Analyte test intrument having improved versatility

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. The analyte test instrument of this invention comprises: (a) a test port for receiving a test strip; (b) a microprocessor for executing instructions downloaded into the analyte test instrument; (c) a test strip circuit capable of having a plurality of configurations, the configurations being set by the microprocessor, whereby an assay can be performed using the test strip.

What is claimed is:  
     
         1 . An analyte test instrument suitable for performing an assay with a test strip, said analyte test instrument comprising: 
 (a) a test port for receiving a test strip;    (b) a microprocessor for executing instructions downloaded into said instrument; and    (c) a test strip circuit capable of having a plurality of configurations, said configurations being set by said microprocessor, whereby an assay can be performed using said test strip.    
     
     
         2 . The analyte test instrument of  claim 1 , further including a memory for storing instructions and information.  
     
     
         3 . The analyte test instrument of  claim 2 , wherein said instructions are selected from the group consisting of measurement delay time(s), sample incubation time(s), number of measurements to be taken during an assay, threshold(s) against which voltage level(s) can be compared, value(s) of excitation voltage level(s) applied to a test strip during an assay, analyte value conversion factors, failsafe assay threshold value(s), and configurations of said test strip circuit of said analyte test instrument.  
     
     
         4 . The analyte test instrument of  claim 2 , wherein said test port is capable of receiving a calibration strip, said calibration strip being removable from said test port to allow a test strip to be inserted into said test port.  
     
     
         5 . The analyte test instrument of  claim 1 , wherein at least one of said plurality of configurations can be used to perform an assay with a test strip having two electrodes.  
     
     
         6 . The analyte test instrument of  claim 1 , wherein at least one of said plurality of configurations can be used to perform an assay with a test strip having three electrodes.  
     
     
         7 . The analyte test instrument of  claim 1 , further comprising a push button.  
     
     
         8 . The analyte test instrument of  claim 1 , further comprising a display.  
     
     
         9 . The analyte test instrument of  claim 1 , wherein said test port comprises two sets of electrical contacts, whereby a first set of electrical contacts engages a first major surface of a test strip and a second set of electrical contacts engages a second major surface of said test strip.  
     
     
         10 . The analyte test instrument of  claim 1 , wherein said test strip is capable of performing an assay for determining concentration of an analyte in a biological sample, said analyte selected from the group consisting of glucose, lactate, and ketone bodies.  
     
     
         11 . A method for determining the concentration of at least one analyte in a biological sample, said method comprising the steps of: 
 (a) providing said analyte test instrument of  claim 1;     (b) inserting a test strip into said test port of said analyte test instrument;    (c) applying a biological sample to said test strip;    (d) allowing said analyte test instrument to set said configuration of said test strip circuit to a mode suitable for performing said determination; and    (e) measuring an electrical response provided by said test strip by means of said test strip circuit.    
     
     
         12 . The method of  claim 11 , wherein said configurations include a first configuration, said first configuration for use with a test strip having two electrodes, and a second configuration, said second configuration for use with a test strip having three electrodes.  
     
     
         13 . The method of  claim 11 , further including the step of allowing said analyte test instrument to identify said test strip when said test strip is inserted into said test port.  
     
     
         14 . The method of  claim 13 , wherein said identification step is performed by having electrical contacts located in said test port interact or fail to interact with electrically conductive material applied to at least one major surface of said test strip.  
     
     
         15 . The method of  claim 13 , wherein said identification step indicates the analyte to be determined with said test strip.  
     
     
         16 . The method of  claim 11 , wherein said microprocessor converts said electrical response provided by said test strip into a value that represents the concentration of said analyte.  
     
     
         17 . The method of  claim 16 , further including the step of reporting said concentration of said analyte to a user of said analyte test instrument.  
     
     
         18 . The method of  claim 11 , further including the step of calibrating said analyte test instrument for each of a plurality of assays that can be performed with said analyte test instrument.  
     
     
         19 . The method of  claim 18 , wherein said calibration step is performed with a calibration strip that has been inserted into said test port.  
     
     
         20 . The method of  claim 19 , further including the step of providing instructions during said calibration step for effecting the switching of said configuration of said test strip circuit from a first configuration, said first configuration for use with a test strip having two electrodes, and a second configuration, said second configuration for use with a test strip having three electrodes.  
     
     
         21 . The method of  claim 20 , wherein said instruction providing step is performed with a calibration strip inserted into said test port.  
     
     
         22 . The method of  claim 11 , further including the step of calibrating said analyte test instrument for each of a plurality of assays, said calibration step involving (a) insertion of a calibration strip into a port in said analyte test instrument, said calibration strip containing instructions for switching the test strip circuit configuration from a first mode to a second mode during said determination, said instructions capable of being downloaded into said analyte test instrument, and (b) removal of said calibration strip from said test port.  
     
     
         23 . The method of  claim 11 , wherein said analyte is selected from the group consisting of glucose, lactate, and ketone bodies.  
     
     
         24 . An analyte test instrument suitable for performing an assay with a test strip, said analyte test instrument comprising: 
 (a) a test port for receiving a test strip;    (b) a microprocessor for executing instructions downloaded into said instrument; and    (c) a test strip circuit capable of having a plurality of configurations, said configurations being set by said microprocessor, wherein at least one of said instruction enables said microprocessor to switch configuration of said test strip circuit during an assay.    
     
     
         25 . The analyte test instrument of  claim 24 , further including a memory for storing instructions and information.  
     
     
         26 . The analyte test instrument of  claim 25 , wherein said instructions are selected from the group consisting of measurement delay time(s), sample incubation time(s), number of measurements to be taken during an assay, threshold(s) against which voltage level(s) can be compared, value(s) of excitation voltage level(s) applied to a test strip during an assay, analyte value conversion factors, failsafe assay threshold value(s), and configurations of said test strip circuit of said analyte test instrument.  
     
     
         27 . The analyte test instrument of  claim 25 , wherein said test port is capable of receiving a calibration strip, said calibration strip being removable from said test port to allow a test strip is inserted into said test port.  
     
     
         28 . The analyte test instrument of  claim 24 , wherein at least one of said plurality of configurations can be used to perform an assay with a test strip having two electrodes.  
     
     
         29 . The analyte test instrument of  claim 24 , wherein at least one of said plurality of configurations can be used to perform an assay with a test strip having three electrodes.  
     
     
         30 . The analyte test instrument of  claim 24 , further comprising a push button.  
     
     
         31 . The analyte test instrument of  claim 24 , further comprising a display.  
     
     
         32 . The analyte test instrument of  claim 24 , wherein said test port comprises two sets of electrical contacts, whereby a first set of electrical contacts engages a first major surface of a test strip and a second set of electrical contacts engages a second major surface of said test strip.  
     
     
         33 . The analyte test instrument of  claim 24 , wherein said test strip is capable of performing an assay for determining concentration of an analyte in a biological sample, said analyte selected from the group consisting of glucose, lactate, and ketone bodies.  
     
     
         34 . A method for determining the concentration of at least one analyte in a biological sample, said method comprising the steps of: 
 (a) providing the analyte test instrument of  claim 24;     (b) inserting a test strip into said test port of said analyte test instrument;    (c) applying a biological sample to said test strip;    (d) allowing said analyte test instrument to set said configuration of said test strip circuit to a mode suitable for performing said determination; and    (e) measuring an electrical response provided by said test strip by means of said test strip circuit.    
     
     
         35 . The method of  claim 34 , wherein said configurations include a first configuration, said first configuration for use with a test strip having two electrodes, and a second configuration, said second configuration for use with a test strip having three electrodes.  
     
     
         36 . The method of  claim 34 , further including the step of allowing said analyte test instrument to identify said test strip when said test strip is inserted into said test port.  
     
     
         37 . The method of  claim 36 , wherein said identification step is performed by having electrical contacts located in said test port interact or fail to interact with electrically conductive material applied to at least one major surface or said test strip.  
     
     
         38 . The method of  claim 36 , wherein said identification step indicates the analyte to be determined with said test strip.  
     
     
         39 . The method of  claim 34 , wherein said microprocessor converts said electrical response provided by said test strip into a value that represents the concentration of said analyte.  
     
     
         40 . The method of  claim 39 , further including the step of reporting said concentration of said analyte to a user of said analyte test instrument.  
     
     
         41 . The method of  claim 34 , further including the step of calibrating said analyte test instrument for each of a plurality of assays that can be performed with said analyte test instrument.  
     
     
         42 . The method of  claim 41 , wherein said calibration step is performed with a calibration strip that has been inserted into said test port.  
     
     
         43 . The method of  claim 42 , further including the step of providing instructions during said calibration step for effecting the switching of said configuration of said test strip circuit from a first configuration, said first configuration for use with a test strip having two electrodes, and a second configuration, said second configuration for use with a test strip having three electrodes.  
     
     
         44 . The method of  claim 43 , wherein said instruction providing step is performed with a calibration strip inserted into said test port.  
     
     
         45 . The method of  claim 34 , further including the step of calibrating said analyte test instrument for each of a plurality of assays, said calibration step involving (a) insertion of a calibration strip into a port in said analyte test instrument, said calibration strip containing instructions for switching the test strip circuit configuration from a first mode to a second mode during said determination, said instructions capable of being downloaded into said analyte test instrument, and (b) removal of said calibration strip from said test port.  
     
     
         46 . The method of  claim 34 , wherein said analyte is selected from the group consisting of glucose, lactate, and ketone bodies.