Analyte Sensor with Insertion Monitor, and Methods

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.

1 .- 19 . (canceled) 
   
   
       20 . An analyte test strip comprising:
 a generally planar substrate;   a plurality of conductive areas disposed on the substrate to define five distinct conductive portions comprising at least five contact lands, and in which two contact lands are located in a single conductive portion.   
   
   
       21 . The test strip of  claim 20 , further comprising an insulation layer, reagent layer and adhesive layer. 
   
   
       22 . The test strip of  claim 20 , in which the at least five contact lands comprise six contact lands. 
   
   
       23 . The test strip of  claim 20 , in which the generally planar substrate extends along a longitudinal axis to define a generally rectangular member. 
   
   
       24 . The test strip of  claim 23 , further comprising first and second working electrodes and reference electrode in electrical communication with respective conductive portions. 
   
   
       25 . The test strip of  claim 23 , further comprising a reagent layer proximate the first and second working electrodes, the reagent layer including an enzyme, ruthenium mediator and a buffer. 
   
   
       26 . The test strip of  claim 25 , in which the enzyme comprises an enzyme selected from a group consisting essentially of glucose oxidase, glucose dehydrogenase, or combinations thereof. 
   
   
       27 . An analyte measurement system comprising:
 a housing including a connector module disposed in the housing, the connector module including a plurality of spaced apart contact leads disposed in the connector module; and   a test strip comprising a generally planar substrate, the test strip including a plurality of conductive areas disposed on the substrate to define five distinct conductive portions comprising at least five contact lands, and in which two contact lands are located in a single conductive portions so that the plurality of spaced apart contact leads engages respective contact lands when the substrate is inserted into the connector module.   
   
   
       28 . The system of  claim 27 , in which the generally planar substrate extends along a longitudinal axis to define a generally rectangular member. 
   
   
       29 . The system of  claim 28 , further comprising first and second working electrodes and reference electrode in electrical communication with respective conductive portions. 
   
   
       30 . The system of  claim 27 , in which the connector module comprises first and second members with the plurality of contact leads located proximate the first and second members. 
   
   
       31 . A method of operating a test measurement device, the method comprising:
 providing a measurement device having six contact leads;   designating two contact leads as strip detection contact leads; and   locating four contact lands as respective vertices of a polygon on a substrate with two contact lands that are in substantial alignment with the strip detection contact leads when the substrate is inserted into the measurement device.   
   
   
       32 . The method of  claim 31 , further comprising turning on the measurement device via a connection between the strip detection contact leads and the contact lands. 
   
   
       33 . The method of  claim 31 , in which the locating comprises forming an electrical connection between the two contact lands.