Assay device and reader

Abstract

The present invention relates to a microfluidic based assay system, comprising a disposable assay cartridge and associated reading device, as well as the individual components themselves. The present invention also relates to methods of conducting assays, using the cartridge and device of the invention, as well as kits for conducting assays.

1 . An assay system for conducting an assay on a fluid sample, the assay system comprising:
 a) a microfluidic cartridge comprising one or more microfluidic channels disposed therein and comprising a binding agent disposed within said channel(s) for binding any of said analyte within the sample;
 a sample port for introducing said fluid sample into the cartridge; 
 at least one input port for allowing one or more fluids to be introduced to the cartridge from an associated reader device and transported through the microfluidic channel(s); and 
 a fluid outlet sink for removing fluid from said channel(s); and 
   b) a reader device, the reader device comprising:    i) a receiving port for introducing the cartridge into the reader;    ii) a reservoir for storing a fluid;    iii) means for delivering the fluid to the fluid input port of the cartridge once inserted within the reader, so that fluid can transported through the microfluidic channel(s) of the cartridge and;    iv) detection means for enabling detection of the analyte or a reaction product formed as a result of the analyte binding the binding agent within the cartridge.   
     
     
         2 . The assay system according to  claim 1  wherein the reader device comprises one or more sealing means which are adapted to co-locate with each of said input ports of the cartridge in order to form a fluid-tight seal with the cartridge once correctly inserted into the reader. 
     
     
         3 . The assay system according to  claim 1 , wherein the reader comprises one or more pumps for delivering the fluid into and throughout the cartridge. 
     
     
         4 . The assay system according to  claim 3  wherein the pump is able to drive the fluid in either direction such that the fluid once delivered to the cartridge may be moved in a reciprocal motion within the cartridge. 
     
     
         5 . The assay device according to  claim 1 , wherein the reader comprises a fluid management system which is capable of controlling fluid delivery to the cartridge. 
     
     
         6 . The assay system according to  claim 5 , wherein the fluid management system is capable of delivering fluid to each of said at least one input ports of the cartridge, independently of the other input ports. 
     
     
         7 . The assay system according to  claim 1 , which is capable of conducting a plurality of assays on a single sample. 
     
     
         8 . The assay system according to  claim 7  wherein the plurality of assays are the same and/or different assays. 
     
     
         9 . The assay system according to  claim 1 , wherein the reader comprises a magnet or means for generating a magnetic field and the binding agent within the cartridge comprises magnetic properties, such that upon application of the magnetic field or moving the magnet of the reader into close proximity with the binding agent with the cartridge, the binding agent is held in place by the magnetic field or magnet. 
     
     
         10 . The assay system according to  claim 9 , wherein the magnet or magnetic field can be controlled, such that the magnetic force applied to the binding agent can be varied, as desired, during the assay. 
     
     
         11 . The assay system according to  claim 9 , wherein the binding agent is in the form of magnetic or paramagnetic particles which comprise a binding moiety on their surface, designed to specifically bind a desired analyte. 
     
     
         12 . The assay system according to  claim 11 , wherein the binding moiety is an antibody, protein, peptide or oligonucleotide. 
     
     
         13 . The assay system according to  claim 1 , wherein the detection means is a fluorescent measurement. 
     
     
         14 . The assay system according to  claim 1 , wherein the wash fluid (fluid introduced into test cartridge from reader) is air. 
     
     
         15 . The assay system according to  claim 13 , wherein the fluorescent measurement is carried out in air. 
     
     
         16 . A microfluidic assay cartridge for use in the assay system according to  claim 1 , the cartridge comprising:
 a substrate comprising one or more microfluidic channels disposed therein and comprising a binding agent disposed within said channel(s) for binding any of said analyte within the sample;   a sample port for introducing said fluid sample into the cartridge;   a fluid outlet sink for removing fluid from said channel(s); and   
       at least one fluid input port for allowing one or more fluids to be introduced to the cartridge from the associated reader device and transported through the microfluidic channel(s). 
     
     
         17 . The microfluidic assay cartridge according to  claim 16  further comprising a detection area where any bound analyte may be detected, wherein the detection area is preferably immediately downstream of the sample port, and within the test sample channel. 
     
     
         18 . The microfluidic assay cartridge according to  claim 16 , wherein the cartridge and the channels and other features disposed therein, are formed by a sandwich of three separate substrates—a top, middle and bottom substrate. 
     
     
         19 . The microfluidic assay cartridge according to  claim 18 , wherein the top and bottom substrates is no thicker than 200 μm, and preferably 50 μm. 
     
     
         20 . The microfluidic assay cartridge according to  claim 16 , wherein the cartridge comprises top and bottom surfaces and at least one wall disposed between said top and bottom faces. 
     
     
         21 - 44 . (canceled)