Abstract: An electrochemical test device for determining the concentration of an analyte in a fluid sample, wherein the electrochemical test device has a substrate is provided. The device comprises a micro-voided synthetic polymer.

Abstract: An electrochemical test device for determining the concentration of an analyte in a fluid sample, wherein the electrochemical test device has a substrate is provided. The device comprises a micro-voided synthetic polymer.

Abstract: A test device for measuring the amount of analyte in a fluid sample, including a substrate having thereon: a first analyte reagent formulated to react with the analyte to generate a signal indicative of the presence or amount of analyte in the sample, the first analyte reagent having a first time-based response characteristic; and a second analyte reagent formulated to react with the analyte to generate a signal indicative of the presence or amount of analyte in the sample, the second analyte reagent having a second time-based response characteristic.

Abstract: Described and illustrated herein are one exemplary method and a measurement system having a meter and a test strip. The test strip has a first working electrode, reference electrode and second working electrode. In this method, acceptable fill data from known first current and known second current are used to predict an estimated second current at proximate the second time period (for a given batch of test strips) during the test sequence. The estimated second current at proximate the second time interval is then compared with a measured actual second current at proximate the second time interval during an actual test to determine if the measured actual second current is substantially equal to or within an acceptable percent deviation from the estimated second current so as to determine sufficient volume of a physiological fluid sample in the test strip.

Abstract: The method includes: providing a test strip comprising a reference electrode and a working electrode coated with a reagent layer; applying a fluid sample to the test strip for a reaction period; applying a test voltage between the reference electrode and the working electrode; measuring a test current as a function of time; measuring a steady state current value when the test current has reached an equilibrium; calculating a ratio of the test current to the steady state current value; plotting the ratio of the test current to the steady state current value as a function of the inverse square root of time; calculating an effective diffusion coefficient from the slope of the linearly regressed plot of the ratio of the test current to the steady state current value as a function of the inverse square root of time; and calculating a hematocrit-corrected concentration of analyte.

Abstract: Described and illustrated herein are one exemplary method and a measurement system having a meter and a test strip. The test strip has a first working electrode, reference electrode and second working electrode. In this method, acceptable fill data from known first current and known second current are used to predict an estimated second current at proximate the second time period (for a given batch of test strips) during the test sequence. The estimated second current at proximate the second time interval is then compared with a measured actual second current at proximate the second time interval during an actual test to determine if the measured actual second current is substantially equal to or within an acceptable percent deviation from the estimated second current so as to determine sufficient volume of a physiological fluid sample in the test strip.

Abstract: A method and system is provided to allow for determination of substantially Hematocrit independent analyte concentration. In one example, an analyte measurement system is provided that includes a test strip and a test meter. The test strip includes a reference electrode and a working electrode, in which the working electrode is coated with a reagent layer. The test meter includes an electronic circuit and a signal processor. The electronic circuit applies a plurality of voltages to the reference electrode and the working electrode over respective durations. The signal processor is configured to determine a substantially hematocrit-independent concentration of the analyte from a plurality of current values as measured by the processor upon application of a plurality of test voltages to the reference and working electrodes over a plurality of durations interspersed with rest voltages lower than the test voltages being applied to the electrodes.

Abstract: A test meter for use with a dual-chamber, multi-analyte test strip includes a test strip receiving module and a signal processing module. The test strip receiving module has a first electrical connector configured for contacting a first analyte contact pad of a first working electrode of the test strip; a second electrical connector configured for contacting a second analyte contact pad of a second working electrode of the test strip, a third electrical connector configured for contacting a first counter/reference contact pad of a first counter/reference electrode layer of the test strip, and a fourth electrical connector configured for contacting a second counter/reference contact pad of a second counter/reference electrode layer of the test strip.

Abstract: The method includes: providing a test strip comprising a reference electrode and a working electrode coated with a reagent layer; applying a fluid sample to the test strip for a reaction period; applying a test voltage between the reference electrode and the working electrode; measuring a test current as a function of time; measuring a steady state current value when the test current has reached an equilibrium; calculating a ratio of the test current to the steady state current value; plotting the ratio of the test current to the steady state current value as a function of the inverse square root of time; calculating an effective diffusion coefficient from the slope of the linearly regressed plot of the ratio of the test current to the steady state current value as a function of the inverse square root of time; and calculating a hematocrit-corrected concentration of analyte.

Abstract: Described herein is an electrochemical enzymatic analyte test strip and method for making the test strip. The test strip utilizes isolated conductive areas inside the electrodes to define electrode whiskers. The method utilizes laser ablation to define electrode patterns.

Abstract: A method for determining an analyte concentration in blood is described that reduces the effects of hematocrit using a test strip attached to a test meter. The test strip includes a working electrode and a reference electrode. The test meter applies a test voltage between the working electrode and the reference electrode. After a user applies a blood sample containing an analyte onto the test strip, the test meter measures a plurality of test currents for a test time interval.

Abstract: Description is provided herein for an embodiment of a method determining a hematocrit-corrected glucose concentration. The exemplary method includes providing a test strip having a reference electrode and a working electrode, wherein the working electrode includes a plurality of microelectrodes and is coated with at least an enzyme and a mediator.

Abstract: A dual chamber, multi-analyte test strip has a first insulating layer, a first electrically conductive layer, with a first working electrode, disposed on the first insulating layer and a first patterned spacer layer positioned above the first electrically conductive layer. The first patterned spacer layer has a first sample-receiving chamber, with first and second end openings, defined therein that overlies the first working electrode. The test strip also includes a first counter/reference electrode layer that is exposed to the first sample receiving chamber and is in an opposing relationship to the first working electrode. The test strip further includes a counter/reference insulating layer disposed over the first counter/reference electrode layer and a second counter/reference electrode layer disposed on the counter/reference substrate. Also included in the test strip is a second patterned spacer layer that is positioned above the second counter/reference electrode layer.

Abstract: A method and system is provided to allow for determination of substantially Hematocrit independent analyte concentration. In one example, an analyte measurement system is provided that includes a test strip and a test meter. The test strip includes a reference electrode and a working electrode, in which the working electrode is coated with a reagent layer. The test meter includes an electronic circuit and a signal processor. The electronic circuit applies a plurality of voltages to the reference electrode and the working electrode over respective durations. The signal processor is configured to determine a substantially hematocrit-independent concentration of the analyte from a plurality of current values as measured by the processor upon application of a plurality of test voltages to the reference and working electrodes over a plurality of durations interspersed with rest voltages lower than the test voltages being applied to the electrodes.

Abstract: An electrochemical-based analytical test strip for the determination of an analyte (such as glucose) in a bodily fluid sample (e.g., a whole blood sample) includes a substrate, at least one working electrode disposed on the substrate, a sample-soluble enzymatic reagent layer disposed above the working electrode, a diffusion-controlling layer (DCL) disposed between the at least one working electrode and the sample-soluble enzymatic reagent layer; and a sample-receiving chamber. In addition, the sample-soluble enzymatic reagent layer is configured and constituted for operable solubility in a bodily fluid sample applied to the electrochemical-based analytical test strip and received in the sample-receiving chamber and for electrochemical enzymatic reaction with an analyte in the bodily fluid sample.

Abstract: A method and system is provided to allow for determination of substantially Hematocrit independent analyte concentration. In one example, an analyte measurement system is provided that includes a test strip and a test meter. The test strip includes a reference electrode and a working electrode, in which the working electrode is coated with a reagent layer. The test meter includes an electronic circuit and a signal processor. The electronic circuit applies a plurality of voltages to the reference electrode and the working electrode over respective durations. The signal processor is configured to determine a substantially hematocrit-independent concentration of the analyte from a plurality of current values as measured by the processor upon application of a plurality of test voltages to the reference and working electrodes over a plurality of durations interspersed with rest voltages lower than the test voltages being applied to the electrodes.

Abstract: A test meter for use with a dual-chamber, multi-analyte test strip includes a test strip receiving module and a signal processing module. The test strip receiving module has a first electrical connector configured for contacting a first analyte contact pad of a first working electrode of the test strip; a second electrical connector configured for contacting a second analyte contact pad of a second working electrode of the test strip, a third electrical connector configured for contacting a first counter/reference contact pad of a first counter/reference electrode layer of the test strip, and a fourth electrical connector configured for contacting a second counter/reference contact pad of a second counter/reference electrode layer of the test strip.

Abstract: A dual chamber, multi-analyte test strip has a first insulating layer, a first electrically conductive layer, with a first working electrode, disposed on the first insulating layer and a first patterned spacer layer positioned above the first electrically conductive layer. The first patterned spacer layer has a first sample-receiving chamber, with first and second end openings, defined therein that overlies the first working electrode. The test strip also includes a first counter/reference electrode layer that is exposed to the first sample receiving chamber and is in an opposing relationship to the first working electrode. The test strip further includes a counter/reference insulating layer disposed over the first counter/reference electrode layer and a second counter/reference electrode layer disposed on the counter/reference substrate. Also included in the test strip is a second patterned spacer layer that is positioned above the second counter/reference electrode layer.

Abstract: A multi-analyte test strip includes a first insulating layer and an electrically conductive layer disposed on the first insulating layer. The electrically conductive layer has a first working electrode with a first analyte contact pad, a shared counter/reference electrode with a counter/reference electrode contact pad, and a second working electrode with a second analyte contact pad. The multi-analyte test strip also includes a second insulating layer disposed above the first insulating layer and a patterned spacer layer positioned between the first insulating layer and the first electrically conductive layer with the patterned spacer layer defining a bodily fluid sample-receiving chamber that overlies the first working electrode, the shared counter/reference electrode and the second working electrode.

Abstract: A method for determining an analyte concentration in blood is described that reduces the effects of hematocrit using a test strip attached to a test meter. The test strip includes a working electrode and a reference electrode. The test meter applies a test voltage between the working electrode and the reference electrode. After a user applies a blood sample containing an analyte onto the test strip, the test meter measures a plurality of test currents for a test time interval.