Abstract: Compositions, methods, devices and kits for use in the calibration of coagulation tests. The control compositions include 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 include 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 include 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 include a control composition including 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: Approaches are described for separating plasma from whole blood samples and include the use of magnetically attractable particles associated with an agglutinating agent. The magnetically attractable particles bind the cellular components in a whole blood sample. Application of a magnetic field gradient to a container with the blood sample and the magnetically attractable particles draws the particles to the surface of the container near the source of the magnetic field gradient. The plasma can be removed and stored or used for monitoring or detecting analytes in the plasma.

Abstract: A chromatography assay device and method for use with whole blood samples utilizing a red blood cell separating agent to aggregate red blood cells and permit plasma or serum to flow by capillary action and a neutralizing agent to neutralize any effects the red blood cell separating agent may have on the device and method.

Abstract: Methods for assessing a patient's risk of having or developing coronary heart disease based on lipoprotein measurements measure and identify values for lipoprotein subclass constituents and analyze according to predetermined test criteria to identify when there is an increased and/or decreased risk of having and/or developing coronary heart disease associated wit the measured lipoprotein subclass constituent values.

Abstract: The invention disclosed is a process for determining the cytoprotective activity of plasma that prevents the destruction of endothelial cells and forestalls the development of a number of diseases such as atherosclerosis, preeclampsia, edema, nephrotic syndrome, and stroke. The present invention includes a method of diagnosing a patient's proclivity to develop a disease having a correlation to a reduction in the concentration of pI 5.6 albumin in the plasma by determining a value indicative of the concentration of the pI 5.6 albumin that is not bound to VLDL (“free pI 5.6 albumin”) in the patient's blood serum. The preferred embodiment of the process utilizes in vitro methods to obtain an indicator of the free pI 5.6 albumin instead of directly measuring the concentration of the free pI 5.6 albumin.

Abstract: The invention concerns calibrators or calibration solutions which are based on a human serum matrix and which are used in a method for detecting cytokeratin, a process for producing them, a method for stabilizing cytokeratin and an immunological method for detecting cytokeratin in a sample.

Abstract: The present invention relates to a device for diagnosing and/or quantifying antibodies present in a biological fluid from a patient and which are specific for a reaction associated with an infection with a microorganism, specific for an autoimmune reaction or specific for an allergy. This device includes as a standard a biological sample selected from a pool of blood plasmas from more than 200 healthy patients.

Abstract: Multi-analyte reference solutions having a stable partial pressure of oxygen (pO2) in zero headspace packaging and methods for preparing such solutions are disclosed. The solutions have long shelf and use lives when stored at room temperature and are packaged in laminated foil containers having low or no oxygen reactivity. Access devices are also disclosed.

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: 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: 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 method for analyzing a patient's risk of coronary heart disease by determining the presence of NMR-derived or based lipoprotein constituent value abnormalities includes determining the presence of atherogenic dyslipidemia based on the existence of a clustering of lipoprotein constituent abnormalities as defined by predetermined test criteria. Computer program products and automatically produced reports for presenting NMR-derived lipoprotein risk assessment based on patient-specific lipoprotein subclass results present the measurement results adjacent to a segmented reference risk analysis portion. The actual measured results are visually aligned and enhanced within the risk analysis portion to provide easy reference and understanding of the results relative to a risk of developing coronary heart disease.

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 diagnostic plot derived from the measurement of 82 assays which characterize two key parameters which significantly contribute to an individual's health status. These two parameters are oxidative stress profile (OSP) and antioxidant profile. Each of the assays which constitute the 82 assays are complimentary with other assays of the profile, thus providing either confirmation information or the synthesis of new information. The diagnostic plot, developed to interpret the assay data which provides information about oxidative damage and antioxidant protection, consists of four quadrants, each with noticeable characteristics.

Abstract: A method of quality control to diagnose the cause of a malfunction of an instrument. The method uses measurements of the physical property of a sample to diagnose the cause of a malfunction of an instrument. The spatial position of a control product sample is analyzed. Alternatively, the spatial position of a statistically significant number of patient blood samples can be used. The method enables the monitoring of an instrument for problems associated with debris and noise caused by red cell lysis inefficiency; instrument reagents pump volume settings; instrument laser alignments; instrument gain settings; and flow noise caused by partial plugs, residual plugs or other flow problems. The method provides a more specific indication of the type and cause of an instrument malfunctioning than non specific flagging provided by prior art methods.

Abstract: A control and system for blood testing, including a control having stabilized blood cells that have been introduced into a suspension including an aggregating agent and preferably a surfactant. The control and system is used advantageously for indirect acute protein plasma measurement, including erythrocyte sedimentation rate testing.

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 method of quality control to diagnose the cause of a malfunction of an instrument. The method uses measurements of the physical property of a sample to diagnose the cause of a malfunction of an instrument. The spatial position of a control product sample is analyzed. Alternatively, the spatial position of a statistically significant number of patient blood samples can be used. The method enables the monitoring of an instrument for problems associated with debris and noise caused by red cell lysis inefficiency; instrument reagents pump volume settings; instrument laser alignments; instrument gain settings; and flow noise caused by partial plugs, residual plugs or other flow problems. The method provides a more specific indication of the type and cause of an instrument malfunctioning than non specific flagging provided by prior art methods.

Abstract: A non invasive method for determining the blood coagulation status of a human or an animal is described. F1+2, F1, F2, FpA, D-dimers, F1+2 combined with F1, or F1+2 combined with F2 are measured in saliva, sputum and related biological samples. The respective concentrations are inversely correlated to the time it takes blood to coagulate and the probability of bleeding, and directly correlated to the probability of in-vivo formation of a thrombus or emboli. The method can be used in any coagulation disorder study, including congenital, acquired or drug-induced.

Abstract: This invention describes a method for pumping or delivering fluids utilizing a flexible vessel subject to controlled pressures within another pressure vessel. The pressure vessel can be sourced with positive and/or negative (e.g., vacuum) pressure.

Abstract: A control serum for a dry process is provided that dose 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 present invention relates to methods for the production of a stable troponin preparation and its use as a calibrator and/or control in immunoassays. The formulation is prepared from mammalian, preferably bovine, heart tissue which provides a calibrator/control composition which remains stable over a long period of time.

Abstract: The present invention relates to the use of sterol esters for the long-term stabilization of biological fluids, in particular even those which are obtained by lyophilization and subsequent reconstitution.

Abstract: This invention is a method comprising preparing a sample by coating a thin film of a precursor material, which is free of fluorescent probe molecules onto a substrate and subjecting the precursor material to conditions to attempt to cause cure of the precursor to an organic, aromatic, polymer having a dielectric constant of less than 3.0, exposing the sample to radiation having a wavelength in the range of 200 to 500 nm, detecting a resulting emission of radiation, and comparing the emission to the emission for a known cured, non-oxidized standard for the polymer.

Abstract: Hematology control compositions and systems used to measure a plurality of parameters in a blood sample are provided. The hematology control compositions are particularly useful as a control for multi-parameter, automated instrument systems. The control compositions comprise a reticulocyte component, a white blood cell component, a red blood cell component, a nucleated red blood cell component, a platelet component and a reticulated platelet component. Methods of making and using the control compositions are also provided.

Abstract: Hematology control compositions and systems used to measure a plurality of parameters in a blood sample are provided. The hematology control compositions are particularly useful as a control for multi-parameter, automated instrument systems. The control compositions comprise a reticulocyte component, a white blood cell component, a red blood cell component, a nucleated red blood cell component, a platelet component and a reticulated platelet component. Methods of making and using the control compositions are also provided.

Abstract: A method of detecting peptide fragments of protein(s) that are differentially present in biological samples. The identity of the peptides may be determined and correlated with the protein(s) that are differentially present in the samples.

Abstract: A quality control material is disclosed which is used to monitor the calibration or used for recalibration of instruments used to screen for interferents in serum or plasma specimens. In particular, the quality control material disclosed is used to monitor instrument calibrations or used for recalibration for instruments which assess the amount of hemolysis, turbidity, bilirubinemia and biliverdinemia, either separately, or any two, or any three, or all four simultaneously, in plasma or serum samples. The quality control material does not contain any blood products such as plasma lipids, bile pigments, or hemoglobin, is stable at room temperature, and is ready for use with up to four constituents.

Abstract: A method of quality control to diagnose the cause of a malfunction of an instrument. The method uses measurements of the physical property of a sample to diagnose the cause of a malfunction of an instrument. The spatial position of a control product sample is analyzed. Alternatively, the spatial position of a statistically significant number of patient blood samples can be used. The method enables the monitoring of an instrument for problems associated with debris and noise caused by red cell lysis inefficiency; instrument reagents pump volume settings; instrument laser alignments; instrument gain settings; and flow noise caused by partial plugs, residual plugs or other flow problems. The method provides a more specific indication of the type and cause of an instrument malfunctioning than non specific flagging provided by prior art methods.

Abstract: This invention describes methods and kits for determining instrument linearity of a flow cytometer and is particularly useful as a control particle for use in conjunction with absolute cell counting methods. The particle used in the practice of this invention comprises a small fluorescent bead.

Abstract: Disclosed is a stabilized enzyme composition for use in clinical examination, comprising: (a) an enzyme component comprising at least two enzymes selected from the group consisting of alkaline phosphatase, creatine kinase and alanine aminotransferase; (b) a stabilizer component comprising effective stabilizing amounts of an albumin, and at least one saccharide selected from the group consisting of trehalose and sorbitol; and (c) an aqueous medium having dissolved therein the components (a) and (b). The enzyme composition of the present invention is stable for a prolonged period of time not only under non-freeze refrigeration conditions, but also under freezing conditions or under conditions for non-freeze refrigeration after thawing of the frozen composition, as compared to the conventional enzymatic compositions.

Abstract: Hematology control compositions and systems used to measure a plurality of parameters in a blood sample are provided. The hematology control compositions are particularly useful as a control for multi-parameter, automated instrument systems. The control compositions comprise a reticulocyte component, a white blood cell component, a red blood cell component, a nucleated red blood cell component, a platelet component and a reticulated platelet component. Methods of making and using the control compositions are also provided.

Abstract: A three-phase suspension suitable for use as an erythrocyte sedimentation rate (ESR) control having the following three components: (1) a synthetic plasma base, (2) an aggregating agent such as a high molecular weight polymer or combination of high molecular weight polymers, and (3) chemically fixed mammalian red blood cells. The control is designed to allow the user to monitor the accuracy and precision of analytical methods for determining the sedimentation rate of human erythrocytes in whole blood specimens. Chemical fixing of the red blood cells provides the ESR control with the capability of providing useful results in the presence of citrate and/or saline.

Abstract: The present invention relates to the use of sterol esters for the long-term stabilization of biological fluids, in particular even those which are obtained by lyophilization and subsequent reconstitution.

Abstract: A method for calibrating thin film measurement tools includes the steps of forming an insulation layer on a semiconductor substrate, and measuring a thickness of the insulation layer using a first measurement tool. The insulation layer is exposed to an ambient environment causing a contamination layer to form thereon. At least a portion of the contamination layer is removed by heating the semiconductor substrate, and the thickness of the insulation layer and the contamination layer is measured after being heated using a second measurement tool. The first and second measurement tools are at respective widely spaced geographic locations. The steps of heating and measuring are repeated until a measurement is obtained indicating that the contamination level has been removed.

Abstract: Method and test kit for assaying in a sample an analyte which is a bloodgroup antigen present on erythrocytes or an antibody binding to such a bloodgroup antigen. To that end, the sample is treated with a reagent containing a binding partner for the analyte, so that a complex of bloodgroup antigen present on erythrocytes and antibody bound thereto is formed if the sample contains analyte. The analyte is a bloodgroup antigen present on erythrocytes, the analyte binding partner is an antibody capable of binding to the bloodgroup antigen and if the analyte is an antibody binding to a bloodgroup antigen, the analyte binding partner is the bloodgroup antigen present on erythrocytes. Erythrocytes, complex or non-complexed, are then separated from non-bound antibodies using a separation medium with a density higher than that of the liquid containing the antibodies but lower than the density of crythrocytes.

Abstract: A method of determining the presence of chronic volume dependent hypertension is provided wherein a determination is made as to whether there has been a substantial reduction in phosphorylation of the blood-derived protein or renal proximal brush border membrane protein and if such reduction exists concluding that chronic volume dependent hypertension exists in a patient. The method may advantageously be practiced by employing blood serum or blood plasma as the body specimen containing the protein in determining whether a patient has chronic volume dependent hypertension, a cellular component of the blood, such as a blood-derived protein coming from the plasma membrane of lymphocytes. The method may include subsequent therapeutic patient treatment. Related diagnostic apparatus is also provided.

Abstract: The present invention relates to a hemoglobin compositions stabilized against the formation of aggregates. The present invention further relates to methods of making such hemoglobin compositions.

Abstract: A method for separating serum from whole blood in a vessel at an insertion speed of 30 cm/sec or less and maintaining the suction pressure of the suction nozzle at 400 mm Hg or less. Improved analytical results are obtained because the serum can be produced without hemolysis.

Abstract: Hematology control compositions and systems used to measure a plurality of parameters in a blood sample are provided. The hematology control compositions are particularly useful as a control for multi-parameter, automated instrument systems. The control compositions comprise a reticulocyte component, a white blood cell component, a red blood cell component, a nucleated red blood cell component, a platelet component and a reticulated platelet component. Methods of making and using the control compositions are also provided.

Abstract: The invention relates to a process for the production of plasmas with added annexins for use as a control or standard in all functional clotting tests which are used for the detection of a lupus anticoagulant.

Abstract: Hematology reference control cells and method of manufacture. The invention relates to the methods of preparing stable white blood cell (“WBC”) and nucleated red blood cell (“NRBC”) fractions and the hematology control reagents containing such stablized cells for primary use on a multi-angle light scatter based hematology instrument.

Abstract: A control or calibration standard for use with instruments for the optical measurement of the hemoglobin content in blood samples, features scattering particles or beads dispersed in aqueous electrolyte solution. To prevent sedimentation of the beads during storage, they have a mean diameter of <0.6 &mgr;m, preferably about 0.3 &mgr;m, and a volume concentration of <1%, preferably <0.3%. To prevent long term agglomeration, a non-ionic surfactant with an added antioxidant can be included in the formulation.

Abstract: A method for stabilizing analyses with antibodies and antibody fragments comprises dissolving the analyte in a liquid to form a solution, adding analyte-specific antibodies, fragments of such antibodies, or both to the solution, heating the solution, and then cooling and filtering the solution. The filtered solution may be diluted in a suitable matrix.

Abstract: A multiple coagulation test system and method for determining an appropriate coagulation promoting substance for administration to a patient as a therapy for improving clotting function in said patient has at least three sample wells. One of the wells is for testing a baseline clotting indicator time of a patient's blood to serve as a control sample. Each of the other wells are for testing clotting indicator times of different coagulation promoting substances when mixed with the patient's blood. The coagulation promoting substances are agents or combination of agents capable of improving clotting function in the patient. An appropriate therapy for improving clotting function in the patient is determined by comparison of the baseline control clotting indicator time with the clotting indicator times of the coagulation promoting substances mixed with the patient's blood. Generally, the agent giving the lowest clotting indicator time is selected as an appropriate treatment for reducing hemorrhaging begun.

Abstract: In a blood analysis system and method, a measurement unit with a measurement cell is alternately filled with blood and at least two specific fluids. At least one of the specific fluids serves as a calibration fluid for the measurement unit. A tag substance is added to at least one of the specific fluids to make the fluids distinguishable from each other and from blood, and the measurement unit includes a detector, arranged in the measurement cell, for determining the identity of fluid present in the measurement cell. The entire blood analysis system can be controlled and monitored on the basis of the identity of the fluid in the measurement cell.

Abstract: A method is provided for detecting shock by measuring the concentration of cyclophilins in a patient's blood and comparing the measured concentration against a control. The severity of shock is then evaluated, an increase in cyclophilin concentrations over control levels being associated with severity. Measuring methods include enzymological techniques, such as rotomase activity assay; immunological procedures, such as radioimmunoassay and ELISA; peptide chemical processes, such as affinity chromatography; and radiochemical approaches, such as contacting the sample with radioactive cyclosporin.

Abstract: A method and system for controlling the concentration of one or more gaseous species of interest in a fluid reference medium throughout a range of temperatures in which a temperature related, dominant independent source of the gaseous species of interest is used to control the partial pressure of one or more gaseous species of interest contained in the reference medium in a manner such that the concentration of the gaseous species of interest in the reference medium is controlled as a predetermined, normally generally linear, function of temperature, f(T), over the temperature range. The source of the one or more gaseous species of interest is a separate reservoir containing an amount of a formulated temperature sensitive source of the one or more gaseous species of interest. The reference medium and the reservoir are contained in separate liquid-tight, gas-permeable enclosures contained in a common substantially gas-tight enclosure.

Abstract: A three-phase suspension suitable for use as an erythrocyte sedimentation rate control having the following three components: (1) a synthetic plasma base, (2) a high molecular weight polymer, and (3) mammalian red blood cells. The control is designed to allow the user to monitor the accuracy and precision of analytical methods for determining the sedimentation rate of human erythrocytes in whole blood specimens.

Abstract: A three-phase suspension suitable for use as an erythrocyte sedimentation rate (ESR) control having the following three components: (1) a synthetic plasma base, (2) an aggregating agent such as a high molecular weight polymer or combination of high molecular weight polymers, and (3) chemically fixed mammalian red blood cells. The control is designed to allow the user to monitor the accuracy and precision of analytical methods for determining the sedimentation rate of human erythrocytes in whole blood specimens. Chemical fixing of the red blood cells provides the ESR control with the capability of providing useful results in the presence of citrate and/or saline.