Electrochemical test strip having a plurality of reaction chambers and methods for using the same

Abstract

Electrochemical test strips and methods for their use in the detection of an analyte in a physiological sample are provided. The subject test strips have a plurality of reaction zones defined by opposing metal electrodes separated by a thin spacer layer. The reagent compositions present in each reaction zone may be the same or different. In addition, each reaction zone may have a separate fluid ingress channel, or two or more of the reaction zones may have fluid ingress channels that merge into a single channel. The subject electrochemical test strips find application in the detection of a wide variety of analytes, and are particularly suited for use the detection of glucose.

What is claimed is:  
     
         1 . An electrochemical test strip comprising: 
 (a) a plurality of reaction zones defined by opposing working and reference electrodes separated by a spacer layer; and    (b) a reagent composition present in each of said reaction zones.    
     
     
         2 . The electrochemical test strip according to  claim 1 , wherein said test strip comprises from 2 to 25 reaction zones.  
     
     
         3 . The electrochemical test strip according to  claim 1 , wherein each of said reaction zones houses the same reagent composition.  
     
     
         4 . The electrochemical test strip according to  claim 1 , wherein at least two of said reaction zones house different reagent compositions.  
     
     
         5 . The electrochemical test strip according to  claim 1 , wherein each of said reaction zones has its own fluid ingress channel to provide for fluid communication between said reaction zone and the external environment of said test strip.  
     
     
         6 . The electrochemical test strip according to  claim 1 , wherein at least two of said reaction zones have fluid ingress channels that merge to produce a single ingress channel to provide for fluid communication between said reactions zones and the external environment of said test strip.  
     
     
         7 . The electrochemical test strip according to  claim 1 , wherein at least one of said reagent compositions is a redox reagent system.  
     
     
         8 . The electrochemical test strip according to  claim 1 , wherein said redox reagent system comprises at least one enzyme and a mediator.  
     
     
         9 . The electrochemical test strip according to  claim 8 , wherein said at least one enzyme includes an oxidizing enzyme.  
     
     
         10 . The electrochemical test strip according to  claim 9 , wherein said oxidizing enzyme in a glucose oxidizing enzyme.  
     
     
         11 . The electrochemical test strip according to  claim 1 , wherein at least one of said electrodes comprises a metal selected from the group consisting of: gold, palladium, silver, iridium, carbon, platinum, nichrome, doped indium tin oxide and stainless steel.  
     
     
         12 . The electrochemical test strip according to  claim 11 , wherein said electrode comprises gold or palladium.  
     
     
         13 . The electrochemical test strip according to  claim 1 , wherein each of said reaction zones has a volume ranging from about 0.1 to 10 μl.  
     
     
         14 . The electrochemical test strip according to  claim 1 , wherein said reference electrode is a gold electrode.  
     
     
         15 . The electrochemical test strip according to  claim 1 , wherein said working electrode is a palladium electrode.  
     
     
         16 . The electrochemical test strip according to  claim 1 , wherein said strip is present in a meter.  
     
     
         17 . A method of determining the concentration of an analyte in a physiological sample, said method comprising: 
 (a) applying said physiological sample to an electrochemical test strip comprising a plurality of reaction zones defined by opposing working and reference electrodes separated by a spacer layer and a reagent composition present in each of said reaction zones;    (b) detecting an electrical signal in said reaction zone using said metallic electrodes; and    (c) relating said detected electrical signal to the amount of said analyte in said sample.    
     
     
         18 . The method according to  claim 17 , wherein said analyte is glucose.  
     
     
         19 . The method according to  claim 18 , wherein said redox reagent system comprises a glucose oxidizing enzyme.  
     
     
         20 . The method according to  claim 17 , wherein said method comprises employing a meter.  
     
     
         20 . A kit for use in determining the concentration of an analyte in a physiological sample, said kit comprising: 
 (a) an electrochemical test strip comprising a plurality of reaction zones defined by opposing working and reference electrodes separated by a spacer layer and a reagent composition present in each of said reaction zones; and    (b) at least one of: 
 (i) a means for obtaining said physiological sample; and  
 (ii) an analyte standard.  
   
     
     
         21 . The kit according to  claim 20 , wherein said means for obtaining said physiological sample is a lance.  
     
     
         22 . The kit according to  claim 20 , wherein said kit further comprises a meter.  
     
     
         23 . A system for use in determining the concentration of an analyte in a physiological sample, said system comprising: 
 (a) an electrochemical test strip comprising a plurality of reaction zones defined by opposing working and reference electrodes separated by a spacer layer and a reagent composition present in each of said reaction zones; and    (b) a meter.    
     
     
         24 . The system according to  claim 23 , wherein said system further comprises a means for obtaining said physiological sample.  
     
     
         25 . The system according to  claim 23 , wherein said system further comprises an analyte standard.