Diagnostic test reader with disabling unit

Abstract

A diagnostic test reader including a test unit and a disabling unit. The test unit is configured to perform one or more tests. Each of the one or more tests employs a diagnostic assay to analyze whether an analyte is present within a sample. The disabling unit is coupled with the test unit and is configured to disable the test unit based on a selected threshold number of tests.

1 . A diagnostic test reader comprising: 
 a test unit configured to perform one or more tests, wherein each of the one or more tests employs a diagnostic assay to analyze whether an analyte is present within a sample; and    a disabling unit coupled with the test unit, the disabling unit configured to disable the test unit based on a selected threshold number of tests.    
     
     
         2 . The diagnostic test reader of  claim 1 , wherein the disabling unit includes: 
 a counter configured to determine an actual number of tests that have been performed by the test unit,    a memory configured to store the threshold number, and    a processor configured to compare the actual number of tests to the selected threshold number.    
     
     
         3 . The diagnostic test reader of  claim 2 , further comprising a trigger coupled to the counter and configured to be activated after a test has been performed by the test unit, wherein the counter increments the actual number each time the trigger is activated.  
     
     
         4 . The diagnostic test reader of  claim 2 , wherein the selected threshold number is commensurate with a predetermined sensitivity level range.  
     
     
         5 . The diagnostic test reader of  claim 2 , wherein the selected threshold number is based on a probable sensitivity of the diagnostic reader.  
     
     
         6 . The diagnostic test reader of  claim 1 , further comprising: 
 a trigger configured to be activated after a test has been performed by the test unit, wherein the activated trigger is configured to instruct the disabling unit to disable the test unit.    
     
     
         7 . The diagnostic test reader of  claim 6 , wherein the trigger is mechanically activated.  
     
     
         8 . The diagnostic test reader of  claim 6 , wherein the trigger is electrically activated.  
     
     
         9 . The diagnostic test reader of  claim 6 , wherein the trigger includes a timer that begins when the test begins, and wherein the trigger is activated when the timer reaches a predetermined time.  
     
     
         10 . The diagnostic test reader of  claim 1 , wherein the test unit includes: 
 an assay interface configured to receive the diagnostic assay,    a memory configured to store a program for analyzing the diagnostic assay, and    a test processor configured to execute the program and analyze the assay.    
     
     
         11 . The diagnostic test reader of  claim 10 , wherein the disabling unit is coupled to the memory and is configured to disable the test unit by deleting at least a portion of the program from the memory.  
     
     
         12 . The diagnostic test reader of  claim 1 , wherein the disabling unit is configured to electrically disable the test unit.  
     
     
         13 . The diagnostic test reader of  claim 1 , wherein the analyte is human chorionic gonadotropin and the diagnostic assay is a lateral flow assay.  
     
     
         14 . The diagnostic test reader of  claim 1 , wherein the analyte indicates drug use by a patient who provided the sample being tested.  
     
     
         15 . A diagnostic test system comprising: 
 a diagnostic test reader including: 
 a test unit configured to perform one or more tests, wherein each of the one or more tests employs a diagnostic assay to analyze whether an analyte is present within a sample, and  
 a disabling unit coupled with the test unit, the disabling unit configured to disable the test unit based on a selected threshold number of tests; and  
   a number of diagnostic assays equal to the threshold number, wherein the diagnostic test reader and the plurality of diagnostic assays are packaged together.    
     
     
         16 . A diagnostic test reader comprising: 
 means for performing one or more tests, wherein each of the one or more tests uses a diagnostic assay to analyze whether an analyte is present within a sample received from a patient; and    means for disabling the diagnostic test reader when a threshold number of tests have already been performed, wherein a disabled diagnostic test reader is unable to perform additional tests.    
     
     
         17 . A method of performing one or more tests employing a disposable diagnostic test reader, the method comprising: 
 performing one or more tests employing the disposable diagnostic test reader including determining with an assay if an analyte is present in a sample introduced to the assay; and    preventing use of the diagnostic test reader based on a selected threshold number of tests performed with the disposable diagnostic test reader.    
     
     
         18 . The method of  claim 17 , further comprising: 
 determining the threshold number of tests that can be performed at a desired sensitivity level.    
     
     
         19 . The method of  claim 17 , further comprising: 
 determining the number of tests performed with the disposable diagnostic test reader; and    comparing the number of tests performed to the threshold number;    wherein preventing use of the disposable diagnostic test reader occurs based on the comparison of the number of tests performed to the threshold number.    
     
     
         20 . The method of  claim 17 , wherein preventing use of the disposable diagnostic test reader includes one of deleting a test program from the disposable diagnostic test reader and electrically disabling the disposable diagnostic test reader.