Abstract: A biosensor includes a substrate with a layer of receptive material disposed thereon. The receptive material is specific for an analyte of interest. A pattern of active and inactive areas of the receptive material are defined in the receptive material layer by a masking process.

Abstract: A biosensor includes a substrate with a layer of receptive material disposed thereon. The receptive material is specific for an analyte of interest. A pattern of active and deactivated areas of the receptive material are defined in the receptive material layer by a masking process.

Abstract: A biosensor includes a substrate with a layer of receptive material disposed thereon overlying a layer containing a photo-reactive agent. The receptive material is specific for an analyte of interest. A pattern of active and inactive areas of the receptive material are defined in the receptive material layer by a masking process wherein the photo-reactive agent is activated in the exposed regions of the mask.

Abstract: A blood sampling device includes a lancet having a skin piercing member disposed at an end thereof. The lancet is slidable within and releasably engaged with an elongated lancet guide that remains stationary with use of the device. A shell is axially movable relative to the lancet guide between a rest position and an actuate position, with the lancet being spring loaded within the lancet guide by movement of the shell from the rest position to the actuate position.

Abstract: A diagnostic test kit for detecting the presence or absence of nitrites within a test sample is provided. The test kit comprises an aromatic primary amine that is capable of reacting with a nitrite to form a diazonium ion. The test kit also comprises a lateral flow device that comprises a chromatographic medium and an absorbent material that receives the test sample after flowing through the chromatographic medium. The chromatographic medium defines a detection zone within which is contained a detection reagent (e.g., nucleophilic aromatic amine) that is capable of reacting with the diazonium ion to form an indicator (e.g., azo compound). The indicator exhibits a color that is different than the color of the detection reagent.

Abstract: A biosensor includes a substrate with a receptive material layer of radiation-absorbing member (RAM)-tagged biomolecules disposed thereon. The receptive material is specific for an analyte of interest. A pattern of active and deactivated areas of the receptive material are defined in the receptive material layer by a masking process wherein areas are exposed through a mask with a light source to induce deactivation.

Abstract: A biosensor includes a substrate with a layer of receptive material disposed thereon. The receptive material is specific for an analyte of interest. A pattern of active and inactive areas of the receptive material are defined in the receptive material layer by a masking process.

Abstract: A diagnostic test kit that employs a lateral flow assay device and a plurality of assay reagents for detecting a test analyte within a test sample is disclosed. The assay reagents include detection probes that are capable of producing a detection signal representing the presence or quantity of the test analyte in the test sample. To further enhance detection accuracy, calibration probes are also used that are capable of producing a calibration signal representing the presence or quantity of a calibration analyte. The calibration signal may be utilized to calibrate the detection signal.

Abstract: Hollow particles for use in various types of assay devices are provided. Due to their hollow or voided structure, the particles may exhibit a variety of beneficial properties. For instance, hollow particles are generally lightweight, and thus, relatively inexpensive in comparison to other types of particles. Hollow particles may also form a stable system without requiring refrigeration or rotation. In addition, hollow particles may possess enhanced light diffraction capabilities, which may be particularly beneficial in certain types of assay devices, e.g., diffraction-based assay devices.

Abstract: An analyzer useful in determining the presence of an analyte using a diffraction based sensing device and methods and systems using this device. The present invention may be used with a variety of different diffraction-based diagnostic methods and systems. The analyzer enhances the accuracy and/or usefulness of these devices in detecting analytes, while providing more ease-of-use and convenience to the user. The analyzer may include a light source, a photodiode, a microprocessor and a display system for informing the user of the result. Other features include mirrors, lenses, a sample holder, and a mask for blocking out some light. The analyzer and related method and system may be used in a large number of environments, including commercial, professional, and individual.

Abstract: There is provided a lateral flow assay device for detecting the presence or quantity of an analyte residing in a test sample where the lateral flow assay device has a porous membrane in communication with a conjugate pad and a wicking pad. The porous membrane has a detection zone which has an immobilized first capture reagent configured to bind to at least a portion of the analyte and analyte-conjugate complexes to generate a detection signal. A control zone may be located downstream from the detection zone on the porous membrane and has a second capture reagent immobilized within the control zone. The conjugate pad is located upstream from the detection zone, and has detection probes with specific binding members for the analyte. The sample is deposited between the control and detection zones. A buffer release zone is located upstream of the conjugate pad and provides for buffer addition to the device, the buffer serving to move the detection probes to the detection and control zones.

Abstract: There is provided a lateral flow assay device for detecting the presence or quantity of an analyte residing in a test sample where the lateral flow assay device has a porous membrane in liquid communication with a conjugate pad and a wicking pad. The conjugate pad has a gold colloid-containing detection probe. The porous membrane has a detection zone where an immobilized first capture reagent configured to bind to at least a portion of the analyte and analyte-conjugate complexes to generate a detection signal. The control zone is located downstream from the detection zone on the porous membrane and has a second capture reagent immobilized within the control zone. The conjugate pad is located upstream from the detection zone, and has detection probes with specific binding members for the analyte. A sample containing an analyte is deposited on the conjugate pad, interacts with the detection probes, and moves toward the control zone for detection.

Abstract: A diagnostic test kit for detecting the presence or quantity of an enzyme or enzyme inhibitor is provided. The diagnostic kit utilizes reactive complexes to facilitate the detection of the enzyme or enzyme inhibitor. The reactive complexes include a substrate joined (e.g., covalently bonded, physically adsorbed, etc.) to a reporter and magnetic substance. In one embodiment, for example, a peptide, protein, or glycoprotein substrate is joined to a reporter (e.g., dyed latex particle) and magnetic particle. In this embodiment, the substrate provides a cleavage target for a proteolytic enzyme. Specifically, upon contacting the reactive complexes, the proteolytic enzyme cleaves the substrate and releases the reporter and/or magnetic particle. The signal exhibited by the released reporters may then be used to indicate the presence or quantity of an enzyme or enzyme inhibitor within the test sample.

Abstract: There is provided herein cross-linked, phosphorescent micro- and nano-particles and applications of those particles. The invention uses halogen-containing polymers and co-polymers (HCPs) as an encapsulation matrix for organic and organometallic phosphorescent compounds to form micro- or nano-particles. The phosphorescence of these encapsulated phosphorescent particles is substantially unaffected by phosphorescence quenchers such as oxygen and water molecules at ambient conditions. The invention provides methods of making cross-linked phosphorescent particles. HCPs may be directly cross-linked through linking moieties that are a part of the polymer, or cross-linked through other separate bridging or cross-linking materials Cross-linked particles are more stable than the non-cross-linked counterparts and more resistant to temperature, surfactants, and organic solvents.

Abstract: An electrochemical-based assay device capable of detecting the presence or quantity of an analyte of interest that is provided. The device contains two or more substrates, one containing a detection working electrode and another containing an auxiliary electrode, such as a counter/reference electrode(s). The substrates are positioned in a face-to-face relationship so that the electrodes are adjacent to each other during performance of the assay. Besides the electrodes, any of a variety of other components may also be employed in the assay device.

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: A healthcare network is provided for sharing information concerning the health of a user with at least one outside source, the network including a biosensor associated with the user that generates a biosensor signal containing the information; and a personal data control means including receiving means for receiving the biosensor signal, input means for receiving a privacy input from the user, and output means for generating a response signal based on the biosensor signal and privacy input. The network also includes a data allocation and processing module including means for receiving the response signal, and means for generating and directing an output signal to the at least one outside source, wherein the module is responsive to the response signal, and wherein the availability of the information to the at least one outside source is responsive to the privacy input.

Abstract: Hollow particles for use in various types of assay devices are provided. Due to their hollow or voided structure, the particles may exhibit a variety of beneficial properties. For instance, hollow particles are generally lightweight, and thus, relatively inexpensive in comparison to other types of particles. Hollow particles may also form a stable system without requiring refrigeration or rotation. In addition, hollow particles may possess enhanced light diffraction capabilities, which may be particularly beneficial in certain types of assay devices, e.g., diffraction-based assay devices.

Abstract: An internal, self-calibrated system for flow-through assay devices is provided. In particular, the present invention employs the use of a single calibration/detection zone defined by a porous membrane of the assay. It has been discovered that the internal, self-calibrated system provides an accurate, inexpensive, and readily controllable method of determining the presence of an analyte in a test sample.