Abstract: An automatic analyzer, capable of obtaining analysis results using reaction liquids with absorbance appropriate for analysis processing, is provided.

Abstract: Disclosed herein are compositions and methods for combining the output obtained from redundant sensor elements in a sensor array.

Abstract: There is described a sample holder and associated fluid container assembly for optical analysis of a fluid sample within a translucent container of the fluid container assembly. The sample holder includes clamping members rotatably mounted to a frame for rotation, about parallel axes spaced apart from each other, between a container accepting position in which the clamping members are spaced apart from the translucent container, and an analysis position in the clamping members abut the translucent container. The clamping members each define an optical waveguide slot extending therethrough that is substantially aligned with the translucent container when the clamping members are disposed in the analysis position, to thereby provide optical access to the translucent container for optical analysis of the fluid sample therein.

Abstract: A method for analyzing blood cells in a whole blood sample obtained from a cat is provided. An electrical measurement result and an optical measurement result of the whole blood sample are acquired. The electrical measurement result is obtainable by electrically measuring blood cells in the whole blood sample and the optical measurement result is obtainable by optically measuring blood cells in the whole blood sample. On the basis of the electrical measurement result and the optical measurement result, volume of red blood cells in the whole blood sample is calculated.

Abstract: The present disclosure provides a nucleated red blood cell simulating particle, which may be leukocytes bound to a fluorescent-staining inhibitor capable of stably binding to the nucleus or a nucleic acid in a cell so as to reduce the binding capacity of the particles to a fluorescent dye during their detection. The present disclosure also provides a method for preparing nucleated red blood cell simulating particles, including the following steps: (a) obtaining purified leukocytes; (b) suspending the leukocytes in a cell treatment solution containing a fluorescent-staining inhibitor which stably binds to the nucleus or a nucleic acid in a cell, and (c) washing the obtained product. The present disclosure also provides a hematology control mixture containing the nucleated red blood cell simulating particles.

Abstract: An assembly for testing platelet aggregation including an electrode subassembly that is mounted in a cuvette subassembly for use with relatively small samples containing platelets.

Abstract: Hemoglobin, its variants, and glycated forms of each are determined individually in a multiplex assay that permits correction of the measured level of HbA1c to account for glycated variants and other factors related to the inclusion of the variants in the sample. New antibodies that are particularly well adapted to the multiplex assay are also provided.

Abstract: A method for analyzing platelets is described. In the method, a measurement sample is prepared by mixing a sample and a dye for staining platelets. The dye is selected from the group consisting of Capri blue, Nile blue and brilliant cresyl blue. Upon irradiating cells in the measurement sample with light, scattered light and fluorescence emitted from the cells are measured. The platelets are detected on the basis of the scattered light and the fluorescence. A reagent kit and a reagent are also described.

Abstract: A method for the enumeration of micronucleated erythrocyte populations while distinguishing platelet and platelet-associated aggregates involves the use of a first fluorescent labeled antibody having binding specificity for a surface marker for reticulocytes, a second fluorescent labeled antibody having binding specificity for a surface marker for platelets, and a nucleic acid staining dye that stains DNA (micronuclei) in erythrocyte populations. Because the fluorescent emission spectra of the first and second fluorescent labeled antibodies do not substantially overlap with one another or with the emission spectra of the nucleic acid staining dye, upon excitation of the labels and dye it is possible to detect the fluorescent emission and light scatter produced by the erythrocyte populations and platelets, and count the number of cells from one or more erythrocyte populations in said sample.

Abstract: The invention relates to a method for detecting a plurality of antigenic molecules carried by erythrocytes and/or a plurality of anti-erythrocyte antibodies of an individual, comprising bringing a sample into contact with distinguishable beads, on which are attached a) antibodies specific for said antigens, or b) erythrocytes, erythrocyte membrane fragments or blood group antigens.

Abstract: The invention relates to a method for detecting a plurality of antigenic molecules carried by erythrocytes and/or a plurality of anti-erythrocyte antibodies, said antigenic molecules carried by the erythrocytes consisting of antigenic molecules carried not only by the erythrocytes, but also by at least one other cell population, other than the blood group antigen molecules, said method comprising bringing a sample into contact with distinguishable beads, on which are attached a) antibodies specific for said antigens, or b) erythrocytes or erythrocyte membrane fragment.

Abstract: Endothelial cells are detected in a blood sample by enriching the endothelial cells from the blood sample followed by performing on the enriched endothelial cells an immunoassay capable of detecting antigens expressed by the endothelial cells. The immunoassay is capable of detecting antigen expressed from 300 endothelial cells per milliliter of blood. The method can be used for assaying mature circulating endothelial cells or circulating endothelial progenitor cells.

Abstract: Disclosed is a self-tuning flow cytometer that uses a mathematical model to perform sort decisions that is based upon the biological response of the particular types of cells that are being sorted. In one embodiment, statistical calculations of the likelihood of an event belonging to a certain population are used to make the sort decisions. Automated self-tuning processes are used to optimize the operating parameters of the flow cytometer to achieve a selected purity with higher yield at optimal sorting speeds. The fully automated processes minimize user input and allows the user to select a desired purity while maximizing yield.

Abstract: Subpopulations of spore-like cells expressing specific cell surface and gene expression markers are provided. In one embodiment, the cells express at least one cell surface or gene expression marker selected from the group consisting of Oct4, nanog, Zfp296, cripto, Gdf3, UtF1, Ecat1, Esg1, Sox2, Pax6, nestin, SCA-1, CD29, CD34, CD90, B1 integrin, cKit, SP-C, CC10, SF1, DAX1, and SCG10. Also provided are methods for purifying a subpopulation of spore-like cells of interest from a population of spore-like cells, and methods for inducing differentiation of the isolated spore-like cells into cells of endodermal, mesodermal or ectodermal origin. The spore-like cells can be used to generate cells originating from all three germ layers and can be used to treat a patient who has a deficiency of functional cells in any of a wide variety of tissues, including the retina, intestine, bladder, kidney, liver, lung, nervous system, or endocrine system.

Abstract: An embodiment relates to a method of detecting a drug resistance in a patient comprising adding nanoparticles to sample platelets to form activated platelets containing the nanoparticles and comparing a difference in activation of the activated platelets and the sample platelets. Another embodiment relates to a method of monitoring a thrombotic risk factor in a subject in a general population comprising adding nanoparticles to sample platelets to form activated platelets containing the nanoparticles and comparing a difference in activation of the activated platelets and the sample platelets. Yet another embodiment relates to a kit comprising nanoparticles, a fluorescence dye tagged antibody and optionally a buffer, wherein the kit is configured to detect a drug resistance in a patient or a likelihood of the thrombotic risk factor in a subject in general population.

Abstract: The inventions relates to compositions and method for determining the absolute counts of cells per unit volume of a sample. Such a method comprises: (a) providing a container containing (i) a predetermined quantity of microparticles; and (ii) a cell-binding agent; in which the microparticles are disposed in or on a matrix which adheres to at least one wall of the container such that substantially all the microparticles are thereby attached to the container; (b) adding a known volume of sample to the container; (c) determining the ratio of microparticles to cells by counting microparticles and cells in a volume of the sample; and (d) determining the absolute count of cells by multiplying the number of cells per microparticle by the concentration of microparticles in the sample.

Abstract: The present invention provides a blood analyzer and a blood analyzing method capable of obtaining information regarding B lymphocytes and T lymphocytes without using a fluorescence-labeled antibody. The blood analyzer of the present invention includes a blood specimen supplying portion, a sample preparation portion that prepares a measurement sample without using a fluorescence-labeled antibody by mixing a blood specimen supplied from the blood specimen supplying portion, a hemolyzing agent, and a fluorescent dye that stains nucleic acid, a light source, a first detector that detects fluorescence, a second detector that detects scattered light, and information processing portion that classifies lymphocytes based on the intensity of fluorescence and scattered light, and based on the fluorescence intensity of the classified lymphocytes, obtains information regarding B-lymphocytes and T-lymphocytes.

Abstract: A system and method for a flow cytometer system including a prepared sample fluid with reference beads; an interrogation zone that analyzes the prepared sample fluid; a peristaltic pump system that draws the sample fluid through the interrogation zone; and a processor that monitors a measured volume of sample fluid sampled by the peristaltic pump system and an expected sample volume based on data generated by the analysis of the sample fluid. A system and method is additionally described using an alternative volume sensing fluidic system.

Abstract: The present invention provides a reagent for analysis of immature leukocytes comprising: a surfactant which can damage cell membranes of erythrocytes and mature leukocytes, a solubilizing agent which can shrink the damaged blood cells and a dye for staining nucleic acid, wherein the reagent has an osmotic pressure of not lower than 10 mOsm/kg and lower than 150 mOsm/kg.

Abstract: The present invention presents a silica particle containing at least one silica compound selected from a group consisting of mercapto-propyl-trimethoxysilane (MPS), mercapto-propyl-triethoxysilane (MPES), mercapto-propyl-methyldimethoxysilane (MPDMS), trimethoxy[2-(7-oxabicyclo[4.1.0]-hepto-3-yl)ethyl]silane (EpoPS), thiocyanatopropyltriethoxysilane (TCPS), and acryloxypropyltrimethoxysilane (AcPS), which can be provided and utilized as a label, a marker, or the like for qualitative test and quantitative test for such as prophylactic agent, therapeutic agent, diagnostic agent, diagnostic and therapeutic agent or the like in dental, medical and veterinary fields regardless of fields.

Abstract: The formulations, systems, and methods disclosed herein permit automated preparation of specimens (e.g., biological specimens) for examination. The formulations can include a cytological fixative solution including Azure B, a surfactant, methanol, and ethylene glycol. The disclosed formulations, systems, and methods provide fast, efficient, and highly uniform specimen processing using minimal quantities of fluids. The methods include at least a fixing phase for fixing a specimen to a substrate such as a microscope slide, a staining phase for staining the specimen, and a rinsing phase for rinsing the specimen. One or more of the fixing, staining, and rinsing phases include one or more agitation phases for distributing reagents evenly and uniformly across the specimen. The systems can be implemented as a standalone device or as a component in a larger system for preparing and examining specimens.

Abstract: Disclosed herein are compositions and methods for combining the output obtained from redundant sensor elements in a sensor array.

Abstract: The present invention reagents and methods for setting up an instruments having a multiplicity of detector channels for analyzing a multiplicity of fluorescent dyes. The present invention is particularly applicable in the field of flow cytometry.

Abstract: The invention provides kits and methods for detecting or monitoring the number of cells in sample. The cell comprises a cell surface associated protein (CSAP) comprising a cytoplasmic (cytosolic) and an extracellular (ecto) domain. The kit comprises: (i) a chromatographic device; and (ii) a CSAP-binding agent. The method comprises: (i) optionally contacting the sample with an agent capable of lysing or permeabilizing CSAP bearing cells; (ii) contacting the sample with a CSAP-binding agent that binds to the cytoplasmic domain of the CSAP; and (iii) directly or indirectly evaluating the level or presence of bound CSAP in the sample.

Abstract: The present invention provides compositions and methods for treating or preventing antibody mediated graft rejection and blood typing.

Abstract: Whole cell, simultaneous target and drug-target assay using differentially labeled antibodies and flow cytometry. First antibody binds to total target and second antibody binds to the drug binding site of the target, thus drug binding will competitively inhibit the second antibody allowing for a competitive inhibition assay of drug-target binding. The assay allows for whole cell analysis and even analysis of mixed populations of cells, yet provides detailed kinetic assessment of drug activity.

Abstract: The present invention relates to methods and kits for diagnosing, ascertaining the clinical course of myelodysplastic syndrome (MDS) and ascertaining response to a therapy regimen of myelodysplastic syndrome. Specifically the invention provides methods and kits useful in the diagnosis and determination of clinical parameters associated with MDS based on surface markers unique to MDS.

Abstract: A blood cell analyzer comprising: a detector for detecting predetermined component of leukocytes contained in a specimen; and a controller, including a memory under the control of a processor, the memory storing: correlation information relating to the correlation between leukocyte distribution data and either stab neutrophil or segmented leukocyte classification data; and instructions enabling the processor to carry out operations, comprising: (a) obtaining leukocyte distribution data of a subject based on the detection results of the detector; (b) obtaining the stab neutrophil or segmented leukocyte classification data based on the correlation information and the leukocyte distribution data of the subject; and (c) outputting the obtained stab neutrophil or segmented leukocyte classification data. A blood cell analyzing method and a computer program product is also disclosed.

Abstract: The present invention provides an approach for the simultaneous determination of the activation states of a plurality of proteins in single cells. This approach permits the rapid detection of heterogeneity in a complex cell population based on activation states, and the identification of cellular subsets that exhibit correlated changes in activation within the cell population. Moreover, this approach allows the correlation of cellular activities or properties. In addition, the use of potentiators of cellular activation allows for characterization of such pathways and cell populations.

Abstract: A reagent for analyzing urine is described. The reagent comprises a fungus membrane damaging agent for damaging a cellular membrane of yeast-like fungus in urine; a first dye for staining yeast-like fungus so that a fluorescent intensity of damaged yeast-like fungus becomes more intense than that of erythrocyte in urine; and a second dye for staining sperm in urine so that a fluorescent intensity of sperm becomes more intense than that of the damaged yeast-like fungus.

Abstract: A reagent for classification of leukocytes includes (a) at least two cationic surfactants; (b) at least one organic compound bearing a hydrophobic group and an anionic group; (c) a buffer for adjusting pH into a range of approximately 2-8. Also disclosed is a method for classifying leukocytes with the reagent. With the reagent and method, erythrocytes are lysed rapidly and classification of leukocytes into five groups is achieved in the same channel. The reaction may be carried out at approximately between 10-40° C. and scattered light signals may be detected at two angles for measuring the classification of leukocytes into five groups.

Abstract: A method for analyzing platelet is described. In the method, a measurement sample is prepared by mixing a sample and a dye for staining platelet. The dye is selected from the group consisting of Capri blue, Nile blue and brilliant cresyl blue. By irradiating cells in the measurement sample with light, scattered light and fluorescence emitted from the cells is measured. The platelet is detected on the basis of the scattered light and the fluorescence. A reagent kite and a reagent are also described.

Abstract: An apparatus for analyzing biologic fluid is provided that includes first and second planar members, and at least three separators. At least one of the first planar member and second planar member is transparent. The separators are disposed between the planar members, and each individually has a height. The separators collectively having a mean height, and separate the planar members to form a chamber having a height extending between the planar members. At least one of the first planar member, second planar member, or separators is sufficiently deformable when the first planar member and second planar member are drawn toward each other by capillary force from a biologic fluid quiescently residing within the chamber to cause the mean chamber height to be substantially equal to the mean height of the separators.

Abstract: The present invention provides methods and systems for performing in vivo flow cytometry. In one embodiments, selected circulating cells of interest of a subject are labeled with fluorescent probe molecules. The labeled cells are irradiated in-vivo so as to excite the fluorescent probes, and the radiation emitted by the excited probes is detected, preferably confocally. The detected radiation is then analyzed to derive desired information, such as relative cell count, of the cells of interest. In some embodiments, the circulating cells comprise apoptotic cells whose detection can allow, e.g., non-invasive monitoring of the efficacy of a cancer treatment, such as an anti-tumor or an anti-angiogenic therapy.

Abstract: The present invention provides an approach for the simultaneous determination of the activation states of a plurality of proteins in single cells. This approach permits the rapid detection of heterogeneity in a complex cell population based on activation states, and the identification of cellular subsets that exhibit correlated changes in activation within the cell population. Moreover, this approach allows the correlation of cellular activities or properties. In addition, the use of potentiators of cellular activation allows for characterization of such pathways and cell populations.

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: A method of correction of particle interference to hemoglobin measurement of a blood sample on a hematology analyzer is provided. The method includes mixing an aliquot of a blood sample with a lytic reagent to lyse red blood cells and forming a sample mixture; measuring absorbance of the sample mixture at a predetermined wavelength of a hemoglobin chromogen formed in the sample mixture, and obtaining an apparent hemoglobin concentration of the blood sample using obtained absorbance; measuring concentration and size of cellular particles remaining in the sample mixture; removing contribution of the cellular particles to the apparent hemoglobin concentration using the concentration and the size of the cellular particles to obtain a corrected hemoglobin concentration of the blood sample; and reporting the corrected hemoglobin concentration of the blood sample.

Abstract: The invention relates to methods of isolating white blood cells (WBCs) from a sample, e.g., whole blood, using magnetic particles that specifically bind to WBCs and a series of specific steps and conditions. The methods can include one or more of decreasing the viscosity of the sample prior to WBC isolation, agitating the sample at specified frequencies, and/or using a sample container arranged such that all of the sample is placed in close proximity (e.g., within 5, 2, 1, or 0.5 mm) to the source of the magnetic field. The new methods provide for isolation of WBC preparations with high yield, purity, and viability. The methods are designed for compatibility with automation protocols for rapid processing of multiple samples.

Abstract: The invention relates to methods and kits for the quantitative analysis of in vivo mutation frequencies of the Pig-A gene in individuals exposed to a genotoxicant, particularly using peripheral blood samples of vertebrates.

Abstract: The invention provides among other things methods and kits based on assaying for cardiac troponin autoantibodies, either in conjunction with an assay for cardiac troponin and/or as an independent indicator of cardiac pathology, such as myocarditis, cardiomyopathy, and/or ischemic heart disease. Assay methods of the invention can be employed among other things to identify cardiac pathology, or risk thereof, in subjects who have an autoimmune disease or who are related to an individual with an autoimmune disease. In particular embodiments, the invention also provides a method of determining whether a subject having, or at risk for, a cardiac pathology is a candidate for immunosuppressive therapy or immunoabsorption therapy. The invention also provides kits and kit components that are useful for performing the methods of the invention.

Abstract: The present invention relates to compositions and methods for identifying and quantifying platelet proteins that relate to various bodily states. The present invention further provides methods and compositions for determining whether an individual is using alcohol or other licit or illicit drugs at levels hazardous or harmful to their health. The invention also provides methods for identifying individuals who would benefit from or who may be harmed by specific medications or therapies.

Abstract: A reagent for four-part differentiation of white blood cells is provided. In one embodiment the reagent has an osmolality below 50 mOsm/kg H2O. A method for differentiating white blood cells using the reagent is also provided. The disclosure provides for a rapid lysis of red blood cells and four-part differentiation of white blood cells. The reagent may be simple in components and a surfactant is not necessary, but optional. A wide range of pH values may be suitable for the reagent.

Abstract: The present invention provides multicolor reagent formulations containing in a single container both fluorescently labeled detection reagents and single-color compensation control reagents, wherein the compensation control reagents consist of reagent-capture particles bound to a fluorescently labeled detection reagent included in the multicolor reagent formulation. The multicolor reagent formulations of the present invention simplify manufacture and commercial distribution of multicolor reagent kits.

Abstract: A method for enumerating cellular elements and particulates within a biologic fluid sample is provided.

Abstract: Measurement of the uncertainty used for quality control typically involves a plurality of factors. When the uncertainty exceeds a clinical permissible value, time is required for a medical technologist to investigate and to determine the factor causing the uncertainty. It is thus beneficial to automatically investigate factors in complicated uncertainty, particularly from the view point of reagents and samples which are subject to quality change and that are prone to affect the measurement quality. Quality control samples having a plurality of concentration levels are measured to calculate the average, coefficient of variation, standard deviation, and other numerical values. When quality control samples having n (n?2) different concentration levels are measured, variation patterns determine the factor causing the uncertainty, the factor being specific to each of 3n different combinations of variation patterns.

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: A reagent for classification of leukocytes includes (a) at least two cationic surfactants; (b) at least one organic compound bearing a hydrophobic group and an anionic group; (c) a buffer for adjusting pH into a range of approximately 2-8. Also disclosed is a method for classifying leukocytes with the reagent. With the reagent and method, erythrocytes are lysed rapidly and classification of leukocytes into five groups is achieved in the same channel. The reaction may be carried out at approximately between 10-40° C. and scattered light signals may be detected at two angles for measuring the classification of leukocytes into five groups.

Abstract: A method for identifying a platelet population, preferably a population of immature, reticulated platelets, in a biological sample involves incubating the biological sample for less than 5 minutes with at least one labeled, ligand (e.g., monoclonal antibody) that binds to an epitope or antigen on platelets and with a nucleic acid dye. In one embodiment, the dye is Acridine Orange and the label on the ligand is PE-Cy7. The sample is then analyzed and one or more platelet populations is rapidly identified or quantified by passing the incubated sample through a sensing region of a flow cytometer. In one embodiment, this method occurs without a washing or physical cell separation step. The incubated sample is irradiated with a laser light source, and fluorescence of the labeled ligand and the nucleic acid dye are measured along with at least one additional parameter, e.g., light scatter, direct current, axial light loss, opacity, radio frequency, and fluorescence.

Abstract: Bodily fluid is analyzed for the presence of drugs of a selected panel of drugs in a simultaneous assay in which sample of the fluid is incubated with additional amounts of all drugs of the panel, antibodies specific to each of the drugs of the panel, and microparticles, the microparticles being divided into subsets, one subset for each drug in the panel and each subset distinguishable from the others. The incubation is performed in a liquid medium in which competitive binding occurs, the drugs in the sample competing with those added to the assay medium for binding to the antibodies. In one procedure, the added drugs are pre-coupled to the microparticles while the antibodies are not, and the incubation is followed by further incubating the microparticles with labeled ligands that have affinity for the antibodies.

Abstract: The present invention provides for novel analogs of fresh human platelets for use in hematological instrument. Methods for preparing such analogs are also described.