Assay cartridges and methods of using the same

Abstract

Assay cartridges are described that have a detection chamber, preferably having integrated electrodes, and other fluidic components which may include sample chambers, waste chambers, conduits, vents, bubble traps, reagent chambers, thy reagent pill zones and the like. In certain embodiments, these cartridges are adapted to receive and analyze a sample collected on an applicator stick. Also described are kits including such cartridges and a cartridge reader configured to analyze an assay conducted using an assay cartridge.

1 - 17 . (canceled) 
     
     
         18 . An assay cartridge for analyzing a sample collected with an applicator stick comprising a shaft and a sample collection head, the assay cartridge comprising:
 a sample chamber having an elongated cavity that has a first region and a second region, wherein:   the first region and the second region are oriented at an angle with respect to each other,   the angle is selected to bend the shaft upon insertion of the applicator stick into the sample chamber and promote fracture of the shaft, and   the sample chamber comprises a sample head retention feature.   
     
     
         19 . The assay cartridge of  claim 18  wherein said retention feature is selected from the group consisting of a barb, a shelf, and combinations thereof. 
     
     
         20 . The assay cartridge of  claim 18  wherein said retention feature is a barb and said barb is angled to allow for insertion of said shaft into said sample chamber and to prevent removal of said collection head from said sample chamber. 
     
     
         21 . The assay cartridge of  claim 20  wherein said sample chamber includes a sample collection head extraction location at or near the terminus of said cavity and said barb is positioned in said cavity so as to retain said collection head in said extraction location. 
     
     
         22 . The assay cartridge of  claim 19  wherein said retention feature is a shelf, wherein said shelf is a stepped discontinuity in an internal surface of said sample chamber. 
     
     
         23 . The assay cartridge of  claim 22  wherein said sample chamber is curved and the radius of curvature of said internal surface, as a function of increasing depth in said elongated cavity, steps from a first value to a second higher value at said discontinuity. 
     
     
         24 . The assay cartridge of  claim 19  wherein said sample chamber includes a sample collection head extraction location at or near the terminus of said cavity and said shelf is positioned in said cavity so as to engage a shaft fragment linked to said collection head after said shaft fracture and to retain said collection head in said extraction location. 
     
     
         25 . The assay cartridge of  claim 19  wherein said second region comprises an integrated filter element, and said assay cartridge further comprises an extraction buffer chamber connected to an extraction buffer vent port and an extraction buffer conduit connected to said sample chamber, wherein said sample chamber is connected to a collection chamber via a sample chamber conduit. 
     
     
         26 . The assay cartridge of  claim 25  wherein said extraction buffer conduit comprises a Z-transition. 
     
     
         27 . The assay cartridge of  claim 25  wherein said sample chamber comprises a sample introduction port and said first region is proximate to said sample introduction port and said second region is distal to said sample introduction port. 
     
     
         28 . The assay cartridge of  claim 27  wherein said sample chamber has an internal terminus and said integrated filter element is positioned at or near said terminus. 
     
     
         29 . The assay cartridge of  claim 25  wherein said extraction buffer conduit is positioned at or near said terminus. 
     
     
         30 . The assay cartridge of  claim 19  wherein said collection component comprises a collection chamber and a sensing chamber, wherein said collection chamber is connected to
 (i) an input conduit connected to the top of said collection chamber, wherein said input conduit is positioned proximal to a wall of said collection chamber; 
 (ii) an output conduit connected to the bottom of said collection chamber; and 
 (iii) a sensing conduit comprising a tube that extends down from the top of said collection chamber to a pre-defined height in said collection chamber, wherein said sensing chamber connects to said sensing conduit at the top of said sensing chamber and proximal to a wall of said sensing chamber and to a sensing chamber vent 
 
     
     
         31 . The assay cartridge of  claim 30  wherein said collection component further comprises a baffle positioned at the top of said collection chamber and adjacent to said input conduit. 
     
     
         32 . The assay cartridge of  claim 30  wherein said collection component further comprises an optical sensor adapted to detect the presence of liquid in said sensing chamber. 
     
     
         33 . The assay cartridge of  claim 18  further comprising a first detection chamber and a second detection chamber. 
     
     
         34 . The assay cartridge of  claim 33  wherein said first detection chamber is configured for detection and typing of influenza virus. 
     
     
         35 . The assay cartridge of  claim 34  wherein said first detection chamber comprises a first set of assay reagents including an antibody directed to a target selected from the group consisting of influenza A nucleoprotein, influenza B nucleoprotein, and combinations thereof. 
     
     
         36 . The assay cartridge of  claim 35  wherein said first set of assay reagents further comprise an antibody directed to an additional target selected from the group consisting of influenza C, adenovirus, parainfluenza, human metapneumovirus, and combinations thereof. 
     
     
         37 . (canceled) 
     
     
         38 . (canceled) 
     
     
         39 . The assay cartridge of  claim 34  wherein
 (i) said first detection chamber comprises a first plurality of working electrodes having said first set of assay reagents immobilized thereon, said first plurality of working electrodes being arranged in a first one-dimensional array within said first detection chamber; and 
 (ii) said second detection chamber comprises a second plurality of working electrodes having said second set of assay reagents immobilized thereon, said second plurality of working electrodes being arranged in a second one-dimensional array within said second detection chamber. 
 
     
     
         40 - 120 . (canceled)