Swab-Based Diagnostic Systems

Abstract

A diagnostic test system for detecting the presence or absence of an analyte within a test sample is provided. For instance, the system may include a swab and a detection unit. The detection unit includes a first component that is capable of receiving the swab, the first component defining an insertion chamber within which a fluid is capable of being retained. The detection unit also includes a second component that defines a detection chamber within which an assay for detecting the presence or absence of the analyte is capable of being contained. The first component is rotatable relative to the second component from an inactive position to an active position. In the inactive position, the fluid remains substantially contained within the insertion chamber. In the active position, the fluid may flow from the insertion chamber to the detection chamber and contact the assay.

1 - 20 . (canceled) 
     
     
         21 . A method for detecting the presence or absence of an analyte within a test sample, said method comprising:
 i) providing a diagnostic test system, said system comprising a swab and a detection unit, said detection unit comprising:
 a) a first component that is capable of receiving said swab, said first component defining an insertion chamber within which a fluid is retained; and 
 b) a second component that defines a detection chamber within which an assay for detecting the presence or absence of the analyte is contained; 
   ii) contacting said swab with the test sample;   iii) inserting said swab into said insertion chamber of said first component so that said swab contacts said fluid; and   iv) rotating said first component relative to said second component so that said fluid flows from said insertion chamber to said detection chamber and contacts said assay.   
     
     
         22 . A method as defined in  claim 21 , wherein said first component defines a sample port through which said swab is inserted. 
     
     
         23 . A method as defined in  claim 22 , wherein said detection unit further comprises a hydraulic seal that forms a sealing fit between said sample port and said swab. 
     
     
         24 . A method as defined in  claim 21 , wherein a flexible packet is contained within said insertion chamber that retains said fluid, said swab rupturing said flexible packet when inserted into said insertion chamber. 
     
     
         25 . A method as defined in  claim 21 , further comprising determining the intensity of a detection signal generated at a detection zone of said assay, wherein the amount of the analyte within the test sample is determined from said detection signal. 
     
     
         26 . A method as defined in  claim 25 , further comprising calibrating said detection signal with a calibration signal generated at a calibration zone of said assay, wherein the amount of the analyte within the test sample is determined from said detection signal as calibrated by said calibration signal.