Method for checking the fitness for purpose of analysis elements

Abstract

For a simple and reliable check of the fitness for purpose of analysis elements, it is proposed to check the deviation of the quotient of a control value and a first standard reference value as compared to a first reference quotient, formed by a control reference value and the first standard reference value, and to reject a checked analysis element, if the deviation is not within a given tolerance range.

1 . Method for checking the fitness for purpose of analysis elements, in which method it is checked, whether a control value measured for at least one control parameter of a checked analysis element is within a tolerance range, 
 wherein 
 a) in a first step, a first standard reference value is determined in a reference value measurement at a reference control means which provides a standardized reference value for the control parameter,  
 b) in a second step, the control parameter of a first analysis element is determined as control reference value,  
 c) in a third step, the quotient from the control reference value and the first standard reference value is calculated and set as first reference quotient for analysis elements measured later,  
 d) in a fourth step, the control parameter of a second analysis element is determined as control value for the second analysis element to be checked,  
 e) in a fifth step, the quotient from the control value and the first standard reference value is calculated as the control quotient,  
 f) in a sixth step, the deviation between the control quotient and the first reference quotient is determined and  
 g) the checked second analysis element is rejected if the deviation is not within a given tolerance range.  
   
     
     
         2 . Method according to  claim 1 , wherein the deviation is determined using a relative difference between the control quotient and the first reference quotient in step g).  
     
     
         3 . Method according to  claim 1 , wherein the deviation is determined using a difference between the control quotient and the first reference quotient in step g).  
     
     
         4 . Method according to  claim 1 , wherein the checked, second analysis element is rejected in step g), if the control quotient is smaller, by a given percentage, than the first reference quotient.  
     
     
         5 . Method according to  claim 1 , wherein the checked, second analysis element is rejected in step g), if the control quotient is smaller, by a given difference value, than the first reference quotient.  
     
     
         6 . Method according to  claim 1 , wherein a tolerance range is used in step g) which is batch-specific for the current batch of analysis elements.  
     
     
         7 . Method according to  claim 1  wherein the first analysis element and the second analysis element, the one to be checked, are comprised in a package or in a storage container, which contains further similar analysis elements, showing a long-time packaging common to all analysis elements.  
     
     
         8 . Method according to  claim 7 , wherein the analysis elements in the package or in the storage container are individually protected by an individual packaging element.  
     
     
         9 . Method according to  claim 7 , wherein the analysis element which is the first one to be removed from a package or from a storage container contained in the package, is chosen in step b).  
     
     
         10 . Method according to  claim 7 , wherein steps a) to c) are performed when a new package is used, when the first analysis element of a package or a storage container is used or when a long-time packaging is opened.  
     
     
         11 . Method according to  claim 1 , wherein the steps a) to c) are repeated, if a change which potentially influences the measured value, was performed on the evaluation device which performs the control measurement or the analytical measurement, respectively.  
     
     
         12 . Method according to  claim 1 , wherein in case of the determination of a given deviation in step g), the control value determined in step d) is used as new control reference value according to step b), calculating a new reference quotient from this according to step c), and that this new reference quotient is used as basis for checking further analysis elements according to steps d) to g).  
     
     
         13 . Method according to  claim 12 , wherein a new reference quotient is formed, if a control quotient determined in step e) exceeds the current reference quotient by more than a fixed limit value.  
     
     
         14 . Method according to  claim 13 , wherein a tolerance value is used, which is batch-specific for the current batch of analysis elements.  
     
     
         15 . Method according to  claim 1 , wherein one or various method steps are performed automatically.  
     
     
         16 . Method according to  claim 1 , wherein a reference control means is used, providing a high measured value for the control parameter in step a).  
     
     
         17 . Method according to  claim 1 , wherein such analysis elements are used which comprise a control means for the measurement of the control reference value or control value, as well as the reference control means for the reference value measurement of step a).  
     
     
         18 . Method according to  claim 1 , wherein the analysis element is a test element for a substrate-based rapid test for the qualitative or quantitative analysis of components of a solid or liquid sample, in particular of body liquids of human beings or animals, in particular for the determination of the blood glucose content.  
     
     
         19 . Method according to  claim 1 , wherein the control parameter is an optical measured value, in particular a remission value.  
     
     
         20 . Evaluation device for measuring an analytic measured value with an analysis element, wherein the evaluation device comprises means to perform a method according to  claim 1.