Abstract: In accordance with one embodiment of the invention, a system is provided for the monitoring of blood analytes using optical probes in the circulatory system. The probes can be inserted on the venous side of the circulatory system. In another embodiment, methods and apparatuses can be used for processing continuous information generated from indwelling intravascular or tissue optical sensors including, but not limited to, measuring gas concentrations, pH, temperature, and other analytes of blood or tissue. In another embodiment, analyte values can be displayed and analyzed to determine if the values fall outside of normal physiological parameters. Trends of one or multiple analyte values can be analyzed and extrapolated to predict any impending, deleterious condition. In one embodiment, an alarm can be transmitted to appropriate personnel when criterion/criteria are met. In yet another embodiment, devices can be inhibited from delivering continuous infusions of medicine to patients.

Abstract: Devices contain dried reagents that may be reconstituted and used in the calibration and quality control of sensors. Methods of producing and using the devices are also disclosed.

Abstract: The present invention provides a gaming machine executing the processing of (A) displaying on the display at least one playing card in a display mode that displays each playing card face down; and (B) changing the display mode of one of the at least one playing card displayed in the processing (A) to a display mode enabling a part of the front of the playing card to be viewable, upon contact on any position within an area of the touch panel corresponding to an area of the display where the one of the at least one playing card is displayed.

Abstract: Devices contain dried reagents that may be reconstituted and used in the calibration and quality control of sensors. Methods of producing and using the devices are also disclosed.

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

Abstract: A method of removing abnormal data in a blood component analysis system using spectroscopy to estimate a concentration of a blood component by analyzing a photo-plethysmographic (PPG) signal obtained by radiating light of first and second wavelengths reacting to the blood component on a subject and detecting light corresponding to the first and second wavelengths output from the subject, includes collecting the PPG signal corresponding to the first and second wavelengths for a predetermined unit period of time, calculating “n” parameters, with respect to “n” pulse data included in the collected PPG signal, where n is a positive integer, calculating an average of the “n” parameters, and comparing a ratio of a number of parameters whose deviation from the average is greater than a predetermined standard deviation to the “n” parameters with a predetermined removal reference value to determine whether the “n” pulse data is valid.

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

Abstract: A method, apparatus and article generates a pseudo-random playing card sequence and distributes playing cards according to the pseudo-random playing card sequence. For example, the method, apparatus and article generates a pseudo-random playing card sequence and prints playing cards in order of the pseudo-random playing card sequence. Further, the method, apparatus and article generates a pseudo-random playing card sequence based on a house advantage. Yet further, the method, apparatus and article can generate a promotional message on one or more playing cards.

Abstract: A method for preparing a composition that includes selecting a pH of the composition; selecting a first buffer with a negative temperature coefficient; selecting a second buffer with a positive temperature coefficient; and forming the composition comprising the first buffer and the second buffer. The composition has an average temperature coefficient, ?pH/?T(Ta,Tb)?1×10?3 pH-unit/K and a ?pH(Ta,Tb)?0.31 pH-unit for Ta=4 K and Tb=313 K.

Abstract: The invention relates to a method for the determination of the concentration of a non-volatile analyte in an aqueous sample medium, with the use of an optical sensor which contains a luminescent dye and is calibrated at the user site by means of a single-point-calibration. To enable the user to completely dispense with all calibration media a luminescence measurement value is obtained at the user site with the sensor in contact with the aqueous or bloodlike sample medium, which value is referenced to the relative characteristic obtained at the factory site and to a measured dry calibration value obtained at the user site, the concentration of the non-volatile analyte being deduced from these data.

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

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

Abstract: H-NOX proteins are mutated to exhibit improved or optimal kinetic and thermodynamic properties for blood gas O2 delivery. The engineered H-NOX proteins comprise mutations that impart altered O2 or NO ligand-binding relative to the corresponding wild-type H-NOX domain, and are operative as physiologically compatible mammalian blood O2 gas carriers. The invention also provides pharmaceutical compositions, kits, and methods that use wild-type or mutant H-NOX proteins for the treatment of any condition for which delivery of O2 is beneficial.

Abstract: The present invention provides a reference solution for use in instruments that determine hematocrit levels in biological samples by measuring the resistance and/or conductivity of the biological samples. A reference solution according to the invention achieves conductivities representative of known hematocrit levels in blood, while maintaining tolerable levels of interference with the measurement of other analytes in the reference solution.

Abstract: A standard material that is used for judging an abnormal portion in a particle analyzer is described. The standard material comprises first standard particles to be fluorescence-stained by a fluorescence-staining treatment and second standard particles that have preliminarily contained a fluorescence dye. A method and an analyzer that can judge an abnormal portion in a particle analyzer by using such a standard material are also described.

Abstract: The present invention provides a reference solution for use in instruments that determine hematocrit levels in biological samples by measuring the resistance and/or conductivity of the biological samples. A reference solution according to the invention achieves conductivities representative of known hematocrit levels in blood, while maintaining tolerable levels of interference with the measurement of other analytes in the reference solution.

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: 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 on 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: 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: 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 electronic system for tracking and monitoring articles to be subjected to a sterilization cycle is disclosed. The method uses a sterilization indicator and electronically links sterilization information with the articles subjected to the sterilization process. 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: 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: Compositions and methods are disclosed for use in the analysis and quantitation of conjugated and unconjugated bilirubin in patient or other 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 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: Multi-analyte reference solutions having a stable partial pressure of oxygen (pO.sub.2) 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: A method is disclosed for reliably calibrating a sensor used in diagnostic sensing of a predetermined parameter, e.g., CO.sub.2 partial pressure, O.sub.2 partial pressure, or pH, of a solution such as blood, the method compensating for expected variations over time in the value of the parameter in a calibration solution. The parameter of the calibration solution has a predetermined initial value, and the solution is initially located within a container that is configured to allow the value of that parameter to vary over time in a predetermined manner. Supplying the calibration solution to the sensor causes the sensor to produce a calibration solution signal, which is compared with a calculated value for the parameter based on its expected variation over time, to produce a calibration factor. Thereafter supplying the test fluid to the sensor causes the sensor produces a test fluid signal, and this test fluid signal then is adjusted in accordance with the calibration factor.

Abstract: A method for calibrating an instrument for the analysis of blood gases which possesses ion-sensitive electrodes and gas-sensitive electrodes and is used for the determination, in a biological fluid, of the concentration of electrolytes and metabolites in solution, and of the pH, pO.sub.2 and pCO.sub.2, the said calibration being carried out with at least one buffered solution containing O.sub.2, a known or tonometer-measured amount of CO.sub.2 and known concentrations of the electrolytes and metabolites to be determined, in which calibration the pO.sub.2 titer is determined beforehand using atmospheric oxygen as reference.

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 reference solution container for an analyzer for measuring gas and/or electrolyte levels in a fluid. The vessel includes a fluid container for holding a reference solution and a self-sealing fluid port for repeatedly accessing the reference solution in the fluid vessel by a fluid carrying device that is external to the reference solution container. The partial pressure of each gas in the reference solution within the fluid vessel is maintained at a substantially constant level.

Abstract: Provided is a method of preparing dye-based reference materials useful for calibrating or qualifying instrument systems that are diagnostic spectroscopically for hemoglobin and CO-ox fractions. The dye-based reference materials are non-proteinaceous and may be interpreted by CO-oximeter instrument systems as providing a spectrum substantially equivalent to the spectrum of blood, particularly with regard to hemoglobin and hemoglobin CO-ox fractions. Dye-based reference materials may be formulated to provide CO-ox fractions approximating those seen in a clinical setting, including normal physiological CO-ox fractions. The dye-based reference materials may be combined with other ingredients thus making the materials useful as references for pH and blood gas instruments and/or electrolyte instruments in addition to CO-oximeter instrument systems.

Abstract: The present invention provides an optical fluorescence based sensor for measuring the concentration of a gas (e.g., CO.sub.2 or ammonia) in a medium such as blood which has improved drift stability. In a preferred embodiment, the sensors of the present invention comprise microcompartments of an aqueous phase having a pH sensitive sensing component within a hydrophobic barrier phase. The sensors of the present invention are substantially free of partitioning species other than the analyte of interest which can migrate from one phase to the other in response to a change in pH in the aqueous phase and which substantially affect the concentration dependent signal. In an alternative embodiment, the sensors of the present invention are constructed so as to retard the migration of partitioning species, thus reducing the initial rate of drift.

Abstract: An apparatus and method of equilibrating the dissolved gas composition of an aqueous fluid to reflect the predetermined gas composition contained in a gas equilibration reservoir. The equilibrated aqueous fluid can be used in a method of determining the concentration of a dissolved gas in a fluid sample. In one embodiment, the method is used to control the equilibrated gas composition of a calibrant fluid which, in turn, is used to measure the concentration of a dissolved gas, such as oxygen and carbon dioxide, in a sample fluid, such as whole blood.

Abstract: A novel flexible package for an oxygen reference solution has been developed. This package is made from a laminated film including preferably polypropylene as the inner layer, aluminum foil as the middle layer, and polyester as the outer layer. The seams are heat sealed, while an optional access device for allowing access to the solution after the storage period, is attached to the inside wall of the bag without breeching the middle barrier layer.

Abstract: The present invention is directed to an in vitro aqueous composition comprising a drug, preferably tacrolimus or rapamycin, having enhanced stability. The invention utilizes a binding protein, preferably FKBP, to stabilize the drug in an aqueous matrix.

Abstract: In a method for calibration of a pH measuring element whose ion-permeable, hydrophilic polymer layer is brought into contact with an aqueous solution prior to calibration, the aqueous solution is displaced or replaced by a gaseous calibrating medium, and residues of the aqueous solution remaining in the ion-permeable polymer layer. The gaseous calibrating medium contains a known amount of at least one component which is acid or basic in aqueous solution which reacts with the remaining residues of the aqueous solution in the polymer layer, such that a defined pH value is established in the polymer layer, which is employed for calibration of the measuring element.

Abstract: Provided is a method of preparing dye-based reference materials useful for calibrating or qualifying instrument systems that are diagnostic spectroscopically for hemoglobin and CO-ox fractions. The dye-based reference materials are non-proteinaceous and may be interpreted by CO-oximeter instrument systems as providing a spectrum substantially equivalent to the spectrum of blood, particularly with regard to hemoglobin and hemoglobin CO-ox fractions. Dye-based reference materials may be formulated to provide CO-ox fractions approximating those seen in a clinical setting, including normal physiological CO-ox fractions. The dye-based reference materials may be combined with other ingredients thus making the materials useful as references for pH and blood gas instruments and/or electrolyte instruments in addition to CO-oximeter instrument systems.

Abstract: In high volume laboratory analysis of patient medical specimens, control materials are inserted at periodical intervals (e.g. once per eight hours) and analyzed. If the results of the analysis deviate from the mean according to statistical rules, the run of analyses prior to the insertion of control materials has in the past been rejected, often causing a substantial loss of results because the control materials were not inserted sufficiently frequently. According to the invention the patient mean of a test is determined, and when the mean deviates from the predetermined mean by more than a selected amount, this determination is used, not to reject the run, but rather to trigger insertion and analysis of control materials. If the analysis of control materials shows that the run is in control, the analyses made prior thereto are reported and the run is resumed. If the control material analysis shows that the run is out of control, then the prior analyses are rejected.

Abstract: Disclosed is an apparatus and method of equilibrating the dissolved gas composition of an aqueous fluid to reflect the predetermined gas composition contained in a gas equilibration reservoir. The equilibrated aqueous fluid can be used in a method of determining the concentration of a dissolved gas in a fluid sample. In one embodiment, the disclosed method is used to control the equilibrated gas composition of a calibrant fluid which, in turn, is used to measure the concentration of a dissolved gas, such as oxygen and carbon dioxide, in a sample fluid, such as whole blood.

Abstract: Disclosed is an apparatus and method of equilibrating the dissolved gas composition of an aqueous fluid to reflect the predetermined gas composition contained in a gas equilibration reservoir. The equilibrated aqueous fluid can be used in a method of determining the concentration of a dissolved gas in a fluid sample. In one embodiment, the disclosed method is used to control the equilibrated gas composition of a calibrant fluid which, in turn, is used to measure the concentration of a dissolved gas, such as oxygen and carbon dioxide, in a sample fluid, such as whole blood.

Abstract: A CO.sub.2 electrode can be calibrated with two PCO.sub.2 calibration standard solutions having known pH values and known bicarbonate ion source concentrations. An O.sub.2 electrode can be calibrated using air as one calibration standard and a solution containing an excess of an O.sub.2 depleting agent as a second calibration standard.

Abstract: A reference solution for calibrating and monitoring blood gas instrumentation that has a shelf line of two years or greater is disclosed. The solution is contained in a closed container having a gas or gas mixture that is inert to the reference solution and comprises an aqueous mixture containing a hemoglobin, a source of bicarbonate ions and an organic buffer. The solution optionally contains a methemoglobin reducing system, reference concentrations of selected electrolytes, a polyphosphate compound and antibiotics. The ampule is subsequently opened and the solution is equilibrated with a gas mixture having components which provide gasses in a physiological range to the solution. The solution is characterized by exhibiting properties similar to fresh blood subsequent to equilibration.

Abstract: Aqueous solutions containing buffers and electrolytes are adjusted to levels required for calibration of both blood gas analyzers and ion selective electrolyte analyzers. A control material, composed of similar matrix, is adjusted to three levels of blood gas and electrolyte conditions. These quality control materials are used to monitor blood gas/electrolyte laboratory instrumentation.

Abstract: A method is disclosed for differentiating white blood cells. The method uses at least one surfactant and at least one dilute acid which together selectively strip the cytoplasm from certain classes of white blood cells and not others. More particularly, the method causes lysis of lymphocytes, monocytes, eosinophils and neutrophils, but not basophils. Thus, basophils are differentiated from other PMN sub-classes by their appearance as intact cells. The method totally avoids the need for dye preparation and the vagaries of staining techniques and can be used either manually or with instrumentation.

Abstract: A hematology control product comprising leukocyte analogs is described. The analogs comprise red blood cells which simulate at least two physical properties of human leukocytes. A method for making leukocyte analogs from blood cells having desired physical properties is also described. The process comprises expanding the cell volume, changing the hemoglobin content of the cell and fixing the cell. Generally, the monocyte and lymphocyte analogs leak hemoglobin from the cell while the eosinophil analog has the hemoglobin precipitated in the cell. A further method is described to use the control product to determine whether an automatic instrument is operating within manufacturer's specification.

Abstract: Aqueous solutions containing buffers and electrolytes are adjusted to levels required for calibration of both blood gas analyzers and ion selective electrolyte analyzers. A control material, composed of similar matrix, is adjusted to three levels of blood gas and electrolyte conditions. These quality control materials are used to monitor blood gas/electrolyte laboratory instrumentation.

Abstract: A calibration system comprising a sensor cassette including at least one sensor to be calibrated and a housing having a liquid passage including a chamber. The housing is coupled to the sensor cassette to place the liquid passage in fluid communication with the sensor cassette. The housing has a gas injection passage through which a gas can be injected into the liquid passage to mix with a calibration liquid in the housing. A gas vent vents the gas from the housing. Porous media is provided in the chamber. The gas and calibration liquid pass through the porous media, and the porous media assists in rapid mixing of the gas and the calibration liquid.

Abstract: The present invention provides an aqueous buffer solution and method and solution for hydrating and calibrating a sensor membrane of a fiber-optic catheter useful for measuring an analyte other than chloride in a physiological milieu. The temperature, gaseous atmosphere, and aqueous buffer solution of the sensor component are controlled throughout the calibration process in order to ensure that the device is calibrated in accordance with its intended use. The solution is chemically compatible with the intended use of the device and provides compensation for evaporative loss, contaminants, or changes in the solution occurring during storage especially in plastic containers.

Abstract: A hematology control product comprising leukocyte analogs is described. The analogs comprise red blood cells which simulate at least two physical properties of human leukocytes. A method for making leukocyte analogs from blood cells having desired physical properties is also described. The process comprises expanding the cell volume, changing the hemoglobin content of the cell and fixing the cell. Generally, the monocyte and lymphocyte analogs leak hemoglobin from the cell while the eosinophil analog has the hemoglobin precipitated in the cell. A further method is described to use the control product to determine whether an automatic instrument is operating within manufacturer's specification.

Abstract: A stable reference solution for calibrating and monitoring blood gas instrumentation is disclosed. The solution comprises an aqueous mixture containing a hemoglobin solution derived from a mammalian source which comprises at least about 95% reduced hemoglobin. The solution additionally contains a bicarbonate buffer and a metal catalyzed methemoglobin reducing system and an organic buffer. To provide a control element having a variety of properties similar to fresh, whole, human blood, the reference solution is stored in a sealed ampule under an inert atmosphere containing CO.sub.2 until just prior to use. The ampule is subsequently opened and the solution is equilibrated with a gas mixture having components which provide gasses in a physiological range to the solution. The solution is characterized by exhibiting properties similar to fresh blood subsequent to equilibration and an extended storage life prior to equilibration.