Abstract: Electronic test devices and methods include data transfer capabilities. In one implementation, an assay device includes wireless communication capabilities to send assay result decisions and/or values to a separate processing and display device such as a smartphone. In another implementation, light sources are modulated both for performing an assay and encoding and transmitting a result of an assay.

Abstract: Systems, methods, and test kits for monitoring and detecting variation in an analyte level in a fluid sample from an individual variation using a uniquely determined analyte threshold value. In one implementation, luteinizing hormone is the monitored analyte and is compared with the determined threshold value to predict the onset of ovulation for the individual.

Abstract: An improved qualitative or semi-quantitative diagnostic test for low levels of any analyte, such as hCG, in a biological sample, such as urine. The test comprises of a test device containing reagents for the detection of the monitored analyte and an electronic reader that measures color development at a detection area of the device. The color development is converted to an electronic or digital signal. Improvements were made to the detection process to optimize the detection of a valid fluid front, increase the detection limit without compromising the reliability and accuracy of the test system, and improve the determination of test result validity.

Abstract: An electronically processed single-step test device for detecting the presence of a preselected analyte in a fluid. The device includes a hollow rectangular outer casing, disposed within co-joined upper and lower sections of the casing are assay material, an electronic processing system, and a display. The display is observable through a viewing window. The assay material is a sorptive material including a fluid sample application region in the form of a sample wick in fluid communication with a test strip. The test strip includes an analyte capture region adjacent to a light shield. The system includes lights which are alternately pulsed or energized over predetermined periods of time to determine if fluid test results show a marker or markers in the capture region indicative of the presence of a preselected analyte in the fluid. If so, Yes+ is displayed on the display otherwise, No? is displayed on the display.

Abstract: An improved qualitative or semi-quantitative diagnostic test for measuring low levels of any analyte, such as hCG, in a biological sample, such as urine. The test comprises a test device containing reagents for the detection of the monitored analyte and an electronic reader that measures color development at a detection area of the device. The color development is converted to an electronic or digital signal. Improvements were made to the electronic reader to optimize the coverage of the detection area on the test strip. This improves the detection sensitivity and consistency of the test result while maintaining its reliability and accuracy.

Abstract: Systems, methods, and test kits for monitoring and detecting variation in an analyte level in a fluid sample from an individual variation using a uniquely determined analyte threshold value. In one implementation, luteinizing hormone is the monitored analyte and is compared with the determined threshold value to predict the onset of ovulation for the individual.

Abstract: Electronic test devices and methods include data transfer capabilities. In one implementation, an assay device includes wireless communication capabilities to send assay result decisions and/or values to a separate processing and display device such as a smartphone. In another implementation, light sources are modulated both for performing an assay and encoding and transmitting a result of an assay.

Abstract: Electronic test devices and methods include data transfer capabilities. In one implementation, an assay device includes wireless communication capabilities to send assay result decisions and/or values to a separate processing and display device such as a smartphone. In another implementation, light sources are modulated both for performing an assay and encoding and transmitting a result of an assay.

Abstract: Test kits for assessing male fertility include a sample holder defining an object plane, a lens, and a two dimensional light sensor defining an image plane arranged along a common linear axis. The distance between the object plane and the image plane may be no more than 50 mm, and may be no more than 30 mm. A lens aperture may have an area of 1-10 mm2. The test kit may have a housing with a maximum linear dimension of no more than 100 mm. Processing circuitry may be provided that is configured to produce a sperm count and/or sperm motility measurements by processing image data from the two-dimensional light sensor.

Abstract: Diagnostic test devices improve communication to a user thereof through provision of audible output. The test device can include a test member, such as lateral flow assay test strip. The test device further includes an electronic communication circuit that can comprise an audio output element as well as a microcontroller. Other elements in the electronic communication circuit includes one or more sensor elements, a display element, and one or more switching elements.—Methods provide indicia for operation of a test device that comprise steps for assembly of a diagnostic test device that provides for audio output.

Abstract: The invention provides an apparatus and methods for the electrochemical detection and/or quantitation of an analyte in a sample, wherein the device comprises a substrate and a detector, wherein the substrate comprises a labeled binding agent, wherein the label is an enteric material particle that encapsulates a ferrocene methanol redox species.

Abstract: An improved qualitative or semi-quantitative diagnostic test for low levels of any analyte, such as hCG, in a biological sample, such as urine. The test comprises of a test device containing reagents for the detection of the monitored analyte and an electronic reader that measures color development at a detection area of the device. The color development is converted to an electronic or digital signal. Improvements were made to the detection process to optimize the detection of a valid fluid front, increase the detection limit without compromising the reliability and accuracy of the test system, and improve the determination of test result validity.

Abstract: An improved qualitative or semi-quantitative diagnostic test for low levels of any analyte, such as hCG, in a biological sample, such as urine. The test comprises of a test device containing reagents for the detection of the monitored analyte and an electronic reader that measures color development at a detection area of the device. The color development is converted to an electronic or digital signal. Improvements were made to the detection process to optimize the detection of a valid fluid front, increase the detection limit without compromising the reliability and accuracy of the test system, and improve the determination of test result validity.

Abstract: Electronic test devices and methods include data transfer capabilities. In one implementation, an assay device includes wireless communication capabilities to send assay result decisions and/or values to a separate processing and display device such as a smartphone. In another implementation, light sources are modulated both for performing an assay and encoding and transmitting a result of an assay.

Abstract: The invention provides an apparatus and methods for the electrochemical detection and/or quantitation of an analyte in a sample, wherein the device comprises a substrate and a detector, wherein the substrate comprises a labeled binding agent, wherein the label is an enteric material particle that encapsulates a ferrocene methanol redox species.

Abstract: Systems, methods, devices and test kits for detecting an analyte and quantifying an analyte level in a biological fluid sample using a lateral flow assay with enhancement solution are disclosed. The fluid sample is applied to a lateral flow strip, and thereafter an enhancement solution is applied that enhances the results of the test. The enhancement solution is contained with the device, such as in a store or blister. The assay may also include a washing fluid applied to the strip in a similar manner.

Abstract: Diagnostic test devices improve communication to a user thereof through provision of audible output. The test device can include a test member, such as lateral flow assay test strip. The test device further includes an electronic communication circuit that can comprise an audio output element as well as a microcontroller. Other elements in the electronic communication circuit includes one or more sensor elements, a display element, and one or more switching elements.- Methods provide indicia for operation of a test device that comprise steps for assembly of a diagnostic test device that provides for audio output.

Abstract: The present disclosure relates to diagnostic test devices that provide enhanced communication to a user thereof through provision of improved digital display. The test device can include a test member, such as lateral flow assay test strip. The test device can further include an electronic communication circuit that can comprise a digital display element as well as a microcontroller. Other elements in the electronic communication circuit can include one or more sensor elements, an audio element, and one or more switching elements. The disclosure further relates to methods of providing indicia of operation of a test device that comprises steps for assembly of a diagnostic test device that includes an improved digital display.

Abstract: Described herein are methods and devices for detecting the presence of an analyte in a liquid sample. In some embodiments, methods and devices for the detection of an antigen in a body fluid using a plurality of species-specific antibodies are provided. A sandwich complex may be formed using primary antibodies derived from two different species.

Abstract: Electronic test devices and methods include data transfer capabilities. In one implementation, an assay device includes wireless communication capabilities to send assay result decisions and/or values to a separate processing and display device such as a smartphone. In another implementation, light sources are modulated both for performing an assay and encoding and transmitting a result of an assay.