Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: A method and apparatus for identifying reticulocytes within a blood sample is provided.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.