Abstract: The present disclosure relates to diagnostic test devices that provide improved communication to a user of one or both of proper functioning of the test device and an analog test result that is provided by the test device. The diagnostic test devices particularly can include one or more sensors effective to indicate application of a sufficient volume of a test fluid and/or can include one or more light sources positioned to illuminate an analog test result for improved visibility and understanding of the analog test result.

Abstract: Machine image detection involving a trained classifier is used to detect a result of a test stick diagnostic device configured to detect the presence of an analyte in a test sample. Example implementations include receiving a digital image comprising a depiction of at least a portion of a test stick diagnostic device and applying the digital image to a classifier configured to determine a relative position, relative orientation, and relative scale of the portion of the test stick diagnostic device with respect to the digital image, identify a test result region of the test stick diagnostic device, and detect a test result marking in the test result region of the test stick diagnostic device. An indication of a result of a diagnostic test may be provided based on the detected test result marking.

Abstract: The present disclosure provides applicators adapted to or configured to deliver a product therefrom. The applicators can be particularly designed for delivery to certain body parts of the human body, such as to the vaginal area. The applicator can comprise a housing formed of a substantially continuous wall extending along a longitudinal housing axis between a base end and an application end, the substantially continuous wall defining: a base segment extending from the base end toward the applicator end; a delivery segment extending from the applicator end toward the base end; and a compression segment interconnecting the base segment and the delivery segment. The housing can define a substantially hollow interior configured for retaining a product for delivery through the delivery segment.

Abstract: Systems, methods, and test kits for detecting and quantifying an analyte level in a biological fluid sample using impedance measurements, are disclosed. The fluid sample is applied to a lateral flow strip, and impedance of the strip is measured as the assay dries. Analysis of the drying-dependent impedance measurements indicates the presence and quantity of the analyte in the fluid sample.

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: 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 detecting and quantifying an analyte level in a biological fluid sample using impedance measurements, are disclosed. The fluid sample is applied to a lateral flow strip, and impedance of the strip is measured as the assay dries. Analysis of the drying-dependent impedance measurements indicates the presence and quantity of the analyte in the fluid sample.

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: 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: 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: 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: The present disclosure relates to diagnostic test devices that provide increased comfort and ease of use. The diagnostic test device can include a test member, such as a lateral flow assay test strip. The test device can further comprise a housing that comprises a substantially arch shaped handle. The housing of the test device can comprise a base member that is attached to a curved lower surface of the housing and that can improve stability of the device in an upward facing position as well as enable angled positioning of the device relative to a flat, horizontal surface. The curvature of the test device in particular can provide secure handling of the device while also improving ease and comfort of use thereof. The disclosure further relates to methods of determining the presence of an analyte in a fluid sample and methods for evaluating a test result of a personal use diagnostic test device.

Abstract: The present invention is related to a diagnostic test kit for detecting luteinizing hormone (LH) in a biological sample at a concentration relative to a threshold concentration of LH. The device can include a release medium formed of a first material and including a labeled conjugate with a detectable label and a first binding member reactive with a first epitope of LH and a capture medium formed of a second, different material, in fluid communication with the release medium. The capture medium includes a result site having immobilized thereon a capture component capable of directly or indirectly binding LH that is bound to the labeled conjugate. The device is calibrated such that color development at the result site occurs only when the LH concentration of the liquid sample is greater than the threshold concentration.

Abstract: The present disclosure relates to diagnostic test devices that provide increased comfort and ease of use. The diagnostic test device can include a test member, such as a lateral flow assay test strip. The test device can further comprise a housing that comprises a substantially arch shaped handle. The housing of the test device can comprise a base member that is attached to a curved lower surface of the housing and that can improve stability of the device in an upward facing position as well as enable angled positioning of the device relative to a flat, horizontal surface. The curvature of the test device in particular can provide secure handling of the device while also improving ease and comfort of use thereof. The disclosure further relates to methods of determining the presence of an analyte in a fluid sample and methods for evaluating a test result of a personal use diagnostic test device.

Abstract: The present invention is related to a diagnostic test kit that assesses ovarian reserve by measuring Follicle Stimulating Hormone (FSH) in a liquid sample. The sample can be deposited on a first portion of the device for transport to a second portion of the device. The device can include a release medium formed of a first material and including a detectable label thereon and a capture medium, including a test site, in fluid communication with the release medium and formed of a second, different material.

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: The present invention related to a pregnancy test device that can selectively detect hyperglycosylated human chorionic gonadotropin (hCG-H) in a liquid sample. The sample can be deposited on a proximal portion of the device for transport to a distal portion of the device. The device can include a release medium formed of a first material and including a detectable label thereon and a capture medium, including a capture site, in fluid communication with the release medium and formed of a second, different material. At least one of the release medium and the capture medium includes a binding member that exhibits a moderate to high affinity for hCG-H and is selectively or preferentially reactive with hCG-H.

Abstract: The present invention related to a pregnancy test device that can selectively detect hyperglycosylated human chorionic gonadotropin (hCG-H) in a liquid sample. The sample can be deposited on a proximal portion of the device for transport to a distal portion of the device. The device can include a release medium formed of a first material and including a detectable label thereon and a capture medium, including a capture site, in fluid communication with the release medium and formed of a second, different material. At least one of the release medium and the capture medium includes a binding member that exhibits a moderate to high affinity for hCG-H and is selectively or preferentially reactive with hCG-H.

Abstract: The present invention related to a pregnancy test device that can selectively detect hyperglycosylated human chorionic gonadotropin (hCG-H) in a liquid sample. The sample can be deposited on a proximal portion of the device for transport to a distal portion of the device. The device can include a release medium formed of a first material and including a detectable label thereon and a capture medium, including a capture site, in fluid communication with the release medium and formed of a second, different material. At least one of the release medium and the capture medium includes a binding member that exhibits a moderate to high affinity for hCG-H and is selectively or preferentially reactive with hCG-H.