentration of a blood sample photometrically. Further disclosed is a lytic reagent system including the lytic reagent composition and a diluent. In addition, a single reagent composition containing salts is also disclosed, which can be used without a separate diluent. The lytic reagent compositions can be used for concurrent measurement of nucleated red blood cells, WBC, and hemoglobin of a blood sample.

Abstract: An improved blood suspension media for hematological compositions, having particular utility with a red blood cell component for devices using electronic and optical means for blood determinations, and processes for using the suspension media. The suspension media finds particular utility in providing the hematology control product with a stable and consistent MCV and RDW for an extended product shelf life.

Abstract: A composition for simulating and evaluating chemical agent contamination which can be used to safely train military personnel in handling chemical agent contamination. It has a vapor generating component having a vapor pressure of from about 0.1 to about 30 mm Hg at 25° C.; a fluorescent dye; and a solvent which uniformly disperses the vapor generating component and fluorescent dye.

Abstract: A method is provided for preparing preservative-free allergen test solutions in a prepared sterile environment. A sterile environment is prepared by utilizing a disinfectant wipe and a sterile barrier field. An antigen is added to a diluent to form a solution of the antigen by dispersing or suspending the antigen in the diluent. The solution is subjected to triple filtration under specific and sequential conditions to provide consistent and preservative-free allergen test solutions. Shelf life is extended by storing the solution at a temperature below 5° F. or by lyophilizing the allergen test solution.

Abstract: The present invention relates to a rapid method for estimation of Chemical Oxygen Demand (COD) of water, COD is an important parameter for determining the extent of pollution in water bodies, the basic principle of COD estimation is not much different from prior art but the time taken is reduced considerably and the results are equally sensitive and reproducible as other methods and the method used to generate data on the performance of effluent treatment plants in remote areas or rural areas, it also provide regular and sequential information on the quality of effluent generated by food processing industries.

Abstract: The invention relates to a process for the obtainment of biological components from body fluids, in particular from blood, blood plasma or serum. The biological components are obtained in native and biologically active form and can be employed, for example, for therapeutic purposes and for the preparation of control samples or standards for diagnostic tests.

Abstract: This invention relates methods for conditioning affinity chromatography resins to decrease leaching of the ligand during purification. The methods involve incubating the resin in a buffered solution of a hydroxyalkylamine compound (e.g., ethanolamine) prior to use of the resin for an affinity purification. The treatment removes unstably bound ligand from the resin.

Abstract: The dyes of the present invention are useful for many purposes that include markers or tags for detecting the presence of a molecule or compound to which they are bound. The dyes may be either red-excitable or blue-excitable. The dyes of the invention are particularly well suited for staining of nucleic acids. For example, these dyes are particularly suitable for staining of RNA in reticulocytes. In another exemplary application, these dyes are suitable for staining DNA in nucleated red blood cells. Typically, when used in staining of nucleic acids, the dyes are formulated into reagent solutions. In addition, the invention provides compositions and methods for facilitating rapid transport of dye molecules through a cell membrane. Such rapid staining requires that a sample be contacted with a dye composition of the invention in the presence of at least one surfactant and optionally, a sulfonic acid or a salt thereof.

Abstract: Disclosed are novel protein and peptide compositions comprising soluble and bound forms of immunologically-active blood group antigens including mammalian Rh antigens. In preferred embodiments methods for the isolation and purification of serologically-active human Rh antigens such as D, c, C, E, and e are disclosed. Also disclosed are methods for the adsorption of immunologically-active Rh antigens to solid supports. Diagnostic kits, methods, and devices for the detection of Rh antibodies in clinical and non-clinical samples are also disclosed. Devices, compositions and methods for the isolation, purification and quantitation of anti-Rh antibodies from solution are also provided.

Abstract: The present invention relates to the field of quantitative microspectroscopy, and in particular to a method for calibrating a sample analyzer to obtain a more precise HCT value.

Abstract: Protective solution for use in a fixation method for the paraffin section technique and comprising (i) at least one amino acid and (ii) at least one sugar compound.

Abstract: This invention provides methods and apparatus that enable consumers to experience, prior to purchase, the aroma of a finished product even though the product as sold is unfinished. Further, methods and apparatus provide users of a product with a reference aroma that may be employed to determine if the product is suitable for use, while, prior to purchase, consumers can experience a selected aroma of a consumer product that has a plurality of aromas, and the aroma bouquet of a consumer product where a particular aroma in the bouquet has been intensified. Among other advantages, this invention enables marketers to employ additional sensual modalities, and particularly the sense of smell, in offering products for sale, and thus permits consumers to make better informed purchasing decisions.

Abstract: The proliferation of uterine fibroid leiomyoma cells is inhibited by certain Fibroid Cell Growth Inhibitor (FGI) agents. The pharmacological doses of these FGI agents in the milieu of uterine fibroid cells can be made high enough to not only inhibit proliferation, but to also causes cell death. Non-invasive or minimally invasive, non-systemic delivery methods are used to deliver the FGI agent to the milieu of the target fibroid leiomyoma cell population, thereby avoiding the disadvantages and side effects of surgical and systemic hormonal therapy interventions in the treatment of uterine fibroids. The FGI agents are substrates that are normally present or are well tolerated in the human body. The efficacy of the FGI agents appears to be related to their ability to moderate the Protein Kinase C and Mitogen Activated Protein Kinase pathways. Specific FGI agents shown to be useful to inhibit growth or proliferation of uterine fibroid cells include: &agr;-tocopherol, &agr;-tocopherol succinate, and troglitazone.

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 is an additive preparation which contains an additive, an organic acid, a metal carbonate compound, and a surfactant agent which is capable of rendering the surface of a collection device to have properties that cause the surface to repel the adsorption of components of a body fluid sample. The preparation effervesces when in contact with a body fluid sample, thereby efficiently dispersing the additive and surfactant in a body fluid sample.

Abstract: An improved rapid diagnostic device, assay and multifunctional buffer reagent are provided for the detection of a target analyte in a fluid test sample. The 2-step assay utilizes a dual component flow-through device comprising a test unit and a post-filter unit capable of receiving the fluid sample and multifunctional buffer, respectively. The test unit comprises a reaction zone containing immobilized capture reagent that can specifically bind to the target analyte, an absorbent zone supporting the reaction zone, and optionally, a blood separation zone in lateral fluid communication with the reaction zone. The post-filter unit comprises a label zone permeated with a dried indicator reagent which is capable of being placed in transient fluid communication with the reaction zone of the test unit during the assay procedure. The rapid diagnostic assay system reduces the number of assay reagents, method steps and time required for performance compared to other conventional assays.

Abstract: The present invention is directed to a fixative composition, the use of the fixative composition in preparing cytological or histological specimens, and a method of preparing particulate matter, such as cytology, hematology and microbiology specimens, for examination by collecting the particulate matter in a uniform layer, preferably a monolayer, and fixing the particles in a composition according to the present invention. The cytological, hematological, microbiological and histological fixative composition of the present invention contains an aldehyde crosslinker, a polyol and a detergent. The method of the present invention for preserving the particulate or histological specimen uses the fixative composition containing an aldehyde crosslinker, a polyol and a detergent.

Abstract: A reagent for measurement of leukocytes and hemoglobin concentration in the blood includes a cationic surfactant in an amount sufficient to lyse erythrocytes and denature hemoglobin, at least one of the following hemoglobin stabilizers: (a) sulfosalicylic acid, or its salt, in an amount effective for promoting the conversion of hemoglobin into methemoglobin, (b) 0.2 to 10.0 g/L of a water-soluble chelating agent having a nitrogen atom and a carboxyl group, and (c) piperazine, or its salt, in an amount effective for promoting the conversion of hemoglobin into methemoglobin, and a buffer for maintaining pH at 4 to 6.