Abstract: Described here are systems, devices, cartridges, methods, and kits for detecting or quantifying at least two different analytes using at least two different techniques, in a single sample. The cartridges typically comprise at least two test sites and the location of at least one test site is not dependent on a corresponding measurement device. The systems generally comprise a device, memory, and a processing module. The device comprises a light source, an array detector, and a port configured to accept at least a portion of a cartridge. The processing module is configured to perform an image analysis of the cartridge. The methods comprise the steps of acquiring calibration information, acquiring an image of the cartridge, performing an image analysis, and cycling through specific detection or quantification techniques corresponding to the techniques required by the test sites. Computer readable media are also described.

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: Described here are systems, devices, cartridges, methods, and kits for detecting or quantifying at least two different analytes using at least two different techniques, in a single sample. The cartridges typically comprise at least two test sites and the location of at least one test site is not dependent on a corresponding measurement device. The systems generally comprise a device, memory, and a processing module. The device comprises a light source, an array detector, and a port configured to accept at least a portion of a cartridge. The processing module is configured to perform an image analysis of the cartridge. The methods comprise the steps of acquiring calibration information, acquiring an image of the cartridge, performing an image analysis, and cycling through specific detection or quantification techniques corresponding to the techniques required by the test sites. Computer readable media are also described.

Abstract: Described here are systems, devices, cartridges, methods, and kits for detecting or quantifying at least two different analytes using at least two different techniques, in a single sample. The cartridges typically comprise at least two test sites and the location of at least one test site is not dependent on a corresponding measurement device. The systems generally comprise a device, memory, and a processing module. The device comprises a light source, an array detector, and a port configured to accept at least a portion of a cartridge. The processing module is configured to perform an image analysis of the cartridge. The methods comprise the steps of acquiring calibration information, acquiring an image of the cartridge, performing an image analysis, and cycling through specific detection or quantification techniques corresponding to the techniques required by the test sites. Computer readable media are also described.

Abstract: The present invention relates to a dry reagent assay device having at least one test zone and at least one reference zone, which provides an internal mechanism for assuring correct and reliable assay procedures and reagent qualities. In one embodiment, the present invention relates to an assay device having, at least one test zone for detecting at least one analyte in a sample by reacting the sample with a labeled indicator reagent, and a reference zone for receiving, unreacted labeled indicator reagent.

Abstract: The present invention relates to a dry reagent assay device having at least one test zone and at least one reference zone, which provides an internal mechanism for assuring correct and reliable assay procedures and reagent qualities. In one embodiment, the present invention relates to an assay device having at least one test zone for detecting at least one analyte in a sample by reacting the sample with a labeled indicator reagent, and a reference zone for receiving unreacted labeled indicator reagent.

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: 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: An assay device, analytical instrument and assay method for determining the presence or amount of an analyte in a fluid is disclosed. The device is a one-step lateral flow dry reagent immunoassay with one, two or more zones along a transverse axis of the device, each zone can contain or be preceded by diffusively or non-diffusively bound reagents. The invention measures an indicator in one or two test zones for each analyte to determine its presence or concentration. The signal reagent (indicator) may be a particle such as a colored latex or colloidal gold. The assay quantitation may be read by an instrument.

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.

Abstract: Disclosed are sulfonate and phosphonate salts of tetrazolium compounds whose enhanced solubility in various solvents renders them particularly suitable for use as redox indicators in dry reagent, diagnostic test systems.

Abstract: An analytical method and test composition for determining whether an analyte is present in a test sample at a predetermined concentration level by measuring or observing a preselected level of indicator response, e.g., color generation. A subtractive reaction is carried out on the test sample prior to the indicator reaction in order to stoichiometrically and specifically consume a predetermined amount of analyte. The resulting indicator reaction generates the preselected level of indicator response only if the analyte is present at the predetermined concentration level or greater. The subtractive reaction is enzymatically specific for the analyte in the reaction mixture and the amount of analyte consumed can be closely controlled by the amount of a regulating coreactant present at initiation. The method enables the determination of analyte without the need for standards or comparators, e.g., color charts, and therefore is self-indicating.

Abstract: A method for controlling a liquid volume flowing onto a reactive surface which includes a sample application port, two systems of capillary channels, a reaction chamber, and an overflow chamber. The liquid sample to be analyzed is applied to the sample application port which gives the liquid entry to a capillary channel leading to the reaction chamber which contains a material capable of detecting the component of interest in the liquid. When the reaction chamber is filled, the remaining liquid will flow through another capillary channel to an overflow chamber. The capillary channel leading to the overflow chamber is controlled so that liquid cannot flow back into the reaction chamber.