Abstract: The present invention relates to the field of immunology and hyperproliferative diseases. More specifically, the present invention relates to a method of detecting and monitoring therapeutic antibody:antigen complex, soluble antigen and soluble therapeutic antibody, wherein a patient has undergone at least one course of immunotherapy. Yet further, levels of therapeutic antibody:antigen complexes, soluble antigens or soluble therapeutic antibodies may be measured and used to stage or monitor a hyperproliferative disease.

Abstract: The present invention provides methods for quantitation of glycated protein in a biological sample using a solid support matrix by making a first bound protein measurement total bound protein under conditions where both glycated and non-glycated protein bind to the support in making a second bound protein measurement under conditions where glycated protein is bound to the support and non-glycated protein is not substantially bound. Diagnostic devices and kits comprising the methods of the present invention are also provided.

Abstract: The invention concerns a method for automatically differentiating between a sample liquid and a control liquid especially within the context of analytical measuring systems, wherein the presence of a special property of the control liquid and/or at least two criteria are used for the differentiation. In addition the invention concerns appropriate control liquids that are suitable for the new method.

Abstract: Disclosed is a single population of simulated leukocyte granules prepared from mammalian whole white blood cells, which is useful in calibrators for a hematology analyzer, a calibrator which includes the single population of simulated leukocyte granules. Disclosed is also a method of preparing the single population of simulated leukocyte granules. The method of preparing single population of simulated leukocyte granules includes the actions of: obtaining mammalian whole white blood cells; treating the mammalian whole white blood cells with a hemolytic agent and a leukocyte treating liquid which includes an isotonic saline solution. The isotonic saline solution may include a fixative, an oxidizer, and a carbohydrate compound; fixing the treated mammalian whole white blood cells with a fixative; and suspending the fixed cells in a preservation medium for long-term preservation of fixed cells.

Abstract: Disclosed are methods for detecting antibody in a sample, where the antibody targets an antigen expressed by red blood cells or red blood cell ghosts. Rather than detecting the binding events between a particular antigen antibody pair (as in traditional agglutination based assays) the methods herein allow for multiplexed detection of clinically important allo-immune antibodies to blood group antigens. Specifically the method involves generating fluorescently encoded red blood cells or red blood cell ghosts with known antigen presentation and using them to detect the presence of antibody in serum/plasma with a fluorescent sandwich type immunoassay. The assay results can be read using flow cytometric or fluorescent microscope based imaging techniques.

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 invention provides compositions and methods for cell separation. These reagents and techniques specifically agglutinate cells via surface antigen recognition and can be used to recover rare cell types in high yield.

Abstract: The present invention provides a method for preparing a five-part differential white blood cell control and a white blood cell control prepared thereby. The white blood cell control obtained by the method of the present invention perfectly retains the light scattering properties of every type of white blood cells and has much higher stability than that of real white blood cells, and therefore can be used for the quality control of five-part differential hematology analyzers based on the principle of multi-angle light scattering.

Abstract: The present invention relates to monitoring chemicals in a process chamber using a spectrometer having a plasma generator, based on patterns over time of chemical consumption. The relevant patterns may include a change in consumption, reaching a consumption plateau, absence of consumption, or presence of consumption. In some embodiments, advancing to a next step in forming structures on the workpiece depends on the pattern of consumption meeting a process criteria. In other embodiments, a processing time standard is established, based on analysis of the relevant patterns. Yet other embodiments relate to controlling work on a workpiece, based on analysis of the relevant patterns. The invention may be either a process or a device including logic and resources to carry out a process.

Abstract: Disclosed is a method for testing a modified specimen such as a dried blood spot, plasma or serum specimen, for an analyte of interest, such as cholesterol. In accordance with the disclosed subject matter, the level of the analyte of interest in the medium from which the modified specimen was obtained (e.g., from a patient's blood) is determined based on the level of an analyte in a solution formed from the modified specimen and on the level of at least one normalizing analyte. The analyte and normalizing analyte each may be an ion, compound, biochemical entity, or property of the specimen. Also disclosed are a fluid collector and a fluid collection device.

Abstract: REG4, a new member of REG family was identified as a biomarker of pancreatic adenocarcinoma. The present invention provides sandwich ELISA to detect serum REG4 in patients with resectable pancreatic cancers i.e. PDACs. The present invention also provides a method for diagnosing a pancreatic cancer using REG4 as a serological marker.

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 method for determining the concentration of factor VIIa-antithrombin complexes is disclosed which has application to estimating the level of intravascular exposure of tissue factor, assessing patient risk for hypercoagulation or other coagulopathies, and monitoring patients for factor VIIa-antithrombin complexes over time which can reveal changes in risk for hypercoagulation or other coagulopathies and/or effectiveness of anticoagulant therapy. Antibodies suitable for use in an in vitro assay for determining the concentration of factor VIIa-antithrombin complexes and methods for making the same are also disclosed.

Abstract: The present invention provides a method of determining whether an individual is at risk for atherosclerosis, comprising the step of: measuring the level of carbamylated LDL in a sample obtained from said individual. Further provided is a method of reducing carbamylation in an individual in need of such reducing, comprising the step of: treating said individual with a monomeric amino acid or another enzymatic or non-enzymatic inhibitor of carbamylation. Also provided is a method of preventing carbamylation in an individual with normal renal function, comprising the step of: treating said individual with a monomeric amino acid. Further provided is a method of treating or preventing atherosclerosis in an individual in need of such reducing, comprising the step of: inhibiting aggregation and/or deposition of carbamylated LDL in said individual.

Abstract: The present invention provides methods for identifying candidate biomarkers in the plasma microparticle proteome. It also provides methods for isolating, identifying, and analyzing microparticles derived from plasma, particularly platelet-poor plasma.

Abstract: The present invention relates to monitoring chemicals in a process chamber using a spectrometer having a plasma generator, based on patterns over time of chemical consumption. The relevant patterns may include a change in consumption, reaching a consumption plateau, absence of consumption, or presence of consumption. In some embodiments, advancing to a next step in forming structures on the workpiece depends on the pattern of consumption meeting a process criteria. In other embodiments, a processing time standard is established, based on analysis of the relevant patterns. Yet other embodiments relate to controlling work on a workpiece, based on analysis of the relevant patterns. The invention may be either a process or a device including logic and resources to carry out a process.

Abstract: A control and a cellular fraction for use therein and methods for making the same, including a first cellular component including a plurality of a first group of processed animal red blood cells other than human blood cells; a second cellular component including a plurality of a second group of processed animal red blood cells other than human blood cells; a third cellular component including a plurality of a third group of processed animal red blood cells other than human blood cells; wherein one or more of the first second and third cellular components include a nucleus; and the control simulates erythroblasts of a human blood sample on an automated blood analyzer that analyzes blood cells using impedance, optical measurements or both.

Abstract: The present invention relates generally to the field of Hepatitis B variants exhibiting a reduced sensitivity to nucleoside analogues, both in vivo and in vitro. More in particular, reverse transcriptase mutant rtA181S is provided. Present invention provides assays and methods for detecting such variant, which assays are useful in monitoring anti-viral therapeutic regimes and adjusting patient therapy. A diagnostic kit for detecting the presence of an HBV variant in a biological sample has also been 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: A method of using a reference control for measurement of immature granulocytes on a blood analyzer is disclosed. The method includes analyzing a reference control that contains an immature granulocyte component made of processed red blood cells for simulating immature granulocytes and a mature white blood cell component for simulating white blood cells of a blood sample on a blood analyzer adapted for measurement of immature granulocytes, and reporting the immature granulocyte component and the mature white blood cell component of the reference control.

Abstract: An immunoassay comprises the steps of: (a) mixing a whole blood sample with sensitized insoluble carrier particles smaller than erythrocytes to cause an immune agglutination reaction; (b) introducing the resulting immune agglutination reaction mixture including agglutinated particles and unagglutinated particles to a flow cell, irradiating the particles passing through the flow cell with laser light, and detecting scattered lights generated thereby; (c) setting a threshold value for distinguishing unagglutinated particles from agglutinated particles and a threshold value for distinguishing the agglutinated particles from blood cells with regard to intensity of the scattered light; and (d) distinguishing and counting the unagglutinated particles, the agglutinated particles and the blood cells from the scattered lights detected in the step (b), in reference to the threshold values set in the step (c).

Abstract: The present invention is directed toward a stable calibrator and/or control, kit and process for using in a glucose monitoring instrumentation. Principally, the instant invention teaches a glycolyzed red blood cell component which has been treated with a glycolysis stabilizing effective amount of at least one non-crosslinking aldehyde compound which may be added to fresh plasma along with an amount of glucose to form a simulated whole blood glucose control product, effective for maintaining a particular and essentially stable glucose concentration over a period of time sufficient for accurate measurement and calibration of a glucose measuring instrument.

Abstract: Heart and brain fatty acid binding proteins (H-FABP, B-FABP) are markers for TSEs, especially CJD. The invention provides a diagnostic assay for either of these markers, preferably by enzyme immunoassay using a specific antibody thereto. Since H-FABP is also a marker for acute myocardial infarction (AMI), to distinguish CJD from AMI requires an assay specific to AMI, e.g. using troponin-1 or CK-MB as a marker, also to be carried out.

Abstract: The invention provides a method for assaying for troponin I in a sample such as serum, the method comprising a determination of the troponin I concentration in a sample using a standard preparation that comprises a complete native troponin complex. One exemplary assay for troponin I concentration according to the invention is an immunoassay. Further contemplated in the method is a step comprising contacting the sample with a Ca2+-binding agent. Another aspect of the invention is the standard preparation comprising a complete native troponin complex. Yet another aspect of the invention is a kit for use in the assay method comprising the standard preparation, a detectable label, and a troponin I binding partner, such as an anti-troponin I antibody. All aspects of the invention are usefully practiced using human materials, such as a human troponin complex, and/or human sources for samples.

Abstract: The present invention provides methods for determining a ratio of an amount of a glycated form of a protein to a total amount of the protein in a sample containing the glycated protein, the glycosylated protein, or the glycoprotein. The method incorporates lateral flow test strip or vertical flow test strip devices having negatively charged carboxyl or carboxylate groups and hydroxyboryl groups immobilized and interspersed on a solid support matrix. The solid support matrix may include derivatives of cellulose (e.g., carboxy cellulose) derivatized with carboxylic acid (e.g., carboxylate, carboxyl) groups and hydroxyboryl compounds including phenylboronic acid (e.g., phenylborate), aminophenylboronic acid, boric acid (e.g., borate), or other boronic acid (e.g., boronate) compounds. The present invention is usefi.il for monitoring glycation or glycosylation of hemoglobin or albumin for monitoring glycemic control (e.g., glycemia in diabetes).

Abstract: A method of monitoring calibration of a spectrophotometric apparatus that includes one or more than one calibration algorithm for one or more than one analyte, involves measuring absorbance of a quality control material with the apparatus to obtain a measurement, calculating one or more than one value from the measurement using the one or more than one calibration algorithm, and comparing the one or more than one value with an assigned value given to the quality control material for each of the one or more than one analyte. The quality control material exhibits an absorbance spectrum having a negative slope for a continuous spectral segment from about 5 nm to about 200 nm in length, and the spectral segment includes a principal calibration wavelength for the one or more than one analyte. A reagentless method for determining the concentration of one or more than one analyte in a sample in a spectrophotometric apparatus having at least one primary calibration algorithm is also disclosed.

Abstract: A method of monitoring calibration of a spectrophotometric apparatus having one or more than one calibration algorithm for one or more than one analyte. This method involves measuring an absorbance of a quality control material to obtain a measurement, calculating one or more than one concentration value from the measurement using the one or more than one calibration algorithm, and comparing the one or more than one concentration value with an assigned value given to the quality control material for each of the one or more than one analyte. The quality control material exhibits an absorbance spectra having a negative slope for a continuous spectral segment from about 5 nm to about 400 nm in length, or a wavelength therebetween. A reagentless method for determining the concentration of one or more than one analyte in a sample in a spectrophotometric apparatus containing one or more than one primary calibration algorithm is also provided.

Abstract: A light gun includes a trigger unit; a grip coupled to the trigger apparatus; and a barrel unit coupled with the trigger apparatus. The trigger unit has a trigger and a hammer, and the barrel unit includes a light emitting unit which emits a light bullet in response to generation of an impact by the hammer when a trigger operation is carried out by pulling the trigger.

Abstract: A sample is prepared from blood in a manner which makes it possible to further analyze proteins in the sample, e.g. to detect prions in the sample. Blood is extracted, allowed to clot and subjected to separation processing (e.g. centrifugation) to obtain serum. The serum is treated with a complexing agent which agent binds prions in the sample forming an agent/protein complex which makes it possible to concentrate the complex. Concentration of the complex results in a sample which can be successfully analyzed, e.g. assayed using a range of different types of assay methodologies for detecting prions.

Abstract: A thromboplastin reagent includes tissue factor, Factor VIIa, and a net negatively charged phospholipid. The thromboplastin reagent is a synthetic thromboplastin reagent, and is in dried form.

Abstract: Heart and brain fatty acid binding proteins (H-FABP, B-FABP) are markers for stroke. The invention provides a diagnostic assay for either of these markers, preferably by ELISA using anti-H-FABP or B-FABP antibody. Since H-FABP is also a marker for acute myocardial infarction (AMI), to distinguish stroke from AMI requires an assay specific to AMI, e.g. using troponin-I or creatine kinase-MB as a marker, also to be carried out.

Abstract: A hematology reference control containing an immature granulocyte component and the method of making are disclosed. The reference control includes an immature granulocyte component made of processed blood cells for simulating human immature granulocytes, and a suspension medium suitable for delivering the component to a blood analyzer for measurement of immature granulocytes. The immature granulocyte component can be made of processed avian, reptile or fish red blood cells, or human immature granulocytes produced in vitro. The reference control further includes a white blood cell component which includes white blood cell sub-components for simulating white blood subpopulations. Further disclosed is the method of using the reference control for measurement of immature granulocytes on a blood analyzer.

Abstract: This invention relates to clinical diagnostic assays, related optical bio-discs, and a disc-reading apparatus. The invention is directed to methods and apparatuses for performing immunohematology assays using an optical bio-disc analysis system. The invention is further directed to an optical bio-disc for performing an immunohematologic assay including a substrate having encoded information associated therewith. The encoded information may be readable by a disc drive assembly to control rotation of the disc. The disc may also include at least one target zone or capture zone associated with the substrate. The target zone is disposed at a predetermined location relative to a center of the substrate. The disc further includes a plurality of capture antibodies immobilized within the target zone, a flow channel, fluidic circuit, or analysis chamber associated with the target zone, and an input site in fluid communication with the analysis chamber.

Abstract: The invention describes quality control devices for assays that measure analytes in cells and tissue samples, and methods of use thereof. In particular, the quality control device comprises a matrix affixed with synthetic controls in different concentrations, or different synthetic controls. The quality control device can be adhered to a microscope slide via an adhesive or chemically attached to a microscope slide and processed simultaneously with a tissue sample.

Abstract: A method and apparatus for characterizing the type of a blood sample and a variety of blood components are provided wherein a transmission spectrum of the sample is collected over a predetermined wavelength range. For blood typing, this spectrum is then compared with a set of control spectra collected from control blood samples having known blood types, from which the type of the blood sample can be determined. Further methods and apparatus are provided for determining the viability of and for cross matching a platelet unit. Additional method and apparatus permit analysis of the sample for the presence of a contaminant. Particles can also be counted in the sample, even when present in low concentrations, including white blood cell.

Abstract: A standard pattern of a differential value of an interference light is set with respect to a predetermined film thickness of a first member to be processed. The standard pattern uses a wavelength as a parameter. Then, an intensity of an interference light of a second member to be processed, composed just like the first member, is measured with respect to each of a plurality of wavelengths so as to obtain a real pattern of an differential value of the measured interference light intensity. The real pattern also uses a wavelength as a parameter. Then, the film thickness of the second member is obtained according to the standard pattern and the real pattern of the differential value.

Abstract: A gaming device with a bonus scheme which includes a symbol generator and a plurality of symbols. When two or more predetermined symbols are generated and displayed, the bonus round terminates. Depending upon which symbols the gaming device generates and displays, the bonus round may or may not terminate. This type of bonus scheme provides an exciting manner of terminating bonus rounds and increases player entertainment.

Abstract: An aqueous control solution is disclosed for use with a spectrophotometer or photometric test strip that includes a predetermined amount of an analyte, a hydrophobic reference dye and a surfactant. In one embodiment, the aqueous control solution is applied to a photometric test strip having a chemical that oxidizes glucose and consequently forms hydrogen peroxide which reacts with an indicator dye that is also present on the strip. In this embodiment, the control solution includes a predetermined amount of glucose, an infrared reference dye, sodium dodecyl sulfate, and the indicator dye, such as sulforhodamine B.

Abstract: A game machine is provided with first, second and third reel rows, and each of the reel rows executes slot game independent from each other. The number of reel rows to be actuated is increased in proportion to the number of bet coins. When less than three coins are betted, a first privilege providing section is operated to judge whether the first winning is generated. The first and a second privilege providing sections are operated to judge whether the first winning and a second winning are generated when four coins are betted. Dividend coins are provided in the first winning and a free game in the second winning. A player may play slot game without betting a coin in the free game.

Abstract: A control serum for a dry process is provided that does 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 invention relates to an assay for testing oxidative stress of a subject by measurement of oxidants in biological fluids such as urine, plasma, bioreactor medium and respiratory aspirants. There is provided a method of determining oxidative stress in a mammalian subject. The method comprises: obtaining a sample of a biological fluid from the subject; mixing the biological fluid with a ferrous reaction reagent; incubating the biological fluid and the reaction reagent; and detecting a colored reaction product. There is further provided a ferrous reaction reagent suitable for use in assaying oxidative stress, said reaction reagent comprising 2-deoxyglucose, TBA, EDTA, and ferrous sulfate, and being substantially free of ascorbic acid.

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: A lateral flow immunoassay device includes a membrane strip for enabling capillary migration of a sample therealong with a labeled reagent disposed on the membrane. The label reagent is formulated for suspension in the sample migrating therepast. A captive reagent is immobilized on the strip on a path of sample migration and the captive reagent is formulated to bind to the labeled reagent to form a visible colored site on the strip. An element is provided for changing the strip to a color which enhances visual perception of the colored site.

Abstract: The invention comprises a method of regenerating a biosensor. It involves passing a background flow of fluid without reactive components through the flow passage. At a selected point in time a sample aliquot is injected into said background flow. At a point in time when a signal from said sensor is obtained the flow rate of the background fluid is increased. The invention also comprises a system for continuous monitoring of analytes in a biological fluid, the system having increased life by virtue of inherent regeneration of sensors employed. It comprises a biosensor (26, 30, 32), a sampling device (4) for providing a sample of said biological fluid, and means (10, 15, 18, 24) for passing a flow of a background fluid through said flow passage at selectable flow rates, means (20, 50, 55) for injecting said sample into said flow of background fluid, and means (50, 55) for increasing the flow rate of said combined flow. Means for achieving a washing action at the signal generating portion are provided.

Abstract: An aqueous control solution is disclosed for use with a spectrophotometer or photometric test strip that includes a predetermined amount of an analyte, a hydrophobic reference dye and a surfactant. In one embodiment, the aqueous control solution is applied to a photometric test strip having a chemical that oxidizes glucose and consequently forms hydrogen peroxide which reacts with an indicator dye that is also present on the strip. In this embodiment, the control solution includes a predetermined amount of glucose, an infrared reference dye, sodium dodecyl sulfate, and the indicator dye, such as sulforhodamine B.

Abstract: A gaming machine with a visual display shows an array of symbols that includes one or more special symbols. During the play of the gaming machine, a bonus game may be triggered by the alignment of these special symbols. This bonus triggers interplay between the special symbols, which portray an action that determines a bonus game outcome. The action portrayed is randomly selected from a plurality of possible actions. An award is made based on the game outcome.

Abstract: Methods of playing games and gaming systems and devices useful for playing games. Gaming devices include a first gaming unit for randomly selecting and displaying indicia associated with play of a primary game and for generating a signal relating to play on the first gaming unit. The gaming device also includes a second gaming unit connected to the first gaming unit for conducting an ongoing bonus game and enabling participation by a player in the ongoing bonus game in response to a signal generated by the first gaming unit. The ongoing bonus game may be administered by and communicated from a second gaming unit in the form of a host server to a number of networked gaming devices. Players may enter and exit play of the ongoing bonus game while it is still in progress, participating only in a segment thereof.

Abstract: A non-animal based mixture of components serves as a control for complete blood count (CBC) analysis instruments and paraphernalia. The centrifugible non-animal based mixture simulates blood, and contains blood cell-simulating and other blood constituent-simulating components which are present in the mixture in controlled and known amounts. The mixture can be gravimetrically separated into its blood constituent-simulating components so as to serve as a control that simulates a centrifuged blood sample, and is thus used to check the accuracy of CBC blood analysis instruments, such as those marketed by Becton Dickinson and Company, under the trademark “QBC”.

Abstract: A control composition, and method of preparing a control composition, that includes stabilized, mammalian granulocytes having altered physical properties so that the granulocytes function as a human lymphocyte analogs when used on an automated blood cell analyzer.