Abstract: A biosensor for quantifying an analyte in a sample and usage thereof are provided. The biosensor includes an insulative substrate, a cover, a sample supply port, an electrode system including at least a working electrode, a counter electrode and a third electrode, and a reaction layer at least formed over the working electrode. The third electrode, used for estimating whether the amount of the sample is sufficient, is disposed nearer to the sample supply port than the counter electrode is. Whether the amount of the added sample is sufficient is estimated by comparing the electrical current value detected between the working electrode and the counter electrode with the electrical current value detected between the working electrode and the third electrode. This invention has a simple structure and produces accurate measurements.

Abstract: A biosensor for quantifying an analyte in a sample and usage thereof are provided. The biosensor includes an insulative substrate, a cover, a sample supply port, an electrode system including at least a working electrode, a counter electrode and a third electrode, and a reaction layer at least formed over the working electrode. The third electrode, used for estimating whether the amount of the sample is sufficient, is disposed nearer to the sample supply port than the counter electrode is. Whether the amount of the added sample is sufficient is estimated by comparing the electrical current value detected between the working electrode and the counter electrode with the electrical current value detected between the working electrode and the third electrode. This invention has a simple structure and produces accurate measurements.

Abstract: The present invention provides biosensor test devices for measuring the presence or amount of an analyte in a biological fluid. The devices have a base plate that has an electrode system embedded therein, and a hydrophilic porous material situated on the base plate. A hydrophobic protective layer is situated on the hydrophilic porous material, and a cover is placed on the hydrophobic protective layer to complete the device. Some embodiments also use an insulating layer, which can be situated between the base layer and the hydrophilic porous material. The cover of the device has an opening present therein, situated over the electrodes, so that the electrodes communicate with the exterior of the device through the groove. The insulating layer can also have a groove situated therein, which in one embodiment is placed to align with the groove in the cover. The invention also provides methods of manufacturing the devices, and methods of using them.

Abstract: The present invention provides devices, methods and kits for detecting the presence of an analyte in a liquid sample. The invention provides devices having a positive control area covered with an opaque, movable material, such as an ink, dye, or other material, that is moved on the device by the flow of liquid sample, thereby exposing the positive control area underneath. Using the interaction of colored signals from the positive control area and the analyte binding area, a recognizable symbol is revealed on the device that correlates with the test results, and appears as the test is conducted.

Abstract: The present invention provides devices, methods and kits for detecting the presence of an analyte in a liquid sample. The invention provides devices having a positive control area covered with an opaque, movable material, such as an ink, dye, or other material, that is moved on the device by the flow of liquid sample, thereby exposing the positive control area underneath. Using the interaction of colored signals from the positive control area and the analyte binding area, a recognizable symbol is revealed on the device that correlates with the test results, and appears as the test is conducted.

Abstract: The present invention provides devices, methods and kits for detecting the presence of an analyte in a liquid sample. The invention provides devices having a positive control area covered with an opaque, movable material, such as an ink, dye, or other material, that is moved on the device by the flow of liquid sample, thereby exposing the positive control area underneath. Using the interaction of colored signals from the positive control area and the analyte binding area, a recognizable symbol is revealed on the device that correlates with the test results, and appears as the test is conducted.

Abstract: The present invention provides devices, methods and kits for detecting the presence of an analyte in a liquid sample. The invention provides devices having a positive control area covered with an opaque, movable material, such as an ink, dye, or other material, that is moved on the device by the flow of liquid sample, thereby exposing the positive control area underneath. Using the interaction of colored signals from the positive control area and the analyte binding area, a recognizable symbol is revealed on the device that correlates with the test results, and appears as the test is conducted.

Abstract: The present invention provides water-soluble conjugates and methods of using them in diagnostic and detection assays. Devices for performing detection and quantitation assays are also provided. In various embodiments the conjugates are useful in immunoassays and later flow assays. The invention also provides methods of preparing the conjugates that result in higher yields and higher sensitivities for the assays.

Abstract: The present invention is directed to spring-activated devices and methods for lancing the skin to obtain a small amount of blood for metabolic testing. In one embodiment, the depth penetration of the lancet needle can be seen by the patient during lancing the skin. In another embodiment, the device has only five moving parts for cocking and firing, a plunger, two springs, a slider and a button. In order to reduce manufacturing costs, the number of parts used in the device has been reduced and their configuration has been simplified to reduce construction time, and thereby save on labor costs.

Abstract: The present invention provides biosensor test devices for measuring the presence or amount of an analyte in a biological fluid. The devices have a base plate that has an electrode system embedded therein, and a hydrophilic porous material situated on the base plate. A hydrophobic protective layer is situated on the hydrophilic porous material, and a cover is placed on the hydrophobic protective layer to complete the device. Some embodiments also use an insulating layer, which can be situated between the base layer and the hydrophilic porous material. The cover of the device has an opening present therein, situated over the electrodes, so that the electrodes communicate with the exterior of the device through the groove. The insulating layer can also have a groove situated therein, which in one embodiment is placed to align with the groove in the cover. The invention also provides methods of manufacturing the devices, and methods of using them.

Abstract: One aspect of the present invention is a reagent test strip that includes: a) a top support layer including a sample aperture; b) a membrane that includes a reagent system for indicating the concentration of a target; c) a spreading layer; d) a bottom support layer including a measuring port in substantial alignment or approximate alignment with the sample aperture. Preferably, the membrane is affixed to the top support layer. Preferably, the membrane is positioned between the top support layer and the bottom support layer. Preferably, the spreading layer is positioned above the top support layer and in substantial or approximate alignment with the sample aperture. Preferably, a fluid applied to the spreading layer, passes through the sample aperture and contacts the membrane.

Abstract: A test strip holder for a reagent test strip, the reagent test strip having a proximal portion, a distal portion, and a reaction zone, the test strip holder including a base including a detection aperture, an engaging means able to engage the distal portion, the engaging means including a first deflection surface able to deflect the distal portion in a first direction, and a second deflection surface able to deflect the distal portion in a second direction. Preferably the reaction zone is in approximate or substantial alignment with the detection aperture when the distal portion is fully engaged.

Abstract: One aspect of the present invention is a reagent test strip that includes: a) a top support layer including a sample aperture; b) a membrane that includes a reagent system for indicating the concentration of a target; c) a spreading layer; d) a bottom support layer including a measuring port in substantial alignment or approximate alignment with the sample aperture. Preferably, the membrane is affixed to the top support layer. Preferably, the membrane is positioned between the top support layer and the bottom support layer. Preferably, the spreading layer is positioned above the top support layer and in substantial or approximate alignment with the sample aperture. Preferably, a fluid applied to the spreading layer, passes through the sample aperture and contacts the membrane.

Abstract: The antigen-binding activity of an antibody immobilized on a siliceous support can be increased by pretreatment of the antibody with acid prior to its immobilization.

Abstract: A method and apparatus for immunoassays utilizes an improved collection technique of fluorescence induced emissions at the solid phase/liquid phase interface from surface plasmon resonance sensing devices. In a preferred embodiment, a solid phase substrate is coated with a thin film of a conducting material on which a first specific binding partner is directly or indirectly immobilized. The coated solid phase substrate is incubated with a liquid component comprised of a biological sample containing a specific ligand or analyte and a fluorescent labeled second specific binding partner in the case of immunometric assays, or a fluorescent labeled ligand or analog thereof in the case of competitive assays.