Abstract: A method for determining contamination of a biosensor in which the biosensor is loaded into a test meter and a sample is then applied. First and second predetermined test voltages are applied between spaced electrodes of the biosensor for respective first and second predetermined time intervals. First and second current values are measured during the respective first and second predetermined time intervals. Reference values are determined based on the measured first and second current values. Based on one or more of the reference values, a determination of contamination is made. Reporting of the analyte concentration of the sample can be suppressed based on the determination.

Abstract: A method for determining contamination of a biosensor in which the biosensor is loaded into a test meter and a sample is then applied. First and second predetermined test voltages are applied between spaced electrodes of the biosensor for respective first and second predetermined time intervals. First and second current values are measured during the respective first and second predetermined time intervals. Reference values are determined based on the measured first and second current values. Based on one or more of the reference values, a determination of contamination is made. Reporting of the analyte concentration of the sample can be suppressed based on the determination.

Abstract: A system and a method for correcting an analyte concentration measurement taken by a test strip is described herein. The test strip includes at least two spaced apart electrodes defining an electrochemical cell or reaction chamber. An initial polarization parameter of the test strip is determined at the time of test strip manufacture and a testing polarization parameter is determined at the time of testing. A resulting correction factor is then determined based on the initial and testing polarization parameters. The correction parameter can be applied to a measured analyte concentration in order to correct the measured analyte concentration.

Abstract: An electrochemical-based analytical test strip for the determination of an analyte (such as glucose) in a bodily fluid sample includes an electrically insulating base layer, a first electrically conductive layer disposed on the electrically insulating base layer and including at least one electrode, an enzymatic reagent layer disposed on the at least one electrode, a patterned spacer layer and a top layer. The electrochemical-based analytical test strip also includes an ultra-thin discontinuous metal layer with a nominal thickness of less than 10 nanometers disposed between the first electrically conductive layer and the top layer. Moreover, at least the patterned spacer layer defines a sample-receiving chamber containing the at least one electrode, and the ultra-thin discontinuous metal layer is disposed at least within the sample-receiving chamber.

Abstract: Electrochemical-based analytical test strip with a soluble electrochemically-active coating opposite a bare electrode An electrochemical-based analytical test strip (EBATS) for the determination of an analyte in a bodily fluid sample includes an electrically insulating base layer, a patterned electrically conductive layer disposed on the electrically insulating base layer and including a plurality of electrodes, and an enzymatic reagent layer disposed on a portion of the patterned conductor layer and defining a bare electrode(s) and a plurality of enzymatic reagent covered electrodes from the plurality of electrodes. The EBATS also includes a patterned spacer layer, a top layer having an underside surface (USS), and a soluble electrochemically-active coating (SEAC) disposed on the USS of the top layer. In addition, at least the patterned spacer layer and top layer define a sample-receiving chamber within the EBATS.

Abstract: An analyte measurement system is disclosed herein. The analyte measurement system includes a test strip. The test strip includes at least two electrodes spaced apart in a reaction chamber, one of said electrodes including a conductive material having a coating applied thereupon. The analyte measurement system also includes an analyte measurement device. The analyte measurement device includes a strip port having connectors configured to coupled to the electrodes of the test strip. The applied coating enables a capacitance value of the test strip to be measured in order to determine compatibility of the test strip with the analyte measurement device.

Abstract: An electrochemical-based analytical test strip for the determination of an analyte (such as glucose) in a bodily fluid sample includes an electrically insulating base layer, an electrically conductive layer disposed on the electrically insulating base layer and including at least one electrode, an enzymatic reagent layer disposed on the at least one electrode, a patterned spacer layer, and a top layer. Moreover, the enzymatic reagent layer includes at least one naphthoquinone-based mediator. The naphthoquinone-based mediator can, for example, be at least one of 1,2-naphthalenedione-4-(3-mercapto-1-propane sulfonic acid) and 1,2-naphthalenedione-4-(3-mercaptopropionic acid); and FAD-GDH enzyme.

Abstract: An electrochemical-based analytical test strip (EBATS) for the determination of an analyte (such as glucose) in a bodily fluid sample (for example, a whole blood sample) includes an electrically insulating base layer (110), a patterned electrically conductive layer (120) disposed on the electrically insulating base layer, an enzymatic reagent layer (140) disposed on the patterned electrically conductor layer, a patterned spacer layer (150), a top layer (170) having an underside surface, and a soluble acidic material coating (160) on the underside surface of the top layer. The patterned spacer layer and top layer define a sample-receiving chamber (180) within the EBATS and the soluble acidic material coating is disposed on the underside surface of the top layer within the sample-receiving chamber. In addition, the soluble acidic material coating is operably dissolvable in the bodily fluid sample such that a pH of the bodily fluid sample in the sample-receiving chamber is reduced during use of the EBATS.

Abstract: Various embodiments that allow for improved accuracy in the measurement of glucose with a glucose meter and a biosensor, principally, by using pulsed signal inputs to the biosensor and selecting at least one specific pulsed output from the biosensor to determine a glucose concentration that is less affected by interfering chemical substances that might be present in the fluid sample.

Abstract: An electrochemical-based analytical test strip (“TS”) for the determination of an analyte in a bodily fluid sample includes an electrically insulating substrate, a patterned conductor layer disposed over the electrically-insulating substrate and having an analyte working electrode (“WE”), a bare interferent electrode (“IE”) and a shared counter/reference electrode (“CE”). The TS also includes a patterned insulation layer (“PIL”) with an electrode exposure slot configured to expose the WE, IE and CE, an enzymatic reagent layer disposed on the WE and CE, and a patterned spacer layer (“PSL”). The PIL and the PSL define a sample receiving chamber with a sample-receiving opening. The IE and the CE constitute a first electrode pair configured for measurement of an interferent electrochemical response and the WE and the CE constitute a second electrode pair configured for measurement of an analyte electrochemical response. The WE and the IE are electrically isolated from one another.

Abstract: An electrochemical-based analytical test strip for the determination of an analyte (e.g., glucose) in a bodily fluid sample (such as a whole blood sample) includes an electrically insulating base layer and a patterned conductor layer (for example, a gold patterned conductor layer) disposed over the electrically-insulating layer. The patterned conductor layer includes at least one electrode with the electrode having electrochemically inert areas and an electrochemically active area(s). Moreover, the electrochemically inert areas and electrochemically active area(s) are of a predetermined size and a predetermined distribution such that electrochemical response of the electrode during use of the electrochemical-based analytical test strip is essentially equivalent to a predetermined electrochemical response.

Abstract: An electrochemical-based analytical test strip for the determination of an analyte (e.g., glucose) in a bodily fluid sample (such as a whole blood sample) includes an electrically insulating base layer and a patterned conductor layer (for example, a gold patterned conductor layer) disposed over the electrically-insulating layer. The patterned conductor layer includes at least one electrode with the electrode having electrochemically inert areas and an electrochemically active area(s). Moreover, the electrochemically inert areas and electrochemically active area(s) are of a predetermined size and a predetermined distribution such that electrochemical response of the electrode during use of the electrochemical-based analytical test strip is essentially equivalent to a predetermined electrochemical response.

Abstract: Various embodiments that allow for improved accuracy in the measurement of glucose with a glucose meter and a biosensor, principally, by using pulsed signal inputs to the biosensor and selecting at least one specific pulsed output from the biosensor to determine a glucose concentration that is less affected by interfering chemical substances that might be present in the fluid sample.

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: An analytical test strip and test meter combination for use in the determination of an analyte in a bodily fluid sample includes an analytical test strip and a test meter, and a method for determination thereof. The analytical test strip has an electrode, a first electrical contact pad in electrical communication with the electrode and configured to communicate an electrical response of the electrode to the test meter; and a second electrical contact pad in electrical communication with the electrode and configured to communicate an electrical response of the electrode to the test meter should the test meter be in electrical communication with the second electrical contact pad. In addition, the second electrical contact pad has electrical continuity with the first electrical contact pad and the first and second electrical contact pads are disposed in either of first and second predetermined spatial relationships to one another.

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: An electrochemical-based analytical test strip for the determination of an analyte (e.g., glucose) in a bodily fluid sample (such as a whole blood sample) includes an electrically insulating base layer and a patterned conductor layer (for example, a gold patterned conductor layer) disposed over the electrically-insulating layer. The patterned conductor layer includes at least one electrode with the electrode having electrochemically inert areas and an electrochemically active area(s). Moreover, the electrochemically inert areas and electrochemically active area(s) are of a predetermined size and a predetermined distribution such that electrochemical response of the electrode during use of the electrochemical-based analytical test strip is essentially equivalent to a predetermined electrochemical response.

Abstract: Various embodiments of a technique in which test strip lots can be prepared without requiring a user to input any calibration information before performing a test measurement with a test strip from the test strip lots. In a first aspect, a method of manufacturing a plurality of test strips by adjusting amount of mediators and working electrode area is described. In another aspect, a method of preparing a reagent ink by adjusting the density of the reagent ink to substantially match a target density is described. In a further aspect, a method using a high numerical Shores Hardness squeegee in conjunction with high pressure is provided. In a further aspect, a method of performing an analyte measurement with a test meter, the test meter being configured to not receive a calibration input, and where the test strip manufactured to any one of the methods or techniques described and illustrated herein.

Abstract: An electrochemical-based analytical test strip for the determination of an analyte (e.g., glucose) in a bodily fluid sample (such as a whole blood sample) includes an electrically insulating base layer and a patterned conductor layer (for example, a gold patterned conductor layer) disposed over the electrically-insulating layer. The patterned conductor layer includes at least one electrode with the electrode having electrochemically inert areas and an electrochemically active area(s). Moreover, the electrochemically inert areas and electrochemically active area(s) are of a predetermined size and a predetermined distribution such that electrochemical response of the electrode during use of the electrochemical-based analytical test strip is essentially equivalent to a predetermined electrochemical response.

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.