On site machine readable IF assaying system

Abstract

A machine readable assaying system comprising a test card having machine readable assaying means. A plurality of individual analysis strips, each strip comprising antibodies and/or reagents capable of indicating the positive presence of distinct illicit substances form a pattern of elements including one or more fixed strips and one or more blank regions. The detection of the presence of a particular substance or drug will result in one or more of the analysis strips changing from a first (light reflective) color to a second darker (light absorbent) color. The pattern of analysis strips, fixed strips and blank regions may be provided to encode one or more characters/digits of information. By the inclusion of the analysis strips with the plurality of fixed strips and blank regions, the detection of one or more illicit substances may alter the overall pattern of fixed and test strips and blank regions, and hence cause the encoded information represented thereby to be altered. Accordingly, the particular pattern of bars and spaces that result from an exposure the physiological fluids of a donor is contemplated to produce a distinct machine readable indicia. The transformation which occurs on the test card will be uninterpretable by the administrator of the test, thus preserving the anonymity and privacy of the tested individual.

What is claimed is:  
     
       1. An on-site machine readable assaying system for detecting the absence of prescribed substances in human physiological fluids such as urine, said fluids emanating from a donor individual, comprising: 
       a) a test card; and  
       b) machine readable assaying means comprising at least one individual analysis strip imprinted upon the test card, each analysis strip consisting of reagents which are capable of analyzing, detecting and visually signaling the presence of proscribed substances within human physiological fluid, at least one fixed strip and at least one blank region also located upon the test card, organized in a pattern with the individual analysis strips to produce an encoded machine readable source of data, wherein the analysis strips, upon detecting a proscribed substance, will change from a first color to a second darker color, hence altering the initial pattern of fixed strips, blank regions and analysis strips, thus producing encoded data which is distinct from that data which was previously encoded therein.  
     
     
       2. The on-site machine readable assaying system of  claim 1 , wherein adulteration detection means which are capable of determining whether a particular specimen of physiological fluid such as urine has been tampered with are located upon the test card. 
     
     
       3. The on-site machine readable assaying system of  claim 2 , further comprising quality control indication means which are configured to generate a signal upon contact with physiological fluid, regardless of the presence of proscribed substances, to ensure that the analysis strips of the machine readable assaying means are functioning properly. 
     
     
       4. The on-site machine readable assaying system of  claim 3 , wherein the adulteration detection means and quality control indication means are configured within the pattern of analysis strips, fixed strips and blank regions which comprise the machine readable source of data. 
     
     
       5. The on-site machine readable assaying system of  claim 4 , wherein a machine readable pattern encoding test card production information is located upon the test card. 
     
     
       6. The on-site machine readable assaying system of  claim 5 , further comprising alignment aids located upon the test card for assisting in the alignment of the test card for reading by an appropriate device. 
     
     
       7. The on-site machine readable assaying system of  claim 1 , further comprising 
       a) a test card reading unit for scanning and decoding the encoded machine readable data source on the test card;  
       b) a controller module comprising a processor and a memory unit, the processor capable of processing and the memory unit of storing the decoded machine readable source of data gathered by the test card reading unit; and  
       c) a communication module and a communication link, the communication module capable of transmitting the decoded data processed by the processor and stored in the memory unit to a distinct location such as a central laboratory via the communication link.  
     
     
       8. The on-site machine readable assaying system of  claim 2 , further comprising 
       a) a test card reading unit for scanning and decoding the encoded machine readable data source on the test card;  
       b) a controller module comprising a processor and a memory unit, the processor capable of processing and the memory unit of storing the decoded machine readable source of data gathered by the test card reading unit; and  
       c) a communication module and a communication link, the communication module capable of transmitting the decoded data processed by the processor and stored in the memory unit to a distinct location such as a central laboratory via the communication link.  
     
     
       9. The on-site machine readable assaying system of  claim 7 , further comprising a user interface module, the user interface module having a keyboard for allowing an individual to input certain data which is transmitted by the communication module along with the decoded and processed information gathered by the test card reading unit. 
     
     
       10. The on-site machine readable assaying system of  claim 8 , further comprising a user interface module, the user interface module having a keyboard for allowing an individual to input certain data which is transmitted by the communication module along with the decoded and processed information gathered by the test card reading unit. 
     
     
       11. A method of utilizing the on-site machine readable assaying system of  claim 7 , comprising the steps of: 
       a) bringing the volume of physiological fluid which has emanated from the donor into contact with the machine readable assaying means located upon the test card;  
       b) allowing a fixed period of time to elapse; and  
       c) placing the test card reading apparatus adjacent to the test card, in order to scan and decode the encoded machine readable data source contained thereon.  
     
     
       12. The method of  claim 11 , further comprising the step of: 
       a) transmitting the decoded data to a distinct location, by means of the communication link.  
     
     
       13. A machine readable system comprising: 
       a) a test surface having machine readable bar-code indicia imprinted thereupon; and  
       b) analysis means configured within said machine readable bar-code indicia, capable of detecting and optically signaling the presence of a desired state, wherein the analysis means, upon detecting said state, cause the configuration of the machine readable bar-code indicia to change from a first configuration to a second configuration, thus producing encoded data in the second configuration which is distinct from that data which was previously encoded in the first configuration.  
     
     
       14. An assaying system for detecting the presence or absence of a proscribed substance in a human physiological fluid, said fluid emanating from a donor individual, said system comprising: 
       
         a test surface adapted to be contacted with said sample and having at least one machine readable indicium thereon, said indicium having an initial state and being capable of changing to an altered state in response to contact with said fluid; and  
       
       
         an adulteration detector capable of detecting whether said fluid has been tampered with, said detector located proximal to said indicium.  
       
     
     
       15. The system of  claim 14 , said surface, indicium and detector supported on a test card.  
     
     
       16. The system of  claim 14 , further comprising quality control indication means configured to generate a signal upon contact with said physiological fluid, regardless of the presence or absence of said proscribed substance, to ensure that said indicium is functioning properly.  
     
     
       17. The system of  claim 14 , said indicium comprising reagents capable of analyzing, detecting and visually signaling the presence or absence of said proscribed substance within said fluid.  
     
     
       18. The system of  claim 14 , there being a plurality of machine readable indicia on said test surface.  
     
     
       19. The system of  claim 18 , said indicia being individual analysis strips, there being at least one fixed strip and at least one blank region on the test surface, said fixed strip, said individual analysis strips, and said blank region organized in a pattern with the individual analysis strips to produce an encoded machine readable source of data, wherein the analysis strips, upon detecting said proscribed substance, will change from a first color to a second darker color, hence altering the initial pattern of fixed strips, blank regions and analysis strips, thus producing encoded data which is distinct from that data which was previously encoded therein.  
     
     
       20. The system of  claim 14 , said indicium being uninterpretable by a test administrator.  
     
     
       21. A method of carrying out a plurality of tests at test locations, each test to detect the presence or absence of at least one proscribed substance in a respective human physiological fluid sample emanating from a donor individual, said method comprising the steps of: 
         providing at the test locations  (   1   )  a test surface adapted to be contacted with a respective fluid sample and having at least one machine readable indicium thereon, said indicium having an initial state and being capable of changing to an altered state in response to contact with the respective sample, said test surface having an adulteration detector capable of determining whether said fluid has been tampered with and  (   2   )  a test card scanning unit capable of scanning the machine readable indicium on said surface;    
       
         contacting a test surface with a respective fluid sample;  
       
       
         after said contacting step, using a scanning unit to scan said at least one indicium, and generating test result data as a result of said scan; and  
       
       
         transmitting said result data using a communications link to a distinct location.  
       
     
     
       22. The method of  claim 21  including the step of analyzing the result data from each of said test locations at said distinct location.  
     
     
       23. The method of  claim 21 , wherein said test surface comprises quality control indication means configured to generate a signal upon contact with said physiological fluid, regardless of the presence or absence of said proscribed substance, to ensure that said indicium is functioning properly.  
     
     
       24. The method of  claim 21 , said indicium comprising reagents capable of analyzing, detecting and visually signaling the presence or absence of said proscribed substance within said fluid.  
     
     
       25. The method of  claim 21 , there being a plurality of machine readable indicia on each of said test surfaces.  
     
     
       26. The method of  claim 25 , said indicia being individual analysis strips, there being at least one fixed strip and at least one blank region on each test surface, said fixed strip, said individual analysis strips, and said blank region organized in a pattern with the individual analysis strips to produce an encoded machine readable source of data, wherein the analysis strips, upon detecting said proscribed substance, will change from a first color to a second darker color, hence altering the initial pattern of fixed strips, blank regions and analysis strips, thus producing encoded data which is distinct from that data which was previously encoded therein.  
     
     
       27. The method of  claim 21 , said indicium being machine readable only and not human interpretable in the absence of said machine reading so that others viewing said indicium after said contact with said sample are unable to directly interpret the results of the individual's test without said machine reading.  
     
     
       28. An on- site machine readable assaying system for detecting the presence or absence of proscribed substances in human physiological fluids such as urine, said fluids emanating from a donor individual, comprising:    
         a )  a test card; and    
         b )  machine readable assaying means comprising at least one individual analysis strip imprinted upon the test card, each analysis strip comprising reagents which are capable of analyzing, detecting and visually signaling the presence or absence of proscribed substances within human physiological fluid, at least one fixed strip and at least one blank region also located upon the test card, organized in a pattern with the individual analysis strips to produce an encoded machine readable source of data, wherein the analysis strips, upon detecting a proscribed substance or absence thereof, will change from a first light color to a second darker color, or visa - versa, hence altering the initial pattern of fixed strips, blank regions and analysis strips, thus producing encoded data which is distinct from that data which was previously encoded therein.    
     
     
       29. A method of carrying out a plurality of tests at test locations, each test to detect the presence or absence of at least one proscribed substance in a respective human physiological fluid sample emanating from a donor individual, said method comprising the steps of: 
         providing at the test locations  (   1   )  a test surface adapted to be contacted with a respective fluid sample and having a plurality of machine readable indicium thereon, said indicium having an initial state and being capable of changing to an altered state in response to contact with the respective sample, and (     2   )  a test card scanning unit capable of scanning the machine readable indicium on said surface,    
       
         said indicia being individual analysis strips, there being at least one fixed strip and at least one blank region on each test surface, said fixed strip, said individual analysis strips, and said blank region organized in a pattern with the individual analysis strips to produce an encoded machine readable source of data, wherein the analysis strips, upon detecting said proscribed substance, will change from a first color to a second darker color, hence altering the initial pattern of fixed strips, blank regions and analysis strips, thus producing encoded data which is distinct from that data which was previously encoded therein;  
       
       
         contacting a test surface with a respective fluid sample;  
       
       
         after said contacting step, using a scanning unit to scan said at least one indicium, and generating test result data as a result of said scan; and  
       
       
         transmitting said result data using a communications link to a distinct location.  
       
     
     
       30. A method of carrying out a plurality of tests at test locations, each test to detect the presence or absence of at least one proscribed substance in a respective human physiological fluid sample emanating from a donor individual, said method comprising the steps of: 
         providing at the test locations  (   1   )  a test surface adapted to be contacted with a respective fluid sample and having at least one machine readable indicium thereon, said indicium having an initial state and being capable of changing to an altered state in response to contact with the respective sample, and  (   2   )  a test card scanning unit capable of scanning the machine readable indicium on said surface;    
       
         contacting a test surface with a respective fluid sample;  
       
       
         after said contacting step, using a scanning unit to scan said at least one indicium, and generating test result data as a result of said scan; and  
       
       
         transmitting said result data using a communications link to a distinct location,  
       
       
         said indicium being machine readable only and not human interpretable in the absence of said machine reading so that others viewing said indicium after said contact with said sample are unable to directly interpret the results of the individual's test without said machine reading.