Abbott Point of Care, Inc. Patent applications |
Patent application number | Title | Published |
20160109466 | TSH ANTIBODIES FOR POINT-OF-CARE IMMUNOASSAY FORMATS - The invention relates to antibody characteristics used to design a whole blood Point of Care Thyroid Stimulating Hormone (TSH) immunoassay using an ELISA sandwich assay lacking one or more wash steps between the antigen capture, detection antibody addition and substrate introduction steps. This invention exhibits low cross reactivity with biologically similar interfering cross reacting species, such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG). | 04-21-2016 |
20160109465 | TSH IMMUNOASSAYS AND PROCESSES FOR PERFORMING TSH IMMUNOASSAYS IN THE PRESENCE OF ENDOGENOUS CONTAMINANTS IN RESTRICTED WASH FORMATS - The invention relates to low wash Thyroid Stimulating Hormone (TSH) immunoassays using an ELISA sandwich assay having limited or no wash step between the antigen capture, detection antibody addition and substrate introduction steps. This invention exhibits low cross reactivity with biologically similar interfering cross reacting species, such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG). | 04-21-2016 |
20160054248 | Methods and Devices for Determining Sensing Device Usability - Methods and devices for determining sensing device usability, e.g., for self-monitoring and point of care devices. In one embodiment, the invention is to a method of determining device usability, comprising the steps of providing a device comprising a first electrical pad; a second electrical pad; and a humidity-responsive polymer layer contacting at least a portion of the first and second electrical pads; applying a potential across the first and second electrical pads; measuring an electrical property associated with the humidity-responsive polymer layer; and determining whether the measured electrical property associated with the humidity-responsive polymer layer has exceeded a humidity threshold level associated with the device usability. | 02-25-2016 |
20160047797 | METHOD AND APPARATUS FOR ANALYZING INDIVIDUAL CELLS OR PARTICULATES USING FLUORESCENT QUENCHING AND/OR BLEACHING - A method for analyzing a blood sample is provided that includes the steps of: providing a blood sample having one or more of each first and second constituents; admixing a colorant with the sample, which colorant is operative to cause the first constituents and second constituents to fluoresce and absorb light; illuminating at least a portion of the sample; e) imaging a portion of the sample; determining a fluorescence value for each the first constituents and second constituents; determining an optical density value for each of the first constituents and second constituents; and identifying the first constituents and the second constituents using the determined fluorescence and optical density values. | 02-18-2016 |
20150275261 | FORMATION OF IMMOBILIZED BIOLOGICAL LAYERS FOR SENSING - The invention is directed to enzyme immobilization compositions comprising: one or more enzymes, a humectant, an acrylic-based monomer, a water-soluble organic photo-initiator and a water-soluble acrylic-based cross-linker in a substantially homogeneous aqueous mixture. The invention is also directed to methods for forming sensors comprising such compositions and to apparati for forming arrays of immobilized layers on an array of sensors by dispensing such compositions onto a substrate. | 10-01-2015 |
20150258546 | Sample Metering Device and Assay Device with Integrated Sample Dilution - In one embodiment, the invention is to a sample metering device, comprising a sample holding chamber oriented between a sample entry port and a sample extraction unit, wherein a portion of said extraction unit defines a metered volume of a sample. A diluent may be transported over and/or through the extraction unit to form a diluted sample for sample analysis. In another embodiment, the invention is to an apparatus and method for rapid determination of analytes in liquid samples by various assays including immunoassays incorporating a sample dilution feature, capable of being used in the point-of-care diagnostic field is provided. The devices and methods of the invention preferably are well-suited for high range sample dilution. | 09-17-2015 |
20150247840 | Sample Metering Device and Assay Device with Integrated Sample Dilution - In one embodiment, the invention is to a sample metering device, comprising a sample holding chamber oriented between a sample entry port and a sample isolation unit and having a diluent introduction port disposed therebetween for introduction of a diluent into the sample holding chamber. The volume within the sample holding chamber between the diluent introduction port and the sample isolation unit defines a metered volume of a sample for analysis. In another embodiment, the invention is to an apparatus and method for rapid determination of analytes in liquid samples by various assays including immunoassays incorporating a sample dilution feature, preferably suitable for low range sample dilution, and preferably capable of being used in the point-of-care diagnostic field. | 09-03-2015 |
20150097939 | METHOD AND APPARATUS FOR DETERMINING A FOCAL POSITION OF AN IMAGING DEVICE ADAPTED TO IMAGE A BIOLOGIC SAMPLE - A method and apparatus for focusing a device for imaging a biologic sample is provided. A method aspect includes the steps of: disposing lenslets within a biologic sample, which lenslets have a height and a refractive index, which refractive index is different from that of the sample, wherein one or both of the imaging device and the sample are relatively locatable so a focal position of the imaging device can be moved along the height of the lenslets; imaging a portion of the sample including lenslets using transmittance at one or more wavelengths; determining an average light transmittance intensity of the sample at the wavelengths; determining an average light transmittance intensity of a region of each lenslet at the wavelengths; and determining the focal position of the imaging device using the average light transmittance intensity of the sample and the average light transmittance intensity of the region of the lenslets. | 04-09-2015 |
20140368631 | METHOD AND APPARATUS FOR DETERMINING A FOCAL POSITION OF AN IMAGING DEVICE ADAPTED TO IMAGE A BIOLOGIC SAMPLE - A method and apparatus for focusing a device for imaging a biologic sample is provided. A method aspect includes the steps of: disposing lenslets within a biologic sample, which lenslets have a height and a refractive index, which refractive index is different from that of the sample, wherein one or both of the imaging device and the sample are relatively locatable so a focal position of the imaging device can be moved along the height of the lenslets; imaging a portion of the sample including lenslets using transmittance at one or more wavelengths; determining an average light transmittance intensity of the sample at the wavelengths; determining an average light transmittance intensity of a region of each lenslet at the wavelengths; and determining the focal position of the imaging device using the average light transmittance intensity of the sample and the average light transmittance intensity of the region of the lenslets. | 12-18-2014 |
20140334712 | METHOD AND APPARATUS FOR DETERMINING HEMOGLOBIN BASED PARAMETERS IN AN UNLYSED BLOOD SAMPLE - A method and apparatus for determining hemoglobin concentration is provided. A method aspect includes the steps of: a) depositing an unlysed, substantially undiluted blood sample into an analysis chamber adapted to quiescently hold the sample for analysis; b) imaging the sample in a region of the analysis chamber where the height of the chamber is no more than about twenty microns (20μ) or no less than about two microns (2μ), to produce image signals representative of the optical density of the imaged region; c) determining a sample representative optical density value using the image signals representative of the optical density of the imaged region; and d) determining the hemoglobin concentration of the sample using the sample representative optical density value. | 11-13-2014 |
20140295476 | GLUTAMATE OXIDASE MUTAGENESIS FOR DIAGNOSTIC TESTING - The described invention provides a method of generating a catalytically active oxidase enzyme preparation. The described invention also provides a means of generating reagents for a protease detection sensor which can use colorimetric, fluorescent, or electrochemical detection. Further, the invention describes a system for a protease detecting sensor. | 10-02-2014 |
20140278832 | MANAGEMENT SYSTEM FOR POINT OF CARE TESTING - The present invention relates to a method and system for quality compliance, system and operator verification, and process management for point of care biological sample testing systems used in hospitals and other medical delivery environments. Specifically, the present invention may be directed to a computing device configured to generate a plurality of attributes configured to assess a competency level of an operator to operate at least one sample testing instrument, obtain operator derived data pertaining to the operator's ability to operate the at least one sample testing instrument, and determine a competency level of the operator for the at least one sample testing instrument based the plurality of attributes and the operator derived data. | 09-18-2014 |
20140273034 | ELECTROCHEMICAL METHODS AND DEVICES FOR AMENDING URINE SAMPLES FOR IMMUNOSENSOR DETECTION - The present invention is directed to methods and devices for amending undiluted and partially diluted urine samples in a manner suitable for performing immunoassays for target analytes, for example NGAL. Generally, the urine sample is treated with reagents including at least one of buffer materials, water soluble proteins, urease, and other interferent mitigants. These reagents control the pH of the urine sample in a manner suitable for immuno-binding reactions and ameliorate interferences, particularly during the detection step. | 09-18-2014 |
20140273014 | ELECTROCHEMICAL METHODS AND DEVICES FOR AMENDING URINE SAMPLES FOR IMMUNOSENSOR DETECTION - The present invention is directed to methods and devices for amending undiluted and partially diluted urine samples in a manner suitable for performing immunoassays for target analytes, for example NGAL. Generally, the urine sample is treated with reagents including at least one of buffer materials, water soluble proteins, urease, and other interferent mitigants. These reagents control the pH of the urine sample in a manner suitable for immuno-binding reactions and ameliorate interferences, particularly during the detection step. | 09-18-2014 |
20140263279 | THERMAL CONTROL SYSTEM FOR CONTROLLING THE TEMPERATURE OF A FLUID - The invention relates to a thermal control system for controlling the temperature of a fluid. In particular, the invention relates to a control system having at least two heating elements, at least one of which is used for directly or indirectly heating a fluid, and at least one of which is used for heating a thermal probe used to determine the temperature of the fluid. The heating systems are controlled by at least one feedback controller. | 09-18-2014 |
20140262777 | BIOSENSOR STRUCTURES FOR IMPROVED POINT OF CARE TESTING AND METHODS OF MANUFACTURE THEREOF - The present invention relates to analytical testing devices and methods for fabricating electrochemical creatinine biosensors, and in particular using point of care electrochemical biosensors for testing for creatinine in samples. For example, the present invention may be directed to a biosensor having an electrode, a first printed layer formed on the electrode and having a first matrix that includes creatinine amidohydrolase (CNH), creatine amidinohydrolase (CRH), and sarcosine oxidase (SOX), and second printed layer formed over the first printed layer and having a second matrix that includes CRH, SOX, and catalase. | 09-18-2014 |
20140262776 | BIOSENSOR WITH IMPROVED INTERFERENCE CHARACTERISTICS - This invention relates to mutagenized redox oxidase enzymes used to design enzyme electrodes with improved interference characteristics in the presence of mediator and oxygen in the assay. This recombinant modified enzyme has enhanced capability to transfer electrons to redox mediator instead of its natural electron acceptors such as O | 09-18-2014 |
20140248647 | METHOD AND APPARATUS FOR ANALYZING INDIVIDUAL CELLS OR PARTICULATES USING FLUORESCENT QUENCHING AND/OR BLEACHING - A method for analyzing a blood sample is provided that includes the steps of: providing a blood sample having one or more of each first and second constituents; admixing a colorant with the sample, which colorant is operative to cause the first constituents and second constituents to fluoresce and absorb light; illuminating at least a portion of the sample; e) imaging a portion of the sample; determining a fluorescence value for each the first constituents and second constituents; determining an optical density value for each of the first constituents and second constituents; and identifying the first constituents and the second constituents using the determined fluorescence and optical density values. | 09-04-2014 |
20140186972 | APPARATUS AND METHOD FOR IDENTIFYING A HOOK EFFECT AND EXPANDING THE DYNAMIC RANGE IN POINT OF CARE IMMUNOASSAYS - The present invention relates to systems and methods for the rapid in situ determination of the existence of a hook effect and expansion of the dynamic range of a point of care immunoassay. For example, a system for identifying a hook effect and expanding the dynamic range of an immunoassay is provided that may include a primary sensor having first immobilized antibodies that may be configured to generate a first signal based on a presence or absence of a target analyte in a sample. The system may further include an attenuated sensor having second immobilized antibodies at a reduced concentration relative to a concentration of the first immobilized antibodies on the primary sensor and that may be configured to generate a second signal based on the presence or absence of the target analyte in the sample. The system may further include a processor configured to determine a presence of a hook effect in the immunoassay based on relative values of the first and second signals and optionally determine the target analyte concentration of the sample. | 07-03-2014 |
20140186216 | APPARATUS AND METHOD FOR IDENTIFYING A HOOK EFFECT AND EXPANDING THE DYNAMIC RANGE IN POINT OF CARE IMMUNOASSAYS - The present invention relates to systems and methods for the rapid in situ determination of the existence of a hook effect and expansion of the dynamic range of a point of care immunoassay. For example, a system for identifying a hook effect and expanding the dynamic range of an immunoassay is provided that may include a primary sensor having first immobilized antibodies that may be configured to generate a first signal based on a presence or absence of a target analyte in a sample. The system may further include an attenuated sensor having second immobilized antibodies at a reduced concentration relative to a concentration of the first immobilized antibodies on the primary sensor and that may be configured to generate a second signal based on the presence or absence of the target analyte in the sample. The system may further include a processor configured to determine a presence of a hook effect in the immunoassay based on relative values of the first and second signals and optionally determine the target analyte concentration of the sample. | 07-03-2014 |
20140172341 | Self Correction for Spatial Orientation and Motion of Portable Clinical Analyzers - The present invention covers the integration and utility of accelerometer features into a clinical analysis system. For example, measurement of dynamic acceleration and orientation of a blood-testing instrument with respect to Earth's gravitational field may be used to determine reliability of a test procedure and optionally to provide corrective elements thereof. | 06-19-2014 |
20140172316 | Portable Clinical Analysis System for Hematocrit Measurement - The present invention covers the integration and utility of accelerometer features into a clinical analysis system. For example, measurement of dynamic acceleration and orientation of a blood-testing instrument with respect to Earth's gravitational field may be used to determine reliability of a test procedure and optionally to provide corrective elements thereof. | 06-19-2014 |
20140172315 | Operation and Verification of A Portable Clinical Analysis System - The present invention covers the integration and utility of accelerometer features into a clinical analysis system. For example, measurement of dynamic acceleration and orientation of a blood-testing instrument with respect to Earth's gravitational field may be used to determine reliability of a test procedure and optionally to provide corrective elements thereof. | 06-19-2014 |
20140170694 | Spatial Orientation Determination In Portable Clinical Analysis Systems - The present invention covers the integration and utility of accelerometer features into a clinical analysis system. For example, measurement of dynamic acceleration and orientation of a blood-testing instrument with respect to Earth's gravitational field may be used to determine reliability of a test procedure and optionally to provide corrective elements thereof. | 06-19-2014 |
20140170672 | Portable Clinical Analysis System for Immunometric Measurement - The present invention covers the integration and utility of accelerometer features into a clinical analysis system. For example, measurement of dynamic acceleration and orientation of a blood-testing instrument with respect to Earth's gravitational field may be used to determine reliability of a test procedure and optionally to provide corrective elements thereof. | 06-19-2014 |
20140141484 | Multiple Hybrid Immunoassay - The invention relates to compositions and methods for the immunoassay of an analyte of interest. The analyte is detected in an immunoassay using three or more antibodies, wherein each antibody specifically binds to a different epitope on the analyte. When the analyte of interest in a clinical marker for an acute disease, the detection of the analyte by immunoassay is a diagnosis of the occurrence of the disease. | 05-22-2014 |
20140072989 | TSH IMMUNOASSAYS EMPLOYING SCAVENGING REAGENTS FOR CROSS-REACTING ENDOCRINE GLYCOPROTEIN HORMONE ANALOGUES - Thyroid Stimulating Hormone (TSH) immunoassays are performed using an ELISA sandwich assay that employs scavenging or sacrificial beads for reducing interference caused by cross-reacting endocrine glycoprotein hormone analogues such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG). | 03-13-2014 |
20140004554 | METHOD AND APPARATUS FOR DETERMINING AT LEAST ONE HEMOGLOBIN RELATED PARAMETER OF A WHOLE BLOOD SAMPLE | 01-02-2014 |
20130343955 | Integrated Cartridge Housings For Sample Analysis - The invention relates to a cartridge housing for forming a cartridge capable of measuring an analyte or property of a liquid sample. The housing including a top portion having a first substantially rigid zone and a substantially flexible zone, a bottom portion separate from the top portion including a second substantially rigid zone, and at least one sensor recess containing a sensor. The top portion and the bottom portion are bonded to form the cartridge having a conduit over at least a portion of the sensor. The invention also relates to methods for forming such cartridges and to various features of such cartridges. | 12-26-2013 |
20130230854 | Method and Device for Immunoassay Using Nucleotide Conjugates - A composition of matter for use in an immunoassay devices and method comprising a signal antibody, e.g., FAB fragment, covalently linked to a first nucleotide; and one or more signal elements, e.g., signal enzymes such as ALP or fluorescent dyes, each covalently linked to a second nucleotide, wherein the first nucleotide has one or more repeated sequences, and the second nucleotide is bound to one of the one or more repeated sequences on said first nucleotide, and wherein the ratio of the signal antibody to the signal element is controlled by the number of repeated sequences. | 09-05-2013 |
20130224775 | Apparatus and Methods for Analyte Measurement Immunoassay - The present invention relates to methods for measuring an amount of an analyte using an electrochemical assay in a conduit comprising a sensor, wherein said sensor comprises an electrode having a surface layer of immobilized antibody that binds said analyte, and a counter/reference electrode disposed within said conduit. A solution comprising a substrate for said enzyme and at least one air segment contacts the sensor to remove unbound analyte and labeled antibody from a region of the sensor. The disclosed invention is adaptable to the point-of-care clinical diagnostic field, including use in accident sites, emergency rooms, surgery, nursing homes, intensive care units, and non-medical environments. | 08-29-2013 |
20130217146 | VIRTUAL SEPARATION OF BOUND AND FREE LABEL IN A LIGAND ASSAY FOR PERFORMING IMMUNOASSAYS OF BIOLOGICAL FLUIDS, INCLUDING WHOLE BLOOD - Detection and characterization of immunologically detected substances are performed electronically on human and animal biological fluids such as whole blood, serum, plasma, urine, milk, pleural and peritoneal fluids, and semen, which fluids are contained in a thin chamber forming a quiescent fluid sample, which chamber has at least two parallel planar walls, at least one of which is transparent. | 08-22-2013 |
20130208972 | 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 and apparatus for determining the hematocrit of a blood sample disposed within an analysis chamber, the method comprising the steps of: a) imaging at least a portion of the sample that contains one or more red blood cells contacting the interior surfaces of the chamber and one or more areas void of red blood cells; b) determining a representative optical density value for a plurality of image units optically aligned with portions of the red blood cells that are in contact the interior surfaces, and assigning an optical density first boundary value to those image units; c) determining a representative optical density value of a plurality of image units optically aligned with the one or more regions of the sample devoid of red blood cells, and assigning a second optical density boundary value to those image units; and d) determining the hematocrit of the sample. | 08-15-2013 |
20130203107 | METHOD FOR MEASURING THE AREA OF A SAMPLE DISPOSED WITHIN AN ANALYSIS CHAMBER - A method for determining the area of an analysis chamber covered by a biologic fluid sample quiescently residing within the chamber is provided. The chamber has a first panel with an interior surface, and a second panel with an interior surface, both of which panels are transparent. The method includes the steps of: a) illuminating the sample residing within the analysis chamber at one or more wavelengths operable to highlight interfaces between the sample and air, and to highlight a constituent within the sample; b) imaging the sample along the one or more wavelengths, and producing image signals representative of the interaction of the one or more wavelengths with the sample; c) determining a location of at least one interface between the sample and air, using the image signals; d) determining a location of one or more constituents within the sample relative to the at least one sample-air interface using the image signals; and e) determining an area of the chamber containing the sample, using the location of the one or more constituents and the at least one sample-air interface. | 08-08-2013 |
20130189794 | Optical Assay Device with Pneumatic Sample Actuation - This invention relates generally to devices and methods for performing optical and electrochemical assays and, more particularly, to test devices, e.g., cartridges, methods and systems, wherein the test devices have an entry port configured to receive a test sample into a holding chamber; a first conduit having at least one lateral flow test strip; and a displacement device, such as a pneumatic pump, configured to move a portion of said test sample from said holding chamber into said first conduit. The present invention is particularly useful for performing immunoassays and/or electrochemical assays at the point-of-care. | 07-25-2013 |
20130184188 | Integrated Test Device for Optical Detection of Microarrays - This invention relates generally to devices and methods for performing optical and electrochemical assays and, more particularly, to testing devices having an optically readable microspot array and/or an electrochemical detector and to methods of performing microspot arrays and electrochemical assays using such devices. The present invention is particularly useful for performing immunoassays and/or electrochemical assays at the point-of-care. | 07-18-2013 |
20130176551 | METHOD AND APPARATUS FOR DETECTING AND COUNTING PLATELETS INDIVIDUALLY AND IN AGGREGATE CLUMPS - A method for enumerating platelets within a blood sample is provided. The method includes the steps of: 1) depositing the sample into a sample container having an analysis chamber adapted to quiescently hold the sample for analysis, and an amount of colorant that platelets absorb and which fluoresces upon exposure to one or more predetermined first wavelengths of light; 2) imaging at least a portion of the sample disposed in the analysis chamber, including producing image signals indicative of fluorescent emissions from the platelets illuminated by first wavelengths of light; 3) identifying the platelets using the image signals; and 4) enumerating individual platelets and clumped platelets within the sample using one or more of fluorescent emissions, area, shape, and granularity. | 07-11-2013 |
20130171044 | BIOLOGIC FLUID SAMPLE ANALYSIS CARTRIDGE WITH SAMPLE COLLECTION PORT - A biological fluid sample analysis cartridge is provided that includes a collection port and a body. The body has one or more internal channels in selective fluid communication with the collection port. The collection port includes a collection bowl, and a slide valve assembly operable to be selectively positioned in an open position and a closed position. In the open position, the collection bowl is accessible for sample deposition, and in the closed position the collection bowl is inaccessible for sample deposition. | 07-04-2013 |
20130170730 | METHOD AND APPARATUS FOR AUTOMATED PLATELET IDENTIFICATION WITHIN A WHOLE BLOOD SAMPLE FROM MICROSCOPY IMAGES - A method and apparatus for identifying platelets within a whole blood sample. The method includes the steps of: a) adding at least one colorant to the whole blood sample, which colorant is operable to tag platelets; b) disposing the blood sample into a chamber defined by at least one transparent panel; c) imaging at least a portion of the sample quiescently residing within the chamber to create one or more images; and d) identifying one or more platelets within the sample using an analyzer adapted to identify the platelets based on quantitatively determinable features within the image using a analyzer, which quantitatively determinable features include intensity differences. | 07-04-2013 |
20130170729 | METHOD AND APPARATUS FOR IDENTIFYING RETICULOCYTES WITHIN A BLOOD SAMPLE - A method and apparatus for identifying reticulocytes within a blood sample is provided. The method includes the steps of: a) depositing the sample into an analysis chamber adapted to quiescently hold the sample for analysis, and the chamber has a known or determinable height extending between the interior surfaces of panels, which height is such that at least one red blood cell, or an aggregate of red blood cells, within the sample contacts both of the interior surfaces; b) admixing a supravital dye with the sample, which dye is operable to cause reticulin to fluoresce when excited by light of one or more predetermined wavelengths; c) imaging the sample using light that includes the one or more predetermined wavelengths that cause reticulin to fluoresce; d) imaging the sample using light that is absorbed by hemoglobin to produce values of optical density on a per image unit basis; and e) identifying reticulocytes within the sample using the image of the sample created with light that causes the dyed reticulin to fluoresce, and using the per image unit optical density values. | 07-04-2013 |
20130169948 | METHOD FOR RAPID IMAGING OF BIOLOGIC FLUID SAMPLES - A method for analyzing a biologic fluid sample is provided. The method includes the steps of: a) disposing the biologic fluid sample within a chamber; b) imaging the biologic fluid sample at a first resolution, and producing first image signals representative of a low resolution image of the sample; c) analyzing the first image signals to identify one or more first characteristics of the sample, and determining a position of each first characteristic within the chamber using a map of the chamber; d) imaging a portion of the biologic fluid sample at a second resolution and producing second image signals, which portion of the sample is determined using the first characteristics and the map, and wherein the second resolution is greater than the first resolution; and e) analyzing the biologic fluid sample using the second image signals. | 07-04-2013 |
20130167945 | BIOLOGIC FLUID ANALYSIS CARTRIDGE WITH VOLUMETRIC SAMPLE METERING - A device for volumetric metering a liquid biologic sample is provided. The device includes an initial chamber, a second chamber, a third chamber, a first valve, a second valve and a third valve. The chambers are each configured so that liquid sample disposed in the respective chamber is subject to capillary forces. Each chamber has a volume, and the volume of the initial chamber is greater than the volume of either the second or the third chambers. The valves each have a burst pressure. The burst pressure of the first valve is greater than the third burst pressure. The first valve is in fluid communication with the second chamber. The second valve is disposed between, and is in fluid communication with, the initial chamber and the third chamber. The third valve is in fluid communication with the third chamber. | 07-04-2013 |
20130162981 | Reader Devices for Optical and Electrochemical Test Devices - This invention relates generally to devices and methods for performing optical and electrochemical assays and, more particularly, to devices having optical and electrochemical detectors and to methods of performing optical and electrochemical assays using such devices. The present invention is particularly useful for performing immunoassays and/or electrochemical assays at the point-of-care. | 06-27-2013 |
20130161190 | Integrated Test Device for Optical and Electrochemical Assays - This invention relates generally to test devices and methods for performing optical and electrochemical assays and, more particularly, to test devices having the ability to perform optical and electrochemical assays on a sample and to methods of performing optical and electrochemical assays using such test devices. The present invention is particularly useful for performing immunoassays and/or electrochemical assays at the point-of-care. | 06-27-2013 |
20130114075 | BIOLOGIC FLUID SAMPLE ANALYSIS CARTRIDGE - A biological fluid sample analysis cartridge, analysis system, and method for analyzing a biologic fluid sample are provided. The cartridge includes a collection port, at least one channel within the cartridge in fluid communication with the collection port, a passage in fluid communication with the at least one channel, and an analysis chamber mounted on a tray. The tray is mounted relative to the cartridge and selectively positionable relative to the passage in a first position where the analysis chamber will engage a bolus of sample extending out from the passage to permit selective transfer of sample from the bolus to the analysis chamber. | 05-09-2013 |
20130112558 | FORMATION OF IMMOBILIZED BIOLOGICAL LAYERS FOR SENSING - The invention is directed to enzyme immobilization compositions comprising: one or more enzymes, a humectant, an acrylic-based monomer, a water-soluble organic photo-initiator and a water-soluble acrylic-based cross-linker in a substantially homogeneous aqueous mixture. The invention is also directed to methods for forming sensors comprising such compositions and to apparati for forming arrays of immobilized layers on an array of sensors by dispensing such compositions onto a substrate. | 05-09-2013 |
20130078668 | METHOD AND APPARATUS FOR DETECTING THE PRESENCE OF INTRAERYTHROCYTIC PARASITES - An apparatus and method for determining the presence of an intraerythrocytic organism within a sample of liquid whole blood is provided. The method includes the steps of a) creating an image of the sample quiescently residing within a sample chamber; b) evaluating the image for the presence of at least one red blood cell within the image containing at least one first region of decreased hemoglobin content and/or hemoglobin concentration within the red blood cell, which red blood cell has an otherwise homogenous distribution of hemoglobin; and c) determining the presence of an intraerythrocytic organism within the sample using the evaluation of the image. | 03-28-2013 |
20130029373 | METHOD AND APPARATUS FOR ANALYZING INDIVIDUAL CELLS OR PARTICULATES USING FLUORESCENT QUENCHING AND/OR BLEACHING - A method for analyzing a blood sample is provided that includes the steps of: providing a blood sample having one or more of each first and second constituents; admixing a colorant with the sample, which colorant is operative to cause the first constituents and second constituents to fluoresce and absorb light; illuminating at least a portion of the sample; e) imaging a portion of the sample; determining a fluorescence value for each the first constituents and second constituents; determining an optical density value for each of the first constituents and second constituents; and identifying the first constituents and the second constituents using the determined fluorescence and optical density values. | 01-31-2013 |
20130002279 | Methods and Devices for Determining Sensing Device Usability - Methods and devices for determining sensing device usability, e.g., for point of care immunoassay devices. In one embodiment, the invention is to a method of determining device usability, comprising the steps of providing a device comprising a first electrical pad; a second electrical pad; and a continuous polymer layer contacting at least a portion of the first and second electrical pads; applying a potential across the first and second electrical pads; measuring an electrical property associated with the continuous polymer layer; and determining whether the measured electrical property associated with the continuous polymer layer has exceeded a threshold level associated with the device usability. | 01-03-2013 |
20130002278 | Methods and Devices for Determining Sensing Device Usability - Methods and devices for determining sensing device usability, e.g., for self-monitoring and point of care devices. In one embodiment, the invention is to a method of determining device usability, comprising the steps of providing a device comprising a first electrical pad; a second electrical pad; and a humidity-responsive polymer layer contacting at least a portion of the first and second electrical pads; applying a potential across the first and second electrical pads; measuring an electrical property associated with the humidity-responsive polymer layer; and determining whether the measured electrical property associated with the humidity-responsive polymer layer has exceeded a humidity threshold level associated with the device usability. | 01-03-2013 |
20130002265 | Methods and Devices for Determining Sensing Device Usability - Methods and devices for determining device usability, e.g., for point of care assay devices. In one embodiment, the invention is to a method of determining device usability in a sensing device, including the steps of: providing a device comprising a first electrical pad; a second electrical pad; and a first polymer layer contacting at least a portion of the first and the second electrical pads and a second polymer layer contacting the first polymer layer and not the first and second electrical pads; applying a potential across the first and the second electrical pads; measuring an electrical property associated with the first and the second polymer layers; and determining whether the measured electrical property associated with the first and the second polymer layers has exceeded a threshold level associated with the device usability. | 01-03-2013 |
20130000378 | Methods and Devices for Sensing Device Signal Correction - Methods and devices for correcting sensing device signals, e.g., for point of care immunoassay devices. In one embodiment, the invention is to a method of correcting a signal in a sensing device, comprising the steps of: providing a sensing device comprising a sensor, a first electrical pad, a second electrical pad, and a continuous polymer layer contacting at least a portion of the first and second electrical pads; applying a potential across the first and second electrical pads; measuring an electrical property associated with the continuous polymer layer; determining a correction factor associated with the measured electrical property; and applying the correction factor to a signal generated by the sensor to produce a corrected signal. | 01-03-2013 |
20120315647 | Immunoassay Reagent Composition - An apparatus and method for sealing a fluid sample collection device, comprising loading a fluid sample collection device with a fluid sample, said device comprising a housing having at least one substantially planar surface that includes an orifice in fluid communication with an internal fluid sample holding chamber which terminates at an internal capillary stop; and slidably moving a sealing element over at least a portion of said substantially planar surface in a way that displaces any excess fluid sample away from the orifice, seals the fluid sample within said holding chamber, and inhibits the fluid sample from prematurely breaking through the internal capillary stop. | 12-13-2012 |
20120305409 | Apparatus and Methods for Analyte Measurement and Immunoassay - The present invention relates to methods for measuring an amount of an analyte using an electrochemical assay in a conduit comprising a sensor, wherein said sensor comprises an electrode having a surface layer of immobilized antibody that binds said analyte, and a counter/reference electrode disposed within said conduit. A solution comprising a substrate for said enzyme and at least one air segment contacts the sensor to remove unbound analyte and labeled antibody from a region of the sensor. The disclosed invention is adaptable to the point-of-care clinical diagnostic field, including use in accident sites, emergency rooms, surgery, nursing homes, intensive care units, and non-medical environments. | 12-06-2012 |
20120301906 | TSH IMMUNOASSAYS EMPLOYING SCAVENGING REAGENTS FOR CROSS-REACTING ENDOCRINE GLYCOPROTEIN HORMONE ANALOGUES - The invention relates to Thyroid Stimulating Hormone (TSH) immunoassays using an ELISA sandwich assay that employs scavenging or sacrificial beads for reducing interference caused by cross-reacting endocrine glycoprotein hormone analogues such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG). | 11-29-2012 |
20120301905 | TSH IMMUNOASSAYS AND PROCESSES FOR PERFORMING TSH IMMUNOASSAYS IN THE PRESENCE OF ENDOGENOUS CONTAMINANTS IN RESTRICTED WASH FORMATS - The invention relates to low wash Thyroid Stimulating Hormone (TSH) immunoassays using an ELISA sandwich assay having limited or no wash step between the antigen capture, detection antibody addition and substrate introduction steps. This invention exhibits low cross reactivity with biologically similar interfering cross reacting species, such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG). | 11-29-2012 |
20120301896 | TSH ANTIBODIES FOR POINT-OF-CARE IMMUNOASSAY FORMATS - The invention relates to antibody characteristics used to design a whole blood Point of Care Thyroid Stimulating Hormone (TSH) immunoassay using an ELISA sandwich assay lacking one or more wash steps between the antigen capture, detection antibody addition and substrate introduction steps. This invention exhibits low cross reactivity with biologically similar interfering cross reacting species, such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG). | 11-29-2012 |
20120295359 | AUTOMATED METHOD AND APPARATUS FOR DETECTING ERRONEOUS SAMPLE COLLECTION IN CLINICAL ASSAYS - An automatic method for identifying biological samples that are collected using the wrong blood preservative for subsequent analytical testing. The method also provides for identification and/or suppression of certain analytical test results that are substantially or partly adversely affected. The invention is particularly suited for use in point-of-care medical diagnostic testing. | 11-22-2012 |
20120295290 | MAGNETIC BEADS FOR REDUCING LEUKOCYTE INTERFERENCE IN IMMUNOASSAYS - Methods and devices for reducing interference from leukocytes in an analyte immunoassay are provided. In one embodiment, a method is provided comprising the steps of amending a biological sample with magnetic sacrificial beads opsonized to leukocytes, binding leukocytes in the sample to the magnetic sacrificial beads, and magnetically retaining the beads out of contact from an immunosensor. | 11-22-2012 |
20120282635 | SELF-CALIBRATING GRADIENT DILUTION IN A CONSTITUTENT ASSAY AND GRADIENT DILUTION APPARATUS PERFORMED IN A THIN FILM SAMPLE - A method and apparatus for measuring antibody titers in a thin film sample in an automated system which does not require multiple dilutions. The system provides a simple method for creating an in-situ dilution within a sample analysis chamber without the use of any precision fluid-handling components, and further, to use the same principles to provide a wide range of sample dilutions within the chamber so as to obviate the need for additional dilution steps when dealing with samples possibly containing wide ranges of analyte concentrations. | 11-08-2012 |
20120270756 | FORMATION OF IMMOBILIZED BIOLOGICAL LAYERS FOR SENSING - The invention is directed to enzyme immobilization compositions comprising: one or more enzymes, a humectant, an acrylic-based monomer, a water-soluble organic photo-initiator and a water-soluble acrylic-based cross-linker in a substantially homogeneous aqueous mixture. The invention is also directed to methods for forming sensors comprising such compositions and to apparati for forming arrays of immobilized layers on an array of sensors by dispensing such compositions onto a substrate. | 10-25-2012 |
20120263369 | METHOD AND APPARATUS FOR COMPRESSING IMAGING DATA OF WHOLE BLOOD SAMPLE ANALYSES - A method and apparatus for analyzing white blood cells (WBCs) within a whole blood sample quiescently residing within a chamber is provided. The chamber is defined by at least one transparent panel, and the whole blood sample includes at least one colorant operable to differentially identify at least one WBC type from another WBC type within the sample. The method includes the steps of: a) creating at least one image of the sample quiescently residing within the chamber; b) identifying portions of the sample image, with each portion representing a single WBC; c) compressing the sample image portions using a first compression algorithm; and d) one of compressing a remainder of the sample image not included in the portions using a second compression algorithm, or discarding the remainder. | 10-18-2012 |
20120252032 | Immunoassay Device with Improved Sample Closure - An apparatus and method for sealing a fluid sample collection device, comprising loading a fluid sample collection device with a fluid sample, said device comprising a housing having at least one substantially planar surface that includes an orifice in fluid communication with an internal fluid sample holding chamber which terminates at an internal capillary stop; and slidably moving a sealing element over at least a portion of said substantially planar surface in a way that displaces any excess fluid sample away from the orifice, seals the fluid sample within said holding chamber, and inhibits the fluid sample from prematurely breaking through the internal capillary stop. | 10-04-2012 |
20120244046 | Fluid-Containing Pouches with Reduced Gas Exchange and Methods for Making Same - 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 CO | 09-27-2012 |
20120233679 | SYSTEMS, METHODS AND ANALYZERS FOR ESTABLISHING A SECURE WIRELESS NETWORK IN POINT OF CARE TESTING - A system and method for initiating and maintaining a secure wireless communication between a wireless analyzer and a target network (e.g., a hospital network connected to a LIS and/or HIS). The present disclosure provides novel processes and systems for securely networking a wireless analyzer with a Wi-Fi network without the need for an operator or user to engage in manual initiation steps on, or through, the wireless analyzer. | 09-13-2012 |
20120232367 | SYSTEMS, METHODS AND ANALYZERS FOR ESTABLISHING A SECURE WIRELESS NETWORK IN POINT OF CARE TESTING - A system and method for initiating and maintaining a secure wireless communication between a wireless analyzer and a target network (e.g., a hospital network connected to a LIS and/or HIS). The present disclosure provides novel processes and systems for securely networking a wireless analyzer with a Wi-Fi network without the need for an operator or user to engage in manual initiation steps on, or through, the wireless analyzer. | 09-13-2012 |
20120219457 | BIOLOGIC FLUID ANALYSIS CARTRIDGE WITH SAMPLE HANDLING PORTION AND ANALYSIS CHAMBER PORTION - A biological fluid analysis cartridge is provided. In certain embodiments, the cartridge includes a base plate extending between a sample handling portion and an analysis chamber portion. A handling upper panel is attached to the base plate within the sample handling portion. A collection port is at least partially formed with the handling upper panel. An initial channel and a secondary channel are formed between the handling upper panel and the base plate. The collection port and initial and secondary channels are in fluid communication with one another. A chamber upper panel is attached to the base plate within the analysis chamber portion. At least one analysis chamber is formed between the chamber upper panel and the base plate. The secondary channel and the analysis chamber are in fluid communication with one another. | 08-30-2012 |
20120195489 | 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 and apparatus for determining the hematocrit of a blood sample disposed within an analysis chamber, the method comprising the steps of: a) imaging at least a portion of the sample that contains one or more red blood cells contacting the interior surfaces of the chamber and one or more areas void of red blood cells; b) determining a representative optical density value for a plurality of image units optically aligned with portions of the red blood cells that are in contact the interior surfaces, and assigning an optical density first boundary value to those image units; c) determining a representative optical density value of a plurality of image units optically aligned with the one or more regions of the sample devoid of red blood cells, and assigning a second optical density boundary value to those image units; and d) determining the hematocrit of the sample. | 08-02-2012 |
20120168305 | Reader Devices for Manipulating Multi-Fluidic Cartridges for Sample Analysis - A reader for mechanical actuation of fluids within a test cartridge. The instrument interface including multiple independently-controlled plungers aligned to respective fluidic pouches on a test cartridge that is inserted into a testing apparatus embodying the instrument interface. The plungers include tips for applying mechanical force to the respective fluidic pouches. | 07-05-2012 |
20120167672 | Multi-Fluidic Cartridges for Sample Analysis and Methods for Using Same - The invention is directed to multi-fluidic cartridges for sample analysis and to methods of using said cartridges. In one embodiment, the cartridge comprises: (a) a first conduit beginning at a sample entry port for receiving a fluid sample and in fluid communication with one or more sensors; (b) a plurality of rupturable fluidic pouches, each containing a different fluid and in fluid communication with a respective delivery conduit configured for delivering a respective fluid to said first conduit; and (c) at least one pneumatic pump configured to move said fluid sample to said one or more sensors and for transporting at least one of said different fluids to said first conduit. | 07-05-2012 |
20120164719 | METHOD AND APPARATUS FOR ANALYZING INDIVIDUAL CELLS OR PARTICULATES USING FLUORESCENT QUENCHING AND/OR BLEACHING - A method for analyzing a blood sample is provided that includes the steps of: providing a blood sample having one or more of each first and second constituents; admixing a colorant with the sample, which colorant is operative to cause the first constituents and second constituents to fluoresce and absorb light; illuminating at least a portion of the sample; e) imaging a portion of the sample; determining a fluorescence value for each the first constituents and second constituents; determining an optical density value for each of the first constituents and second constituents; and identifying the first constituents and the second constituents using the determined fluorescence and optical density values. | 06-28-2012 |
20120164682 | METHOD AND APPARATUS FOR ANALYZING INDIVIDUAL CELLS OR PARTICULATES USING FLUORESCENT QUENCHING AND/OR BLEACHING - A method for analyzing a blood sample residing within an analysis chamber, which sample has one or more first and second constituents, which constituents are different from one another. The method includes the steps of: a) imaging the sample containing the first and second constituents, which sample is mixed with a colorant that causes the first and second constituents to fluoresce upon exposure to light, and which colorant is also operative to absorb light, the imaging produces image signals representative of fluorescent emissions from the sample and optical density of the sample; b) determining one or more values representative of fluorescent emission from the first and second constituents; c) determining one or more values representative of optical density for the first and second constituents; and d) distinguishing the first constituents from the second constituents using the fluorescent emission representative values and the optical density representative values. | 06-28-2012 |
20120149118 | APPARATUS AND METHOD USING ANTI-ADSORPTION AGENT TO FACILITATE SAMPLE MIXING AND ANALYSIS - 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. | 06-14-2012 |
20120147357 | METHOD AND APPARATUS FOR DETECTING AND COUNTING PLATELETS INDIVIDUALLY AND IN AGGREGATE CLUMPS - A method for enumerating platelets within a blood sample is provided. The method includes the steps of: 1) depositing the sample into a sample container having an analysis chamber adapted to quiescently hold the sample for analysis, and an amount of colorant that platelets absorb and which fluoresces upon exposure to one or more predetermined first wavelengths of light; 2) imaging at least a portion of the sample disposed in the analysis chamber, including producing image signals indicative of fluorescent emissions from the platelets illuminated by first wavelengths of light; 3) identifying the platelets using the image signals; and 4) enumerating individual platelets and clumped platelets within the sample using one or more of fluorescent emissions, area, shape, and granularity. | 06-14-2012 |
20120142026 | Assay Devices with Integrated Sample Dilution and Dilution Verification and Methods of Using Same - The invention is to devices and method for rapid determination of analytes in liquid samples by various assays including immunoassays incorporating a sample dilution feature for forming a diluted sample for analysis. The devices and methods also include a dilution verification feature for verifying the degree of dilution of the diluted sample. The devices preferably are capable of being used in the point-of-care diagnostic field is provided. | 06-07-2012 |
20120142025 | Ratiometric Immunoassay Method and Blood Testing Device - The invention is to devices and methods for rapid determination of analytes in liquid samples. The devices and methods incorporate a sample dilution feature and multiple immunosensors for performing a ratiometric immunoassay on a first analyte and a second analyte, for example, hemoglobin and hemoglobin A1c or albumin and glycosylated albumin. The devices are preferably capable of being used in the point-of-care diagnostic field. | 06-07-2012 |
20120142020 | Sample Metering Device and Assay Device with Integrated Sample Dilution - In one embodiment, the invention is to a sample metering device, comprising a sample holding chamber oriented between a sample entry port and a sample extraction unit, wherein a portion of said extraction unit defines a metered volume of a sample. A diluent may be transported over and/or through the extraction unit to form a diluted sample for sample analysis. In another embodiment, the invention is to an apparatus and method for rapid determination of analytes in liquid samples by various assays including immunoassays incorporating a sample dilution feature, capable of being used in the point-of-care diagnostic field is provided. The devices and methods of the invention preferably are well-suited for high range sample dilution. | 06-07-2012 |
20120142019 | Sample Metering Device and Assay Device with Integrated Sample Dilution - In one embodiment, the invention is to a sample metering device, comprising a sample holding chamber oriented between a sample entry port and a sample isolation unit and having a diluent introduction port disposed therebetween for introduction of a diluent into the sample holding chamber. The volume within the sample holding chamber between the diluent introduction port and the sample isolation unit defines a metered volume of a sample for analysis. In another embodiment, the invention is to an apparatus and method for rapid determination of analytes in liquid samples by various assays including immunoassays incorporating a sample dilution feature, preferably suitable for low range sample dilution, and preferably capable of being used in the point-of-care diagnostic field. | 06-07-2012 |
20120099108 | METHOD AND APPARATUS FOR DETERMINING A FOCAL POSITION OF AN IMAGING DEVICE ADAPTED TO IMAGE A BIOLOGIC SAMPLE - A method and apparatus for focusing a device for imaging a biologic sample is provided. A method aspect includes the steps of: disposing lenslets within a biologic sample, which lenslets have a height and a refractive index, which refractive index is different from that of the sample, wherein one or both of the imaging device and the sample are relatively locatable so a focal position of the imaging device can be moved along the height of the lenslets; imaging a portion of the sample including lenslets using transmittance at one or more wavelengths; determining an average light transmittance intensity of the sample at the wavelengths; determining an average light transmittance intensity of a region of each lenslet at the wavelengths; and determining the focal position of the imaging device using the average light transmittance intensity of the sample and the average light transmittance intensity of the region of the lenslets. | 04-26-2012 |
20120073969 | Amelioration of Heterophile Antibody Immunosensor Interference - 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 μg/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. | 03-29-2012 |
20120034647 | METHOD AND APPARATUS FOR AUTOMATED WHOLE BLOOD SAMPLE ANALYSES FROM MICROSCOPY IMAGES - 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. | 02-09-2012 |
20120034624 | OSCILLATING IMMUNOASSAY METHOD AND DEVICE - The present invention provides apparatus and methods for the rapid determination of analytes in liquid samples by immunoassays incorporating magnetic capture of beads on a sensor capable of being used in the point-of-care diagnostic field. | 02-09-2012 |
20120021456 | METHOD AND APPARATUS FOR DETECTING THE PRESENCE OF ANISOTROPIC CRYSTALS AND HEMOZOIN PRODUCING PARASITES IN LIQUID BLOOD - An apparatus and method for detecting the presence of anisotropic crystals within a biologic fluid sample is provided. The method includes the steps of: a) disposing the sample within a sample chamber in a sample layer having a height riot greater than about fifteen microns (15μ); b) disposing the sample layer within the sample chamber between a polarizing filter and an analyzing filter; a) disposing the polarizing filter, sample chamber, and analyzing filter in a configuration relative to a light source such that polarized light passes through the sample, and subsequently impinges on the analyzing filter; and d) wherein polar orientations of the polarizing filter and the analyzing filter are such that the polarized light will not pass through the analyzing filter, and light passing through an anisotropic crystal disposed within the sample will pass through the analyzing filter and appear as a point of light. | 01-26-2012 |
20110306070 | MAGNETIC BEADS FOR REDUCING LEUKOCYTE INTERFERENCE IN IMMUNOASSAYS - Methods and devices for reducing interference from leukocytes in an analyte immunoassay are provided. In one embodiment, a method is provided comprising the steps of amending a biological sample with magnetic sacrificial beads opsonized to leukocytes, binding leukocytes in the sample to the magnetic sacrificial beads, and magnetically retaining the beads out of contact from an immuno sensor. | 12-15-2011 |
20110294200 | VIRTUAL SEPARATION OF BOUND AND FREE LABEL IN A LIGAND ASSAY FOR PERFORMING IMMUNOASSAYS OF BIOLOGICAL FLUIDS, INCLUDING WHOLE BLOOD - Detection and characterization of immunologically detected substances are performed electronically on human and animal biological fluids such as whole blood, serum, plasma, urine, milk, pleural and peritoneal fluids, and semen, which fluids are contained in a thin chamber forming a quiescent fluid sample, which chamber has at least two parallel planar walls, at least one of which is transparent. | 12-01-2011 |
20110290669 | Apparatus and Methods for Analyte Measurement and Immunoassay - The present invention relates to an apparatus for conducting a variety of assays for the determination of analytes in liquid samples, and relates to the methods for such assays. In particular, the invention relates to a single-use cartridge designed to be adaptable to a variety of real-time assay protocols, preferably assays for the determination of analytes in biological samples using immunosensors or other ligand/ligand receptor-based biosensor embodiments. The cartridge provides novel features for processing a metered portion of a sample, for precise and flexible control of the movement of a sample or second fluid within the cartridge, for the amending of solutions with additional compounds during an assay, and for the construction of immunosensors capable of adaptation to diverse analyte measurements. The disclosed device and methods of use enjoy substantial benefits over the prior art, including simplicity of use by an operator, rapid in situ determinations of one or more analytes, and single-use methodology that minimizes the risk of contamination of both operator and patient. The disclosed invention is adaptable to the point-of-care clinical diagnostic field, including use in accident sites, emergency rooms, surgery, nursing homes, intensive care units, and non-medical environments. | 12-01-2011 |
20110269222 | Immunoassay Device with Improved Sample Closure - An apparatus and method for sealing a fluid sample collection device, comprising: loading a fluid sample collection device with a fluid sample, said device comprising a housing having at least one substantially planar surface that includes an orifice in fluid communication with an internal fluid sample holding chamber which terminates at an internal capillary stop; and slidably moving a sealing element over at least a portion of said substantially planar surface in a way that displaces any excess fluid sample away from the orifice, seals the fluid sample within said holding chamber, and inhibits the fluid sample from prematurely breaking through the internal capillary stop. | 11-03-2011 |
20110269159 | REAGENTS FOR REDUCING LEUKOCYTE INTERFERENCE IN IMMUNOASSAYS - Methods and devices for reducing interference from leukocytes in an analyte immunoassay are provided. In one embodiment, a method is provided comprising the steps of amending a biological sample such as a whole blood sample with one or more leukocidal reagents that reduce or eliminate the metabolic activity of leukocytes, and performing an immunoassay on the amended sample to determine the concentration of analyte in the sample. Preferably, the sample is amended with one or more enzymes and optionally one or more enzyme substrates and cofactors. | 11-03-2011 |
20110269153 | Immunoassay Device with Improved Sample Closure - An apparatus and method for sealing a fluid sample collection device, comprising: loading a fluid sample collection device with a fluid sample, said device comprising a housing having at least one substantially planar surface that includes an orifice in fluid communication with an internal fluid sample holding chamber which terminates at an internal capillary stop; and slidably moving a sealing element over at least a portion of said substantially planar surface in a way that displaces any excess fluid sample away from the orifice, seals the fluid sample within said holding chamber, and inhibits the fluid sample from prematurely breaking through the internal capillary stop. | 11-03-2011 |
20110256573 | METHOD AND APPARATUS FOR DETERMINING AT LEAST ONE HEMOGLOBIN RELATED PARAMETER OF A WHOLE BLOOD SAMPLE - A method and apparatus for determining at least one hemoglobin related parameter of a whole blood sample is provided. The method includes the steps of: a) depositing the sample into an analysis chamber adapted to quiescently hold the sample for analysis, the chamber defined by an interior surface of a first panel, and an interior surface of a second panel, and the chamber has a height extending between the interior surfaces of the panels, wherein the chamber is configured to increase the oxygenation state of the sample to a substantially oxygenated state within a predetermined amount of time after entry into the chamber; b) imaging the at least one red blood cell contacting the interior surfaces, and producing image signals; c) determining an optical density of at least a portion of the imaged red blood cell contacting both interior surfaces; and d) determining the at least one hemoglobin related parameter of the red blood cell contacting the interior surfaces, using the determined optical density and a molar extinction coefficient for oxygenated hemoglobin. | 10-20-2011 |
20110244593 | METHOD AND APPARATUS FOR SELECTIVELY ADMIXING REAGENTS IN A SUBSTANTIALLY UNDILUTED BIOLOGIC FLUID SAMPLE ANALYSIS - A biologic fluid sample analysis method and system is provided that includes a reagent depository, and analysis chamber, a biologic fluid transfer system, and a programmable analyzer. The reagent depository has a plurality of reagent deposits, and each reagent deposit located at a position within the depository independent of the other reagent deposits. The analysis chamber is adapted to quiescently hold a biologic fluid sample and one or more reagents during analysis. The biologic fluid transfer system has at least one fluid transfer device. The programmable analyzer is adapted to control the biologic fluid transfer system to acquire a volume of sample from a sample reservoir, dispense a volume of the sample into the reagent depository, acquire a volume of sample and reagent from the reagent depository, and to transfer the sample and reagent to the analysis chamber, and to analyze the combined sample and reagent. | 10-06-2011 |
20110244581 | BIOLOGIC FLUID ANALYSIS SYSTEM WITH SAMPLE MOTION - An apparatus for and method of analyzing a biologic fluid sample is provided. The method includes the steps of: a) providing a sample cartridge having at least one channel for fluid sample passage; b) providing an analysis device having imaging hardware, a programmable analyzer, and a sample motion system, which sample motion system includes a bidirectional fluid actuator operable to selectively move a bolus of sample axially within the channel, and to cycle the bolus back and forth within the channel; and c) cycling the bolus of sample disposed within the channel at a predetermined frequency until constituents within the sample are substantially uniformly distributed, using the bidirectional fluid actuator. | 10-06-2011 |
20110243794 | BIOLOGIC FLUID ANALYSIS CARTRIDGE WITH DEFLECTING TOP PANEL - A cartridge for analyzing a biologic fluid sample is provided that includes a base plate, a sample inlet port, a first chamber wall, a second chamber wall, and an optically transparent cover panel disposed in contact with the first and second chamber walls. The base plate has a body with a chamber surface, a body passage, and a chamber entry passage. The body passage is in fluid communication with the chamber entry passage, and the chamber entry passage extends through to the chamber surface. The sample inlet port has an inlet passage in fluid communication with the body passage. The first and second chamber walls each have a height extending outwardly from the chamber surface, and the two walls are spaced apart from one another. The cover panel is sufficiently flexible to deflect and contact a central region of the chamber surface. | 10-06-2011 |
20110230740 | 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 adapted to quiescently hold the sample for analysis, the chamber defined by the interior surfaces of first and second panels and a height extending there between, wherein both panels are transparent, and the height is such that at least some of the red blood cells within the sample contact both interior surfaces of the panels and one or more lacunae 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 average 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. | 09-22-2011 |
20110206557 | BIOLOGIC FLUID ANALYSIS CARTRIDGE - A biological fluid sample analysis cartridge is provided. The cartridge includes a housing, a fluid module, and an analysis chamber. The fluid module includes a sample acquisition port and an initial channel, and is connected to the housing. The initial channel is sized to draw fluid sample by capillary force, and is in fluid communication with the acquisition port. The initial channel is fixedly positioned relative to the acquisition port such that at least a portion of a fluid sample disposed within the acquisition port will draw into the initial channel. The analysis chamber is connected to the housing, and is in fluid communication with the initial channel. | 08-25-2011 |
20110193957 | METHOD AND APPARATUS FOR DETECTING AND COUNTING PLATELETS INDIVIDUALLY AND IN AGGREGATE CLUMPS - 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. | 08-11-2011 |
20110166427 | Point-of-Care Inventory Management System and Method - A system and method are disclosed for controlling an inventory of point-of-care diagnostic devices. The inventory includes a main inventory and at least one subinventory. Each device has an ambient temperature shelf life. Data associated with the devices is entered, including: the current quantity and predetermined minimum quantity of devices in the main inventory; and the current quantity and predetermined minimum quantity of devices in the subinventory. A first timestamp is associated with each device when the device is transferred from the main inventory to the ambient temperature subinventory. The first timestamp is compared to a second timestamp prior to use of the device to determine whether the device's ambient temperature shelf life is exceeded. The current quantity of devices in the subinventory is updated in response to an event that causes a change in the current quantity of devices in the subinventory. | 07-07-2011 |
20110164803 | METHOD AND APPARATUS FOR DETERMINING MEAN CELL VOLUME OF RED BLOOD CELLS - A method and apparatus for determining a cell volume of a red blood cell is provided. The method includes the steps of: a) depositing a sample into an analysis chamber, the chamber defined by an first panel interior surface, a second panel interior surface, and a known or determinable height, which height is such that at least one red blood cell subject to a sphering agent assumes a partially compressed spherical shape in contact with the interior surfaces; b) imaging the at least one partially compressed spherical red blood cell contacting the interior surfaces, and producing image signals; c) determining a radius of the partially compressed spherical red blood cell from the image signals; and d) determining a volume of the imaged red blood cell using the determined radius. | 07-07-2011 |
20110157344 | METHOD AND APPARATUS FOR FAST FOCUS IMAGING BIOLOGIC SPECIMENS - A method and apparatus for imaging a biologic fluid sample quiescently residing within a chamber is provided. The method includes the steps of: a) positioning the chamber at a Z-axis position relative to an objective lens having a lens axis, wherein the Z-axis is parallel to the lens axis; b) moving one or both of the chamber and the objective lens relative to one another at a velocity along the Z-axis; and c) creating one or more images of the biologic fluid sample as one or both of the chamber and the objective lens are moving at a velocity relative to one another within a focus search range along the Z-axis. | 06-30-2011 |
20110157343 | METHOD AND APPARATUS FOR SECURING PLANAR ORIENTATION OF ANALYSIS CHAMBER - An apparatus and method for imaging a biologic fluid sample quiescently residing within a chamber is provided. The chamber includes a first panel and a second panel, between which the biologic fluid sample quiescently resides. At least one of the first and second panels is flexible. The chamber has one or more fields that are each defined by a cross-sectional area. The apparatus comprises a field illuminator, a chamber flattener, a positioner, and an image dissector. The field illuminator has an objective lens. The chamber flattener has a platen with a window and a cover plate. The chamber flattener is operable to cause the chamber to assume a substantially uniform Z-axis position for substantially all of the fields within the chamber. The positioner is adapted to position the objective lens and the chamber relative to one another. The image dissector is adapted to image the sample residing within the chamber. | 06-30-2011 |
20110150705 | Integrated Hinged Cartridge Housings for Sample Analysis - 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. | 06-23-2011 |
20110149061 | METHOD AND APPARATUS FOR IDENTIFYING RETICULOCYTES WITHIN A BLOOD SAMPLE - A method and apparatus for identifying reticulocytes within a blood sample is provided. The method includes the steps of: a) depositing the sample into an analysis chamber adapted to quiescently hold the sample for analysis, and the chamber has a known or determinable height extending between the interior surfaces of panels, which height is such that at least one red blood cell, or an aggregate of red blood cells, within the sample contacts both of the interior surfaces; b) admixing a supravital dye with the sample, which dye is operable to cause reticulin to fluoresce when excited by light of one or more predetermined wavelengths; c) imaging the sample using light that includes the one or more predetermined wavelengths that cause reticulin to fluoresce; d) imaging the sample using light that is absorbed by hemoglobin to produce values of optical density on a per image unit basis; and e) identifying reticulocytes within the sample using the image of the sample created with light that causes the dyed reticulin to fluoresce, and using the per image unit optical density values. | 06-23-2011 |
20110139616 | Photoformed Silicone Sensor Membrane - A sensing device includes a sensing surface, and a matrix overlaying the sensing surface. The sensing device includes a photoformed membrane overlaying at least a portion of the matrix. The photoformed membrane includes a directly photoformed organosiloxane polymer that is substantially permeable to gaseous molecules and substantially impermeable to non-gaseous molecules and ions. | 06-16-2011 |
20110117581 | REDUCING LEUKOCYTE INTERFERENCE IN COMPETITIVE IMMUNOASSAYS - The invention is directed to methods and devices for reducing interference from leukocytes in an competitive analyte 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 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. | 05-19-2011 |
20110117580 | REDUCING LEUKOCYTE INTERFERENCE IN NON-COMPETITIVE IMMUNOASSAYS - 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. | 05-19-2011 |
20110059481 | 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 - A method for the determination of the red blood cell indices including the volume, and hemoglobin content and concentration for individual red blood cells, as well as red blood cell population statistics, including total number of red blood cells present in the sample, and mean values for each of the aforementioned indices within a substantially undiluted blood sample is provided. | 03-10-2011 |
20100330575 | MOLECULAR DIAGNOSTICS REAGENTS AND METHODS - The present invention relates to automated devices and methods for the extraction of nucleic acids from cells, the amplification of segments of nucleic acid and the detection of nucleic acids, all in a convenient and portable manner. The invention is particularly suited for use in point-of-care medical diagnostics testing. | 12-30-2010 |
20100297708 | MOLECULAR DIAGNOSTICS SYSTEM AND METHODS - The present invention relates to automated devices and methods for the extraction of nucleic acids from cells, the amplification of segments of nucleic acid and the detection of nucleic acids, all in a convenient and portable manner. The invention is particularly suited for use in point-of-care medical diagnostics testing. | 11-25-2010 |
20100248273 | AMELIORATION OF HETEROPHILE ANTIBODY IMMUNOSENSOR INTERFERENCE - 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 μg/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. | 09-30-2010 |
20100240136 | APPARATUS AND METHOD FOR ASSAYING COAGULATION IN FLUID SAMPLES - This invention is a disposable cartridge for use at the patient side to perform traditional coagulation assays on fresh whole blood or blood derivative samples. The cartridge, in use with an electronic analyzer allows a fluid sample to be metered and quantitatively mixed with reagents which activate the coagulation cascade. An artificial substrate for thrombin, the enzyme whose action results in clot formation is also provided. Clot formation is subsequently detected using a microfabricated sensor also housed within the cartridge which detects electrochemically the product of the thrombin reaction upon the synthetic substrate. | 09-23-2010 |
20100240067 | APPARATUS AND METHOD FOR ASSAYING COAGULATION IN FLUID SAMPLES - This invention is a disposable cartridge for use at the patient side to perform traditional coagulation assays on fresh whole blood or blood derivative samples. The cartridge, in use with an electronic analyzer allows a fluid sample to be metered and quantitatively mixed with reagents which activate the coagulation cascade. An artificial substrate for thrombin, the enzyme whose action results in clot formation is also provided. Clot formation is subsequently detected using a microfabricated sensor also housed within the cartridge which detects electrochemically the product of the thrombin reaction upon the synthetic substrate. | 09-23-2010 |
20100203550 | METHOD OF PERFORMING AN IMMUNOASSAY IN BLOOD - 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
| 08-12-2010 |
20100173396 | AMPEROMETRIC IMMUNOSENSOR - 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
| 07-08-2010 |
20100167386 | IMMUNOSENSOR SYSTEM FOR BLOOD WITH REDUCED INTERFERENCE - 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
| 07-01-2010 |
20100167312 | METHOD FOR ASSAYING A TARGET ANALYTE WHILE REDUCING INTERFERENCE IN AN IMMUNOSENSOR SYSTEM - 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
| 07-01-2010 |
20100167308 | METHOD FOR MEASURING AN ANALYTE IN BLOOD - 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
| 07-01-2010 |
20100167301 | METHOD AND DEVICE FOR IMMUNOASSAY USING NUCLEOTIDE CONJUGATES - A composition of matter for use in an immunoassay devices and method comprising a signal antibody, e.g., FAB fragment, covalently linked to a first nucleotide; and one or more signal elements, e.g., signal enzymes such as ALP or fluorescent dyes, each covalently linked to a second nucleotide, wherein the first nucleotide has one or more repeated sequences, and the second nucleotide is bound to one of the one or more repeated sequences on said first nucleotide, and wherein the ratio of the signal antibody to the signal element is controlled by the number of repeated sequences. | 07-01-2010 |
20100061890 | IMMUNOASSAY DEVICE WITH IMPROVED SAMPLE CLOSURE - An apparatus and method for sealing a fluid sample collection device, comprising loading a fluid sample collection device with a fluid sample, said device comprising a housing having at least one substantially planar surface that includes an orifice in fluid communication with an internal fluid sample holding chamber which terminates at an internal capillary stop; and slidably moving a sealing element over at least a portion of said substantially planar surface in a way that displaces any excess fluid sample away from the orifice, seals the fluid sample within said holding chamber, and inhibits the fluid sample from prematurely breaking through the internal capillary stop. | 03-11-2010 |
20090258371 | METHOD OF DETECTING VERY LOW LEVELS OF ANALYTE WITHIN A THIN FILM FLUID SAMPLE CONTAINED IN A THIN THICKNESS CHAMBER - A method and apparatus for the detection and quantification of very low levels of a target analyte using an imaging system is provided. In the case of some analytes such as certain hormones, for example TSH, their levels may be as low as several tens of thousands of molecules per micro liter. These extremely low levels can be measured by using the present invention to count the individual molecules of analyte. The invention also has the advantage of being a primary quantitative method, which is one which needs no standardization. | 10-15-2009 |
20090257632 | METHOD FOR MEASURING THE AREA OF A SAMPLE DISPOSED WITHIN AN ANALYSIS CHAMBER - A method for determining the area of an analysis chamber covered by a biologic fluid sample quiescently residing within the chamber is provided. The chamber has a first panel with an interior surface, and a second panel with an interior surface, both of which panels are transparent. The method includes the steps of: a) illuminating the sample residing within the analysis chamber at one or more wavelengths operable to highlight interfaces between the sample and air, and to highlight a constituent within the sample; b) imaging the sample along the one or more wavelengths, and producing image signals representative of the interaction of the one or more wavelengths with the sample; c) determining a location of at least one interface between the sample and air, using the image signals; d) determining a location of one or more constituents within the sample relative to the at least one sample-air interface using the image signals; and e) determining an area of the chamber containing the sample, using the location of the one or more constituents and the at least one sample-air interface. | 10-15-2009 |
20090253218 | METHOD FOR SEROLOGIC AGGLUTINATION AND OTHER IMMUNOASSAYS PERFORMED IN A THIN FILM FLUID SAMPLE - A method and system for performing a serological agglutination assay in a liquid sample. The system provides a simple method for creating an in-situ sample/reagent admixture within a sample analysis chamber without the use of any precision fluid-handling components. | 10-08-2009 |
20090252399 | SELF-CALIBRATING GRADIENT DILUTION IN A CONSTITUENT ASSAY AND GRADIENT DILUTION APPARATUS PERFORMED IN A THIN FILM SAMPLE - A method and apparatus for measuring antibody titers in a thin film sample in an automated system which does not require multiple dilutions. The system provides a simple method for creating an in-situ dilution within a sample analysis chamber without the use of any precision fluid-handling components, and further, to use the same principles to provide a wide range of sample dilutions within the chamber so as to obviate the need for additional dilution steps when dealing with samples possibly containing wide ranges of analyte concentrations. | 10-08-2009 |
20090251683 | VIRTUAL SEPARATION OF BOUND AND FREE LABEL IN A LIGAND ASSAY FOR PERFORMING IMMUNOASSAYS OF BIOLOGICAL FLUIDS, INCLUDING WHOLE BLOOD - Detection and characterization of immunologically detected substances are performed electronically on human and animal biological fluids such as whole blood, serum, plasma, urine, milk, pleural and peritoneal fluids, and semen, which fluids are contained in a thin chamber forming a quiescent fluid sample, which chamber has at least two parallel planar walls, at least one of which is transparent. | 10-08-2009 |
20090239257 | METHOD AND APPARATUS FOR ANALYZING INDIVIDUAL CELLS OR PARTICULATES USING FLUORESCENT QUENCHING AND/OR BLEACHING - A method for analyzing a blood sample is provided that includes the steps of: a) providing a blood sample having one or more first constituents and one or more second constituents, which second constituents are different from the first constituents; b) 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; c) admixing a colorant with the sample, which colorant is operative to cause the first constituents and second constituents to fluoresce upon exposure to predetermined first wavelengths of light, and which colorant is operative to absorb light at one or more predetermined second wavelengths of light; d) illuminating at least a portion of the sample containing the first constituents and the second constituents at the first wavelengths and at the second wavelengths; e) imaging the at least a portion of the sample, including producing image signals indicative of fluorescent emissions from the first constituents and the second constituents and the optical density of the first constituents and the second constituents; f) determining a fluorescence value for each the first constituents and second constituents using the image signals; g) determining an optical density value for each of the first constituents and second constituents, which optical density is a function of the colorant absorbed by the constituents, using the image signals; and h) identifying the first constituents and the second constituents using the determined fluorescence and optical density values. | 09-24-2009 |
20090238439 | METHOD AND APPARATUS FOR DETECTING AND COUNTING PLATELETS INDIVIDUALLY AND IN AGGREGATE CLUMPS - 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. | 09-24-2009 |
20090238438 | 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 - A method for the determination of the red blood cell indices including the volume, and hemoglobin content and concentration for individual red blood cells, as well as red blood cell population statistics, including total number of red blood cells present in the sample, and mean values for each of the aforementioned indices within a substantially undiluted blood sample is provided. | 09-24-2009 |
20090238437 | 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 adapted to quiescently hold the sample for analysis, the chamber defined by the interior surfaces of first and second panels and a height extending there between, wherein both panels are transparent, and the height is such that at least some of the red blood cells within the sample contact both interior surfaces of the panels and one or more lacunae 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 average 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. | 09-24-2009 |
20090237665 | METHOD AND APPARATUS FOR DETERMINING A FOCAL POSITION OF AN IMAGING DEVICE ADAPTED TO IMAGE A BIOLOGIC SAMPLE - A method and apparatus for focusing a device for imaging a biologic sample is provided. A method aspect of the disclosure includes the steps of: 1) disposing lenslets within a field of a biologic sample, which lenslets have a height, and have a refractive index and which refractive index is different from that of the sample, wherein one or both of the imaging device and the sample are relatively locatable so a focal position of the imaging device can be moved along the height of the lenslets; 2) imaging at least a portion of the sample including a plurality of lenslets using transmittance at one or more predetermined wavelengths; 3) determining an average light transmittance intensity of the sample at the wavelengths; 4) determining an average light transmittance intensity of a region of each lenslet at the wavelengths; and 5) determining the focal position of the imaging device using the average light transmittance intensity of the sample and the average light transmittance intensity of the region of the lenslets. | 09-24-2009 |
20090204513 | POINT-OF-CARE INVENTORY MANAGEMENT SYSTEM AND METHOD - A system and method are disclosed for controlling an inventory of point-of-care diagnostic devices. The inventory includes a main inventory and at least one subinventory. Each device has an ambient temperature shelf life. Data associated with the devices is entered, including: the current quantity and predetermined minimum quantity of devices in the main inventory; and the current quantity and predetermined minimum quantity of devices in the subinventory. A first timestamp is associated with each device when the device is transferred from the main inventory to the ambient temperature subinventory. The first timestamp is compared to a second timestamp prior to use of the device to determine whether the device's ambient temperature shelf life is exceeded. The current quantity of devices in the subinventory is updated in response to an event that causes a change in the current quantity of devices in the subinventory. | 08-13-2009 |
20090173641 | AUTOMATED METHOD AND APPARATUS FOR DETECTING ERRONEOUS SAMPLE COLLECTION IN CLINICAL ASSAYS - A method for identifying biological samples that are collected using the wrong anticoagulant for subsequent analytical testing. The method also provides for identification of certain analytical test results that are substantially or partly adversely affected. | 07-09-2009 |
20090170140 | BLOOD UREA NITROGEN (BUN) SENSOR - A BUN (blood urea nitrogen) sensor containing immobilized carbonic anhydrase and immobilized urease for the in vitro detection of urea nitrogen in blood and biological samples with improved performance and precision characteristics. | 07-02-2009 |
20090159443 | BLOOD UREA NITROGEN (BUN) SENSOR - A BUN (blood urea nitrogen) sensor containing immobilized carbonic anhydrase and immobilized urease for the in vitro detection of urea nitrogen in blood and biological samples with improved performance and precision characteristics. | 06-25-2009 |