Abstract: A hand-held test meter for use with an analytical test strip in the determination of an analyte in a bodily fluid sample includes a housing; a microcontroller block disposed in the housing; and a phase-shift-based hematocrit measurement block. The phase-shift-based hematocrit measurement block includes a signal generation sub-block, a low pass filter sub-block, an analytical test strip sample cell interface sub-block, a transimpedance amplifier sub-block, and a phase detector sub-block. In addition, the phase-shift-based hematocrit measurement block and microcontroller block are configured to measure the phase shift of a bodily fluid sample in a sample cell of an analytical test strip inserted in the hand-held test meter and the microcontroller block is configured to compute the hematocrit of the bodily fluid sample based on the measured phase shift.

Abstract: A biosensor apparatus and method with sample type and cell volume detection. The apparatus includes a sine wave generator to apply an AC signal to a biosensor cell containing a sample, a current-to-voltage converter, a phase shifter, a square wave generator, a synchronous demodulator, and a low pass filter which yields a signal proportional to the effective capacitance across the biosensor cell, which is proportional to the volume of the sample. In addition, the current-to-voltage converter yields a signal indicative of the type of sample contained within the biosensor cell. The method includes applying a sine wave to the biosensor cell, shifting the phase of the resultant signal, generating a square wave synchronous with the sine wave, demodulating the resultant signal with the square wave, and filtering the demodulated signal to produce a signal proportional to the effective capacitance across the biosensor cell.

Abstract: A method for monitoring a fluorescent light-emitting bead implanted in a user's body includes removably adhering an adhesive plate of a kinematic adhesive fluorescence measurement patch to a user's body. The method also includes attaching an optical plate of the kinematic adhesive fluorescence measurement patch to the adhered adhesive plate in a kinematic manner such that the optical plate is in operative alignment with the fluorescent light-emitting bead and, thereafter, monitoring the fluorescent light-emitting bead by emitting incident light from the light emitter and detecting fluorescent light emitted from the fluorescent light-emitting bead with the light detector. In addition, the method optionally includes detaching the optical plate from the adhered adhesive plate and reattaching the optical plate in a kinematic manner.

Abstract: A fluorescence measurement band for use with a fluorescent light-emitting bead implanted within a user's body includes a band configured for secure and removable positioned about a portion of the user's body, a light emitter attached to the band and a light detector attached to the band. The light emitter of the fluorescence measurement band is configured for emitting light that is absorbed by the fluorescent light-emitting bead while the light detector configured for detecting fluorescent light emitted by the fluorescent light-emitting bead.

Abstract: An adhesive fluorescence measurement patch for use with a fluorescent light-emitting bead implanted within a user's body includes an adhesive sheet configured for removable adhesion to the user's body, a light emitter attached to the adhesive sheet, and a light detector attached to the adhesive sheet. The light emitter is configured for emitting light that is absorbed by the fluorescent light-emitting bead while the light detector is configured for detecting fluorescent light emitted by the fluorescent light-emitting bead.

Abstract: A method for monitoring an implanted fluorescent light-emitting bead includes adhering and adhesive fluorescence measurement patch to a user's body. The method also includes monitoring the implanted fluorescent light-emitting bead implanted in the user's by emitting light from a light emitter included in the adhesive fluorescence measurement patch and detecting fluorescent light emitted from the fluorescent light-emitting bead with a light detector included in the adhesive fluorescence measurement patch.

Abstract: A fluorescence measurement analytical kit includes an adhesive fluorescence measurement patch, a fluorescent light-emitting bead and a remote module. The adhesive fluorescence measurement patch has an adhesive sheet configured for removable adhesion to the user's body, a light emitter attached to the adhesive sheet, and a light detector attached to the adhesive sheet. The light emitter is configured for emitting light that is absorbed by the fluorescent light emitting bead while the light detector is configured for detecting fluorescent light emitted by the fluorescent light-emitting bead.

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: A system for piercing dermal tissue includes a skin-piercing element (e.g., an integrated micro-needle and biosensor medical device), at least one electrical contact (e.g., an electrical skin contact) and a meter configured for measuring an electrical characteristic (e.g., resistance and/or impedance) existent between the skin-piercing element and the electrical contact(s) when the system is in use. The electrical contact(s) can be integrated with a pressure/contact ring of the meter to provide a compact and inexpensive system compatible with integrated micro-needle and biosensor medical devices. Also, a method for piercing dermal tissue that includes contacting dermal tissue (e.g., skin) with at least one electrical contact and inserting a skin-piercing element into the dermal tissue while measuring an electrical characteristic existent between the skin-piercing element and the electrical contact(s).

Abstract: A biosensor apparatus and method with sample type and cell volume detection. The apparatus includes a sine wave generator to apply an AC signal to a biosensor cell containing a sample, a current-to-voltage converter, a phase shifter, a square wave generator, a synchronous demodulator, and a low pass filter which yields a signal proportional to the effective capacitance across the biosensor cell, which is proportional to the volume of the sample. In addition, the current-to-voltage converter yields a signal indicative of the type of sample contained within the biosensor cell. The method includes applying a sine wave to the biosensor cell, shifting the phase of the resultant signal, generating a square wave synchronous with the sine wave, demodulating the resultant signal with the square wave, and filtering the demodulated signal to produce a signal proportional to the effective capacitance across the biosensor cell.

Abstract: Methods and devices for determining the concentration of an analyte in a physiological sample are provided. In the subject methods, the physiological sample is introduced into an electrochemical cell having a working and reference electrode. A first electric potential is applied to the cell and the resultant cell current over a period of time is measured to determine a first time-current transient. A second electric potential of opposite polarity is then applied and a second a time-current transient is determined. The preliminary concentration of the analyte is then calculated from the first and/or second time-current transient. This preliminary analyte concentration less a background value is then multiplied by a hematocrit correction factor to obtain the analyte concentration in the sample, where the hematocrit correction factor is a function of the preliminary analyte concentration and the variable ? of the electrochemical cell.

Abstract: The present invention provides methods and systems for passively and automatically detecting the presence of a sample (the “sample detection phase”) upon application of the sample to a biosensor, identifying the sample detection time and then initiating the measurement of a targeted characteristic, e.g., the concentration of one or more analytes, of the sample (the “measurement phase”), immediately upon sample detection. The subject methods and systems do not employ or involve the application of an electrical signal from an external source to the electrochemical cell for purposes of performing the sample detection phase and are, thus, less complicated and involve fewer steps and components.

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: Methods and systems are provided for determining whether a volume of biological sample is adequate to produce an accurate electrochemical analyte concentration measurement. Certain such methods and systems provide the additional function of compensating for a sample volume determined to be less than adequate in order to proceed with an accurate analyte concentration measurement. The present invention is employed with a biosensor, such as an electrochemical test strip to which the sample volume of biological solution is deposited, and a meter configured to receive such test strip and to measure the concentration of selected analytes within the biological sample.