Abstract: An electrochemical test device for use in determining a concentration of each of a first analyte and a second analyte in a fluid sample is provided. The electrochemical test device comprises a set of electrodes including a first working electrode having sensing chemistry for the first analyte and a second working electrode having sensing chemistry for the second analyte, wherein the first analyte is lactate and the sensing chemistry for the lactate comprises lactate oxidase and an electron transfer agent, and wherein the sensing chemistry for the second analyte comprises a diaphorase, an electron transfer agent, an NAD(P)+-dependent dehydrogenase and a cofactor for the NAD(P)+-dependent dehydrogenase.

Abstract: A method of verifying operation of a meter for reading electrochemical test devices, includes obtaining a reference output signal indicative of a response generated at an electrochemical test device when the electrochemical test device reacts with a reference test fluid; applying with the meter an algorithm to the reference output signal so as to obtain a reference test result, wherein the algorithm is for use in estimating an unknown concentration of an analyte in a sample of the reference test fluid; and determining whether the reference test result is valid so as to verify operation of the meter.

Abstract: An electrochemical test device for determining a concentration of one or more analytes in a fluid sample is provided. The electrochemical test device comprises a set of electrodes including two or more working electrodes, each working electrode for determining the concentration of a corresponding analyte, and sensing chemistry for each working electrode, wherein the sensing chemistry for a first of the two or more working electrodes comprises a diaphorase, an electron transfer agent, an NAD(P)+-dependent dehydrogenase and a cofactor for the NAD(P)+-dependent dehydrogenase, wherein at least some of the diaphorase for the first working electrode is disposed in a diaphorase-containing layer which extends over the first working electrode and at least a second of the two or more working electrodes.

Abstract: An electrochemical test device for detecting a first analyte and a second analyte in a fluid sample is provided. The device comprises a first conductor layer arranged to receive a fluid sample, wherein the first conductor layer comprises a first working electrode for receiving sensing chemistry for the first analyte and a second working electrode for receiving sensing chemistry for the second analyte; and wherein a layer of the electrochemical test device is arranged to provide error correction information for correcting a measurement of a response of the fluid sample with at least one sensing chemistry received on the first conductor layer.

Abstract: A method of verifying operation of a meter for reading electrochemical test devices, includes obtaining a reference output signal indicative of a response generated at an electrochemical test device when the electrochemical test device reacts with a reference test fluid; applying with the meter an algorithm to the reference output signal so as to obtain a reference test result, wherein the algorithm is for use in estimating an unknown concentration of an analyte in a sample of the reference test fluid; and determining whether the reference test result is valid so as to verify operation of the meter.

Abstract: A method of processing data from a test device is provided. The method comprises determining a concentration of a first analyte in a fluid sample using first sensing chemistry, wherein the first analyte is an acidosis-related analyte; determining a concentration of a second analyte in the fluid sample using second sensing chemistry, wherein the second analyte is glucose; displaying a first indication related to the determined concentration of the second analyte; if the determined concentration of the first analyte is equal to or greater than a first threshold, providing a user-selectable option to display a second indication related to the determined concentration of the first analyte.

Abstract: An electrochemical test device for use in determining a concentration of each of a first analyte and a second analyte in a fluid sample is provided. The electrochemical test device comprises a set of electrodes including a first working electrode having sensing chemistry for the first analyte and a second working electrode having sensing chemistry for the second analyte, wherein the first analyte is lactate and the sensing chemistry for the lactate comprises lactate oxidase and an electron transfer agent, and wherein the sensing chemistry for the second analyte comprises a diaphorase, an electron transfer agent, an NAD(P)+-dependent dehydrogenase and a cofactor for the NAD(P)+-dependent dehydrogenase.

Abstract: An electrochemical test device for determining a concentration of one or more analytes in a fluid sample is provided. The electrochemical test device comprises a set of electrodes including two or more working electrodes, each working electrode for determining the concentration of a corresponding analyte, and sensing chemistry for each working electrode, wherein the sensing chemistry for a first of the two or more working electrodes comprises a diaphorase, an electron transfer agent, an NAD(P)+-dependent dehydrogenase and a cofactor for the NAD(P)+-dependent dehydrogenase, wherein at least some of the diaphorase for the first working electrode is disposed in a diaphorase-containing layer which extends over the first working electrode and at least a second of the two or more working electrodes.

Abstract: A method for configuring a device to determine a concentration of an analyte uses a plurality of m fluid samples, each having a corresponding known analyte concentration. The method includes, for each sample: generating an output signal from the sample; recording values of the signal over time; and modelling a subset of the values of the signal using n basis functions to obtain n coefficients. Each coefficient is associated with a corresponding basis function, the n basis functions and n coefficients representing the signal for the subset. The method also includes performing a statistical analysis of the m×n coefficients and corresponding known analyte concentrations to determine a set of n parameters from which an analyte concentration can be estimated based on a set of n coefficients obtained for a sample for which the analyte concentration is unknown; and storing the set of n parameters in a memory of a device.

Abstract: There is described a method of detecting or determining volumetric sufficiency in an electrochemical test strip having at least first and second conductive elements. The method comprises depositing or applying a fluid sample on the test strip, the test strip being arranged so as to allow the applied sample to flow from one of the conductive elements into contact with the other of the conductive elements and thereby form an electrical connection or other electrical continuity therebetween. The method further comprises applying a potential difference across the first and second conductive elements. A voltage across a capacitive element connected to one of the first and second conductive elements is then measured. The invention is able to provide a reliable means of establishing a point in time at which electrical continuity between two or more conductive elements (for example electrodes) of an electrochemical test strip is deemed to have occurred.

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 (such as glucose) in a bodily fluid sample (e.g., a whole blood sample) includes an electrically-insulating substrate, at least one working electrode disposed on the electrically-insulating substrate and a graded enzymatic reagent layer disposed on the at least one working electrode. The graded enzymatic reagent layer includes an upper reaction grade that contains an enzyme. The graded enzymatic layer also has a lower spacer grade devoid of the enzyme, the lower spacer grade disposed between the upper reaction grade and the working electrode such that the upper reaction grade is spaced equidistant from the working electrode by the lower spacer grade by a predetermined distance during use of the electrochemical-based analytical test strip.

Abstract: This invention describes a method of reducing the effect of interfering compounds in a bodily fluid when measuring an analyte using an electrochemical sensor (62). In particular, the present method is applicable to electrochemical sensors where (62) the sensor includes a substrate (50), first and second working electrodes (10, 12), and a reference electrode (14) and either the first and second or only the second working electrode include regions which are bare of reagent (22). In this invention, an algorithm is described with mathematically corrects for the interference effect using the test strip embodiments of the present invention.

Abstract: A cap for use with a dermal tissue lancing device (that includes a housing and a lancet movable with respect to the housing) includes a proximal end for engaging with the housing, a distal end for engaging with dermal tissue and an opening for a portion of the lancet to pass through. The distal end of the cap includes portions for engaging dermal tissue. These portions are resiliently deformable such that, when the cap contacts and is urged towards dermal tissue, the portions deform resiliently, engaging the dermal tissue and approaching theretogether. A process for the collection of a fluid sample (e.g., blood) from dermal tissue includes providing a dermal tissue lancing device with a housing, a cap and a lancet that is moveable with respect to the housing and the cap. The cap includes a proximal end for engaging with the housing, a distal end for engaging with dermal tissue, and an opening for a portion of the lancet to pass through.

Abstract: The present invention is directed to an electrochemical sensor or electrochemical strip which includes a substrate, a first working electrode disposed on the substrate, a second working electrode disposed on the substrate, a reference electrode, an active reagent layer disposed on the first working electrode, wherein the active reagent layer completely covers the first working electrode and an inactive reagent layer disposed on the second working electrode, wherein the inactive reagent completely covers the second working electrode.

Abstract: This invention describes an electrochemical sensor which is adapted to reduce the effects of interfering compounds in bodily fluids when measuring an analyte in such fluids using an electrochemical strip. The sensor includes a substrate, a first and second working electrodes, and a reference electrode. A reagent layer is disposed on the electrodes such that, in one embodiment it completely covers all of the first working electrode, but only partially covers the second working electrode and, in a second embodiment, it only covers a portion of the first and the second working electrode. The portion of the working electrodes not covered by the reagent layer and is used to correct for the interference effect on the analyte measurement.

Abstract: This invention describes a method of reducing the effect of interfering compounds in a bodily fluid when measuring an analyte using an electrochemical sensor. In particular, the present method is applicable to electrochemical sensors where the sensor includes a substrate, first and second working electrodes, and a reference electrode and either the first and second or only the second working electrode include regions which are bare of reagent. In this invention, an algorithm is described with mathematically corrects for the interference effect using the test strip embodiments of the present invention.