Abstract: The present disclosure relates to enhancements in diagnostic assays for detection of analytes. The improved assays are suitable for management of infections and pandemics in humans and animal reservoirs, including but not limited to SARS-CoV-2 (CoV2), and for measurement of biomarkers of disease (both human and veterinary).

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 efficient design for an expanded dynamic range in a lateral flow one step assay for the detection of an analyte in a biological sample is disclosed. The device comprises a multiple strip design, each constructed of four zones; a sample receiving zone, a sample treatment zone, a labeling zone, and a capture zone. The sample containing analyte is accepted in the sample receiving zone in the form of blood, serum, plasma, or urine. It is then carried into the sample treatment zone where it is rendered compatible with the chemistries of the assay strip. The treated sample then flows into the labeling zone where it interacts with visible particles that are coupled to analyte specific binding proteins. The flow continues, carrying the labeled analyte into the capture zone where it is immobilized in specific regions with analyte specific binding proteins. Excess flow is absorbed in an absorbent zone that is in contact with the capture zone.

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: A combination body fluid analyte meter and cartridge system, having: (a) a body fluid analyte meter, with: a housing; a logic circuit disposed within the housing; a visual display disposed on the housing; and a measurement system disposed within the housing; and (b) a cartridge, having: at least one lateral flow assay test strip, the lateral flow assay test strip having: (i) a lateral flow transport matrix; (ii) a specific binding assay zone on the transport matrix for receiving a fluid sample and performing a specific binding assay to produce a detectable response, and (iii) a general chemical assay zone on the transport matrix for receiving the fluid sample and performing a general chemical assay to produce a detectable response; wherein the cartridge is dimensioned to be receivable into the body fluid analyte meter such that the measurement system is positioned to detect the responses in the specific binding assay zone and the general chemical assay zone in the lateral flow assay test strip.

Abstract: The disclosure relates to a dry reagent assay device having two or more test zones for detecting two or more analytes in a test sample. In one embodiment, the test zones may be the site of a binding reaction between members of a binding pair, or they may be the site of a general chemistry reaction. The disclosure also relates to methods for performing assays to detect analytes in test samples using such devices.

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 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.