Abstract: A tube and float system for use in separation and axial expansion of the buffy coat includes a transparent or semi-transparent, flexible sample tube and a rigid separator float having a specific gravity intermediate that of red blood cells and plasma. The float includes a main body portion of reduced diameter to provide a clearance gap between the inner wall of the sample tube and the float. One or more protrusions on the main body portion serve to support the flexible tube. During centrifugation, the centrifugal force causes the diameter of the flexible tube to expand and permit density-based axial movement of the float in the tube. The float further includes a pressure relief system to alleviate pressure build up in the trapped red blood cell blood fraction below the float, thereby preventing red blood cells from being forced into the annular gap containing the buffy coat layers.

Abstract: Analyzers and methods of analysis are described for performing blood cell counting and immunoassay on a whole blood specimen in one measurement section. An assay sample is prepared by blending carrier particles sensitized with an antibody or an antigen against a substance to be immunoassayed and a fluorescent dye for staining blood cells with the whole blood specimen. Optical information is detected from a particle in the assay sample, and the blood cells are differentiated and counted based on the detected optical information. A rate of agglutination of the carrier particles is obtained based on the detected optical information, thereby enabling detection of the substance to be immunoassayed.

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: A measurement cell 1 includes: an opening part 106 for supplying a sample into a sample holding part 105 for holding a sample; an optical window portion for allowing light to enter the sample holding part 105 and allowing light to exit the sample holding part 105; a protection cover 101 for protecting the optical window portion, provided along the circumference of the sample holding part 105; and a first protection-cover-holding part 102 for holding the protection cover 101 at the position where the optical window portion is covered.

Abstract: Immunological assays for several biological markers for thyroid disorders in a biological sample are performed in a single test with a combination of sandwich-type, sequential competitive, and serological assays by the use of particles classified into groups that are distinguishable by flow cytometry, one group for the assay of each marker. Each group of particles is coated with a different immunological binding member, and coating densities, co-coating materials, and special buffer solutions are used to adjust for differences in the sensitivities and dynamic ranges of each of the markers in the typical sample.

Abstract: The present invention relates to tests for monitoring oral anticoagulation therapy and hepatocellular carcinoma (HCC). Particularly, the invention provides a method for determining prothrombin time of a plasma or whole blood sample taking account the effect which protein induced by vitamin K absence or antagonists (Pivka) has on clotting time and INR result. The primary object of the invention is to harmonise prothrombin time methods for international normalized ratio (INR) results and measure INRpivka.

Abstract: A method for obtaining a percent aggregation or inhibition of platelets resulting from anti-platelet using a single blood sample is achieved. An assay device is provided. The assay device has multiple channels, each coupled to a common introduction port. A first platelet activator is sensitive to activation pathway targeted by the anti-platelet drug. A second platelet activator is insensitive to the activation pathway targeted by the anti-platelet drug. An anti-coagulated sample is introduced simultaneously to the first and second channels. A level of platelet aggregation is simultaneously made in both channels.

Abstract: A test element for the determination of coagulation in a plasma or whole blood sample having a first surface (2a) and a second surface (4a) in a predetermined distance opposite from each other, said both surfaces being provided with two substantially equivalent patterns forming areas of high and low surface energy which are aligned mostly congruent, whereby the areas of high surface energy create a sample distribution system (6) with at least one detection area (6a), wherein the detection area(s) (6a, 6?a) of the first and second surfaces (2a, 4a) is/are provided with at least one coagulation stimulation reagent. The coagulation test element is provided with an integrated quality control system suitable for dry reagent test strip format with a very small sample volume of about 0.5 ?L. The production of the inventive coagulation test element involves only a small number of uncomplicated production steps enabling an inexpensive production of the element.

Abstract: An electrically operated, particle detecting, or characterizing, sensor structured as a thin film multilayer sandwich. Three or more electrodes are deposited onto thin layers of film, and stacked to form the sandwich. A representative stacking arrangement provides a pair of stimulated electrodes spaced apart from an intermediate measurement electrode by insulating layers of thin film. A fluid conducting channel, having an axis perpendicular to the film layers, provides electrolytic electrical communication between the three electrodes. Contact pads, arranged to permit electrical interrogation of the electrodes by electrical circuitry, are desirably arranged for access to electrical interrogation probes from a single side of the sensor. Certain sensors may be included in single-use, disposable cartridges adapted for analysis by an interrogation platform.

Abstract: Heterogeneous assays for different analytes in a single biological sample are performed simultaneously in a multiplexed assay that combines flow cytometry with the use of magnetic particles as the solid phase and yields an individual result for each analyte. The particles are distinguishable from each other by characteristics that permit them to be differentiated into groups, each group carrying an assay reagent bonded to the particle surface that is distinct from the assay reagents of particles in other groups. The magnetic particles facilitate separation of the solid and liquid phases, permitting the assays to be performed by automated equipment. Assays are also disclosed for the simultaneous detection of antibodies of different classes and a common antigen specificity or of a common class and different antigen specificities.

Abstract: An analytical test cartridge is provided. The analytical test cartridge can be used for medical analyses of liquid samples removed from a patient, for example blood. The analytical test cartridge is configured to provide for titration experiments. An example of a titration experiment that can be performed with the arrangement, is titration of heparin with protamine. Methods of assembly and use are provided.

Abstract: Methods and apparatus are disclosed for determining a new anticoagulant therapy factors for monitoring oral anticoagulant therapy to help prevent excessive bleeding or deleterious blood clots that might otherwise occur before, during or after surgery. New anticoagulant therapy factors maybe based upon the time to maximum acceleration from the time of reagent injection (TX) into a plasma sample, Embodiments include methods and apparatus for determining an anticoagulant therapy factor without requiring use of a mean normal prothrombin time determination or ISI, and may be carried out with the patient sample and a coagulation reagent.

Abstract: An immunodiagnostic test card includes a flat planar member and at least one dilution chamber that is supported by the flat planar member. The at least one dilution chamber can be disposed adjacent chambers used for testing a patient sample that are provided on the immunodiagnostic test card or can be provided separately.

Abstract: An apparatus for correcting for cell aggregates in a cell suspension from patients. The apparatus includes a laser cytometry scanning mechanism for scanning cells of a sample of a cell suspension to obtain data about the samples patients. The apparatus includes a memory for storing the data, the memory in communication with the scanning mechanism patients. The apparatus includes a computer for identifying in the data cell aggregates in the samples from the samples that have been scanned with an APT function, the computer in communication with the memory. A method for correcting for cell aggregates in a cell suspension from patients with an APT function. A method for correcting for cell aggregates in a cell suspension from patients with up to 98.6% accuracy. A computer readable medium.

Abstract: The invention provides methods and compositions for simultaneously detecting the activation state of a plurality of proteins in single cells using flow cytometry. The invention further provides methods and compositions of screening for bioactive agents capable of coordinately modulating the activity of a plurality of proteins in single cells. The methods and compositions can be used to determine the protein activation profile of a cell for predicting or diagnosing a disease state, and for monitoring treatment of a disease state.

Abstract: Microfluidic methods and devices for heterogeneous binding and agglutination assays are disclosed, with improvements relating to mixing and to reagent and sample manipulation in systems designed for safe handling of clinical test samples.

Abstract: A method of rapidly assaying nucleotide receptor P2X7 pore activity in white blood cells contained within a blood sample. A method according to the invention includes the steps of: (a) labeling the white blood cells with a white blood cell-specific label; (b) depolarizing the labeled white blood cells with an isotonic depolarizing solution; (c) contacting the labeled white blood cells with a dye and a P2X7 agonist in an amount sufficient to activate nucleotide receptor P2X7 pore activity; (d) contacting the labeled white blood cells with a divalent cation in an amount sufficient to deactivate nucleotide receptor P2X7 pore activity; and (e) analyzing dye uptake in labeled white blood cells whereby nucleotide receptor P2X7 pore activity is quantified by the amount of dye taken up in labeled white blood cells treated with P2X7 agonist relative to labeled white blood cells in the absence of P2X7 agonist.

Abstract: The invention relates to a device for detecting one or several analytes in a sample, characterized in that it comprises one or more reaction chambers and/or one or more reagent application channels, and one or more capillary systems and one or more negative vessels. The invention also relates to a method for detecting one or more analytes in a sample fluid by visualization of agglutination, characterized in that a) the sample fluid is brought into contact with a reagent, b) the reaction mixture is exposed to the effects of gravitation or magnetism, wherein the reaction mixture is strained through the capillary system of the inventive device with a negative vessel connected to the inventive device, and c) the reaction between the analyte and the reagent is determined. The invention also relates to one such method wherein the reaction mixture is brought into contact with another reagent during step b).

Abstract: An assay implementation in a microfluidic format in a cartridge relating to a point-of-care instrument platform for monitoring and diagnosing infectious diseases (e.g., AIDS and malaria). The platform may also provide a complete blood count. The instrument platform may hold the cartridge and a portion of an optical system for fluorescent and scattered light related analyses of blood sample in a flow channel of the cartridge.

Abstract: The invention relates to a method and a device for detecting very small quantities of particles. The inventive method is based on a detection of antigen-antibody reaction products and provides a very high detection sensitivity all the way to the femtomolar or attomolar range.

Abstract: Embodiments of the present invention relate to multiple coagulation test cartridges and methods of using such cartridges. In one embodiment the cartridge is a disposable single-use cartridge for use in evaluating blood clotting. The cartridge includes multiple containers, such as tubes, each of which includes one or more coagulation affecting substances. The containers can be pre-filled with substances in amounts suitable for use with a single patient's blood sample. The cartridge may include one or more containers, each of which has multiple sections, or volumes, each section storing a different coagulation affecting substance. In another embodiment the cartridge is used in a method for determining at least one appropriate coagulation affecting substance for modifying a patient's coagulation status using a multiple coagulation test system.

Abstract: The present subject matter concerns methods for determining platelet medicated clot formation. Specifically, the subject matter provides a method for determining platelet-medicated clot formation in a blood sample. The method may include obtaining sample of blood, and optionally mixing same with an anti-coagulant in an amount effective to inhibit clot formation. Additionally, the method may include mixing the sample in a vessel with a minute amount of an initiator to obtain a mixed sample, the amount being effective to initiate coagulation. The method may further include rotating the mixed sample inside the vessel, whereby shear forces are developed at the surface of the vessel in a manner and for a time sufficient to allow adhesion of platelets at the surface of the vessel. In addition, the method may include determining clot formation at the surface of the adherent platelets.

Abstract: A flow cell and flow cytometer in which a nozzle at the end of a flow channel is disposed on a removable substrate held at a registered location on a flow cell. Other elements including illumination optics, light collection optics, and the flow cell may then be positioned at fixed locations and would not require subsequent periodic adjustment. The registered location for positioning the nozzle allows removal and replacement of the nozzle key with the nozzle subsequently positioned in the identical location.

Abstract: Integrated apparatus and method for hematological analyses, wherein the apparatus comprises, arranged substantially in line and integrated substantially in a single machine, a device (14) of the optical type to detect substantially instantaneously the speed of blood sedimentation (ESR) by measuring the optical density, or absorbance, of the blood sample, and a measuring assembly (18) with a cell-counter function or suchlike.

Abstract: The invention provides a method of monitoring platelet function in a mammal by passing blood removed from the body of the mammal through a passageway to contact an obstruction or irregularity in the passageway to generate a platelet mass in the passageway, and monitoring the flow or composition of the blood in the passageway to detect the platelet mass. The flow and composition change in response to the formation of a platelet mass in the passageway. Devices, articles, and kits for performing the methods are also disclosed.

Abstract: A cartridge A to be mounted to a separate apparatus is provided. The cartridge includes a liquid introduction port 3 for introducing a sample liquid, and a diluter 4 including a diluent tank 41 for storing a diluent 40 for diluting the sample liquid, a sample liquid measurer 43 for separating a predetermined amount of sample liquid from the sample liquid introduced from the liquid introduction port 3, and a dilution tank 42A for mixing at least part of the sample liquid and at least part of the diluent. The sample liquid measurer 4 includes an introduction flow path 43a extending from the liquid introduction port 3, and a measurement flow path 43c and, an overflow path 43d which are connected to the introduction flow path 43a via a branch portion 43b. The measurement flow path 43c extends toward the dilution tank 42A.

Abstract: Detection systems and methods for capturing and analyzing particles within a particle sample are provided. The detection system may include, for example, a particle concentrator that can be used to collect and concentrate particles on a sample collection surface, an energy source for providing energy to induce fluorescence in the particles, and a detector for detecting at least some fluorescence induced in the particles by the energy source. The detection system may include a heater and/or cooler for controlling the temperature of the particle sample during testing.

Abstract: Rare cells are separated from a sample fluid by a positive selection or negative selection antibody by centrifuging in a tube containing a harvesting float. The harvesting float has an axial passage and a density to settle in the sample fluid and expand the layer of the target component. The positive selection antibody is preferably coupled to a particulate carrier, such as a microbead, to attach to the target component. The negative selection antibody forms a complex or conjugate with a contaminating component. In the positive separation, the particulate carrier is recovered in the axial passage of the float.

Abstract: A cartridge for monitoring the function of a device for blood platelet diagnosis has a housing which includes a test chamber and a holding chamber. A fluid volume of a test fluid is present inside the holding chamber. An air cushion is arranged above the fluid volume. A measurement cell, which has a capillary tube, is fitted in the upper part of the test chamber.

Abstract: Described are determination procedures for fibrinogen and/or fibrinogen-derivatives by matrix-independent turbidimetry. In the FIFTA called procedure the fibrinogen activity is preferably determined in an undiluted sample by addition of thrombin and/or albumin, as well as polybrene if appropriate, in PBS and determination of the increase in absorbance at 405 nm. In the FIATA called procedure the fibrinogen-concentration and/or the concentration of fibrinogen-derivatives is preferably determined by addition of vancomycin and determination of the increase in turbidity at 405 nm. It is standardized by usage of plasma standards of known fibrinogen-activity and/or fibrinogen-concentration.

Abstract: A method for detecting aberrant phenotypes expressed by neoplastic cells includes the steps of: 1) staining one or more normal/reactive samples and one neoplastic sample with multiple combinations of monoclonal antibodies, 2) measuring fluorescence emissions associated to the stained cells, 3) storing two independent list mode data files of information on light scatter and fluorescence characteristics of each cell, 4) creating new data files by mixing list mode data from the data file containing information the neoplastic sample into the data file containing information on the normal samples, 5) defining corresponding to normal cells and areas corresponding to empty spaces in normal/reactive samples that may be occupied by tumor cells in neoplastic samples, 6) identifying events corresponding to neoplastic cells and events corresponding to normal cells coexisting in a multidimensional space, and 7) establishing the most relevant phenotypic aberrations displayed by the neoplastic cells as compared to their nor

Abstract: A microplate assembly comprising a multi-well microplate and a plurality of reagent wells proximal the multi-wells. The microplate includes a frame that houses a plurality of open wells in a rectangular array. Reagent wells mounted within the microplate to react with the contents of the open wells during a g-force acting upon the microplate. The open wells function as a vessel for liquid samples that occupy predetermined spaces within the interior volumes. Each liquid sample remains within its predetermined space for all orientations of the microplate assembly.

Abstract: A blood crossmatching apparatus, kit and methods for testing the compatibility of mammals for blood transfusion. Particulate layers in the apparatus allow nonagglutinated red blood cells to permeate through, while agglutinated red blood cells cannot. The apparatus also has a density solution. The density solution separates white blood cells from red blood cells in the whole blood when centrifuged, without lysing the red blood cells. Thus, the apparatus can be used to test whole blood.

Abstract: A microplate assembly comprising a multi-well microplate and a plurality of reagent wells proximal the multi-wells. The microplate includes a frame that houses a plurality of open wells in a rectangular array. Reagent wells mounted within the microplate to react with the contents of the open wells during a g-force acting upon the microplate. The open wells function as a vessel for liquid samples that occupy predetermined spaces within the interior volumes. Each liquid sample remains within its predetermined space for all orientations of the microplate assembly.

Abstract: The invention relates to measuring of the adhesion of platelets ex vivo. In this method, monodisperse polymer particles are added to blood, and the number of platelets in the blood are measured before and after shaking of the sample. The level of adhesion of the platelets is determined by comparing the number of platelets prior to shaking with the number of platelets after shaking. Methods of establishing an adhesion index and diagnosis of a patient are also provided.

Abstract: Methods of prevention and correction of white blood cell interferences to the measurements of mean cell volume (MCV), red blood cell concentration (RBC) and hematocrit (Hct) of a blood sample are disclosed. The interference to MCV can be prevented by identifying a valley between the red blood cell and white blood cell modes on the red blood cell distribution histogram, defining a red blood cell region using the valley and calculating MCV within the defined region. Alternatively, a curve fit of the white blood cell population on the red blood cell distribution histogram can be used to exclude the white blood cells. RBC can be corrected by subtracting the white blood cell concentration obtained from the analysis of a second aliquot sample, when the white blood cell concentration (WBC) exceeds a predetermined criterion. Hct of the blood sample can be calculated using the obtained MCV and RBC.

Abstract: A micro-cassette 1 stores a sample, a reagent, and an additive, and comprises a sensor measures the component of measurement item. Analysis device 2 comprises liquid control unit controls each liquid in micro-cassette 1. Mixing controller 33 mixes the sample and the additive sent to sample processing unit 13, and generates the first sample includes a formed element. Isolation unit 14 generates the second sample from the first sample sent from sample processing unit 13. Sensor 18 measures the compound liquid of the second sample and reagent, and generates the analysis signal.

Abstract: The present invention provides apparatus and methods for performing assays for determining the time required for a sample of blood to coagulate. The apparatus comprises reaction chambers coated with one or more clotting agent. A drop of blood or equivalent is placed at the sample application port, diluted, and contacted with the clotting agents in the reaction chambers. The diluted blood sample can be moved back and forth through the reaction chambers until blood clots. The blood clotting process forms fibrin stands that prevent the flow of the blood sample in the reaction chambers. The clotting time is the total time from the sample entering the reaction chambers to the time at which the waveform in the reaction chambers change, or the motion or flow of the sample ceases, and can be measured by turbidity.

Abstract: A fluidic device employs one or more sorting stations for separating target species from other species in a sample. At least one of the sorting stations employs a magnetic field gradient to accomplish separation. In addition, the sorting station is integrated on a single substrate with one or more other modules for processing the sample. For example, the fluidic device may include both a sorting station and a separate trapping station that holds some or all components of the sample for additional processing. The trapping station may be located at a position upstream or downstream from the sorting module.

Abstract: The present invention provides a device, test cards, methods and kits which are useful for determining the particle fraction and rate of viscosity of a fluid sample, the presence of an analyte in a fluid sample, or the aggregation of particles in a fluid sample to detect an analyte or as an immunologic assay.

Abstract: Disclosed herein is a sample supply device that alternates between the supply of samples from one sample line while cleaning a second sample line and then supplying a second sample from the second sample line while cleaning the first sample line. This is repeated in rapid succession to allow greater speed in analyzing a plurality of samples in a shorter amount of time.

Abstract: A flow cytometer subsystems monitors a particle sensing zone within a fluid transport chamber for the presence of a particle (e.g., blood cell) traveling therethrough, and produces an output pulse, whose width is representative of the trajectory and thereby the length of time that the particle is within the particle sensing zone as it travels through the fluid transport chamber. This output pulse is then processed in accordance with geometry parameters of successive time delay zones of the particle fluid transport chamber through which the particle passes, in order to derive a composite time delay between the sensing of the particle to the time at which a fluid droplet containing the particle will break off from the carrier fluid. The composite time delay is employed to accurately establish the time at which the particle is controllably charged as the particle breaks off from the carrier fluid.

Abstract: A system and method for sorting of objects that includes a pathway network that has a plurality of pathways and one or more branch points. A fluid composition including one or more objects can be transported through the pathway network, where one or more of the objects are analyzed and sorted at one or more branch points based on the analysis of the objects.

Abstract: A lytic reagent composition and methods for differential analysis of leukocytes are disclosed. In embodiments, the analysis may utilize optical measurements in flow cytometry based hematology analyzers. The reagent system includes an anionic surfactant in a hypotonic solution, an inorganic buffer to maintain the pH in a range from about 6 to about 10, and optionally a leukocyte stabilizer. The reagent system is used to lyse red blood cells and stabilize the leukocytes to enable multi-part differentiation of leukocytes in a near physiologic pH environment on a flow cytometry based hematology analyzer using axial light loss, light scatter intensity, high-numerical aperture side scatter, and time-of-flight measurements.

Abstract: A blood crossmatching apparatus, kit and methods for testing the compatibility of mammals for blood transfusion. Particulate layers in the apparatus allow nonagglutinated red blood cells to permeate through, while agglutinated red blood cells cannot. The apparatus also has a density solution layered above particulate layers. The density solution separates white blood cells from red blood cells in the whole blood when centrifuged, without lysing the red blood cells. Thus, the apparatus can be used to test whole blood.

Abstract: A control system monitors salt level in a brine tank having a water inlet. The control system comprises a memory device storing an amount representing actual salt level in the brine tank. A sensor determines water level in the brine tank. A control valve is operatively connected between a water supply and the water inlet for controllably supplying water to the brine tank. A logic circuit is operatively connected to the memory device, the sensor and the control valve for determining salt level in the brine tank. The logic circuit periodically operates the control valve responsive to sensed water levels to fill the brine tank with water, updates the stored actual salt level in the memory device responsive to water supplied to the brine tank, and provides an indication when actual salt level in the brine tank falls below a select salt level.

Abstract: A drop-on-demand system for manufacturing diagnostic test strips includes a drop-on-demand mechanism, and a drop volume feedback subsystem and/or a vision subsystem. The drop-on-demand mechanism dispenses one or more reagents on the diagnostic test strips in one or more desired volumes and at one or more desired locations. The drop volume feedback subsystem control volumes of the reagents dispensed by the drop-on-demand mechanism so that the drop-on-demand mechanism dispenses the reagents on the diagnostic test strips in the desired volumes. The vision subsystem aligns the drop-on-demand mechanism in relation to the diagnostic test strips so that the drop-on-demand mechanism dispenses the reagents on the diagnostic test strips at the desired locations.

Abstract: A system and method for determining a coagulation time, e.g., thrombin time, PT, aPTT, and ACT, of a blood sample deposited in a test cartridge is disclosed. The test cartridge includes a blood receptacle that is open to the atmosphere into which a blood sample is to be deposited, a vacuum port that is open to atmosphere, and a spiral capillary within the test cartridge having a capillary length and cross-section area, a first capillary end of the spiral capillary open to the blood receptacle and a second capillary end of the spiral capillary open to the vacuum port, whereby the spiral capillary is closed to atmosphere. When a blood sample is deposited in the blood receptacle, a vacuum is drawn through the vacuum port and the blood is drawn through the spiral capillary until coagulation occurs. A pressure change is detected, and the coagulation time is measured.

Abstract: The present invention is to present a sample analyzer which is capable of respond immediately when a need to perform analysis of multiple items arises. The sample analyzer 1 includes a table 12 capable of holding a first rack 320 and a second rack 330; a reagent dispensing arm 120 which comprises a pipette part 121; a reagent dispensing driving section 120a for moving the reagent dispensing arm 120; a reagent barcode reader 350; and a control section 501 for controlling the reagent dispensing driving section 120a so as to move the pipette part 121 to a predetermined reagent aspirating position according to the identification information obtained by the reagent barcode reader 350.

Abstract: A biosensor not requiring washing of an unbonded label molecular by analyzing an object to be measured such as an antigen, an antibody, a DNA, and an RNA through magnetic field sensing. The biosensor is small in size, low in price, and high in sensing accuracy. Semiconductor Hall devices are arrayed two-dimensionally on the bottoms of recesses in the surface of a sensor chip to which bonded is a magnetic molecule with which a magnetic particle is labeled so as to sense the magnetic field produced along the sensor surface of the sensor chip. The surface area of each semiconductor Hall device is less than the maximum cross section of the magnetic molecule, and the intervals of the arrayed semiconductor Hall devices are larger than the diameter of the magnetic Hall molecule. Thus, the analysis accuracy is enhanced. An interconnection is used commonly to the semiconductor Hall devices, thereby reducing the size of the sensor.