Abstract: An analytical test strip for the determination of an analyte (such as glucose and/or hematocrit) in a bodily fluid sample (such as a whole blood sample) includes a first capillary sample-receiving chamber, a second capillary sample-receiving chamber, and a physical barrier island disposed between the first and second capillary sample-receiving chambers. Moreover, the physical island barrier is disposed such that bodily fluid sample flow between the first capillary sample-receiving chamber and the second capillary sample-receiving chamber is prevented during use of the analytical test strip.

Abstract: An electrochemical-based analytical test strip for the determination of an analyte (such as glucose) in a bodily fluid sample (for example, a whole blood sample) and/or a characteristic of the bodily fluid sample (e.g., hematocrit) includes a sample-entry chamber with a sample-application opening disposed on an end edge of the electrochemical-based analytical test strip, and first and second sample-determination chambers, each in direct fluidic communication with the sample-entry chamber. The electrochemical-based analytical test strip also includes first and second electrodes (such as first and second hematocrit electrodes) disposed in the first sample-determination chamber, and a third and fourth electrodes (for example working and reference electrodes) disposed in the second sample-determination chamber.

Abstract: An analytical test strip for the determination of an analyte (such as glucose) in, or a characteristic of, a bodily fluid sample includes an electrically-insulating base layer, a first patterned spacer layer disposed on the electrically-insulating base layer, a second patterned spacer layer disposed on the first patterned spacer layer; and a top hydrophilic layer disposed on the second patterned spacer layer. In addition, the electrically-insulating base layer, the first and second patterned spacer layers and the top hydrophilic layer define a tiered capillary chamber(s) that has a first tiered capillary chamber portion defined in the first patterned spacer layer and a second tiered capillary chamber portion defined in the second patterned spacer layer. Moreover, the first tiered capillary chamber portion and the second tiered capillary chamber portion are in direct fluidic communication with one another.

Abstract: An electrochemical-based analytical test strip for the determination of an analyte (such as glucose) in a bodily fluid sample (for example, a whole blood sample) and/or a characteristic of the bodily fluid sample (e.g., hematocrit) includes a sample-entry chamber with a sample-application opening disposed on an end edge of the electrochemical-based analytical test strip, and first and second sample-determination chambers, each in direct fluidic communication with the sample-entry chamber. The electrochemical-based analytical test strip also includes first and second electrodes (such as first and second hematocrit electrodes) disposed in the first sample-determination chamber, and a third and fourth electrodes (for example working and reference electrodes) disposed in the second sample-determination chamber.

Abstract: An analytical test strip for the determination of an analyte (such as glucose and/or hematocrit) in a bodily fluid sample (such as a whole blood sample) includes a first capillary sample-receiving chamber, a second capillary sample-receiving chamber, and a physical barrier island disposed between the first and second capillary sample-receiving chambers. Moreover, the physical island barrier is disposed such that bodily fluid sample flow between the first capillary sample-receiving chamber and the second capillary sample-receiving chamber is prevented during use of the analytical test strip.

Abstract: Various embodiments for methods and systems that allow for detecting of a direction in which a sample is flowing towards a plurality of electrodes and detecting a fill error of an electrochemical test strip.

Abstract: An analytical test strip for the determination of an analyte (such as glucose and/or hematocrit) in a bodily fluid sample (such as a whole blood sample) includes a first capillary sample-receiving chamber, a second capillary sample-receiving chamber, and a physical barrier island disposed between the first and second capillary sample-receiving chambers. Moreover, the physical island barrier is disposed such that bodily fluid sample flow between the first capillary sample-receiving chamber and the second capillary sample-receiving chamber is prevented during use of the analytical test strip.

Abstract: An electrochemical-based analytical test strip for the determination of an analyte (such as glucose) in a bodily fluid sample (for example, a whole blood sample) and/or a characteristic of the bodily fluid sample (for example, hematocrit) includes a first sample-receiving chamber with first and second sample-application openings, and first and second electrodes. The first and second electrodes are disposed in the first sample-receiving chamber between the first and second sample-application openings. The electrochemical-based analytical test strip also includes a second sample-receiving chamber and a plurality of electrodes disposed in the second sample-receiving chamber. In addition, the second sample-receiving chamber intersects the first sample-receiving chamber between the first and second electrodes, thereby defining a chamber intersection.

Abstract: Various embodiments for methods and systems that allow for detecting of a direction in which a sample is flowing towards a plurality of electrodes and detecting a fill error of an electrochemical test strip.

Abstract: An 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 first and second capillary sample-receiving chambers and first and second stop junctions that are disposed between the first and second capillary sample-receiving chambers. The first stop junction defines a discontinuity boundary of the first capillary sample-receiving chamber and the second stop junction defines a discontinuity boundary of the second capillary sample-receiving chamber. In addition, the first stop junction and the second stop junction are disposed such that bodily fluid sample flow between the first capillary sample-receiving chamber and the second capillary sample-receiving chamber during use of the analytical test strip is prevented.

Abstract: An electrochemical-based analytical test strip for the determination of an analyte (such as glucose) in a bodily fluid sample (for example, a whole blood sample) and/or a characteristic of the bodily fluid sample (for example, hematocrit) includes a first sample-receiving chamber with first and second sample-application openings, and first and second electrodes. The first and second electrodes are disposed in the first sample-receiving chamber between the first and second sample-application openings. The electrochemical-based analytical test strip also includes a second sample-receiving chamber and a plurality of electrodes disposed in the second sample-receiving chamber. In addition, the second sample-receiving chamber intersects the first sample-receiving chamber between the first and second electrodes, thereby defining a chamber intersection.

Abstract: An analytical test strip for the determination of an analyte (such as glucose and/or hematocrit) in a bodily fluid sample (such as a whole blood sample) includes a first capillary sample-receiving chamber, a second capillary sample-receiving chamber, and a physical barrier island disposed between the first and second capillary sample-receiving chambers. Moreover, the physical island barrier is disposed such that bodily fluid sample flow between the first capillary sample-receiving chamber and the second capillary sample-receiving chamber is prevented during use of the analytical test strip.

Abstract: An electrochemical-based analytical test strip (“EBAT”) for the determination of an analyte in a bodily fluid sample includes an electrically insulating substrate layer with a distal end and a patterned conductor layer that is disposed over the electrically-insulating substrate layer and has a working electrode (“WE”) and a counter/reference electrode (“C/RE”). The EBAT also includes a patterned insulation layer with an electrode exposure window configured to expose a WE exposed portion and a C/RE exposed portion, an enzymatic reagent layer; and a patterned spacer layer. The patterned insulation layer and the patterned spacer layer define a sample receiving chamber with a sample-receiving opening (“SRO”) at the distal end of the electrically insulating substrate layer and that extends across the WE exposed portion and the C/RE exposed portion. Furthermore, the enzymatic reagent layer is disposed over the WE and C/RE exposed portions and extends no more than 400 ?m toward the SRO.

Abstract: An analytical test strip (“ATS”) for use with a hand-held test meter in the determination of an analyte in a bodily fluid sample includes an electrically insulting substrate, a first patterned conductor layer disposed on the electrically insulating substrate and having a working electrode and a reference electrode. The ATS also includes an enzymatic reagent layer disposed on the working electrode, a first patterned spacer layer disposed over the first patterned conductor layer and defining both a first sample-receiving channel and an analyte determination sample chamber within the ATS, and a second patterned spacer layer disposed over the first patterned spacer layer and defining at least a second sample-receiving channel. The ATS further includes a bodily fluid phase-shift sample chamber in fluidic communication with the second sample-receiving channel.

Abstract: The invention provides a method of controlling the slope, intercept and bias for a batch of test strips by increasing or decreasing the enzyme pad height of the strips. The invention provides an improved method for the production of single calibration code strip lots with good yields.

Abstract: An electrochemical-based analytical test strip for the determination of an analyte (such as glucose) in a bodily fluid sample (for example, whole blood) includes an electrically insulating base layer, a patterned conductor layer disposed over the electrically-insulating layer, and a patterned insulation layer, with an electrode exposure window therethrough, disposed over the patterned conductor layer. The patterned conductive layer of the electrochemical-based analytical test strip includes at least one working electrode and a counter/reference electrode. In addition, at least a portion of the electrode exposure window is configured to expose a working electrode exposed portion and a counter/reference electrode exposed portion, with the working electrode exposed portion being rectangular in shape and the counter/reference electrode exposed portion being one of a crossroads shape and an at least six-sided portion of a crossroads shape.

Abstract: An electrochemical-based analytical test strip includes an electrically-insulating substrate, a patterned conductive layer disposed over the electrically-insulating substrate, a patterned insulating layer disposed over the patterned conductive layer, an enzymatic reagent layer disposed over the patterned conductive layer, a patterned adhesive layer disposed above the enzymatic reagent layer and a top layer disposed over the enzymatic reagent layer. In addition, the test strip has a sample-receiving chamber defined by the electrically-insulating substrate, the patterned conductive layer, the patterned insulating layer, the enzymatic reagent layer, the patterned adhesive layer and the top layer. The sample receiving chamber of the test strip has a working portion and a non-working portion and the top layer has a first portion and an opaque second portion.

Abstract: A method for determining an analyte (such a glucose) in a bodily fluid sample includes introducing a bodily fluid sample (e.g., a whole blood sample) into a sample-receiving chamber of an analytical test strip. The method also includes verifying that the bodily fluid sample has filled at least a working portion of the sample-receiving chamber by user visual observation of the working portion through a first portion of a top layer of the analytical test strip, while an opaque second portion of the top layer precludes user visual observation of a non-working portion of the sample-receiving chamber. Thereafter, in the method, the concentration of analyte in the bodily fluid sample is determined only if during the verifying step the user has verified that the bodily fluid sample has filled the working portion.

Abstract: An electrochemical-based analytical test strip includes an electrically-insulating substrate, a patterned conductive layer disposed over the electrically-insulating substrate, a patterned insulating layer disposed over the patterned conductive layer, an enzymatic reagent layer disposed over the patterned conductive layer, a patterned adhesive layer disposed above the enzymatic reagent layer and a top layer disposed over the enzymatic reagent layer. In addition, the test strip has a sample-receiving chamber defined by the electrically-insulating substrate, the patterned conductive layer, the patterned insulating layer, the enzymatic reagent layer, the patterned adhesive layer and the top layer. The sample receiving chamber of the test strip has a working portion and a non-working portion and the top layer has a first portion and an opaque second portion.