Abstract: An electrochemical cell for detection and quantification of analytes in a liquid sample, particularly a liquid sample having a small volume. In a preferred embodiment, the electrochemical cell comprises an assembly of conducting layers and insulating layers. The electrochemical cell can be formed by depositing conducting materials and insulating materials in alternating layers on an insulating substrate. It is preferred that the layer furthest from the insulating substrate be an insulating layer to minimize the damage of the conducting layers during handling of the electrochemical cell. In another embodiment, the assembly of conducting layers and insulating layers can be formed on both major surfaces of the insulating substrate. The assembly can comprise at least one working electrode and at least one other electrode, e.g., a dual-purpose reference/counter electrode.

Abstract: A test strip including a reagent end for receiving a body fluid sample and an insertion end which is received at a test strip receptacle slot of a measuring device, the insertion end including one or more on-strip indicators for indicating to a measuring device that the test strip has been inserted into the device so that the device will power-up in preparation to perform a test, and the one or more on-strip indicators having a distinct pattern indicating whether calibration is automatic or whether the user needs to input calibration information to the said device, and corresponding methods are disclosed.

Abstract: A biosensor in which at least one reagent constitutes a portion of a working electrode, a conductive track leading from a working electrode to an electrical contact associated with a working electrode, or an electrical contact associated with a working electrode. For example, the biosensor can have a mediator or an enzyme or both incorporated into the working electrode, into the conductive track leading from the working electrode to an electrical contact associated with the working electrode, and/or into the electrical contact associated with the working electrode. Other reagents can be dispensed on the electrode itself either directly or by impregnating a matrix, such as a mesh or a membrane, with the enzyme, and then placing the impregnated mesh or membrane over the electrode.

Abstract: An electrochemical cell for detection and quantification of analytes in a liquid sample, particularly a liquid sample having a small volume. In a preferred embodiment, the electrochemical cell comprises an assembly of conducting layers and insulating layers. The electrochemical cell can be formed by depositing conducting materials and insulating materials in alternating layers on an insulating substrate. It is preferred that the layer furthest from the insulating substrate be an insulating layer to minimize the damage of the conducting layers during handling of the electrochemical cell. In another embodiment, the assembly of conducting layers and insulating layers can be formed on both major surfaces of the insulating substrate. The assembly can comprise at least one working electrode and at least one other electrode, e.g., a dual-purpose reference/counter electrode.

Abstract: A device having a flow channel, wherein a layer of mesh is adhered to a surface forming a wall of a flow channel, but the layer of mesh is of such dimensions that the layer of mesh does not contact those portions of the device where electrochemical reactions occur and electrons flow. In one aspect, the invention provides a sensor, such as, for example, a biosensor, in the form of a strip, the sensor being suitable for electrochemical or optical measurement. The sensor comprises a base layer and a cover layer having a layer of mesh adhered thereto, and the base layer is separated from the cover layer by a spacer layer. The base layer, the cover layer having a layer of mesh adhered thereto, and the spacer layer define a flow channel into which a liquid sample is drawn therein and flows therethrough by means of wicking.

Abstract: A sensor, and methods of making, for determining the concentration of an analyte, such as glucose or lactate, in a biological fluid such as blood or serum, using techniques such as coulometry, amperometry, and potentiometry. The sensor includes a working electrode and a counter electrode, and can include an insertion monitoring trace to determine correct positioning of the sensor in a connector.

Abstract: A device having a flow channel, wherein at least one flow-terminating interface is used to control the flow of liquid in the flow channel. The flow-terminating interface prevents the flow of the liquid beyond the interface. In one aspect, the invention provides a sensor, such as, for example, a biosensor, in the form of a strip, the sensor being suitable for electrochemical or optical measurement. The sensor comprises a base layer and a cover layer, and the base layer is separated from the cover layer by a spacer layer. The base layer, cover layer, and spacer layer define a flow channel into which a liquid sample is drawn therein and flows therethrough by means of capillary attraction. The flow of the sample is terminated by a flow-terminating interface positioned in the flow channel.

Abstract: A biosensor in the form of a strip. In one embodiment, the biosensor strip comprises an electrode support, a first electrode, i.e., a working electrode, a second electrode, i.e., a counter electrode, and a third electrode, i.e., a reference electrode. Each of the electrodes is disposed on and supported by the electrode support. Each of the electrodes is spaced apart from the other two electrodes. The biosensor strip can include a covering layer, which defines an enclosed space over the electrodes. This enclosed space includes a zone where an analyte in the sample reacts with reagent(s) deposited at the working electrode. This zone is referred to as the reaction zone. The covering layer has an aperture for receiving a sample for introduction into the reaction zone. The biosensor strip can also include at least one layer of mesh interposed in the enclosed space between the covering layer and the electrodes in the reaction zone.

Abstract: Sensors that are capable measuring the rate of flow of a fluid that passes over the electrodes of the sensor. In these sensors, an electrode, designated the flow rate-determining electrode, is used in conjunction with the conventional electrodes, e.g., the working electrode, the reference electrode, and the counter electrode, to determine the rate of flow of the fluid. In one aspect, this invention provides a sensor for measuring the concentration of an analyte in a sample of fluid when the sample flows continuously over the electrodes of the sensor, especially when the rate of flow of the sample is relatively low. In another aspect, this invention provides a method for measuring the concentration of an analyte in a sample of fluid, wherein the rate of flow of the sample varies during the period of time that the sensor is in place. In a preferred embodiment, the sensor employs four electrodes, namely, a working electrode, a reference electrode, a counter electrode, and a flow rate-determining electrode.

Abstract: An analyte test instrument that has a test strip circuitry that can be configured using information provided by a calibration strip to perform assays with test strips having two electrodes and test strips having three electrodes.

Abstract: A biosensor that utilizes a mediator, i.e., an isomer of phenanthroline quinone, 1,10-phenanthroline-5,6-dione, and a metal ion, such as manganese, with an enzyme dependent upon NAD(P)+, such as, for example, glucose dehydrogenase, for improving the hematocrit bias and oxygen bias of biosensors. The electrodes of the biosensors employing this mediator and a metal ion provide an accurate clinical response over a hematocrit range that ranges from about 20% to about 70% and over an oxygen tension range that ranges from about 1 kPa to about 20 kPa.

Abstract: A device having a flow channel, wherein at least one flow-terminating interface is used to control the flow of liquid in the flow channel. The flow-terminating interface prevents the flow of the liquid beyond the interface. In one aspect, the invention provides a sensor, such as, for example, a biosensor, in the form of a strip, the sensor being suitable for electrochemical or optical measurement. The sensor comprises a base layer and a cover layer, and the base layer is separated from the cover layer by a spacer layer. The base layer, cover layer, and spacer layer define a flow channel into which a liquid sample is drawn therein and flows therethrough by means of capillary attraction. The flow of the sample is terminated by a flow-terminating interface positioned in the flow channel.

Abstract: Sensors that are capable measuring the rate of flow of a fluid that passes over the electrodes of the sensor. In these sensors, an electrode, designated the flow rate-determining electrode, is used in conjunction with the conventional electrodes, e.g., the working electrode, the reference electrode, and the counter electrode, to determine the rate of flow of the fluid. In one aspect, this invention provides a sensor for measuring the concentration of an analyte in a sample of fluid when the sample flows continuously over the electrodes of the sensor, especially when the rate of flow of the sample is relatively low. In another aspect, this invention provides a method for measuring the concentration of an analyte in a sample of fluid, wherein the rate of flow of the sample varies during the period of time that the sensor is in place. In a preferred embodiment, the sensor employs four electrodes, namely, a working electrode, a reference electrode, a counter electrode, and a flow rate-determining electrode.