Test element for determining a body fluid and measurement method

Abstract

A test element for determining a body fluid is provided. The test element, in particular for determining the blood glucose level, includes a detection region which is charged with a reagent sensitive to the body fluid. A function element is arranged in or adjacent to the detection region for detecting at least one status parameter for the detection region, such that the functional element can be evaluated by means of a status measurement. A method for measuring the test element is also disclosed.

1 - 19 . (canceled) 
     
     
         20 . A test element for evaluating a body fluid or component thereof, the test element comprising a detection zone which includes a multi-layer structure and which is charged with a reagent sensitive to the body fluid or component thereof by means of a detection reaction configured for determination of a measurement value for the body fluid or component thereof, the test element further including a function element arranged at one or both of the detection zone and adjacent to the detection zone, the function element being configured for conducting a status measurement for evaluating and registering a status parameter for the detection zone. 
     
     
         21 . The test element according to  claim 20 , wherein the function element is sensitive to the status parameter. 
     
     
         22 . The test element according to  claim 20 , wherein the function element is further configured for conducting an additional status measurement for evaluating and registering a test element parameter for the condition of the test element. 
     
     
         23 . The test element according to  claim 22 , wherein the function element is sensitive to the test element parameter. 
     
     
         24 . The test element according to  claim 22 , wherein the test element is configured to provide a corrected measurement value from the measurement value in consideration of the status measurement and the additional status measurement. 
     
     
         25 . The test element according to  claim 22 , wherein the test element parameter relates to an indication of functional integrity of the test element. 
     
     
         26 . The test element according to  claim 20 , wherein the test element is configured to provide a corrected measurement value from the measurement value in consideration of the status measurement. 
     
     
         27 . The test element according to  claim 20 , wherein the function element is arranged in one or several layers of the multi-layer structure. 
     
     
         28 . The test element according to  claim 20 , wherein the function element is inert with respect to the detection reaction. 
     
     
         29 . The test element according to  claim 20 , wherein the status parameter comprises a reaction parameter of the detection reaction. 
     
     
         30 . The test element according to  claim 20 , wherein the function element is configured to be evaluated by means of an optical status measurement. 
     
     
         31 . The test element according to  claim 30 , wherein the optical status measurement comprises a time-resolved optical status measurement. 
     
     
         32 . The test element according to  claim 30 , wherein the optical status measurement comprises an intensity-dependent optical status measurement. 
     
     
         33 . The test element according to  claim 20 , wherein the function element is mixed at least partly with the reagent. 
     
     
         34 . The test element according to  claim 20 , wherein the function element is arranged in several zones which are separated spatially from each other. 
     
     
         35 . The test element according to  claim 20 , further comprising a further function element arranged in one or both of the detection zone and adjacent thereto, the further function element being configured for conducting a further status measurement for evaluating and registering a further status parameter for the detection zone. 
     
     
         36 . The test element according to  claim 35 , wherein the test element is configured to provide a corrected measurement value from the measurement value in consideration of the status parameter and the further status parameter. 
     
     
         37 . The test element according to  claim 35 , wherein the function element and the further function element are embedded in one or several layers of the multi-layer structure. 
     
     
         38 . The test element according to  claim 20 , wherein the detection zone determines blood sugar in the body fluid when the body fluid is placed in the detection zone. 
     
     
         39 . A measurement method for a test element that is configured for evaluating a body fluid or component thereof, the test element comprising a detection zone including a multi-layer structure and charged with a reagent sensitive to the body fluid or component thereof by means of a detection reaction with the body fluid or component thereof, the method comprising:
 conducting a status measurement comprising evaluating measurement signals from a function element arranged at one or both of the detection zone and adjacent thereto;   registering a status parameter for the detection zone indicated by the status measurement; and   determining a measurement value for the body fluid or component thereof from the detection reaction.   
     
     
         40 . The method according to  claim 39 , wherein the status parameter comprises a reaction parameter for the detection reaction. 
     
     
         41 . The method according to  claim 39 , further comprising the steps of conducting a further status measurement comprising evaluating measurement signals from the function element and registering a test element parameter for the condition of the test element indicated by the additional status measurement. 
     
     
         42 . The method according to  claim 41 , wherein the test element parameter relate to an indication of the functional integrity for the test element. 
     
     
         43 . The method according to  claim 41 , further comprising providing a corrected measurement value from the measurement value in consideration of the registered status measurement and the registered additional status measurement. 
     
     
         44 . The method according to  claim 39 , wherein determining the measurement value for the body fluid includes comparing the measurement value with comparative values. 
     
     
         45 . The method according to  claim 39 , further comprising altering reaction parameters influencing the detection reaction on the basis of the status parameter indicated by the status measurement. 
     
     
         46 . The method according to  claim 39 , wherein conducting the status measurement includes carrying out an optical measurement comprising measuring optical measurement signals. 
     
     
         47 . The method according to  claim 39 , wherein the test element is configured for determining blood glucose in the body fluid. 
     
     
         48 . The method according to  claim 39 , further comprising providing a corrected measurement value from the measurement value in consideration of the registered status measurement.