Method for verifying fitness of an analysis element

Abstract

The present invention discloses a method for verifying fitness of an analysis element. The method comprises determining 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 . A method of verifying proper working of an analysis element, in particular a test strip used for analysis of blood glucose content, the method comprising: 
 providing a first analysis element having a test field capable of receiving a sample and a reference control means, wherein the test field has at least one measurable control parameter;    determining a first standard reference value at the reference means, wherein the reference control means provides a standard reference value for the control parameter;    determining a first control value from the control parameter of the test field of the first analysis element;    deriving a first reference quotient from the first control value and the first standard reference value;    providing a second analysis element having a test field capable of receiving a sample, wherein the test field has at least one measurable control parameter;    determining a second control value from the control parameter of the test field of the second analysis element;    deriving a control quotient from the second control value and the first standard reference value;    determining the deviation between the control quotient and the first reference quotient;    predetermining a tolerance range for the deviation; and    rejecting the second analysis element if the deviation is greater than the pre-determined tolerance range.    
     
     
         2 . The method according to  claim 1 , wherein the deviation is determined using a relative difference between the control quotient and the first reference quotient.  
     
     
         3 . The method according to  claim 1 , wherein the deviation is determined using a difference between the control quotient and the first reference quotient.  
     
     
         4 . The method according to  claim 1 , rejecting the second analysis element if the control quotient is smaller, by a given percentage, than the first reference quotient.  
     
     
         5 . The method according of  claim 1 , rejecting the second analysis element if the control quotient is smaller, by a given difference value, than the first reference quotient.  
     
     
         6 . The method according to  claim 1 , wherein the at least one measurable control parameter is an optical measurable value, in particular a remission value.  
     
     
         7 . The method according to  claim 1 , wherein the predetermination of the tolerance range is done for a particular batch of the analysis elements.  
     
     
         8 . The method according to  claim 1 , wherein deriving a new reference quotient from the second control value and the first standard reference value.  
     
     
         9 . The method according to  claim 1 , wherein the first analysis element and the second analysis element are packed in a container such substantially prevents long term deterioration of the first analysis element and the second analysis element.  
     
     
         10 . The method according to  claim 9 , wherein when the first analysis element and the second analysis element are packed in a container, the first analysis element is tested before the second analysis element.  
     
     
         11 . The Method according to  claim 1 , wherein the standardized reference value for the control parameter is high.  
     
     
         12 . The method according to  claim 1 , wherein a predetermined tolerance range for the deviation is given and a deviation between the control quotient and the first reference quotient is determined, by the second control value from the control parameter of the test field of the second analysis element, wherein the second control value is set to be an amended first control value for further checking of other analysis elements; 
 deriving an amended first reference quotient from the amended first control value and the first standard reference value;    providing a third analysis element having a test field capable of receiving a sample, wherein the test field has at least one measurable control parameter;    determining a third control value from the control parameter of the test field of the third analysis element;    deriving a control quotient from the third control value and the first standard reference value;    determining the deviation between the control quotient and the amended first reference quotient;    predetermining a tolerance range for the deviation; and    rejecting the third analysis element if the deviation is greater than the pre-determined tolerance range.    
     
     
         13 . The method according to  claim 12 , wherein an amended first reference quotient is formed in case that the deviation between the control quotient and the first reference quotient is determined to exceed a fixed tolerance value.  
     
     
         14 . The method according to  claim 13 , wherein a tolerance value is used which is specific for the batch of analysis elements checked.