Abstract:
A blood glucose meter having a test strip port (20) and an adjustable lancet device (30) disposed at the same end of the device body (10) is disclosed. The device body (10) further includes an enclosure (70) at the proximal end of the device body (10) which houses a test strip storage vial (75) and which facilitates one-handed opening and closing of the vial (75) to simplify access to test strips contained therein. The enclosure (70) is further provided with a window (72) which allows the reading of the lot numbers on the label of the test strip vial (75) therein without necessitating removal of the vial (75). A data connector (90) is also provided on the device body (10) for communication access, such as to upload data from other devices or to download data to other devices. By combining these multiple components into a single device body, the blood glucose meter requires fewer steps for sampling and testing, and makes device use easier and more convenient.
Abstract:
A method for manufacturing a test strip is provided. The method comprises selecting a test strip substrate material and positioning the test strip substrate material a predetermined distance from a matrix material disposed on a second substrate, wherein at least one enzyme to be deposited on the test strip substrate and having glucose as an enzymatic substrate is held within the matrix material. A laser pulse is directed towards the matrix material to release at least a portion of the at least one enzyme having glucose as an enzymatic substrate from the matrix material and deposit the enzyme on the test strip substrate.
Abstract:
An analyte test element for the qualitative and/or quantitative determination of at least one analyte in a physiological or aqueous sample fluid having a first surface (2a) and a second surface (4a) in a predetermined distance opposite from each other, said both surfaces are provided with two substantially equivalent patterns forming areas of high and low surface energy which are aligned mostly congruent, whereby the areas of high surface energy (6, 6') create a sample distribution system with at least two detection areas (6a, 6'a), said at least one of the detection areas (6a, 6'a) of the first and second surfaces (2a, 4a) is provided with at least one non-enzymatic recognition element (32). The analyte test element is suitable for analyte test systems evaluating the affinity reaction between an analyte of interest and a recognition element and therefore provides a suitable test system to perform immunoassays, receptor-assays, or other affinity assays with a simple test element containing qualitative or quantitative calibration mechanisms suitable for point of care and home settings.
Abstract:
This invention provides a device for determining the concentration of an analyte like glucose, cholesterol, free fatty acids, triglycerides, proteins, ketones, phenylalanine or enzymes, in a physiological fluid like blood, serum, plasma, saliva, urine, interstitial and/or intracellular fluid, the device having an integrated calibration and quality control system suitable for dry reagent test strips with a very small sample volume of about 0.5µL based on to a new sample distribution system. The production of the inventive analyte test element involves only a small number of uncomplicated production steps enabling an inexpensive production of the strips.
Abstract:
A multilayer test strip [20] and method of using the test strip [20] for determining concentration of HDL cholesterol in a whole blood sample. The inventive test strip [20] includes a two-stage blood separation mechanism, including a first glass fiber matrix [38] which separates most of the blood cells and an adjacent, second matrix [40] preferably also containing glass fibers that separates the remainder of the blood cells. The second layer [40] also precipates and retains non-HDL cholesterol, thereby providing plasma that is substantially free of red blood cells and substantially free of non-HDL cholesterol to a reaction layer [42]. Precipitation and retention on non-HDLs takes place by vertical or dead-end filtration in a single layer [40]. The reaction layer [42] produces a color, the intensity of which is proportional to the concentration of HDL cholesterol in the blood sample which is applied to the test strip. Advantageously, the inventive test strip [20] is a vertical flow device, which can be made more compact and operates more efficiently than a lateral flow device.
Abstract:
The invention relates to a sample collection device which allows the rapid and volumetric collection of a body fluid sample upon which an assay can be conducted which provides a reliable measurement of a biomolecule.
Abstract:
A device (10) for simultaneously measuring a plurality of analytes in blood or other fluids comprising a plurality of reagent pads (12) containing reagents specific to particular analytes.
Abstract:
The present invention is directed to a multi-layer test device (10) and method for analyzing the concentration of fructosamine in a liquid sample. The multi-layer test device (10) has a buffer layer (14) containing a buffer having a pH value of at least 9 which is either superposed above or juxtaposed to an indicator layer (15) containing an indicator capable of being reduced by fructosamine. Supporting the buffer layer (14), the indicator layer (15), and any additional layers in the multi-layer device (10) is at least one support member (16) which optionally has a detection aperture (13) for analyzing the concentration of fructosamine on the indicator layer.
Abstract:
An assay device (14) for measuring the concentration of a soluble analyte, such as HDL-associated cholesterol, in a fluid sample containing interfering compounds, such as LDL- or VLDL-associated cholesterol, which can be selectively precipitated. The device includes a sieving matrix (26) capable of separating soluble and precipitated material migrating through the matrix, and a reservoir (34) which holds a precipitating agent which is effective, within a given concentration range, to selectively precipitate the interfering compounds. The reservoir is designed to delay the release of agent, on contact with the fluid sample, to maintain the concentration of precipitating agent in contact with the fluid sample within the given concentration range. The device additionally includes an assay pad (64, 66, 68, 70) in which the soluble analyte present in the fluid sample can be assayed. A method of separating high-density lipoproteins (HDL) from low- and very-low-density lipoproteins (LDL and VLDL) employs a coated glass fiber matrix which inhibits binding of HDL as a blood fluid sample containing HDL and precipitated LDL and VLDL passes through the matrix.