The present invention relates to systems that utilize a combination of immunoassay and magnetic immunoassay techniques to detect an analyte within an extended range of specified concentrations. In particular, a device is provided for detecting an analyte in a biological sample. The device includes a first electrochemical sensor positioned on a substrate. The first electrochemical sensor includes an immobilized layer of antibody configured to bind to the analyte. The device further includes a second electrochemical sensor positioned adjacent to the first electrochemical sensor on the substrate, and a magnetic material that generates a magnetic field aligned with respect to the second electrochemical sensor. The magnetic field captures magnetic beads that have an immobilized layer of antibody configured to bind to the analyte, and concentrates the magnetic beads on or near a surface of the second electrochemical sensor.
An apparatus and method for analyzing a biological fluid sample is provided. The method includes the steps of: a) providing an analysis cartridge having a channel and an analysis chamber, wherein the channel is in fluid communication with the analysis chamber and includes at least one hydrophobic interior wall surface; b) admixing one or more anti-adsorption agents with fluid sample disposed within the channel, wherein the anti-adsorption agents are operable to inhibit adsorption of fluid sample onto the interior wall surface of the channel; c) moving the fluid sample into the analysis chamber; and d) analyzing the sample within the analysis chamber.
An apparatus and method for analyzing a biological fluid sample is provided. The method includes the steps of: a) providing an analysis cartridge having a channel and an analysis chamber, wherein the channel is in fluid communication with the analysis chamber and includes at least one hydrophobic interior wall surface; b) admixing one or more anti-adsorption agents with fluid sample disposed within the channel, wherein the anti- adsorption agents are operable to inhibit adsorption of fluid sample onto the interior wall surface of the channel; c) moving the fluid sample into the analysis chamber; and d) analyzing the sample within the analysis chamber.
A method and apparatus for identifying one or more target constituents (e.g., white blood cells) within a biological sample is provided. The method includes the steps of: a) adding at least one colorant to the sample; b) disposing the sample into a chamber defined by at least one transparent panel; c) creating at least one image of the sample quiescently residing within the chamber; d) identifying target constituents within the sample image; e) quantitatively analyzing at least some of the identified target constituents within the image relative to one or more predetermined quantitatively determinable features; and f) identifying at least one type of target constituent within the identified target constituents using the quantitatively determinable features.
The invention relates to a cartridge housing for forming a cartridge capable of measuring an analyte or property of a liquid sample. The housing comprising a first substantially rigid zone, a second substantially flexible zone, a hinge region, and at least one sensor recess containing a sensor. The housing is foldable about said hinge region to form a cartridge having a conduit over at least a portion of said sensor. The invention also relates to methods for forming such cartridges and to various features of such cartridges.
The invention is directed to methods and devices for reducing interference from leukocytes in an analyte immunoassay, and in particular in non-competitive immunoassays. In one embodiment, the invention is to a method comprising the steps of (a) amending a biological sample such as a whole blood sample with sacrificial beads; and (b) performing a non-competitive immunoassay on the amended sample to determine the concentration of said analyte in said sample. Preferably, the sample is amended with IgG-coated sacrificial beads.
The invention is directed to methods and devices for reducing interference from leukocytes in a competitive analyte immunoassay. In one embodiment, the invention is to a method comprising the steps of (a) amending a biological sample such as a whole blood sample with sacrificial beads opsonized for leukocytes; and (b) performing a competitive immunoassay on the amended sample to determine the concentration of said analyte in said sample. Preferably, the sample is amended with IgG-coated sacrificial beads.
The invention is directed to methods and devices for reducing interference from heterophile antibodies in an analyte immunoassay. In one embodiment, the invention is to a method comprising the steps of (a) amending a biological sample such as a whole blood sample with non-human IgM or fragments thereof by dissolving into said sample a dry reagent to yield a non-human IgM concentration of at least about 20 g/mL or equivalent fragment concentration; and (b) performing an electrochemical immunoassay on the amended sample to determine the concentration of said analyte in said sample. Preferably, the sample is amended with IgG or fragments thereof in addition to the IgM of fragments thereof.
The invention is directed to fluid-containing pouches and to methods for forming fluid-containing pouches. In one embodiment, the invention is to a fluid-containing pouch, comprising first and second opposing sheets, and a fluid (e.g., a calibrant fluid, a reactant fluid or a wash fluid) disposed between the first and second opposing sheets. The first sheet and the second sheet have a substantially liquid and gas impermeable perimeter seal. The sheets may be sealed, for example, by one or more of heat crimping, pressure crimping, heat and pressure crimping, ultrasonic welding, metal-to-metal welding or laser welding. Fluid-containing pouches sealed according to the disclosed methods and apparatuses show substantially improvement in terms of reduced gas exchange, notably CO2 pressurization levels.
B32B 37/00 - Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding
B32B 38/00 - Ancillary operations in connection with laminating processes
B65B 9/04 - Enclosing successive articles, or quantities of material, between opposed webs one or both webs being formed with pockets for the reception of the articles, or of the quantities of material
B65B 51/14 - Applying or generating heat or pressure or combinations thereof by reciprocating or oscillating members
B65B 51/22 - Applying or generating heat or pressure or combinations thereof by friction or ultrasonic or high-frequency electrical means
B65D 75/32 - Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
F16J 15/02 - Sealings between relatively-stationary surfaces
10.
METHOD AND APPARATUS FOR DETERMINING RED BLOOD CELL INDICES OF A BLOOD SAMPLE UTILIZING THE INTRINSIC PIGMENTATION OF HEMOGLOBIN CONTAINED WITHIN THE RED BLOOD CELLS
Method and apparatus for determining the concentration of haemoglobin within red blood cells. An undiluted, whole blood sample is deposited into a transparent analysis chamber (10) whose height is such that the red blood cells are in contact with both surfaces (14, 18). Then the optical density of a portion of the red blood cells in contact with both' surf aces is measured. The haemoglobin concentration of the red blood cell is calculated from the optical density and the known distinction coefficient of haemoglobin. This is repeated with other cells until an average haemoglobin concentration can be determined with confidence. Dependent claims include use of zwitterionic isovolumetric sphering agent make the measurement independent of a geometrical form factor.
A method for enumerating platelets within a blood sample is provided. The method includes the steps of: 1) depositing the sample into an analysis chamber adapted to quiescently hold the sample for analysis, the chamber defined by a first panel and a second panel, both of which panels are transparent; 2) admixing a colorant with the sample, which colorant is operative to cause the platelets to fluoresce upon exposure to one or more predetermined first wavelengths of light; 3) illuminating at least a portion of the sample containing the platelets at the first wavelengths; 4) imaging the sample, including producing image signals indicative of fluorescent emissions from the platelets, which fluorescent emissions have an intensity; 5) identifying the platelets by their fluorescent emissions, using the image signals; 6) determining an average fluorescent emission intensity value for the individual platelets identified within the sample; 7) identifying clumps of platelets within the sample using one or more of their fluorescent emissions, area, shape, and granularity; and 8) enumerating platelets within each platelet clump using the average fluorescent emission intensity value determined for the individual platelets within the sample.
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
G01N 33/58 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
G01N 33/80 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood groups or blood types
12.
METHOD AND APPARATUS FOR DETERMINING THE HEMATOCRIT OF A BLOOD SAMPLE UTILIZING THE INTRINSIC PIGMENTATION OF HEMOGLOBIN CONTAINED WITHIN THE RED BLOOD CELLS
A method for determining the hematocrit of a blood sample is provided that includes the steps of : 1) depositing the sample into an analysis chamber (10) adapted to quiescently hold the sample for analysis, the chamber defined by the interior surfaces (14, 18) of first and second panels (12, 16) and a height (20) extending there between, wherein both panels are transpar-ent, and the height is such that at least some of the red blood cells (22) within the sample contact both interior surfaces of the pan-els and one or more lacunae (24) within the quiescent sample extend between the interior surfaces; 2) imaging at least a portion of the quiescent sample, which sample portion contains the red blood cells and one or more lacunae to determine an optical density of the imaged portion of the sample on a per image unit basis; 3) selecting and averaging the optical density values of the image units aligned with the red blood cells contacting the interior surfaces, and assigning an upper boundary value of 100% to the aver-age optical density value of those image units; 4) selecting the optical density values of the image units aligned with the one or more lacunae, and assigning a lower boundary value of 0% to the optical density values of those image units; and 5) determining the hematocrit of the sample by assigning relative values to the optical density value of each image of the imaged sample portion as a function of the upper and lower boundary values, and averaging the relative values.
A sample analysis and medical data acquisition system for patient management includes a first user interface (UI) display module for displaying a medical chart page that includes selectable items associated with patient management. The first UI display module displays a set of medical delivery systems associated with a selectable medical delivery selection item, from which a medical delivery system is chosen. The system includes a second UI display module, in communication with the first UI display module, for displaying parameter fields for entry of operation data associated with the chosen medical delivery system. Medical data is captured from a patient by an analyzer configured to perform analysis of samples from the patient. The medical data is analyzed in accordance with entered operation data. The system includes an analysis display module, in communication with at least the first UI display module, for displaying sample analysis results.
A61G 99/00 - Subject matter not provided for in other groups of this subclass
G16H 10/20 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
G16H 15/00 - ICT specially adapted for medical reports, e.g. generation or transmission thereof
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
G16H 40/60 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
A61B 5/157 - Devices for taking samples of blood characterised by integrated means for measuring characteristics of blood
14.
IMMUNOASSAY DEVICE WITH IMMUNO-REFERENCE ELECTRODE
Disclosed is an immunoassay device for measuring an analyte in blood and correcting for the hematocrit of the blood sample to give an equivalent plasma analyte concentration, comprising a conduit for receiving a blood sample in an immunoassay device, said conduit containing an immunosensor and a bulk conductivity sensor, an aqueous solution having a known conductivity and containing reagents sufficient to generate a detectable product related to the amount of analyte from the blood sample bound to the immunosensor, and a computation means for processing signals from said sensors and determining the equivalent plasma analyte concentration.
G01N 27/06 - Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance by investigating resistance of a liquid
G01N 27/27 - Association of two or more measuring systems or cells, each measuring a different parameter, where the measurement results may be either used independently, the systems or cells being physically associated, or combined to produce a value for a furthe
An electrochemical immunosensor system with reduced interference, comprising: a first immunosensor that generates an electrochemical signal based on the formation of a sandwich between an immobilized antibody, a target analyte and a labeled antibody, wherein a portion of the signal arises from non-specific binding of the labeled antibody in the region of the first immunosensor, and a second immunosensor that acts as an immuno-reference sensor and generates a signal that is the same as or predictably related to the degree of non- specific binding which occurs in the region of the first immunosensor, and has an immunocomplex between an immobilized antibody and an endogenous or exogenous protein that is in the sample and that is not the target analyte.
A method for performing an immunoassay for an analyte in blood and correcting for the heamatocrit of the sample, comprising the steps of contacting an immunosensor with a blood sample, contacting the blood sample with a bulk conductivity sensor and measuring its resistance, contacting the immunosensor and conductivity sensor with an aqueous solution having known conductivity and containing reagents sufficient to generate a detectable product related to the amount of analyte bound to the immunosensor by antibody-antigen binding, wherein the reagents comprise a label that reacts with a substrate to generate the detectable product, measuring the signal at the immunosensor generated by said product, converting the signal from the immunosensor to an analyte concentration, calculating the hematocrit value of the blood sample from the measured resistance of the blood sample and known conductivity of the aqueous solution, and correcting the calculated analyte concentration for the hematocrit of the sample.
G01N 27/06 - Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance by investigating resistance of a liquid
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