Abstract: The current invention provides a device, and a method for using the device, for ensuring that a capillary or wicking fill device is fully filled. In particular this invention is directed to, but not limited to, use with capillary or wicking action filled electrochemical sensors suitable for use in analyzing blood or interstitial fluids.

Abstract: A novel method for purifying various lectins is disclosed. More specifically a novel method for purifying Concanavalin A is set forth. Methods of expressing purifying and characterizing a mutant Concanavalin A, and sensors including the foregoing are also disclosed.

Abstract: A method for selectively combining multiple membranes for assembly into test strips (such as visual blood glucose test strips with side-by-side membranes). The method includes first measuring a plurality of color parameters (e.g., L*, a* and b*color parameters) associated with membrane samples from at least two membrane lots. Next, response characteristics (e.g., blood glucose response levels) are simulated for a speculative test strip that includes, for purposes of the simulation, combined multiple membranes tentatively selected from the at least two membrane lots. The simulated response characteristics are based on the measured plurality of color parameters of the tentative selection of combined multiple membranes. Optionally, the simulated response characteristics can also be based on simulated color parameters of the tentative selection of combined multiple membranes.

Abstract: Methods, devices and kits for facilitating medical diagnostic assays and reducing the time required for taking of such assays. The methods comprise initiating a reaction, obtaining at least three measurements, at three different time points, of a value or level of an observable associated with the reaction, and estimating an end point value for the observable from the measurements.

Abstract: Data entry and display apparatus and methods that provide greater efficiency in data processing devices. The apparatus comprises a keypad with a plurality of first keys and plurality of secondary keys, the first keys each having at least one primary alphanumeric symbol and at least one of the first keys having a secondary alphanumeric symbol associated therewith, the first key with the secondary symbol being operable to selectively display the secondary alphanumeric symbols in association with the second keys. The apparatus may further comprise a display, which may be embodied in a common touch screen user interface with the keypad. The methods comprise actuating one of the first keys on the keypad and displaying a set of secondary alphanumeric symbols in association with the secondary keys, and selecting the primary alphanumeric symbol associated with the first key or selecting one of the set of secondary alphanumeric symbols by actuating one of the second keys.

Abstract: A redox polymer for use in an electrochemical-based sensor includes a hydrophobic polymer backbone (e.g., a hydrophobic poly(methyl methacrylate) polymer backbone) and at least one hydrophilic polymer arm (such as a hydrophilic oligo(N-vinylpyrrolidinone) polymer arm) attached to the hydrophobic polymer backbone. The redox polymer also includes a plurality of redox mediators (e.g., ferrocene-based redox mediators) attached to the at least one hydrophilic polymer arm.

Abstract: The invention relates to a sensor adapted for electrical connection to a power source having an electrical contact means (3). The sensor has a first insulating substrate (1) carrying a first electrode (2) and a second insulating substrate (7) carrying a second electrode (6). The electrodes are disposed to face each other in spaced apart relationship, sandwiching a spacer (4) therebetween. A first cut-out portion extends through the first insulating substrate (1) and a spacer (4) to expose a first contact area (23) on the second insulating substrate (7). This permits the electrical contact means (31) to effect electrical connection with the first contact (23) which in turn is in electrically conductive connection with the second electrode (6). A similar contact arrangement may be disposed on the opposite side of the sensor.

Abstract: The invention relates to an amperometric electrochemical cell having a first insulating substrate carrying a first electrode, a second insulting substrate carrying a second electrode, said electrodes being disposed to face each other and spaced apart by less than 500 ?m, and defining a sample reservoir therebetween, and wherein at least one, and preferably both, insulating substrates and the electrode carried thereon include an electromagnetic radiation transmissive portion in registration with said reservoir. The walls of the electrochemical cell may be formed from a thin metallic portion on a transparent substrate. Such cells are useful in providing visual confirmation of the validity of the electrochemical measurement.

Abstract: Methods and devices are provided for determining the presence and/or concentration of at least one analyte in a sample of low transmissivity. In the subject methods, a forward beam and a backward beam are produced by or introduced into an interferometer from at least one infrared radiation source. The forward beam is passed into the sample and then collected to produce a sample beam while the backward beam is passed into a reference and then collected to provide a reference beam. The sample and reference beams are recombined either optically into a null beam which is detected at a single detector or electronically nulled after detection on two separate detectors. The presence, and often amount, of at least one analyte in the sample is then derived from the detected null beam. Also provided are devices for practicing the above methods.

Abstract: Methods and devices are provided for determining a suitable site for sampling physiological fluid. In the subject methods, a potentially suitable physiological sampling site is selected, the fluid flow of the site is characterized and the site is then determined to be suitable based on the whether the site has high or low flow. Suitability may also be determined based on the type of sample obtainable from the site, where the order of the above-described steps may be altered. The subject devices include at least one site flow characterization element for determining the flow characteristics of a potential physiological sampling site and/or at least one sample type characterization element for determining whether the vasculature is arterial, venous or neither, i.e., an interstitial fluid sampling site. The subject methods and devices are particularly suited for use in the detection of physiological sampling sites in the fingers, arms, legs, earlobes, heels, feet, nose and toes.

Abstract: Disclosed herein are methods and devices for detecting the presence of an analyte of interest. A biosensor device can include a reaction chamber and an electrochemical detection chamber. The reaction chamber can include at least one immobilized binding site and a probe conjugate adapted to bind to at least one of the target analyte and the immobilized binding site, while the detection chamber can include electrodes for detecting an electrochemical reaction. If present, the target analyte in the fluid sample results in a change in the amount of probe conjugate bound in the reaction chamber, which can be detected electrochemically in the detection chamber.

Abstract: Methods of fabricating devices for collecting a sample of physiological and for measuring a characteristic, e.g., an analyte concentration, of the sampled physiological sample. The devices are in the form of a test strip which include a biosensor and at least one skin-piercing element which is a planar extension of a portion of the biosensor. The fabrication methods provide various or forming the test strip and the skin-piercing element.

Abstract: A method for manufacturing a tissue factor-based prothrombin-time reagent includes combining predetermined quantities of tissue factor (TF), phospholipid and detergent-containing buffer to create a TF/phospholipid mixture. In this combining step, the quantity of TF is predetermined based upon its measured TF activity. Next, the detergent is removed from the TF/phospholipid mixture to produce an essentially detergent-free TF/phospholipid mixture that is useful as a tissue factor-based PT reagent. The method can include the use of hydrophobic resin that has been prescreened based on phospholipid recovery to accomplish the removal of the detergent.

Abstract: A flexible diagnostic device has a measurement cell that is sandwiched between the conductive surfaces of two conductive-coated insulating layers. At least one of the conductive surfaces is scored with an insulating pattern, so that the flow of a conductive fluid sample into the cell can be monitored.

Abstract: The invention relates to a sensor adapted for electrical connection to a power source having an electrical contact means (3). The sensor has a first insulating substrate (1) carrying a first electrode (2) and a second insulating substrate (7) carrying a second electrode (6). The electrodes are disposed to face each other in spaced apart relationship, sandwiching a spacer (4) therebetween. A first cut-out portion extends through the first insulating substrate (1) and a spacer (4) to expose a first contact area (23) on the second insulating substrate (7). This permits the electrical contact means (31) to effect electrical connection with the first contact (23) which in turn is in electrically conductive connection with the second electrode (6). A similar contact arrangement may be disposed on the opposite side of the sensor.

Abstract: The current invention provides a device, and a method for using the device, for ensuring that a capillary or wicking fill device is fully filled. In particular this invention is directed to, but not limited to, use with capillary or wicking action filled electrochemical sensors suitable for use in analyzing blood or interstitial fluids.

Abstract: Devices, systems, methods and kits are provided for use in determining the concentration of chemical and biochemical components in aqueous fluids. The subject devices include test strips which define a longitudinal axis and include a distal edge configured for insertion into a measurement instrument and having an alignment notch formed in the distal edge for engagement with an alignment member of the measurement instrument. The alignment notch has opposing edges wherein at least a portion of the opposing edges is in substantially parallel relation to the longitudinal axis. In using the subject devices, the devices are inserted into a measurement instrument having an alignment pin. When operatively engaged with the alignment pin, the notch serves to maintain the device in a substantially motionless position. The invention is useful in a variety of applications, particularly in the determination of blood glucose concentrations.

Abstract: The invention relates to an amperometric electrochemical cell having a first insulating substrate carrying a first electrode, a second insulting substrate carrying a second electrode, said electrodes being disposed to face each other and spaced apart by less than 500 ?m, and defining a sample reservoir therebetween, and wherein at least one, and preferably both, insulating substrates and the electrode carried thereon include an electromagnetic radiation transmissive portion in registration with said reservoir. The walls of the electrochemical cell may be formed from a thin metallic portion on a transparent substrate. Such cells are useful in providing visual confirmation of the validity of the electrochemical measurement.

Abstract: The present invention relates to the measurement of the progress of a chemical reaction that generates an electroactive reaction product that is subsequently detected at an electrode amperometrically or coulometrically. The method is useful in applications where it is desirable to follow the progress of a chemical reaction, particularly in sensor applications where the progress of the reaction of an analyte can be useful in determining the analyte concentration.

Abstract: A fluidic medical diagnostic device permits measurement of analyte concentration or a property of a biological fluid, particularly the coagulation time of blood. The device has at one end a sample port for introducing a sample and at the other end a bladder for drawing the sample to a measurement area. A channel carries the sample from the sample port to the measurement area, and a stop junction, between the measurement area and bladder, halts the sample flow. The desired measurement can be made by placing the device into a meter which measures a physical property of the sample—typically, optical transmittance—after it has interacted with a reagent in the measurement area.