Abstract: A device for preparing a fluid sample for use in a fluid analyte meter, including: a first portion, comprising: a septum piercing projection, a capillary channel, and a vent on an outer surface of the first portion; and a second portion, comprising: a treatment solution chamber, and a septum sealing the treatment solution chamber, wherein the vent is open when the first portion of the device is initially inserted into the second portion of the device, and wherein the vent is closed when the first portion of the device is fully inserted into the second portion of the device.

Abstract: A method of adjusting a final signal value measured on a lateral flow assay test strip, by: identifying a pre-determined calibration method for the test strip, wherein the pre-determined calibration method corresponds to the manufacturing lot from which the test strip has been made; measuring signal values while performing a lateral flow assay reaction on a test strip; determining a final signal value; and adjusting the final signal value based upon the identified pre-selected calibration method for the test strip.

Abstract: The invention provides a system for quantitative measurement of percent glycated hemoglobin as hemoglobin A1c in whole blood having extended shelf life at room temperature. The system comprising a blood dilution solution and a device adapted for receiving at least a portion of diluted blood solution, for contacting the blood solution with a dry reagent system, for detecting a change in the reagent system and for providing an indication of the analytical result to the user, and the extended shelf life and the elimination of a requirement for refrigeration for storage is achieved by having the blood dilution solution which comprises a first surfactant for hemolysis and a second surfactant for stability. The system of this invention is useful in other analysis kits and systems as well.

Abstract: The present invention provides an optics assembly, a reflectometer, and a diagnostic device for providing quantitative measurement of optical radiation reflected from a sampling area on an assay matrix. The reflectometer includes an optical radiation source and a detector. The optical radiation source and the detector are mounted in a single plane. An optics assembly is configured to direct the illumination from the optical radiation source to the sampling area on the assay matrix and to direct the radiation diffusely reflected from the sampling area to the detector. The optics assembly is positioned over the face of the circuit board having the optical radiation source and detector mounted directly thereto. The present invention also provides a method for determining the presence of one or more selected analytes in a sample employing a plurality of sampling areas on one or more assay matrixes.

Abstract: Compositions and processes for qualitative or quantitative one-step, two-site, tag/anti-tag or competitive non-bibulous lateral flow (immunochromatographic) assays for analytes in body fluids including chemically modified proteins as blocking and/or dispersing agents in conjunction with additives eliminating non-specific interference with the detection agents and/or binding partner caused by endogenous polypeptide constituents. Composition of the chemically modified proteins can be albumins. Composition of the chemically modified albumins can have altered charge and/or molecular weight. Process for composition of the chemically modified proteins can be prepared by modification of the nucleophilic groups. The chemical modification of nucleophilic groups in albmins can be introduced by anhydrides, alkyl acetimidates, methylating and/or cross-linking agents. The additives eliminating non-specific interference can be chemically modified albumins, heterophilic blockers and chaotropic agents.

Abstract: The present invention provides an assay composition for producing a physically detectable change upon contact with a sample which correlates with the amount of selected analyte in the sample. The composition includes a support matrix pervious to optical radiation and a chemical reagent yielding a physically detectable change which correlates with the amount of selected analyte in the sample. The support matrix has at least one detection zone for detecting the physical change with a cross-sectional area and depth profile. The composition includes an opacifier present in an amount sufficient to increase the resolution of the physically detectable change. The opacifier is distributed uniformly across the cross-sectional area of the detection zone and is distributed through at least a portion of the depth profile of the support matrix within the detection zone. The chemical reagent is substantially immobilized relative to the opacifier when detecting the physical change.

Abstract: The invention provides a filter for separating red blood cells from a whole blood sample to form plasma. The filter includes a solid phase support and an agglutinin for red blood cells. The agglutinin is insoluble in the whole blood sample and is immobilized on the solid phase support. The present invention also includes a device and method for determining the presence of at least one of a plurality of analytes in a sample of whole blood.

Abstract: A transport matrix and diagnostic device are provided which produce a physically detectable change in a predetermined distribution across a detection zone which correlates with the amount of selected analyte in a sample. The matrix includes a detection zone having a capture reagent yielding a physically detectable change which correlates with the amount of selected analyte in the sample. The detection zone has a leading boundary which first encounters the sample and a trailing boundary which encounters the sample after being transported across the detection zone. The capture reagent is immobilized on the matrix in a predetermined distribution from the leading boundary to the trailing boundary of the detection zone. A method is also provided which determines the level of a selected analyte in a sample by distributing a physically detectable change in a predetermined pattern across a detection zone on a transport matrix which correlates with the amount of selected analyte.

Abstract: The present invention provides a filter for effectively removing substances from a sample of bodily fluid which can interfere with the results of an assay. The filter includes a solid phase support and an active chemical component for binding to the interfering substance. The active chemical component is insoluble in the sample and is immobilized on the solid phase support. The present invention also includes a filter device, transport matrix, assay device, and method for removing substances which interfere with determining the presence of one or more analytes in a sample.

Abstract: The present invention provides an assay device for determining the presence of one or more selected analytes in a sample. The device includes a housing having an exterior surface and defining an interior area. A sample receptor receives the sample. A sample treatment strip reacts the sample with a reagent to yield a physically detectable change which correlates with the amount of selected analyte in the sample. A detector responds to the physically detectable change and produces an electrical signal which correlates to the amount of the selected analyte in the sample. A processor converts the electrical signal to a digital output. A starter automatically activates the processor and detector upon the application of the sample to the device. A display visually displays the digital output external to the housing and is connected to the processor.