Abstract: Improvements in blood collection and testing. In one aspect, an improved method of manufacturing a blood collection tube, particularly illustrated for use in sedimentation rate testing, including providing an elongated glass tube with an open first end for receiving a venipuncture blood sample of at least 1 ml, formed with a closed end opposite the first end; and applying to a substantial portion of the receptacle a containment barrier.

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: 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: An apparatus for determining the volume fractions of the phases in a suspension includes a body, a channel structure, which is formed in the body, and an inlet area and a blind channel, which is fluidically connected to and capable of being filled via the same. Furthermore, a drive for imparting the body with rotation, so that phase separation of the suspension in the blind channel takes place, is provided. The blind channel includes such a channel cross-section and/or such wetting properties that, when filling same via the inlet area, higher capillary forces act in a first cross-sectional area than in a second cross-sectional area, so that at first the first cross-sectional area fills in the direction from the inlet area toward the blind end of the blind channel and then the second cross-sectional area fills in the direction from the blind end toward the inlet area.

Abstract: A method of separating a cell-containing sample into a substantially cell-depleted portion, and a cell-containing portion comprising at least one of a stem cell, a lymphocyte, and a leukocyte comprises a step in which the sample is received in a vessel with at least one flexible wall. In another step, an additive and particles are added to the sample, wherein the additive substantially binds to the at least one of the stem cell, lymphocyte, and leukocyte, and the particles and wherein the particles substantially bind to the at least one of the stem cell, lymphocyte, and leukocyte, and the additive, thereby producing a cell-containing network. In a further step, the network is separated from the substantially cell-depleted portion by applying a magnetic force.

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: Improvements in blood collection and testing. In one aspect, an improved method of manufacturing a blood collection tube, particularly illustrated for use in sedimentation rate testing, including providing an elongated glass tube with an open first end for receiving a venipuncture blood sample of at least 1 ml, formed with a closed end opposite the first end; and applying to a substantial portion of the receptacle a containment barrier. The improvements also pertain to resulting blood collection tubes, additives for blood collection tubes that permit reliable sedimentation test data after 8 hours from the blood draw, and methods of administering health care using the aforenoted tubes, additives or both.

Abstract: A disposable apparatus for use in blood testing and being adapted for simultaneous dilution of a blood sample into two different dilution ratios, said apparatus including a block-shaped housing having integrated therein a first and a second receptacle, one of which as a first blood sample receiver being adapted to receive a blood sample; a first and a second container, each containing a defined volume of a diluent; a valve including a valve body having three valve body channels extending therethrough and being positionable in three distinct positions, one of which putting the receptacles in simultaneous communication with a respective one of the containers through pairs of the channels; and displacers for displacing diluent and diluted sample through said channels between said containers and said receptacles.

Abstract: Improved methods and apparatus that make more accurate and reduces risk of filling reaction chambers of cartridge cells with blood samples to conduct blood coagulation tests of the type employing the plunger technique are disclosed. A cartridge holder is provided that secures a test cartridge in a fixed upright position and deflects the plunger flag of each cartridge cell to enable manual insertion of a blood dispenser deeply into the reaction chamber to fill the reaction chamber and avoid contamination of surfaces of the cartridge outside the reaction chamber. Preferably, the cartridge holder provides illumination of the reaction chamber during filling, so that the user can judge when the reaction chamber is properly filled with blood dispensed from the blood dispenser. The cartridge holder may incorporate image magnification to facilitate viewing of the reaction chamber as it is filled.

Abstract: A method and apparatus is described by which means molecules in suspension may be characterized in terms of the size and mass distributions present. As a sample solution is separated by centrifugal means, it is illuminated at a particular radial distance from the axis of rotation by a fine, preferably monochromatic, light beam. Despite the high resolution of such devices, a key problem associated with most separators based upon use of centrifugal forces is the difficulty in deriving the absolute size and/or molar mass of the separating molecules. By integrating means to detect light scattered, over a range of scattering angles, from samples undergoing centrifugal separation, molecular sizes in the sub-micrometer range may be derived, even in the presence of diffusion. Adding a second light beam at a displaced rotational angle, preferably of an ultraviolet wavelength, that intersects the sample at the same radial region as the first beam permits determination of the molecular concentration at that region.

Abstract: Hematocrit in a blood sample is visualized by separating blood plasma from red blood cells in the blood sample on an absorbent substrate provided with a blood plasma soluble dye. Methods and devices to achieve the visualization are described.

Abstract: A method and apparatus for performing a first measurement on a biological fluid or control, which first measurement varies with both the concentration of a first component and at least one of the presence and concentration of a second component. The method and apparatus perform a second measurement on the biological fluid or control, which second measurement varies primarily only with the at least one of the presence and concentration of the second component to develop an indication of the at least one of the presence and concentration of the second component. The first and second measurements may be made sequentially or simultaneously. The method and apparatus then remove an amount representative of the indicated presence or concentration of the second component from the concentration of the first component indicated by the first measurement.

Abstract: An erythrocyte sedimentation rate (ESR) measurement instrument having a Blood Collection Configuration and an ESR Measurement Configuration. The ESR measurement instrument includes a sedimentation measurement tube having an hollow interior volume containing a predetermined quantity of blood sample diluting agent therewithin and being air/fluid sealed with respect to the ambient environment; and a blood collection tube having a hollow interior volume containing a predetermined quantity of anti-coagulant and being vacuum-sealed with respect to the ambient environment, and physically coupled to the air-sealed sedimentation measurement tube, by at least a portion of the sedimentation measurement tube being inserted within a portion of the hollow interior volume of the blood collection tube.

Abstract: Methods and reagents for rapid purification and/or identification of particles in a liquid sample are described. The technique uses centrifugation to concentrate particles against a slanted surface having an agent specifically binding to the particles. This method is applicable for the rapid identification of viruses and other difficult or impossible to culture microorganisms without replication or amplification of the microorganism.

Abstract: An apparatus for analyzing a sample of biologic fluid quiescently residing within a chamber is provided. The apparatus includes a light source, a positioner, a mechanism for determining the volume of a sample field, and an image dissector. The light source is operable to illuminate a sample field of known, or ascertainable, area. The positioner is operable to selectively change the position of one of the chamber or the light source relative to the other, thereby permitting selective illumination of all regions of the sample. The mechanism for determining the volume of a sample, field can determine the volume of a sample field illuminated by the light source. The image dissector is operable to convert an image of light passing through or emanating from the sample field into an electronic data format.

Abstract: A method for determining the value of MCV of a fresh sample of blood when the value of MCV for that sample of blood is known, but the period of time that the sample of blood has been stored is not known. The method of this invention allows an automated hematology analyzer to provide a more reliable indication of the initial value of MCV of a sample of blood, i.e., the value of MCV that would have been expected for the sample of blood when the sample was fresh. Furthermore, the method of this invention uses data that is readily available as part of the blood count data.

Abstract: An apparatus and method for analyzing a sample of biologic fluid quiescently residing within a chamber is provided. The apparatus includes a light source, a positioner, a mechanism for determining the volume of a sample field, and an image dissector. The light source is operable to illuminate a sample field of known, or ascertainable, area. The positioner is operable to selectively change the position of any or any or all of the chamber, the light source, or the image dissector, thereby enabling selective illumination of all regions of the sample. The mechanism for determining the volume of a sample field can determine the volume of a sample field illuminated by the light source. The image dissector is operable to convert an image of light passing through or emanating from the sample field into an electronic data format.

Abstract: An apparatus for analyzing a sample of biologic fluid quiescently residing within a chamber is provided. The apparatus includes a light source, a positioner, a mechanism for determining the volume of a sample field, and an image dissector. The light source is operable to illuminate a sample field of known, or ascertainable, area. The positioner is operable to selectively change the position of one of the chamber or the light source relative to the other, thereby permitting selective illumination of all regions of the sample. The mechanism for determining the volume of a sample field can determine the volume of a sample field illuminated by the light source. The image dissector is operable to convert an image of light passing through or emanating from the sample field into an electronic data format.

Abstract: The adsorption rate of proteins from solutions on surfaces in the region of interface layers is often so large that a depletion of the protein in the interface layer results. Due to this, the total reaction becomes transport-dependent, sensitively disrupting the determination of the rate constants. In known TIRF-analysis chambers or bio-sensor systems with a liquid interface layer of ˜10 ?m thickness and mass transport coefficients of 10?6-10?5 m/s it has up limitation. With the help of a TIRF-flow-through shear analyzer in which a certain volume unit of an immiscible fluid, for example an air bubble, is fed into the buffer flow, an ultra-thin liquid layer arises on the surface with a thickness of 100-200 nm, wherein interface surfaces below 10 nm thickness are technically possible.

Abstract: A luminescence microarray plate suitable for use in luminescent reaction, and a luminescence detecting device utilizing the microarray plate. A partition wall is provided around each microarray minute reaction region to prevent the entry of surrounding luminescence. Luminescence from each minute region is detected by a photoconducting guide. The amount of entry of surrounding luminescence can be reduced and improvements in accuracy and sensitivity can be achieved.

Abstract: A method and device for blood hemostasis analysis is disclosed. A blood sample is displaced to reach a resonant state. The resonant frequency of the blood sample is determined before, during and after a hemostasis process. The changes in the resonant frequency of the blood sample are indicative of the hemostasis characteristics of the blood sample.

Abstract: An erythrocyte sedimentation rate (ESR) measurement instrument having a Blood Collection Configuration and an ESR Measurement Configuration. The ESR measurement instrument comprises a sedimentation measurement tube having an hollow interior volume containing a predetermined quantity of blood sample diluting agent therewithin and being air/fluid sealed with respect to the ambient environment; and a blood collection tube having a hollow interior volume containing a predetermined quantity of anti-coagulant and being vacuum-sealed with respect to the ambient environment, and physically coupled to the air-sealed sedimentation measurement tube, by at least a portion of the sedimentation measurement tube being inserted within a portion of the hollow interior volume of the blood collection tube.

Abstract: A method of measuring an analyte in a biological fluid comprises applying an excitation signal having a DC component and an AC component. The AC and DC responses are measured; a corrected DC response is determined using the AC response; and a concentration of the analyte is determined based upon the corrected DC response. Other methods and devices are disclosed.

Abstract: A method for determining the value of MCV of a fresh sample of blood when the value of MCV for that sample of blood is known, but the period of time that the sample of blood has been stored is not known. The method of this invention allows an automated hematology analyzer to provide a more reliable indication of the initial value of MCV of a sample of blood, i.e., the value of MCV that would have been expected for the sample of blood when the sample was fresh. Furthermore, the method of this invention uses data that is readily available as part of the blood count data.

Abstract: The present invention relates to a hematocrit sensor and a method for measuring hematocrit values using such a device, which comprises a hematocrit sensor in a blood circuit that measures hematocrit value, a blood purifier that purifies a patient's blood while extracorporeally circulating the patient's blood, a housing having a slot connected to a portion of the blood circuit, a slit or plurality of pores built in the slot of the housing, and a light emission means and a light reception means positioned in the housing such that both means face the blood circuit through the slit or the plurality of pores.

Abstract: This invention relates to methods and apparatus for performing microanalytic and microsynthetic analyses and procedures. The invention provides a microsystem platform and a micromanipulation device for manipulating the platform that utilizes the centripetal force resulting from rotation of the platform to motivate fluid movement through microchannels. The microsystem platforms of the invention are also optionally provided having system informatics and data acquisition, analysis and storage and retrieval informatics encoded on the surface of the disk opposite to the surface containing the fluidic components. Methods specific for the apparatus of the invention for performing any of a wide variety of microanalytical or microsynthetic processes are provided.

Abstract: The present invention provides bioactive porous partition members for use in connection with studies or tests of the blood coagulation process, wherein the porous partition members have an aperture and have incorporated therein at least one agent capable of initiating blood coagulation or platelet aggregation.

Abstract: New dye-polysaccharide and dye-cyclosaccharide conjugates and their use as a diagnostic agent especially for determining the glomerular filtration rate in humans.

Abstract: Hematocrit in a blood sample is visualized by separating blood plasma from red blood cells in the blood sample on an absorbent substrate provided with a blood plasma soluble dye. Methods and devices to achieve the visualization are described.

Abstract: Method and apparatus to determine the speed of sedimentation of blood and other parameters connected thereto, said method being carried out by detecting the development over time of the optical density, or absorbance, of a sample of blood, said sample being sent in the form of a flow inside a capillary container (12), said detection being made in correspondence with a point of said capillary container (12) and the relative data acquired being processed to obtain said speed of sedimentation and said connected parameters, said method providing to instantly interrupt the flow of the blood sample flowing inside said capillary container (12), in order to determine a thickening of the red cells in said blood sample and their consequent sedimentation, said detection being made substantially simultaneously with said instant interruption.

Abstract: The present invention relates to the field of diagnostics by means of microscopic sample analysis, and specifically relates to a method and apparatus for preparing thin microscopic samples of liquids, and in particular monolayers of red blood cells.

Abstract: A method and apparatus is disclosed for determining the erythrocyte sedimentation rate and hematocrit simultaneously with the centrifugation of whole blood. A centrifuge separates the whole blood into its erythrocytes and its fluid portion. A video camera measures the levels of whole blood, erythrocytes and the fluid portion of the blood-and records the time of the formation of an interface between the erythrocytes and fluid portion. A monitor displays the results of the recording. Also disclosed are the method steps performed.

Abstract: A method and apparatus for performing a first measurement on a biological fluid or control, which first measurement varies with both the concentration of a first component and at least one of the presence and concentration of a second component. The method and apparatus perform a second measurement on the biological fluid or control, which second measurement varies primarily only with the at least one of the presence and concentration of the second component to develop an indication of the at least one of the presence and concentration of the second component. The first and second measurements may be made sequentially or simultaneously. The method and apparatus then remove an amount representative of the indicated presence or concentration of the second component from the concentration of the first component indicated by the first measurement.

Abstract: The present invention relates to the field of quantitative microspectroscopy, and in particular to a method for calibrating a sample analyzer to obtain a more precise HCT value.

Abstract: A control and system for blood testing, including a control having stabilized blood cells that have been introduced into a suspension including an aggregating agent and preferably a surfactant. The control and system is used advantageously for indirect acute protein plasma measurement, including erythrocyte sedimentation rate testing.

Abstract: Methods for enhancing the value of the traditional erythrocyte sedimentation rate (ESR) test are provided by including an ESR-modifying agent, such as a metal ion, in the sample. Results of the resulting modified ESR are correlated with the health status of the animal.

Abstract: A system for handling and testing fluids and gases such as, for example, blood samples, includes a tube in cooperation with at least one input port and at least one pressure source mounted in a novel arrangement to enable precise, accurate, and relatively spill-proof handling of fluids and gases to perform mixing and visual inspection and other tests. After testing, various components may be easily disassembled and discarded. A method of operation includes energizing the pressure source, in the form of a flexible bulb, to draw blood from a standard blood tube into a measuring tube according to a preferred embodiment of the invention said system in order to visually inspect sediment or red blood cell settling level after a predetermined time in order to test for certain blood characteristics.

Abstract: A method and apparatus is disclosed for determining the erythrocyte sedimentation rate and hematocrit simultaneously with the centrifugation of whole blood. A centrifuge separates the whole blood into its erythrocytes and its fluid portion. A video camera measures the levels of whole blood, erythrocytes and the fluid portion of the blood and records the time of the formation of an interface between the erythrocytes and fluid portion. A monitor displays the results of the recording. Also disclosed are the method steps performed.

Abstract: Methods and devices for determining the concentration of an analyte in a physiological sample are provided. In the subject methods, the physiological sample is introduced into an electrochemical cell having a working and reference electrode. A first electric potential is applied to the cell and the resultant cell current over a period of time is measured to determine a first time-current transient. A second electric potential of opposite polarity is then applied and a second a time-current transient is determined. The preliminary concentration of the analyte is then calculated from the first and/or second time-current transient. This preliminary analyte concentration less a background value is then multiplied by a hematocrit correction factor to obtain the analyte concentration in the sample, where the hematocrit correction factor is a function of the preliminary analyte concentration and the variable &ggr; of the electrochemical cell.

Abstract: A device for promoting sedimentation within microfluidic channels which uses gravity to separate particles from fluid. Particles such as blood cells or beads are separated from a carrier fluid using gravity combined with various devices such as membranes and sonic energy in different embodiments.

Abstract: The present invention relates to the field of quantitative microspectroscopy, and in particular to a method for calibrating a sample analyzer, which is preferably a disposable sample analyzer.

Abstract: This invention relates to methods and apparatus for performing microanalytic and microsynthetic analyses and procedures. The invention provides a microsystem platform and a micromanipulation device for manipulating the platform that utilizes the centripetal force resulting from rotation of the platform to motivate fluid movement through microchannels. The microsystem platforms of the invention are also optionally provided having system informatics and data acquisition, analysis and storage and retrieval informatics encoded on the surface of the disk opposite to the surface containing the fluidic components. Methods specific for the apparatus of the invention for performing any of a wide variety of microanalytical or microsynthetic processes are provided.

Abstract: Methods for enhancing the value of the traditional erythrocyte sedimentation rate (ESR) test are provided by including an ESR-modifying agent, such as a metal ion, in the sample. Results of the resulting modified ESR are correlated with the health status of the animal.

Abstract: A capillary hematocrit separation structure is included within a housing having a fluid inlet port, a reaction region, and a capillary pathway connecting the inlet port and the reaction region. The capillary pathway is dimensioned so that the driving force for the movement of liquid through the capillary pathway arises from capillary pressure. A plurality of obstructions are fixed in the capillary pathway, each obstruction having a concave portion facing toward the vented reaction region on the down stream side of the obstructions as viewed with reference to a liquid flowing from the inlet port to the reaction region. The capillary pathway in a hematocrit separation structure for a single drop sample size includes about 105 obstructions, each obstruction including a concave portion having a volume of between about 10−4 to 10−5 &mgr;l for selectively receiving hematocrit.

Abstract: On a base structure (101, 103), an assembly (104) oscillates about a horizontal axis (X—X) between two limit positions; on said assembly, a rotor (106) is capable of rotating about an axis (Y—Y) of rotation orthogonal to said horizontal axis (X—X) and has a ring of seats (121) for test tubes (1); an actuator (145) moves said assembly into a position with the axis of rotation (Y—Y) roughly horizontal, to carry out an agitation stage, and into a position with the axis of rotation (Y—Y) vertical, to carry out, before the reading stage, a centrifugation stage. The ring of seats (121) for test tubes has the test tubes (1) oriented, in the vertical position of said axis of rotation (Y—Y), with their bottom facing downwards and outwards.

Abstract: On a base structure (101, 103), an assembly (104) oscillates about a horizontal axis (X-X) between two limit positions; on said assembly, a rotor (106) is capable of rotating about an axis (Y-Y) of rotation orthogonal to said horizontal axis (X-X) and has a ring of seats (121) for test tubes (1); an actuator (145) moves said assembly into a position with the axis of rotation (Y-Y) roughly horizontal, to carry out an agitation stage, and into a position with the axis of rotation (Y-Y) vertical, to carry out, before the reading stage, a centrifugation stage. The ring of seats (121) for test tubes (1) oriented, in the vertical position of said axis of rotation (Y-Y), with their bottom facing downwards and outwards.

Abstract: An improved system can be used to examine a centrifuged sample of anticoagulated whole blood for evidence of blood borne rare events such as: circulating cancer cells; malarial parasites; other hemato-parasites; bacteria; and the like; and can also be used in the measurement of hematocrit and hemoglobin, as well as white cell and platelet count values in the centrifuged blood sample. The system includes a transparent blood sample tube and an insert that is placed in the tube. The insert floats on the packed erythrocyte layer in the centrifuged blood sample, and expands all of the layers above the packed erythrocyte layer. The insert also forces any blood borne rare events to the periphery of the blood sample in the tube where such events can be detected through the tube wall.

Abstract: High-performance liquid chromatography (HPLC) methods and systems are disclosed that combine sequential, serial injection of a plurality of samples into mobile-phases supplied in parallel to two or more chromatographic columns, such that staggered, parallel separation of the plurality of samples is effected. Because injection of samples is relatively fast as compared to separation, substantial efficiencies are gained with respect to overall sample throughput.

Abstract: A three-phase suspension suitable for use as an erythrocyte sedimentation rate (ESR) control having the following three components: (1) a synthetic plasma base, (2) an aggregating agent such as a high molecular weight polymer or combination of high molecular weight polymers, and (3) chemically fixed mammalian red blood cells. The control is designed to allow the user to monitor the accuracy and precision of analytical methods for determining the sedimentation rate of human erythrocytes in whole blood specimens. Chemical fixing of the red blood cells provides the ESR control with the capability of providing useful results in the presence of citrate and/or saline.

Abstract: A three-phase suspension suitable for use as an erythrocyte sedimentation rate control having the following three components: (1) a synthetic plasma base, (2) a high molecular weight polymer, and (3) mammalian red blood cells. The control is designed to allow the user to monitor the accuracy and precision of analytical methods for determining the sedimentation rate of human erythrocytes in whole blood specimens.