Church Dwight & Co., Inc.

Timothy Snowden

Albert R Nazareth

Jonathan Andrew Wharton

Yea-Shun Cheng

Sujata Sundara Rajan

Brian Michael Orme

Ming Zeng

Shang Li

Mary Beth Boyle

Pamela Dozier

Giles H W Sanders

Meredith Ingrassia

Nicholas James Wooder

Christopher Brian King

Ovidiu Romanoschi

Dean M Mohamed

Mathew Palmer

Ashley Tomasello

Kristen Buentello

Mary-Beth Boyle

Anthony Cass

Kristin Buentello

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.

Diagnostic test device with improved use and visual detection of an analog test result

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.

Applicator for delivery of a product therethrough

Applicator

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.

Systems, devices and methods for a hydroscopic based lateral flow assay

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.&#x2014;Methods provide indicia for operation of a test device that comprise steps for assembly of a diagnostic test device that provides for audio output.

Diagnostic test device with audible feedback

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.

Diagnostic detection devices and methods

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.

Diagnostic test device with improved structure

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.

Ovulation predictor test

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.

Female fertility test

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.

Hyperglycosylated hCG detection device

The invention comprises a device for detecting an analyte in a liquid sample deposited on a first portion of the device for transport to a second portion of the device that is in fluid contact with the first portion. In specific embodiments, the device comprises a labeled conjugate comprising a binding member reactive with a first epitope of the analyte and a label comprising a gold colloid, preferably having a mean particle size of 50 nm to 100 nm. In further embodiments, the device comprises a capture component comprising polymerized streptavidin. The diagnostic device is particularly useful in the preparation of pregnancy test kits.

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Howell, NJ, United States of America

Timothy Snowden