Electrochemical detection of ischemia

Abstract

The subject invention comprises electrochemical methods and devices for in vitro detection of an ischemic event in a patient sample. Following addition of a known amount of a transition metal ion to the patient sample, electrodes are used to measure the current or potential difference of non-sequestered transition metal ion in the sample. The amount of non-sequestered transition metal ion in the sample reflects the degree of modification to albumin that is the result of an ischemic event.

1 . A device for in vitro electrochemical detection or measurement of albumin derivatives which can be diagnostic for an ischemic event, said device comprising: 
 an electronics module housing comprising a display means, a data entry and control means, an aperture, internal contacts in said aperture in electrical continuity with the display means, a power source and optionally a link to a laboratory information system; and    a sample analysis strip comprising a sample well, and a plurality of electrodes, each said electrode positioned in said sample well and connected via a corresponding trace to a corresponding contact on said strip;    wherein insertion of said strip into said module housing engages each said strip contact with said corresponding contact in the module aperture, which permits electrical continuity with said display means, whereby said albumin derivatives may be detected or measured.    
   
   
       2 . The device of  claim 1  wherein said link to a laboratory information system is selected from the group consisting of a direct electrical connection, an infrared link and/or a wireless link.  
   
   
       3 . A device for in vitro electrochemical detection or measurement of albumin derivatives in a sample which may be diagnostic for an ischemic event, said method comprising: 
 a housing having an aperture formed therein for receiving a sample analysis strip, the sample analysis strip having a sample well, a plurality of electrodes positioned in the sample well and a like plurality of first contacts interconnected to the electrodes;    control means within said housing; and    a plurality of second contacts in said aperture electrically coupled with said control means for interconnecting with the plurality of first contacts when the sample analysis strip is inserted within the aperture;    wherein, upon insertion of the sample analysis strip into said aperture, each first contact engages a corresponding second contact whereby the albumin derivatives can be detected or measured by said control means.    
   
   
       4 . The device of  claim 3 , further comprising a link to a laboratory information system.  
   
   
       5 . The device of  claim 4  wherein said link to a laboratory information system is selected from the group consisting of a direct electrical connection, an infrared link and a wireless link.  
   
   
       6 . The device of  claim 3 , further comprising display means within said housing and electrically coupled with said control means, said display means operable to display information indicative of detected albumin derivatives.  
   
   
       7 . The device of  claim 3 , further comprising data entry means electrically coupled to said control means.  
   
   
       8 . The device of  claim 3 , said control means comprising: 
 means for measuring a characteristic electrochemical output signal associated with the sample in the sample analysis strip; and    means for determining whether the electrochemical output signal exceeds a predetermined value, whereby an ischemic event is indicated.    
   
   
       9 . The device of  claim 8 , wherein the electrochemical output signal is a current associated with non-sequestered metal ion in the sample comprising albumin and/or derivatives thereof to which has been added a known amount of a transition metal ion.  
   
   
       10 . The device of  claim 8 , wherein: 
 one of the electrodes comprises an ion selective electrode comprising a barrier that is selectively permeable to a transition metal ion;    the electrochemical output signal is a voltage associated with an ion activity difference across the barrier in the sample comprising albumin and/or derivatives thereof to which has been added a known amount of a transition metal ion.