Abstract: Non-limiting embodiments of methodologies for preparing diagnostic assay(s) calibrator(s), calibration material(s), and/or control(s), as well as kits, devices, and method(s) of calibration related thereto.

Abstract: A physiological information measuring apparatus includes a first detection unit, having a first light emitting unit and a first light receiving unit, separated from one another by a first distance. A second detection unit of the physiological information measuring apparatus has a second light emitting unit and a second light receiving unit, separated from one another by a second, different distance. Alternatively, the second detection unit shares the first light emitting unit with the first detection unit and has a second light receiving unit. Alternatively, the second detection unit shares the first light receiving unit with the first detection unit and has a second light emitting unit. A measuring unit of the physiological information measuring apparatus measures the physiological information of a user based on light received by the light receiving unit or light receiving units.

Abstract: A method for determining total hemoglobin concentration in a blood sample comprising spectrophotometric analysis of a blood sample at two wavelengths and determining a ratio of the detected radiation at a first wavelength to the detected radiation at a second wavelength; and determining a concentration of total hemoglobin in the blood sample based on the ratio.

Abstract: Disclosed is an inspecting equipment for inspecting a light emission characteristic of a display screen includes: a carrying device provided for carrying the display screen, a cover device and a data analyzing device. The cover device has a detecting surface provided with a plurality of luminance detectors, and covers an emitting surface of the display screen to form a darkroom between the cover device and the detecting surface. A plurality of corresponding luminance information is generated by the luminance detectors provided for detecting a plurality of measuring zones of the emitting surface. The data analyzing device receives the luminance information and analyzes the light emission characteristic of the display screen according to the luminance information. And, it is thus able to rapidly inspect the light emission characteristic of the display screen during manufacture process, and is easy to be applied to a present producing line.

Abstract: Provided herein are an examination device and an examination method that can efficiently perform examination even when both whole blood and serum/blood plasma specimens are to be examined. A solid-phase extraction cartridge or a filter is placed on a continuous track of a cartridge table. A cup table is disposed below the cartridge table. A cup is placed on a continuous track of the cup table to receive a sample purified by the filter. When viewed from above, the continuous track of the cartridge table and the continuous track of the cup table cross each other at a position “m”, and each of the tracks crosses a position at which a sample probe operates. A pretreatment for serum/blood plasma is completed in one rotation of the cartridge table. A pretreatment for whole blood is completed in two rotations of the cartridge table.

Abstract: An optical waveguiding optical format enables consistent optical analysis of small sample volumes. The optical format is comprised of an illumination light guide, a read window upon which a sample is placed, a sample collection needle or capillary, and a detection guide. Light redirecting facets are provided within the format itself such that the format serves as a unitary component for accepting light, directing light through a sample, and emitting light for detection.

Abstract: A method and apparatus are disclosed that reduces variation in radiation therapy treatment planning among plurality of users within the same or different geographic locations. The system includes a method and an apparatus that provide users with the knowledge information and utilizing the knowledge information to contour target volumes for radiation treatment planning. The mode of operation includes utilizing a stand-alone workstation or a server computer connected to the plurality of thin client workstations.

Abstract: The systems and methods described herein provide for fast and accurate image segmentation through the application of a multi-stage classifier to an image data set. An image processing system is provided having a processor configured to apply a multi-stage classifier to the image data set to identify a distinctive region. The multi-stage classifier can include two or more component classifiers. The first component classifier can have a sensitivity level configured to identify one or more target regions in the image data set and the second component classifier can have a specificity level configured to confirm the presence of the distinctive region in any identified target regions. Also provided is a classification array having multiple multi-stage classifiers for identification and confirmation of more than one distinctive region or for the application of different classification configurations to the image data set to identify a specific distinctive region.

Abstract: The present invention provides a test tape unit suitable for testing blood sugar. The test tape unit comprises an analytical test tape, a feed spool for unwinding unused test tape, a take-up spool for winding used test tape, and a tape guide to expose a section of test tape at a measuring site for receiving an application of body fluid. The tape guide has a flat support frame which stretches the test tape at the measuring site and forms the border of a measuring opening which is kept free from optical elements for producing an optical measurement.

Abstract: A method for determining a test strip calibration code for use in a meter includes inserting a test strip into the meter. The inserted test strip having a substrate with a working surface for receiving the body fluid sample and a reverse surface that is in opposition to the working surface. The test strip also includes a permutative grey scale calibration pattern disposed on either of the working and reverse surfaces, with the permutative grey scale calibration pattern including more than one grey scale region. Moreover, the scale regions of the test strip define a grey scale permutation that uniquely corresponds to a calibration code of the test strip. The method also includes detecting the permutative grey scale calibration pattern with a grey scale photodetector module of the meter and determining a calibration code that uniquely corresponds to a grey scale permutation defined by the permutative grey scale calibration pattern based on permutation matrix stored in the meter.

Abstract: A system for measuring an analyte in a body fluid sample includes a meter, with a grey scale photodetector module, and a memory module. The system also includes a test strip. The test strip has a substrate with a working surface for receiving the body fluid sample and a reverse surface that is in opposition to the working surface. The test strip also includes a permutative grey scale calibration pattern disposed on either of the working and reverse surfaces, with the permutative grey scale calibration pattern including more than one grey scale region. Moreover, the scale regions of the test strip define a grey scale permutation that uniquely corresponds to a calibration code of the test strip. The grey scale photodetector module is configured to detect the permutative grey scale calibration pattern of the test strip when the test strip is inserted into the meter.

Abstract: A calibration strip for use with a package of test strips includes a substrate with and a permutative grey scale calibration pattern disposed on a surface of the substrate with the permutative grey scale calibration pattern including more than one grey scale region. Moreover, the grey scale regions of the calibration strip define a grey scale permutation that uniquely corresponds to a calibration code of test strips in a package associated with the calibration strip.

Abstract: A method for determining a test strip calibration code for use in a meter includes inserting a calibration strip into the meter, with the calibration strip having a substrate and a permutative grey scale calibration pattern disposed on the substrate. In addition, the permutative grey scale calibration pattern includes more than one grey scale region that define a grey scale permutation uniquely corresponding to a calibration code of test strips in a package associated with the calibration strip. The method also includes: (i) detecting the permutative grey scale calibration pattern with a grey scale photodetector module of the meter, and (ii) determining a calibration code that uniquely corresponds to a grey scale permutation defined by the permutative grey scale calibration pattern based on a permutation matrix stored in the meter.

Abstract: A test strip for the determination of an analyte, such as glucose, in a body fluid sample (for example, a whole blood sample) includes a substrate with a working surface for receiving the body fluid sample and a reverse surface that is in opposition to the working surface. The test strip also includes a permutative grey scale calibration pattern disposed on either of the working and reverse surfaces with the permutative grey scale calibration pattern including more than one grey scale region. Moreover, the scale regions of the test strip define a grey scale permutation that uniquely corresponds to a calibration code of the test strip.

Abstract: A test strip reader is provided with an optical mouse integrated circuit sensor that reads the test line, reference line and control line of a lateral flow assay strip by light absorption and determines the position of the test strip beneath the image on the integrated circuit board using digital signal processing algorithms. The digital signal processing algorithms process the imaged surface at a very high rate (e.g., 1500 frames per second) to determine the direction and speed of movement of the lateral strip with respect to the reader optics and image capture components. The sensor outputs this position information in a quadrature pattern format. A microcontroller uses the known position of the strip with respect to the reader to calculate the optical absorption of each colored reagent line, and the diagnostic significance (i.e., either qualitative or quantitative) of the test strip.

Abstract: A self-calibrated, magnetic binding assay (e.g., sandwich, competitive, etc.) for detecting the presence or quantity of an analyte residing in a test sample is provided. The magnetic binding assay includes detection probes capable of generating a detection signal (e.g., fluorescent non-magnetic particles) and calibration probes capable of generating calibration signal (e.g., fluorescent magnetic particles). The amount of the analyte within the test sample is proportional to the intensity of the detection signal calibrated by the intensity of the calibration signal.

Abstract: The present invention provides an immunoassay method in which blood can be measured even without pretreatment by means of a centrifuge etc. In the present invention, antibodies or antigens in a sample are subjected to agglutination reaction with insoluble carriers onto which antigens or antibodies specifically reacting with the antibodies or antigens in the sample have been immobilized and the resulting agglutination mixture is determined for the change in its absorbance or in its scattered light by irradiation with light, wherein said sample is whole blood and the whole blood is forcibly lyzed.

Abstract: A solid element for use as a control or calibration element which can be used in a diagnostic analyzer. The element includes a translucent or transparent solid material which when illuminated by a light source emits light corresponding to a specified concentration of a specific analyte as an analyte being measured.

Abstract: Computer programs and computer-implemented methods implement techniques for evaluating experimental data from a library of materials. The techniques receive a plurality of images of a library of materials that includes an array of members associated with locations in the library. User input identifying a plurality of regions of interest is received. A series of reduced data values is determined for one or more of the regions of interest as a statistical function of a plurality of pixel values for pixels in the corresponding regions. A figure of merit is calculated from one or more of the series of reduced data values for a library member at the corresponding library location. The regions of interest include a plurality of pixels in the images and correspond to locations in the library.

Abstract: The present invention provides an immunoassay method in which blood can be measured even without pretreatment by means of a centrifuge etc. In the present invention, antibodies or antigens in a sample are subjected to agglutination reaction with insoluble carriers onto which antigens or antibodies specifically reacting with the antibodies or antigens in the sample have been immobilized and the resulting agglutination mixture is determined for the change in its absorbance or in its scattered light by irradiation with light, wherein said sample is whole blood and the whole blood is forcibly lyzed.

Abstract: Described is a method for calibrating a spectrophotometric apparatus. This method involves obtaining a first set of absorbance measurements of a set of calibrators on a First Apparatus that is in control at wavelengths from a first wavelength calibration table. A second wavelength calibration table on a second apparatus is established, wherein the first and the second wavelength calibration tables may be the same or different. A second set of absorbance measurements of the set of calibrators is obtained on the Second Apparatus, at wavelengths from the second wavelength calibration table. First and second interpolated absorbances are determined, for the first and the second absorbance measurement, respectively, for at least one wavelength of a Standard Set of Wavelengths. Using the first and the second interpolated absorbances, a linear regression equation for each wavelength of said Standard Set of Wavelengths is determined.

Abstract: Described is a method for calibrating a spectrophotometric apparatus which is used to measure analytes in plasma and/or serum samples based on the calibration of a First Apparatus, and for recalibrating such apparatus, including recalibration of the First Apparatus all using synthetic calibrators. These apparatus use absorption of radiation to measure analytes in serum or plasma samples. The method described includes using synthetic calibrators which are submitted to the First Apparatus for measurement and compared with measurements of similar calibrators in a Second Apparatus and using the comparison to derive concentrations of analytes in samples measured on the Second Apparatus. As an alternative to making all apparatus identical, in terms of wavelength calibration, the absorbances of all apparatus should be mapped onto a standard set of wavelengths.

Abstract: Centrifuged material layer volumes are measured and quantified during centrifugation of the material layers contained in a sample tube in a centrifuge assembly, which sample tube is disposed on a centrifuge platen. The material layers in the sample tube are periodically illuminated during centrifugation by a pulsed light source which differentially excites one or more fluorescent dyes or stains which are admixed with the sample being analyzed. This kinetic procedure is particularly useful in performing differential blood cell and platelet counts. A fluorscent target reference device is positioned on the centrifuge platen along with a detectable platen position sensor. The centrifuge assembly includes a processor controller which receives information from the platen position sensor, and from the target reference device, and which controls operation of the light source.

Abstract: Centrifuged material layer volumes are measured and quantified during centrifugation of the material layers. The material layers are differentially highlighted by means of one or more supravital fluorescent dyes or stains which are admixed with the sample being analyzed. This kinetic quantification procedure is particularly useful in performing differential blood cell and platelet counts. The blood sample is centrifuged while being subjected to an intense filtered strobed light source at two different wavelengths. At least one photometric cell layer compaction measurement is made in conjunction with the light flashes so as to record a degree of cell layer compaction as the sample is being centrifuged. In certain cases, after several successive cell layer compaction readings are derived, a compaction curve is identified and the ultimate degree of cell layer compaction is calculated from the derived compaction curve prior to the achievement of the ultimate degree of cell layer compaction.

Abstract: A Bioenergetic Data Collection Apparatus utilizing a modified oximeter (1) to collect signals characteristic of blood flow in terminal tissue, such as a finger tip (12). A processing means (7) in signal connection with the modified oximeter (1) receives and analyzes the signals to produce pulse waveforms, or a pulse waveform sequence, that is displayed on a high resolution video display (5). An isolation means (8) is provided between the modified oximeter (1) and the processing means (7) to ensure no lethal voltages can threaten a patient. A variety of aids are provided to assist an appropriately skilled practitioner to make a prognosis from the displayed data. The tools include measurement of the ratio of heart activity to heart rest, variation in systolic pulse amplitude, variation in pulse shape, etc.

Abstract: In a method for the non-invasive determination of the oxygen saturation in tissue supplied with blood, the tissue is irradiated with red and infrared light and the DC and AC components of the emerging light are measured. During a first time interval, a calibration factor k is determined from the DC and AC components of the emerging light. During a second time interval, the oxygen saturation in the tissue is computed progressively from the DC components of the emerging light and the determined calibration factor k.

Abstract: Described is a method and a system for detecting the arterial oxygen saturation of hemoglobin (also called blood oxygenation, SpO2 or SaO2 measuring), comprising a measuring device for performing a blood oxygenation measurement and a controller unit. The measuring device is controllable by the controller unit so that the blood oxygenation measurement can be performed non-continuously. In a first step the measuring device is powered on, in a second step the blood oxygenation measurement is performed, and in a third step the measuring device or parts thereof are powered down, whereby the three steps are repeatable periodically. This provides SpO2 measurement applicable in telemetric or handhold instruments. The system is preferably used in telemetric or handhold instruments.

Abstract: Apparatus and a method for monitoring a percentage of the oxygen saturation in the hemoglobin of blood flowing through a blood vessel. An optical sensor that detects the percentage oxygen saturation in blood is disposed proximate a proximal end of the catheter. A thermistor is disposed adjacent to the distal end of the catheter and it is employed to detect changes in blood temperature that indicate the position of the catheter's distal end in the blood vessel. Indicia or marks visible at intervals on the outer surface of the catheter enable a medical practitioner to determine the length of the catheter that has been introduced into the blood vessel. A strain relief that is flexible and resists stretching extends along the length of the catheter. For flushing the distal end of the catheter, a fluid supply may be connected to a lumen running through the catheter to provide the flushing fluid.

Abstract: A method, and a calibration device, for calibrating a system for analyzing aqueous solutions and that includes a pixel array and a variable focus line for focusing onto the pixel array illuminated images of the aqueous solutions. The method includes the steps of illuminating a pattern on the calibration device to form an illuminated image of that pattern, and directing that illuminated image through the lens and onto the pixel array. The method includes the further step of deriving data values representing the image on the pixel array, and using those data values to adjust the focus of the lens and to adjust the position of the calibration device relative to the pixel array.

Abstract: A method for calibrating a flow cytometer or fluorescence microscope and for quantitating binding proteins, such as antibodies. Populations of microbeads are provided which are in equilibrium with a saturating amount of fluorescently-labeled protein. The microbeads may have an incorporated fluorescent dye which has a strong signal in a selected channel of a flow cytometer, but no signal in other channels.

Abstract: A method for checking cytological system illumination including the steps of checking global illumination variation, static field uniformity, dynamic field uniformity, specimen thickness variation, strobe repeatability, calibration plate cleanliness, and strobe dropout. A calibration plate and test target is employed for various illumination checks.

Abstract: The invention is a rapid, continuous test for glycated hemoglobin using a non-equilibrium affinity binding method. Agarose beads derivatized with 3-aminophenylboronic acid specifically bind glycated hemoglobin. This solid phase is incorporated into a sample processor card, modified to mix and to separate the test solution from the solid phase prior to absorbance readings. Two absorbance readings are made on the test solution, one immediately after mixing the reagent/diluent with the specimen, and one after a significant amount of binding has occurred. A linear correlation between total glycated hemoglobin and hemoglobin A.sub.1c permits standardization and reporting of units equivalent to % hemoglobin A.sub.1c. Stable glycated hemoglobin solutions for use as standards in the assay, and a method for preparing the standards are also disclosed.

Abstract: A measuring apparatus of the present invention measures the constituent concentration of a specimen after loading into the apparatus a test piece having a test material which develops coloring as a result of a reaction with the constituents of a specimen. When the apparatus detects that the test piece having the test material has been loaded, it automatically begins to measure the constituent concentration of the specimen. That is, after the loading of the test piece is detected, a predetermined time period is measured. During this time measurement, the time period is displayed at a predetermined time interval. After the time measurement of this predetermined time period is terminated, the test material is irradiated with a light, and the intensity of the light from the test material is detected. The constituent concentration of the specimen applied to the test material can be determined on the basis of the reflected light intensity thus detected.

Abstract: An apparatus for calibrating a pulse oximeter which can improve the repetitivity of measured values for calibration tests and which can calibrate the pulse oximeter with a high reliability. A tissue model having a light-absorbing characteristic approximated to that of the tissue of a living body is inserted into a space between a light-emitting section and a light-receiving section of a measuring probe that is connected to the pulse oximeter, and a blood model having a light-absorbing characteristic that is approximated to that of the blood is moved within the tissue model so as to enter into or exit from the space between the light-emitting section and the light-receiving section.

Abstract: A light beam having a first wavelength (.lambda..sub.1) is applied to the blood from a first light radiation section, while a light beam having a second wavelength (.lambda..sub.2) is applied from second and third light radiation sections different in positions from the first radiation section and from each other to the blood and the respective reflected-light intensity (I.sub.1, I.sub.2, I.sub.3) is detected. A first correction value (X) for correcting the reflected-light intensity ratio (I.sub.2 /I.sub.3) is calculated by a first correction value operation section (40) and a second correction value (C.sub.1) is calculated by a second correction value operation section (42) by use of this first correction value and the reflected-light intensity (I.sub.3). The reflected-light intensity ratio (I.sub.1 /I.sub.2) is corrected by use of this second correction value and an oxygen saturation in the blood is operated based on correlation function by use of the corrected reflected-light intensity ratio (R.sub.s).

Abstract: A qualitative and quantitative method of determining the fluorescence threshold of an instrument and of determining whether the instrument is sensitive enough to measure the autofluorescence of a sample. The method utilizes non-fluorescent particles such a microbeads which are run on a flow cytometer. The peak channel position of the microbeads is used as the fluorescence threshold.

Abstract: The use of a combination of calibrated microbead populations with one or more calibrated biological cell populations to correct calibration of a flow cytometer for size and fluorescence intensity determinations of biological cell samples. The use of calibrated biological cells permits correction for factors related to the instrument and calibration microbeads so long as the excitation and emission spectra of the calibration microbeads, the calibration cells and the cell samples are all the same, respectively.

Abstract: A color comparison device uses a rotatable color sample-bonding wheel to hold a sticker containing a plurality of color shades for matching with a color of a test portion of a test stick as the wheel rotates. At least one recess is formed in a part of the sticker bonding surface of the wheel to permit access to an edge of the sticker to facilitate its removal from the wheel.

Abstract: A device and method for calibration of pulse oximeters is disclosed. A standard specimen that has optical characteristics of hemoglobin of a known oxygen saturation is placed in the light path of a pulse oximeter probe. The image of a pulse is created by a filter that periodically increases and decreases the amount of light allowed to reach the sensor of the probe. In one embodiment, the filter comprises a pair of polarizing filters rotated with respect to one another under the control of a digital computer with a motor interface device. In another embodiment, a wedge of a light-attenuating medium, such as a cuvette containing oxygenated blood, is reciprocated in the light path, the wide portions of the wedge attenuating a greater amount of light than the narrow portions. Such a cuvette can include filler openings, with outwardly extending tubes at both the wide and narrow ends.

Abstract: A colorimeter comprises a case, a liquid crystal display (LCD) mounted on the case, a color chart provided on the case to permit holding of a specimen to be compared in close proximity to the color chart, and switches for indicating which color on the color chart the color of the specimen most closely approximates. Each switch is located adjacent a color on the color chart, and the states of the switches drive the LCD to display a reading corresponding to the color on the color chart which most closely approximates the color of the specimen.

Abstract: A device and method for calibration of pulse oximeters is disclosed. A standard specimen that has optical charactertistics of hemoglobin of a known oxygen saturation is placed in the light path of a pulse oximeter probe. The image of a pulse is also created by providing a filter that periodically increases and decreases the amount of light allowed to reach the sensor of the probe. In one embodiment, the filter can comprise a pair of polarizing filters rotated with respect to one another. In another embodiment, a wedge of a filtering medium, such as oxygenated blood, is reciprocated in the light path, the wide portions of the wedge attenuating a greater amount of light than the narrow portions.

Abstract: A noninvasive optical oximeter for measuring oxygen saturation of arterial blood. A sample of blood is illuminated with light at two different wavelengths. Light reflected by the blood is sensed by a photodetector and an output signal is created in response thereto. The output signal is processed to form a quotient representing the AC components of the reflected light at each wavelength. The oxygen saturation of the blood is calculated by correlating this quotient with an oxygen saturation reference curve uniquely representative of the blood oxygen saturation characteristics of a particular individual. The reference curve used in the preferred embodiment of the invention is calibrated in a two-step process which minimizes the effects of calibration errors. A first oxygen saturation reference curve is calculated which is based on a linear relationship between the ratio of the AC components of the reflected light.

Abstract: The catheter tip fits into a cavity in the boot and is held gently (in the longitudinal direction) by a detent formed within the cavity. A calibration substance faces the tip in a mechanically and optically standardized calibration relationship, to reflect light from within the catheter back into the catheter. The calibration substance is held in constant, precise contact with the tip--but passively, not by springs or other longitudinally forcible devices but by close fit between the tip and the precision-molded internal surfaces of the cavity. In the lateral direction the boot may tightly grip the tip, at a point where the optic fibers are protected against such force. To provide a reflection standard for calibration, the calibration substance is of standardized character and quality: it is preferably a homogeneous suspension of reflecting particles in translucent or transparent polymer.

Abstract: A calibrating device for an optical catheter is provided in order to calibrate the catheter for use in a catheter oximeter system. The calibrating device includes a tube having a reference block therein which is spring-loaded into compliant engagement with the distal end of the catheter carrying the fiberoptic light transmitting and receiving guides. A releasable strap tightly secures the catheter to the calibrating device. The packaged catheter is therefore ready for calibration by simply removing the proximal end thereof from a sealed package while the calibrating device and major length of the catheter remain in their sealed and sterilized condition and connecting it to a processor for performing the calibration operation.

Abstract: Endothelial cell density is determined by comparing the specular image of the endothelium at a predetermined magnification with a set of grids each having a plurality of apertures formed in a hexagonal, honeycomb pattern. The apertures in each of the grids are closely spaced and of predetermined size corresponding to a predetermined cell density at the predetermined magnification.

Abstract: An optical scattering reference medium is formed of a plurality of scattering particles substantially uniformly dispersed in a substantially compliant, non-compressable transparent solid medium which is selectively positionable against the distal end of an optical catheter for use therewith within a sterilizable disposable package for performing repeatable photometric measurements to standardize the performance of the photometric measuring instrument.

Abstract: This invention encompasses a standard for determining glycosylated hemoglobin comprising a mixture of hemoglobin or methemoglobin and about 1% to 25% of the 2,4-dinitrophenyl derivative of hemoglobin or methemoglobin wherein a 2,4-dinitrophenyl group blocks the allosteric binding site of hemoglobin or methemoglobin.

Abstract: This invention encompasses a standard for determining glycosylated hemoglobin comprising a mixture of hemoglobin or methemoglobin and about 1% to 25% of the N-[5-nitrotropon-2-yl] hemoglobin or methemoglobin derivative wherein the allosteric binding site is blocked.

Abstract: A mechanism for carrying a calibration standard and receiving a cuvette containing a blood sample to be tested is disclosed. The mechanism permits convenient shifting to either the test position or calibration position.

Abstract: A single diagnostic test reagent for use as a multiple-analysis hematology reference control for monitoring the precision and accuracy of measurements or determinations of red blood cell, white blood cell and platelet blood cell counting, hemoglobin content, hematocrit, mean cell volume and mean platelet volume determination, red cell distribution width and platelet distribution width determination, and determination of mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and thrombocytocrit. The control reagent includes ingredients for monitoring platelet parameters also notwithstanding that potential interfering effects of red blood cells normally observed in blood specimens also are present in the control reagent. The control reagent is suitable for use in automated or semi-automated hematology instruments and by users of manual methodologies.The invention includes a method of making said control reagent.