Assay device

Abstract

An assay device and method are provided which allow the determination of the presence or absence of at least one analyte in a test sample, while providing specific identification of the test subject. The assay device includes a reaction medium having at least one reaction zone and at least one control zone, which is capable of providing a pattern suitable for identifying the test subject. The pattern suitable for identifying the test subject is preferably a fingerprint. In a preferred embodiment of the invention, the reaction zone and the control zone include at least one member of a ligand/receptor pair.

What is claimed:  
     
         1 . A method for detecting an analyte in a test sample provided by a test subject having an identifying body part surface comprising: 
 (a) providing a self-contained assay device wherein said test sample medium is in a first position in spaced relationship to said reaction medium and said signal producing agent is in a first position in spaced relationship to said reaction medium;    (b) contacting said test sample with said test sample medium, wherein at least a portion of said test sample is transferred to said test sample medium;    (c) moving said test sample medium to a second position in test sample-transferring contact with said reaction medium, wherein at least a portion of said test sample is transferred from said test sample medium to said reaction medium;    (d) moving said test sample medium to a first position in spaced relationship to said reaction medium;    (e) moving said signal-producing medium to a second position in signal producing agent-transferring contact with said reaction zone, wherein at least a portion of said signal producing agent is transferred to said reaction medium; and    (f) detecting said analyte;    said method further comprising    (g) contacting said signal-producing agent with said identifying body part surface of said test subject wherein at least a portion of said signal-producing agent is transferred to said identifying body part surface;    (h) placing said identifying body part surface in signal-producing agent-transferring contact with said identifying control zone wherein at least a portion of said signal-producing agent is transferred to said identifying control zone such that an identifying imprint of said identifying body part surface is created on said identifying control zone.    
     
     
         2 . The method according to  claim 1 , further comprising the step of treating said test sample medium with dilute detergent after step (c).  
     
     
         3 . A method for detecting an analyte in a test sample provided by a test subject having an identifying body part surface comprising: 
 (a) providing a self-contained assay device;    (b) contacting said test sample with said identifying body part surface of said test subject, wherein at least a portion of said test sample is transferred to said identifying body part surface;    (c) placing said identifying body part surface in test sample-transferring contact with said reaction medium, wherein at least a portion of said test sample is transferred from said identifying body part surface to said reaction medium;    (d) removing said identifying body part surface to position in spaced relationship to said reaction medium;    (e) moving said signal-producing medium to a second position in signal producing agent-transferring contact with said reaction zone, wherein at least a portion of said signal producing agent is transferred to said reaction medium; and    (f) detecting said analyte;    said method optionally further comprising    (g) contacting said signal-producing agent with said identifying body part surface of said test subject wherein at least a portion of said signal-producing agent is transferred to said identifying body part surface;    (h) placing said identifying body part surface in signal-producing agent-transferring contact with said identifying control zone wherein at least a portion of said signal-producing agent is transferred to said identifying control zone such that an identifying imprint of said identifying body part surface is created on said identifying control zone.    
     
     
         4 . The method according to  claim 3 , further comprising the step of treating said test sample medium with dilute detergent after step (d).