Abstract: Sterilization apparatus includes a monitoring system capable of continuously monitoring levels of a sterilant, such as hydrogen peroxide vapor. The monitoring system includes a sensor chamber joined in fluid communication with a sterilant supply conduit of the sterilization apparatus. A gas-detecting semiconductor sensing element, and associated temperature sensor, are provided within the sensor chamber to provide output signals corresponding to detected levels of sterilant. The sensor chamber isolates parametric influence, such as relative humidity, temperature and flow rate, to provide more accurate concentration level readings. A data collection circuit is operatively coupled to the sensors to provide an output corresponding to detected levels of sterilant within the apparatus.

Abstract: A system for monitoring concentrations of sterilant, such as hydrogen peroxide vapor, within a sterilization apparatus, includes a self-contained, sterilant monitoring assembly that is freely positionable within the sterilization apparatus. The assembly includes a gas-detecting sensor and associated temperature sensor mounted on a portable structure, as well as a suitable data collection circuit for receiving output signals from the sensors. The assembly also includes signals connectors, such as a physical data port or a remote transmitter, or both. Signals can be transmitted concurrently with data collection, or an electronic memory may be provided for subsequent transfer of the collected data. Collected data is transferred to a remote communication unit positioned exteriorly of the sterilization apparatus.

Abstract: A method for the determination of concentrations of analytes, e.g., glucose, and other metabolites in human tissue, wherein the temperature of a defined cutaneous volume of tissue, e.g., human skin, is controlled. The method involves calculating the concentration of an analyte in the tissue by taking into consideration the values of optical parameters of a sample of tissue measured in the defined cutaneous volume of the tissue at various temperatures. The selection of the defined volume is a function of the sampling distance along the surface of the tissue, the wavelength of light used to illuminate the tissue, and the temperature in the defined volume of tissue, which is a function of the temperature at the surface of the tissue. In one embodiment of the method of this invention, an optical signal re-emitted from a defined cutaneous volume of the tissue is measured, as the temperature of this volume is maintained at a constant value.

Abstract: Sterilant monitoring assembly includes an external housing defining an inlet and an outlet, and an internal flow path extending therethrough. An internal housing is located within the external housing and substantially surrounded by the internal flow path. The internal housing defines an interior sensor chamber therein, and includes a valve arrangement to join the interior sensor chamber selectively in fluid communication with the internal flow path. Preferably, the valve arrangement of the internal housing is defined by a base portion and a cover portion moveable relative to each other between an open position and a closed position. In one embodiment, the cover portion has an open end section configured for sealing engagement with an opposing surface of the base portion when moved axially to the closed position. In another preferred embodiment, the base portion and cover portion include mating peripheral walls.

Abstract: A glucose monitoring device suitable for use in total darkness or in limited light environment. The glucose monitoring device comprises a housing, which encloses the components of the device that determine the blood glucose level of a blood sample on a test strip. The exterior surface of the housing comprises a phosphorescent material. The portion of the test strip where the blood sample is to be applied can be illuminated by a light. The area of the glucose monitoring device where the test strip is inserted into the device can also be illuminated by a light. The display of the device, i. e., the area of the glucose monitoring device where the result is read, is also illuminated by a light.

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises: (a) a housing having a sealable chamber located therein and a sealable opening in fluid communication with the sealable chamber; (b) a vacuum pump in communication with the sealable chamber; (c) a device for forming an unobstructed opening in an area of skin from which a sample is to be collected, preferably a lancing assembly, the device positioned within the sealable chamber; (d) a movable support for supporting and positioning a port for a fluid collector in the sealable chamber, the movable support capable of moving the port within the sealable chamber between a first position and a second position; and (e) a stop for aligning the fluid collector.

Abstract: A method for synthesizing dyes excitable by a helium-neon laser (excitable at 633 nm) from hololepidines, e. G., 7-halolepidine, which dyes are suitable for the detection and enumeration of reticulocytes in human blood samples. In another aspect, this invention provides a method for immunotyping phenocytes. The method is based on the phenomenon that when dyes of certain structure intercalate into DNA or RNA, the intensity of the dyes increases. The general structure of dyes suitable for use in this invention is shown below: wherein: R1, R2, R3, R4, R5, R6, R7, R8, R9, R10, R11, R12, R13, Y, and n are as defined in the specification.

Abstract: The present invention involves apparatus and methods for use in collecting bodily fluids, such as interstitial fluids, from the epidermal layer of an animal. A preferred apparatus includes a pressure head and, optionally, a holder therefor for supplying a positive pressure to the head. The methods include the application of a positive pressure to the area surrounding an epidermal site from which stratum corneum has been breached, such as by laser ablation, to cause bodily fluids, such as interstitial fluids, to exude from the site and collecting the fluids exuding therefrom.

Abstract: A device for the in vivo measurement of the concentration of an analyte in an aqueous solution comprises a transmitter for illuminating a body part with light at a plurality of predetermined wavelengths. A detector receives light from such body part and generates input signals representative of the intensity of received light at each of the predetermined wavelengths, and a computer coupled to the detector generates an output signal representative of the analyte concentration in the body part by analysis of the input signals received from the detector. The detector is adapted to generate input signals representative of the intensity of light received at three discrete wavelengths, and a formula is provided for calculating the output signal on the basis thereof.

Abstract: Apparatus and method for determining at least one parameter, e. g., concentration, of at least one analyte, e. g., urea, of a biological sample, e. g., urine. A biological sample particularly suitable for the apparatus and method of this invention is urine. In general, spectroscopic measurements can be used to quantify the concentrations of one or more analytes in a biological sample. In order to obtain concentration values of certain analytes, such as hemoglobin and bilirubin, visible light absorption spectroscopy can be used. In order to obtain concentration values of other analytes, such as urea, creatinine, glucose, ketones, and protein, infrared light absorption spectroscopy can be used. The apparatus and method of this invention utilize one or more mathematical techniques to improve the accuracy of measurement of parameters of analytes in a biological sample.

Abstract: Method and apparatus for mounting a sample comprising a crystal for X-ray crystallographic analysis, a method for aligning a sample comprising a crystal for X-ray crystallographic analysis, which sample is mounted on a positioning device, and a method for determining the structure of a sample containing a crystal by means of X-ray crystallography.

Abstract: A system for measuring a biological parameter, such as blood glucose, the system comprising the steps of directing laser pulses from a light guide into a body part consisting of soft tissue, such as the tip of a finger to produce a photoacoustic interaction. The resulting acoustic signal is detected by a transducer and analyzed to provide the desired parameter.

Abstract: An analyte test instrument having improved calibration and communication processes. The instrument employs a calibration method that allows it to communicate with any one of a plurality of data storage strips. A data storage strip including a memory device is inserted into the test port of the instrument. The data storage strip is identified, and the instrument establishes communications with the data storage strip using a protocol corresponding to the data storage strip. Second, the instrument employs a method for ensuring that the instrument is operated using valid calibration strips and test strips. The instrument determines whether one or more of test parameters stored in the instrument is invalid for a test strip inserted into the test port of the instrument. If a test parameter is invalid, an indication of the invalid strip parameter is displayed on the display.

Abstract: Apparatus and method for determining at least one parameter, e.g., concentration, of at least one analyte, e.g., urea, of a biological sample, e.g., urine. A biological sample particularly suitable for the apparatus and method of this invention is urine. In general, spectroscopic measurements can be used to quantify the concentrations of one or more analytes in a biological sample. In order to obtain concentration values of certain analytes, such as hemoglobin and bilirubin, visible light absorption spectroscopy can be used. In order to obtain concentration values of other analytes, such as urea, creatinine, glucose, ketones, and protein, infrared light absorption spectroscopy can be used. The apparatus and method of this invention utilize one or more mathematical techniques to improve the accuracy of measurement of parameters of analytes in a biological sample.

Abstract: Apparatus and method for non-invasively measuring at least one optical parameter of a sample, particularly a sample of tissue that comprises a plurality of layers. The at least one parameter can be used to determine the presence or concentration of an analyte of interest in the sample of tissue. The apparatus and method of the present invention (1) measure light that is substantially reflected, scattered, absorbed, or emitted from a shallower layer of the sample of tissue, (2) measure light that is substantially reflected, scattered, absorbed, or emitted from a deeper layer of the sample of tissue, (3) determine at least one optical parameter for each of these layers, and (4) account for the effect of the shallower layer on the at least one optical parameter of the deeper layer. Specifying the sampling depth allows determinations of the optical properties of a specific layer of the sample of the tissue, e.g., dermis, and decreases interference from other layers, e. g.

Abstract: A system for monitoring concentrations of sterilant, such as hydrogen peroxide vapor, within a sterilization apparatus, includes a self-contained, sterilant monitoring assembly that is freely positionable within the sterilization apparatus. The assembly includes a gas-detecting sensor and associated temperature sensor mounted on a portable structure, as well as a suitable data collection circuit for receiving output signals from the sensors. The assembly also includes signals connectors, such as a physical data port or a remote transmitter, or both. Signals can be transmitted concurrently with data collection, or an electronic memory may be provided for subsequent transfer of the collected data. Collected data is transferred to a remote communication unit positioned exteriorly of the sterilization apparatus.

Abstract: An article and a method for monitoring the concentration of an analyte, e. g., glucose, in blood. In one aspect, the invention involves an article comprising a multiple-layer element. In one embodiment, the article comprises: a multiple-layer element comprising: (a) a base layer (b) a cover layer, the cover layer having a first opening for venting the multiple-layer element and a second opening for receiving a biological sample; and (c) a core layer having a first major surface and a second major surface, the core layer disposed between the base layer and the cover layer, the core layer comprising a sample introduction chamber and a optical reading chamber, the first major surface of the core layer in face-to-face contact with the base layer, the second major surface of the core layer in face-to-face contact with the cover layer.

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of: (a) placing a blood collection device over a region on the surface of the skin from which said sample is to be obtained, (b) forming a seal between said blood collection device and said surface of the skin, (c) creating a vacuum sufficient to result in said surface of the skin becoming stretched and engorged with blood, (d) triggering a lancing assembly and causing a lancet to penetrate said skin, (e) retracting said lancet, (f) withdrawing blood toward and onto a fluid collector, and (g) releasing the vacuum. In another aspect of the invention, an apparatus for carrying out the method described previously is provided.

Abstract: Assay methods utilizing the response of a magnetically responsive reagent to the influence of a magnetic field to qualitatively or quantitatively measure binding between specific binding pair members. According to the invention, the presence of an analyte mediates whether or not the magnetically responsive reagent binds to a mobile solid phase reagent. The extent of binding will modulate the response of the magnetically responsive reagent or that of the mobile solid phase reagent, or both, to the influence of a magnetic field. Hence, by measuring the response to the magnetic field of the magnetically responsive reagent, or that of the mobile solid phase reagent, the presence or amount of analyte contained in a test sample can accurately be determined. The invention utilizes various devices to carry out the assay methods described.

Abstract: Diagnostic tool for the identification of anti-HCMV antibodies in human serum. The tool comprises a means of solid support having two sections, a first section bearing a plurality of HCMV proteins (vp) obtained from purified virions concentrated in separate bands forming a predetermined pattern, one of these bands being pp 150 of HCMV; a second section bearing recombinant fusion proteins as controls, at least one band comprising a recombinant fusion protein carrying at least one epitope of pp 150.