Abstract: A flow-through assay device capable of detecting the presence or quantity of an analyte of interest is provided that is accurate, reliable, and easy-to-use. The device contains a substrate printed with a channel to facilitate the flow of a test sample to a detection working electrode. The detection working electrode communicates with affinity reagents, such as redox mediators and capture ligands. For instance, capture ligands that are specific binding members for the analyte of interest are applied to the detection electrode to serve as the primary location for detection of the analyte.

Abstract: A diagnostic test unit is provided. The test unit comprises a stem having a first end and a second end, the stem defining at least one flow channel extending between the first end and the second end. A swab is disposed at the first end of the stem, the swab being configured to collect a test sample derived from a biological source that is suspected of containing an analyte. The test unit also comprises a fluid chamber configured to contain a fluid, wherein the fluid chamber is in fluid communication with the swab via the flow channel. The test unit also comprises a rupturable seal that inhibits leakage of the fluid from the fluid chamber prior to use, and an assay for detecting the presence or absence of the analyte. The assay is in fluid communication with the swab, the flow channel, and the fluid chamber.

Abstract: The premature rupture of amniotic fluid (PROM) may be discovered through a number of inventive means. Methods of evaluating whether PROM is present include; a) through the testing of the pH of vaginal fluids using an irreversible pH test; b) through the detection of analytes (e.g. enzymes) specific to amniotic fluid in the vaginal fluids; c) though the detection of hydrogen peroxide (H2O2) in the vaginal fluid; and d) through the detection of cholesterol in vaginal fluid. While individually indicative of PROM, it is desirable to combine at least two of these techniques to yield a powerful tool of even greater reliability. Test devices and feminine hygiene pads into which the test methods may be incorporated are also included herein.

Abstract: There is provided a personal care product having a body side liner, a baffle and an indicator strip with two ends. The indicator has an amine sensitive dye near at least one end. The indicator extends from the target area just below the liner to just above the baffle such that the dye deposit is visible to an unaided eye. The dye changes color in the presence of amines which are characteristic of infection, thus alerting the user to the possibility of infection. Such an indicator placed in a feminine hygiene pad, for example, may be useful in the diagnosis of vaginitis.

Abstract: The present invention relates to a visual indicating device and an article for controlling odors, in particular foot, garbage, basement, cooking, pet, tobacco, feces and urine odors. The article comprises a visual indicating agent that is color sensitive to the odor, and optionally, an odor absorbing agent. The visual indicating agent changes color when the article has been exposed to a sufficient amount of odor to saturate the article. The indicating agent may be applied in differing concentrations to two or more zones so as to indicate to a user of the article how much of the odor absorbing capacity has been used, or conversely, how much of the odor absorbing capacity remains. Suitable visual indicating agents that change color in response to odors are also described. The article for controlling odors may be a disposable odor absorbing sheet, air freshening product, diaper, undergarment pad, face mask, air filtration device, sanitary napkin, tampon, panty shield or incontinence pad.

Abstract: A flow-through assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes multiple detection zones, one of which is premised on “competitive” binding of the analyte and the other is premised on “sandwich” binding of the analyte. The present inventors believe that the combination of these zones may enable the detection of an analyte over extended concentration ranges.

Abstract: The invention provides a breath testing device which includes a visual indicating agent which changes color in the presence of an odor associated with bad breath, such as sulfur and ammonia odors. An example of the visual indicating agent is 4,4?-bis(dimethylamino)-benzhydrol (Michler's hydrol or BDMB) and related dyes having a similar chemical structure. The indicating agent is applied to a substrate which is then inserted into a tube or straw, or which covers one end of a straw. When a user with bad breath blows into the tube or straw, the indicating agent will change color. The breath testing devices provide a quick and affordable means for a user to test their breath, and they may be packaged in discreet, pocket-sized dispensers which can be carried in a pocket or purse.

Abstract: The invention provides a breath testing device which visually indicates the presence of ammonia in a patient's breath, in particular ammonia from helicobacter pylori urease infection. The breath testing device comprises a visual indicating agent which changes color in response to ammonia odors, such as 4,4?-bis(dimethylamino)-benzhydrol (Michler's hydrol or BDMB), pararosaniline base and alpha-naphtholbenzein. The indicating agent is applied to a substrate which is then inserted into a tube or straw, which can be attached to the inlet of a breath collection balloon. When the patient blows into the tube or straw, the indicating agent will change color if it detects levels of ammonia which are consistent with helicobacter pylori urease infection.

Abstract: A flow-through assay device capable of detecting the presence or quantity of an analyte of interest is provided. The device is in communication with an electrochemical biosensor that utilizes detection and calibration working electrodes that communicate with affinity reagents, such as redox mediators and capture ligands. For instance, capture ligands that are specific binding members for the analyte of interest may be applied to the detection electrode to serve as the primary location for detection of the analyte. The calibration working electrode may be used to calibrate the detection working electrode for any intrinsic background current not generated by the reagents of the biosensor system. Moreover, capture ligands that are non-specific binding members for the analyte of interest may also be applied to the calibration electrode.

Abstract: The invention provides methods for identifying antibody preparations that can form a pair of antibodies that optimally detect a target antigen, for example, in a sandwich immunoassay. These methods provide high affinity and epitope-specific antibodies.

Abstract: An enhanced diffraction based biosensor system and method are provided for detecting an analyte of interest in a test medium. The system incorporates at least one additional detection tag substance with the analyte of interest, the tag emitting a measurable parameter that is different from optical diffraction characteristics of the analyte. The biosensor may be a “fluoroptical” system wherein the detection tag is a fluorescence emitting substance, including fluorescent-labeled diffraction enhancing elements. The enhanced diffraction biosensor system may determine the presence of analytes in biological fluids both qualitatively and quantitatively.