Abstract: A lateral flow assay test device providing a structure for the lateral flow assay reactions provides for a continuous flow path of bibulous material provided in separate but contiguous regions of the device in which the bibulous layers are in fluid contact with each other thereby providing flow control of the timing and speed of the assay reaction. Increased flow control results in increasing reliability of use, increasing sophistication of reactions and increases the range of molecules or diagnosis that can be identified. Such flow control can extend processing times and allow users or test givers to manually delay test processing providing enhanced test results.

Abstract: A universal assay reader comprising a base, a shroud, a camera, and an illumination source. The base has a receiver for receiving sample containers with assay strips, the receiver having a plurality of form fit patterns for receiving and seating more than one type of configured container or assay device. A method of using the assay reader to perform an assay includes identifying a received assay device, retrieving image data of the device, adjusting a light exposure, capturing an image of a portion of the assay device and a portion of the background, the background including an image of a portion of the shroud. Analyzing the captured image includes performing a registration process to determine an angle of rotation and distance offsets of the device with respect to an expected position, and determining the presence or absence of an indicator line in a region of interest of the captured image.

Abstract: A lateral flow assay test device providing a structure for the lateral flow assay reactions provides for a continuous flow path of bibulous material provided in separate but contiguous regions of the device in which the bibulous layers are in fluid contact with each other thereby providing flow control of the timing and speed of the assay reaction. Increased flow control results in increasing reliability of use, increasing sophistication of reactions and increases the range of molecules or diagnosis that can be identified. Such flow control can extend processing times and allow users or test givers to manually delay test processing providing enhanced test results.

Abstract: Devices, methods, and systems are provided for testing for or detecting the presence of illegal or prohibited drugs, compounds or metabolites in non-controlled environments for testing using lateral flow drug test strips and a smart phone with digital imaging, data processing, data storage and wireless electronic transmission of resulting data, the system or method to test dry buffer conditioned oral fluids using lateral flow test strips for determination of the presence or absence, or other quantitative or qualitative measurement, of specific and/or selected drugs, compounds or metabolites thereof.

Abstract: Provided are methods and devices for separating particulate analytes or aggregates of analytes from a fluid, after the separation medium of the device is saturated with the fluid. The endpoint indicating completion of the separation is determined by saturation; therefore, no precise metering of the fluid sample is necessary. The separated analyte of interest can be detected, quantitated or its migration measured in the separation medium. The measured property of the analyte can then be correlated with a parameter of interest. In some embodiments, the device can be marked to directly read the value of the parameter of interest. In one embodiment, the fluid is blood and the device includes a volumetric capillary reservoir for collecting the blood, a separation paper or indicator strip, and graduations for correlating the migration of red blood cells with hematocrit or hemoglobin concentration.

Abstract: The present invention concerns methods, compositions and apparatus for detection and/or determination of concentration of target molecules. In preferred embodiments the methods comprise allowing target molecules to form a complex with a first binding agent conjugated to a detection molecule and a second binding agent conjugated to a capture molecule, allowing the complex to further bind to an essentially uncharged polymer capable of binding to the capture agent, and performing a vertical gradient electrophoresis to separate the complex from unbound target, first and second binding agents and polymer. The intact complex is concentrated by electrophoresis at a stacking layer and the detection molecule is detected and/or quantified. Because the complex contains a very high mass to charge ratio, it becomes essentially immobile at the stacking layer, while unbound components migrate through the stacking layer and are separated from the complex.

Abstract: A lateral flow assay test device providing a structure for the lateral flow assay reactions provides for a continuous flow path of bibulous material provided in separate but contiguous regions of the device in which the bibulous layers are in fluid contact with each other thereby providing flow control of the timing and speed of the assay reaction. Increased flow control results in increasing reliability of use, increasing sophistication of reactions and increases the range of molecules or diagnosis that can be identified. Such flow control can extend processing times and allow users or test givers to manually delay test processing providing enhanced test results.

Abstract: Methods and devices for analyzing fluid variables. The devices analyze fluid variables by measuring cessation of fluid flow through the medium or a change in flow rate due to an inherent property of the fluid variable, or due to a modification of the fluid variable as the fluid migrates through the medium; or by measuring relative rates of capillary flow down two or more arms of a common element of porous media in some alternatives, converging in which at least one of the arms has been modified by the addition of flow-modifying agents which affect the flow rate in response to the concentration of the analyte; or by detecting changes in the rate of the capillary flow of the sample fluid along a path through an element of porous media, or through multiple elements of porous media.

Abstract: Methods and devices for analyzing fluid variables such as viscosity, surface tension, analyte concentration, and the presence of particulates or aggregates are provided. The devices analyze fluid variables by measuring cessation of fluid flow through the medium or a change in flow rate due to an inherent property of the fluid variable, or due to a modification of the fluid variable as the fluid migrates through the medium. The lateral flow devices measure relative rates of capillary flow down converging arms of a common element of porous media in which at least one of the arms has been modified by the addition of flow-modifying agents which affect the flow rate in response to the concentration of the analyte. The fluid fronts will converge at a position determined by their relative flow rates, which is thus indicative of a fluid variable, such as analyte concentration, in the sample fluid.

Abstract: Embodiments herein concern systems, methods, compositions and apparatus for detection and/or determination of the presence and/or concentration of target molecules in a sample. In certain embodiments, target molecules can be separated and analyzed using non-gel electrophoresis technologies.

Abstract: Embodiments herein concern systems, methods, compositions and apparatus for detection and/or determination of the presence and/or concentration of target molecules in a sample. In certain embodiments, target molecules can be separated and analyzed using non-gel electrophoresis technologies.

Abstract: Methods and devices for analyzing fluid variables such as viscosity, surface tension, analyte concentration, the presence of particulates or aggregates are provided. The devices analyze fluid variables by measuring cessation of fluid flow through the medium or a change in flow rate due to an inherent property of the fluid variable, or due to a modification of the fluid variable as the fluid migrates through the medium. One lateral flow device provided analyzes a fluid variable in a sample by measuring relative rates of capillary flow down two or more converging arms of a common element of porous media, such as filter paper, in which at least one of the arms has been modified by the addition of flow-modifying agents which affect the flow rate in response to the concentration of the analyte. The fluid fronts will converge at a position determined by their relative flow rates, which is thus indicative of a fluid variable, such as analyte concentration, in the sample fluid.

Abstract: Provided are methods and devices for separating particulate analytes or aggregates of analytes from a fluid, after the separation medium of the device is saturated with the fluid. The endpoint indicating completion of the separation is determined by saturation; therefore, no precise metering of the fluid sample is necessary. The separated analyte of interest can be detected, quantitated or its migration measured in the separation medium. The measured property of the analyte can then be correlated with a parameter of interest. In some embodiments, the device can be marked to directly read the value of the parameter of interest. In one embodiment, the fluid is blood and the device includes a volumetric capillary reservoir for collecting the blood, a separation paper or indicator strip, and graduations for correlating the migration of red blood cells with hematocrit or hemoglobin concentration.

Abstract: The present invention concerns methods, compositions and apparatus for detection and/or determination of concentration of target molecules. In preferred embodiments the methods comprise allowing target molecules to form a complex with a first binding agent conjugated to a detection molecule and a second binding agent conjugated to a capture molecule, allowing the complex to further bind to an essentially uncharged polymer capable of binding to the capture agent, and performing a vertical gradient electrophoresis to separate the complex from unbound target, first and second binding agents and polymer. The intact complex is concentrated by electrophoresis at a stacking layer and the detection molecule is detected and/or quantified. Because the complex contains a very high mass to charge ratio, it becomes essentially immobile at the stacking layer, while unbound components migrate through the stacking layer and are separated from the complex.